[Title 21 CFR J]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION,]
[Subchapter J - RADIOLOGICAL HEALTH]
[From the U.S. Government Publishing Office]
21
FOOD AND DRUGS
8
1996-04-01
1996-04-01
false
RADIOLOGICAL HEALTH
J
SUBCHAPTER J
FOOD AND DRUGS
FOOD AND DRUG ADMINISTRATION,
SUBCHAPTER J--RADIOLOGICAL HEALTH
PART 1000--GENERAL--Table of Contents
Subpart A--General Provisions
Sec.
1000.1 General.
1000.3 Definitions.
Subpart B--Statements of Policy and Interpretation
1000.15 Examples of electronic products subject to the Radiation
Control for Health and Safety Act of 1968.
Subpart C--Radiation Protection Recommendations
1000.50 Recommendation for the use of specific area gonad shielding on
patients during medical diagnostic x-ray procedures.
1000.55 Recommendation for quality assurance programs in diagnostic
radiology facilities.
1000.60 Recommendation on administratively required dental x-ray
examinations.
Authority: Secs. 530-542 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360hh-360ss).
Source: 38 FR 28624, Oct. 15, 1973, unless otherwise noted.
Subpart A--General Provisions
Sec. 1000.1 General.
References in this Subchapter J to regulatory sections of the Code
of Federal Regulations are to Chapter I of Title 21 unless otherwise
noted.
[50 FR 33688, Aug. 20, 1985]
Sec. 1000.3 Definitions.
As used in this Subchapter J:
(a) Accidental radiation occurrence means a single event or series
of events that has/have resulted in injurious or potentially injurious
exposure of any person to electronic product radiation as a result of
the manufacturing, testing, or use of an electronic product.
(b) Act means the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360hh-360ss).
(c) Chassis family means a group of one or more models with all of
the following common characteristics:
(1) The same circuitry in the high voltage, horizontal oscillator,
and power supply sections;
(2) The same worst component failures;
(3) The same type of high voltage hold-down or safety circuits; and
(4) The same design and installation.
(d) Commerce means:
(1) Commerce between any place in any State and any place outside
thereof, and
(2) Commerce wholly within the District of Columbia.
(e) Component, for the purposes of this part, means an essential
functional part of a subassembly or of an assembled electronic product,
and which may affect the quantity, quality, direction, or radiation
emission of the finished product.
(f) Dealer means a person engaged in the business of offering
electronic products for sale to purchasers, without regard to whether
such person is or has been primarily engaged in such business, and
includes persons who offer such products for lease or as prizes or
awards.
(g) Director means the Director of the Center for Devices and
Radioloical Health.
(h) Distributor means a person engaged in the business of offering
electronic products for sale to dealers, without regard to whether such
person is or has been primarily or customarily engaged in such business.
(i) Electromagnetic radiation includes the entire electromagnetic
spectrum of radiation of any wavelength. The electromagnetic spectrum
illustrated in Figure 1 includes, but is not limited to, gamma rays, x-
rays, ultra-violet, visible, infrared, microwave, radiowave, and low
frequency radiation.
[[Page 483]]
[GRAPHIC] [TIFF OMITTED] TR01FE93.029
(j) Electronic product means:
(1) Any manufactured or assembled product which, when in operation:
(i) Contains or acts as part of an electronic circuit and
(ii) Emits (or in the absence of effective shielding or other
controls would emit) electronic product radiation, or -
(2) Any manufactured or assembled article that is intended for use
as a component, part, or accessory of a product described in paragraph
(j)(1) of this section and which, when in operation, emits (or in the
absence of effective shielding or other controls would emit) such
radiation.
(k) Electronic product radiation means:
(1) Any ionizing or nonionizing electromagnetic or particulate
radiation, or
(2) Any sonic, infrasonic, or ultrasonic wave that is emitted from
an electronic product as the result of the operation of an electronic
circuit in such product.
(l) Federal standard means a performance standard issued pursuant to
section 534 of the Federal Food, Drug, and Cosmetic Act.
(m) Infrasonic, sonic (or audible) and ultrasonic waves refer to
energy transmitted as an alteration (pressure, particle displacement or
density) in a property of an elastic medium (gas, liquid or solid) that
can be detected by an instrument or listener.
(n) Manufacturer means any person engaged in the business of
manufacturing, assembling, or importing electronic products.
(o) Model means any identifiable, unique electronic product design,
and refers to products having the same structural and electrical design
characteristics and to which the manufacturer has assigned a specific
designation to differentiate between it and other products produced by
that manufacturer.
(p) Model family means products having similar design and radiation
characteristics but different manufacturer model numbers.
[[Page 484]]
(q) Modified model means a product that is redesigned so that actual
or potential radiation emission, the manner of compliance with a
standard, or the manner of radiation safety testing is affected.
(r) Particulate radiation is defined as:
(1) Charged particles, such as protons, electrons, alpha particles,
or heavy particles, which have sufficient kinetic energy to produce
ionization or atomic or electron excitation by collision, electrical
attractions or electrical repulsion; or
(2) Uncharged particles, such as neutrons, which can initiate a
nuclear transformation or liberate charged particles having sufficient
kinetic energy to produce ionization or atomic or electron excitation.
(s) Phototherapy product means any ultraviolet lamp, or product
containing such lamp, that is intended for irradiation of any part of
the living human body by light in the wavelength range of 200 to 400
nanometers, in order to perform a therapeutic function.
(t) Purchaser means the first person who, for value, or as an award
or prize, acquires an electronic product for purposes other than resale,
and includes a person who leases an electronic product for purposes
other than subleasing.
(u) State means a State, the District of Columbia, the Commonwealth
of Puerto Rico, the Virgin Islands, Guam, and American Samoa.
[60 FR 48380, Sept. 19, 1995; 61 FR 13422, Mar. 27, 1996]
Subpart B--Statements of Policy and Interpretation
Sec. 1000.15 Examples of electronic products subject to the Radiation Control for Health and Safety Act of 1968.
The following listed electronic products are intended to serve as
illustrative examples of sources of electronic product radiation to
which the regulations of this part apply.
(a) Examples of electronic products which may emit x-rays and other
ionizing electromagnetic radiation, electrons, neutrons, and other
particulate radiation include:
Ionizing electromagnetic radiation:
Television receivers.
Accelerators.
X-ray machines (industrial, medical, research, educational).
Particulate radiation and ionizing electromagnetic radiation:
Electron microscopes.
Neutron generators.
(b) Examples of electronic products which may emit ultraviolet,
visible, infrared, microwaves, radio and low frequency electromagnetic
radiation include:
Ultraviolet:
Biochemical and medical analyzers.
Tanning and therapeutic lamps.
Sanitizing and sterilizing devices.
Black light sources.
Welding equipment.
Visible:
White light devices.
Infrared:
Alarm systems.
Diathermy units.
Dryers, ovens, and heaters.
Microwave:
Alarm systems.
Diathermy units.
Dryers, ovens, and heaters.
Medico-biological heaters.
Microwave power generating devices.
Radar devices.
Remote control devices.
Signal generators.
Radio and low frequency:
Cauterizers.
Diathermy units.
Power generation and transmission equipment.
Signal generators.
Electromedical equipment.
(c) Examples of electronic products which may emit coherent
electromagnetic radiation produced by stimulated emission include:
Laser:
Art-form, experimental and educational devices.
Biomedical analyzers.
Cauterizing, burning and welding devices.
Cutting and drilling devices.
Communications transmitters.
Rangefinding devices.
Maser:
Communications transmitters.
(d) Examples of electronic products which may emit infrasonic,
sonic, and ultrasonic vibrations resulting from operation of an
electronic circuit include:
Infrasonic:
[[Page 485]]
Vibrators.
Sonic:
Electronic oscillators.
Sound amplification equipment.
Ultrasonic:
Cauterizers.
Cell and tissue disintegrators.
Cleaners.
Diagnostic and nondestructive testing equipment.
Ranging and detection equipment.
Subpart C--Radiation Protection Recommendations
Sec. 1000.50 Recommendation for the use of specific area gonad shielding on patients during medical diagnostic x-ray procedures.
Specific area gonad shielding covers an area slightly larger than
the region of the gonads. It may therefore be used without interfering
with the objectives of the examination to protect the germinal tissue of
patients from radiation exposure that may cause genetic mutations during
many medical x-ray procedures in which the gonads lie within or are in
close proximity to the x-ray field. Such shielding should be provided
when the following conditions exist:
(a) The gonads will lie within the primary x-ray field, or within
close proximity (about 5 centimeters), despite proper beam limitation.
Except as provided in paragraph (b) or (c) of this section:
(1) Specific area testicular shielding should always be used during
those examinations in which the testes usually are in the primary x-ray
field, such as examinations of the pelvis, hip, and upper femur;
(2) Specific area testicular shielding may also be warranted during
other examinations of the abdominal region in which the testes may lie
within or in close proximity to the primary x-ray field, depending upon
the size of the patient and the examination techniques and equipment
employed. Some examples of these are: Abdominal, lumbar spine and
lumbosacral spine examinations, intravenous pyelograms, and abdominal
scout film for barium enemas and upper GI series. Each x-ray facility
should evaluate its procedures, techniques, and equipment and compile a
list of such examinations for which specific area testicular shielding
should be routinely considered for use. As a basis for judgment,
specific area testicular shielding should be considered for all
examinations of male patients in which the pubic symphysis will be
visualized on the film;
(3) Specific area gonad shielding should never be used as a
substitute for careful patient positioning, the use of correct technique
factors and film processing, or proper beam limitation (confinement of
the x-ray field to the area of diagnostic interest), because this could
result in unnecessary doses to other sensitive tissues and could
adversely affect the quality of the radiograph; and
(4) Specific area gonad shielding should provide attenuation of x-
rays at least equivalent to that afforded by 0.25 millimeter of lead.
(b) The clinical objectives of the examination will not be
compromised.
(1) Specific area testicular shielding usually does not obscure
needed information except in a few cases such as oblique views of the
hip, retrograde urethrograms and voiding cystourethrograms,
visualization of the rectum and, occasionally, the pubic symphysis.
Consequently, specific area testicular shielding should be considered
for use in the majority of x-ray examinations of male patients in which
the testes will lie within the primary beam or within 5 centimeters of
its edge. It is not always possible to position shields on male patients
so that no bone is obscured. Therefore, if all bone structure of the
pelvic area must be visualized for a particular patient, the use of
shielding should be carefully evaluated. The decision concerning the
applicability of shielding for an individual patient is dependent upon
consideration of the patient's unique anthropometric characteristics and
the diagnostic information needs of the examination.
(2) The use of specific area ovarian shielding is frequently
impractical at present because the exact location of the ovaries is
difficult to estimate, and the shield may obscure visualization of
portions of adjacent structures such as the spine, ureters, and small
and large bowels. However, it may be possible for practitioners to use
specific area ovar-
[[Page 486]]
ian shielding during selected views in some examinations.
(c) The patient has a reasonable reproductive potential.
(1) Specific area shielding need not be used on patients who cannot
or are not likely to have children in the future.
(2) The following table of statistical data regarding the average
number of children expected by potential parents in various age
categories during their remaining lifetimes is provided for x-ray
facilities that wish to use it as a basis for judging reproductive
potential:
Expected Number of Future Children Versus Age of Potential Parent\1\
------------------------------------------------------------------------
Male Female
Age parent parent
------------------------------------------------------------------------
Fetus............................................... 2.6 2.6
0 to 4.............................................. 2.6 2.5
5 to 9.............................................. 2.7 2.5
10 to 14............................................ 2.7 2.6
15 to 19............................................ 2.7 2.6
20 to 24............................................ 2.6 2.2
25 to 29............................................ 2.0 1.4
30 to 34............................................ 1.1 .6
35 to 39............................................ .5 .2
40 to 44............................................ .2 .04
45 to 49............................................ .07 0
50 to 54............................................ .03 0
55 to 64............................................ .01 0
Over 65............................................. 0 0
------------------------------------------------------------------------
\1\Derived from data published by the National Center for Health
Statistics, ``Final Natality Statistics 1970,'' HRA 74-1120, vol. 22,
No. 12, Mar. 20, 1974.
[41 FR 30328, July 23, 1976; 41 FR 31812, July 30, 1976]
Sec. 1000.55 Recommendation for quality assurance programs in diagnostic radiology facilities.
(a) Applicability. Quality assurance programs as described in
paragraph (c) of this section are recommended for all diagnostic
radiology facilities.
(b) Definitions. As used in this section, the following definitions
apply:
(1) Diagnostic radiology facility means any facility in which an x-
ray system(s) is used in any procedure that involves irradiation of any
part of the human body for the purpose of diagnosis or visualization.
Offices of individual physicians, dentists, podiatrists, and
chiropractors, as well as mobile laboratories, clinics, and hospitals
are all examples of diagnostic radiology facilities.
(2) Quality assurance means the planned and systematic actions that
provide adequate confidence that a diagnostic x-ray facility will
produce consistently high quality images with minimum exposure of the
patients and healing arts personnel. The determination of what
constitutes high quality will be made by the facility producing the
images. Quality assurance actions include both ``quality control''
techniques and ``quality administration'' procedures.
(3) Quality assurance program means an organized entity designed to
provide ``quality assurance'' for a diagnostic radiology facility. The
nature and extent of this program will vary with the size and type of
the facility, the type of examinations conducted, and other factors.
(4) Quality control techniques are those techniques used in the
monitoring (or testing) and maintenance of the components of an x-ray
system. The quality control techniques thus are concerned directly with
the equipment.
(5) Quality administration procedures are those management actions
intended to guarantee that monitoring techniques are properly performed
and evaluated and that necessary corrective measures are taken in
response to monitoring results. These procedures provide the
organizational framework for the quality assurance program.
(6) X-ray system means an assemblage of components for the
controlled production of diagnostic images with x-rays. It includes
minimally an x-ray high voltage generator, an x-ray control, a tube-
housing assembly, a beam-limiting device, and the necessary supporting
structures. Other components that function with the system, such as
image receptors, image processors, view boxes, and darkrooms, are also
parts of the system.
(c) Elements. A quality assurance program should contain the
elements listed in paragraphs (c)(1) through (10) of this section. The
extent to which each element of the quality assurance program is
implemented should be determined by an analysis of the facility's
objectives and resources conducted by its qualified staff or by
qualified outside consultants. The extent of implementation should be
determined on the basis of whether the expected benefits in radiation
exposure reduction, im-
[[Page 487]]
proved image quality, and/or financial savings will compensate for the
resources required for the program.
(1) Responsibility. (i) Responsibility and authority for the overall
quality assurance program as well as for monitoring, evaluation, and
corrective measures should be specified and recorded in a quality
assurance manual.
(ii) The owner or practitioner in charge of the facility has primary
responsibility for implementing and maintaining the quality assurance
program.
(iii) Staff technologists will generally be delegated a basic
quality assurance role by the practitioner in charge. Responsibility for
specific quality control monitoring and maintenance techniques or
quality administration procedures may be assigned, provided that the
staff technologists are qualified by training or experience for these
duties. The staff technologists should also be responsible for
identifying problems or potential problems requiring actions beyond the
level of their training. They should bring these problems to the
attention of the practitioner in charge, or his or her representative,
so that assistance in solving the problems may be obtained from inside
or outside the facility.
(iv) In facilities where they are available, physicists, supervisory
technologists, or quality control technologists should have a major role
in the quality assurance program. Such specialized personnel may be
assigned responsibility for day-to-day administration of the program,
may carry out monitoring duties beyond the level of training of the
staff technologist or, if desired by the facility, may relieve the staff
technologists of some or all of their basic monitoring duties. Staff
service engineers may also be assigned responsibility for certain
preventive or corrective maintenance actions.
(v) Responsibility for certain quality control techniques and
corrective measures may be assigned to personnel qualified by training
or experience, such as consultants or industrial representatives, from
outside of the facility, provided there is a written agreement clearly
specifying these services.
(vi) In large facilities, responsibility for long-range planning of
quality assurance goals and activities should be assigned to a quality
assurance committee as described in paragraph (c)(9) of this section.
(2) Purchase specifications. Before purchasing new equipment, the
staff of the diagnostic radiology facility should determine the desired
performance specifications for the equipment. Initially, these
specifications may be stated in terms of the desired performance of the
equipment, or prospective vendors may be informed solely of the
functions the equipment should be able to perform and asked to provide
the performance specifications of items from their equipment line that
can perform these functions. In either case, the responses of the
prospective vendors should serve as the basis for negotiations to
establish the final purchase specifications, taking into account the
state of the art and balancing the need for the specified performance
levels with the cost of the equipment to meet them. The final purchase
specifications should be in writing and should include performance
specifications. The availability of experienced service personnel should
also be taken into consideration in making the final purchase decisions.
Any understandings with respect to service personnel should be
incorporated into the purchase specifications. After the equipment is
installed, the facility should conduct a testing program, as defined in
its purchase specifications, to ensure that the equipment meets the
agreed upon specifications, including applicable Federal and State
regulatory requirements. The equipment should not be formally accepted
until any necessary corrections have been made by the vendor. The
purchase specifications and the records of the acceptance testing should
be retained throughout the life of the equipment for comparison with
monitoring results in order to assess continued acceptability of
performance.
(3) Monitoring and maintenance. A routine quality control monitoring
and maintenance system incorporating state-of-the-art procedures should
be established and conducted on a regular schedule. The purpose of
monitoring is to permit evaluation of the performance of the facility's
x-ray system(s) in
[[Page 488]]
terms of the standards for image quality established by the facility (as
described in paragraph (c)(4) of this section) and compliance with
applicable Federal and State regulatory requirements. The maintenance
program should include corrective maintenance to eliminate problems
revealed by monitoring or other means before they have a serious
deleterious impact on patient care. To the extent permitted by the
training of the facility staff, the maintenance program should also
include preventive maintenance, which could prevent unexpected
breakdowns of equipment and disruption of departmental routine.
(i) The parameters to be monitored in a facility should be
determined by that facility on the basis of an analysis of expected
benefits and cost. Such factors as the size and resources of the
facility, the type of examinations conducted, and the quality assurance
problems that have occurred in that or similar facilities should be
taken into account in establishing the monitoring system. The monitoring
frequency should also be based upon need and can be different for
different parameters.
(ii) Although the parameters to be monitored will vary somewhat from
facility to facility, every diagnostic radiology facility should
consider monitoring the following five key components of the x-ray
system:
(a) Film processing.
(b) Basic performance characteristics of the x-ray unit.
(c) Cassettes and grids.
(d) View boxes.
(e) Darkroom.
(iii) Examples of parameters of the above-named components and of
more specialized equipment that may be monitored are as follows:
(a) For film processing:
An index of speed.
An index of contrast.
Base plus fog.
Solution temperatures.
Film artifact identification.
(b) For basic performance characteristics of the x-ray unit:
(1) For fluoroscopic x-ray units:
Table-top exposure rates.
Centering alignment.
Collimation.
kVp accuracy and reproducibility.
mA accuracy and reproducibility.
Exposure time accuracy and reproducibility.
Reproducibility of x-ray output.
Focal spot size consistency.
Half-value layer.
Representative entrance skin exposures.
(2) For image-intensified systems:
Resolution.
Focusing.
Distortion.
Glare.
Low contrast performance.
Physical alignment of camera and collimating lens.
(3) For radiographic x-ray units:
Reproducibility of x-ray output.
Linearity and reproducibility of mA stations.
Reproducibility and accuracy of timer stations.
Reproducibility and accuracy of kVp stations.
Accuracy of source-to-film distance indicators.
Light/x-ray field congruence.
Half-value layer.
Focal spot size consistency.
Representative entrance skin exposures.
(4) For automatic exposure control devices:
Reproducibility.
kVp compensation.
Field sensitivity matching.
Minimum response time.
Backup timer verification.
(c) For cassettes and grids:
(1) For cassettes:
Film/screen contact.
Screen condition.
Light leaks.
Artifact identification.
(2) For grids:
Alignment and focal distance.
Artifact identification.
(d) For view boxes:
Consistency of light output with time.
Consistency of light output from one box to another.
View box surface conditions.
(e) For darkrooms:
Darkroom integrity.
Safe light conditions.
(f) For specialized equipment:
(1) For tomographic systems:
Accuracy of depth and cut indicator.
[[Page 489]]
Thickness of cut plane.
Exposure angle.
Completeness of tomographic motion.
Flatness of tomographic field.
Resolution.
Continuity of exposure.
Flatness of cassette.
Representative entrance skin exposures.
(2) For computerized tomography:
Precision (noise).
Contrast scale.
High and low contrast resolution.
Alignment.
Representative entrance skin exposures.
(iv) The maintenance program should include both preventive and
corrective aspects.
(a) Preventive maintenance. Preventive maintenance should be
performed on a regularly scheduled basis with the goal of preventing
breakdowns due to equipment failing without warning signs detectable by
monitoring. Such actions have been found cost effective if
responsibility is assigned to facility staff members. Possible
preventive maintenance procedures are visual inspection of the
mechanical and electrical characteristics of the x-ray system (covering
such things as checking conditions of cables, watching the tomographic
unit for smoothness of motion, assuring cleanliness with respect to
spilling of contaminants in the examination room or the darkroom, and
listening for unusual noises in the moving parts of the system),
following the manufacturer's recommended procedures for cleaning and
maintenance of the equipment, and regular inspection and replacement of
switches and parts that routinely wear out or fail. The procedures
included would depend upon the background of the staff members
available. Obviously, a large facility with its own service engineers
can do more than an individual practitioner's office.
(b) Corrective maintenance. For maximum effectiveness, the quality
assurance program should make provision, as described in paragraph
(c)(5) of this section, for ascertaining whether potential problems are
developing. If potential or actual problems are detected, corrective
maintenance should be carried out to eliminate them before they cause a
major impact on patient care.
(4) Standards for image quality. Standards of acceptable image
quality should be established. Ideally, these should be objective, e.g.,
acceptability limits for the variations of parameter values, but they
may be subjective, e.g., the opinions of professional personnel, in
cases where adequate objective standards cannot be defined. These
standards should be routinely reviewed and redefined as needed, as
described in paragraph (c)(10) of this section.
(5) Evaluation. The facility's quality assurance program should
include means for two levels of evaluation.
(i) On the first level, the results of the monitoring procedures
should be used to evaluate the performance of the x-ray system(s) to
determine whether corrective actions are needed to adjust the equipment
so that the image quality consistently meets the standards for image
quality. This evaluation should include analysis of trends in the
monitoring data as well as the use of the data to determine the need for
corrective actions on a day-by-day basis. Comparison of monitoring data
with the purchase specifications and acceptance testing results for the
equipment in question is also useful.
(ii) On the second level, the facility quality assurance program
should also include means for evaluating the effectiveness of the
program itself. Possible means include ongoing studies of the retake
rate and the causes of the repeated radiographs, examination of
equipment repair and replacement costs, subjective evaluation of the
radiographs being produced, occurrence and reasons for complaints by
radiologists, and analysis of trends in the results of monitoring
procedures such as sensitometric studies. Of these, ongoing studies of
the retake rate (reject rate) and its causes are often the most useful
and may also provide information of value in the first level of
evaluation. Such studies can be used to evaluate potential for
improvement, to make corrections, and to determine whether the
corrective actions were effective. The number of rejects should be
recorded daily or weekly, depending on the facility's analysis of its
needs. Ideally, the reasons for the rejection should also be determined
and recorded. Should determining these rea-
[[Page 490]]
sons be impossible on a regular basis with the available staff, the
analysis should be done for a 2-week period after major changes have
occurred in diagnostic procedures or the x-ray system and at least semi-
annually.
(6) Records. The program should include provisions for the keeping
of records on the results of the monitoring techniques, any difficulties
detected, the corrective measures applied to these difficulties, and the
effectiveness of these measures. The extent and form of these records
should be determined by the facility on the basis of its needs. The
facility should view these records as a tool for maintaining an
effective quality assurance program and not view the data in them as an
end in itself but rather as a beginning. For example, the records should
be made available to vendors to help them provide better service. More
importantly, the data should be the basis for the evaluation and the
reviews suggested in paragraphs (c)(5) and (10) of this section.
(7) Manual. A quality assurance manual should be written in a format
permitting convenient revision as needed and should be made readily
available to all personnel. The content of the manual should be
determined by the facility staff, but the following items are suggested
as providing essential information:
(i) A list of the individuals responsible for monitoring and
maintenance techniques.
(ii) A list of the parameters to be monitored and the frequency of
monitoring.
(iii) A description of the standards, criteria of quality, or limits
of acceptability that have been established for each of the parameters
monitored.
(iv) A brief description of the procedures to be used for monitoring
each parameter.
(v) A description of procedures to be followed when difficulties are
detected to call these difficulties to the attention of those
responsible for correcting them.
(vi) A list of the publications in which detailed instructions for
monitoring and maintenance procedures can be found. Copies of these
publications should also be readily available to the entire staff, but
they should be separate from the manual. (Publications providing these
instructions can usually be obtained from FDA or private sources,
although the facility may wish to make some modifications to meet its
needs more effectively.)
(vii) A list of the records, with sample forms, that the facility
staff has decided should be kept. The facility staff should also
determine and note in the manual the length of time each type of record
should be kept before discarding.
(viii) A copy of each set of purchase specifications developed for
new equipment and the results of the acceptance testing for that
equipment.
(8) Training. The program should include provisions for appropriate
training for all personnel with quality assurance responsibilities. This
should include both training provided before the quality assurance
responsibilities are assumed and continuing education to keep the
personnel up-to-date. Practical experience with the techniques conducted
under the supervision of experienced instructors, either in the facility
or in a special program, is the most desirable type of training. The use
of self-teaching materials can be an adequate substitute for supervised
instruction, especially in continuing education programs, if supervised
instruction is not available.
(9) Committee. A facility whose size would make it impractical for
all staff members to meet for planning purposes should consider the
establishment of a quality assurance committee whose primary function
would be to maintain lines of communication among all groups with
quality assurance and/or image production or interpretation
responsibilities. For maximum communication, all departments of the
facility with x-ray equipment should be represented. The committee may
also be assigned policy-making duties such as some or all of the
following:
Assign quality assurance responsibilities; maintain acceptable standards
of quality; periodically review program effectiveness, etc.
Alternatively, the duties of this committee could be assigned to an
already-existing committee such as the Radiation Safety Committee. In
smaller facilities, all staff
[[Page 491]]
members should participate in the committee's tasks. The Quality
Assurance Committee should report directly to the head of the radiology
department, or, in facilities where more than one department operates x-
ray equipment, to the chief medical officer of the facility. The
committee should meet on a regular basis.
(10) Review. The facility's quality assurance program should be
reviewed by the Quality Assurance Committee and/or the practitioner in
charge to determine whether its effectiveness could be improved. Items
suggested for inclusion in the review include:
(i) The reports of the monitoring and maintenance techniques to
ensure that they are being performed on schedule and effectively. These
reports should be reviewed at least quarterly.
(ii) The monitoring and maintenance techniques and their schedules
to ensure that they continue to be appropriate and in step with the
latest developments in quality assurance. They should be made current at
least annually.
(iii) The standards for image quality to ensure that they are
consistent with the state-of-the-art and the needs and resources of the
facility. These standards should be evaluated at least annually.
(iv) The results of the evaluations of the effectiveness of the
quality assurance actions to determine whether changes need to be made.
This determination should be made at least annually.
(v) The quality assurance manual should also be reviewed at least
annually to determine whether revision is needed.
[44 FR 71737, Dec. 11, 1979]
Sec. 1000.60 Recommendation on administratively required dental x-ray examinations.
(a) The Food and Drug Administration recommends that dental x-ray
examinations be performed only after careful consideration of the dental
or other health needs of the patient, that is, when the patient's
dentist or physician judges them to be necessary for diagnosis,
treatment, or prevention of disease. Administratively required dental x-
ray examinations are those required by a remote third party for reasons
not related to the patient's immediate dental needs. These x-ray
examinations are usually a source of unnecessary radiation exposure to
the patient. Because any unnecessary radiation exposure should be
avoided, third parties should not require dental x-ray examinations
unless they can demonstrate that such examinations provide a direct
clinical benefit to the patient, and the patient's dentist or physician
agrees with that assessment.
(b) Some examples of administrative x-ray examinations that should
not be required by third parties are those intended solely:
(1) To monitor insurance claims or detect fraud;
(2) To satisfy a prerequisite for reimbursement;
(3) To provide training or experience;
(4) To certify qualifications or competence.
(c) This recommendation is not intended to preclude dental x-ray
examinations ordered by the attending practitioner, based on the
patient's history or physical examination, or those performed on
selected populations shown to have significant yields of previously
undiagnosed disease. This recommendation is also not intended to
preclude the administrative use by third parties of dental radiographs
that are taken on the order of the patient's dentist or physician as a
necessary part of the patient's clinical care.
[45 FR 40978, June 17, 1980]
PART 1002--RECORDS AND REPORTS--Table of Contents
Subpart A--General Provisions
Sec.
1002.1 Applicability.
1002.2 [Reserved]
1002.3 Notification to user of performance and technical data.
1002.4 Confidentiality of information.
1002.7 Submission of data and reports.
Subpart B--Required Manufacturers' Reports for Listed Electronic
Products
1002.10 Product reports.
1002.11 Supplemental reports.
1002.12 Abbreviated reports.
1002.13 Annual reports.
[[Page 492]]
Subpart C--Manufacturers' Reports on Accidental Radiation Occurrences
1002.20 Reporting of accidental radiation occurrences.
Subpart D--Manufacturers' Records
1002.30 Records to be maintained by manufacturers.
1002.31 Preservation and inspection of records.
Subpart E--Dealer and Distributor Records
1002.40 Records to be obtained by dealers and distributors.
1002.41 Disposition of records obtained by dealers and distributors.
1002.42 Confidentiality of records furnished by dealers and
distributors.
Subpart F--Exemptions From Records and Reports Requirements
1002.50 Special exemptions.
1002.51 Exemptions for manufacturers of products intended for the U.S.
Government.
Authority: Secs. 502, 510, 519, 520, 531-542, 701, 704 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352, 360, 360i, 360j,
360hh-360ss, 371, 374).
Source: 38 FR 28625, Oct. 15, 1973, unless otherwise noted.
Subpart A--General Provisions
Sec. 1002.1 Applicability.
The provisions of this part are applicable as follows:
(a) All manufacturers of electronic products are subject to
Sec. 1002.20.
(b) Manufacturers, dealers, and distributors of electronic products
are subject to the provisions of part 1002 as set forth in Table 1 of
this section, unless excluded by paragraph (c) of this section, or
unless an exemption has been granted under Sec. 1002.50 or Sec. 1002.51.
(c) The requirements of part 1002 as specified in Table 1 of this
section are not applicable to:
(1) Manufacturers of electronic products intended solely for export
if such product is labeled or tagged to show that the product meets all
the applicable requirements of the country to which such product is
intended for export.
(2) Manufacturers of electronic products listed in Table 1of this
section if such product is sold exclusively to other manufacturers for
use as components of electronic products to be sold to purchasers, with
the exception that the provisions are applicable to those manufacturers
certifying components of diagnostic x-ray systems pursuant to provisions
of Sec. 1020.30(c) of this chapter.
(3) Manufacturers of electronic products that are intended for use
by the U.S. Government and whose function or design cannot be divulged
by the manufacturer for reasons of national security, as evidenced by
government security classification.
(4) Assemblers of diagnostic x-ray equipment subject to the
provisions of Sec. 1020.30(d) of this chapter, provided the assembler
has submitted the report required by Sec. 1020.30(d)(1) or (d)(2) of
this chapter and retains a copy of such report for a period of 5 years
from its date.
[[Page 493]]
Table 1.--Record and Reporting Requirements By Product
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturer Dealer &
----------------------------------------------------------------------------------------------------------------------------------------- Distributor
---------------
Product Supplemental Abbreviated Distribution Distribution
Products reports Sec. reports Sec. reports Sec. Annual reports Test records Sec. records Sec. records
1002.10 1002.11 1002.12 Sec. 1002.13 1002.30(a)1 1002.30(b)2 1002.40 and
1002.41
--------------------------------------------------------------------------------------------------------------------------------------------------------
DIAGNOSTIC X-RAY3 (1020.30, ............... ............... ............... ............... .................. .................. ..............
1020.31, 1020.32, 1020.33)
Computed tomography X X ............... X X X X
X-ray system4 X X ............... X X X X
Tube housing assembly X X ............... X X X ..............
X-ray control X X ............... X X X X
X-ray high voltage generator X X ............... X X X X
X-ray table or cradle ............... ............... X ............... X X X
X-ray film changer ............... ............... X ............... X X ..............
Vertical cassette holders ............... ............... X ............... X X X
mounted in a fixed location
and cassette holders with
front panels
Beam-limiting devices X X ............... X X X X
Spot-film devices and image X X ............... X X X X
intensifiers manufactured
after April 26, 1977
Cephalometric devices ............... ............... X ............... X X ..............
manufactured after February
25, 1978
Image receptor support ............... ............... X ............... X X X
devices for mammographic X-
ray systems manufactured
after September 5, 1978
CABINET X RAY (Sec. ............... ............... ............... ............... .................. .................. ..............
1020.40)
Baggage inspection X X ............... X X X X
Other X X ............... X X X ..............
PRODUCTS INTENDED TO PRODUCE ............... ............... ............... ............... .................. .................. ..............
PARTICULATE RADIATION OR X-
RAYS OTHER THAN DIAGNOSTIC
OR CABINET DIAGNOSTIC X-RAY
Medical ............... ............... X X X X ..............
Analytical ............... ............... X X X X ..............
Industrial ............... ............... X X X X ..............
TELEVISION PRODUCTS (Sec. ............... ............... ............... ............... .................. .................. ..............
1020.10)
<25 kilovolt (kV) and <0.1 ............... ............... X X6 .................. .................. ..............
milliroentgen per hour (mR/
hr IRLC5,6
25kV and <0.1mR/hr IRLC5 X X ............... X .................. .................. ..............
0.1mR/hr IRLC5 X X ............... X X X ..............
MICROWAVE/RF ............... ............... ............... ............... .................. .................. ..............
MW ovens (Sec. 1030.10) X X ............... X X X ..............
MW diathermy ............... ............... X ............... .................. .................. ..............
MW heating, drying, security ............... ............... X ............... .................. .................. ..............
systems
RF sealers, electromagnetic ............... ............... X ............... .................. .................. ..............
induction and heating
equipment, dielectric
heaters (2-500 megahertz)
OPTICAL ............... ............... ............... ............... .................. .................. ..............
Phototherapy products X X ............... ............... .................. .................. ..............
Laser products (Secs. ............... ............... ............... ............... .................. .................. ..............
1040.10, 1040.11)
Class I lasers and products X ............... ............... X X .................. ..............
containing such lasers7
Class I laser products X ............... ............... X X X ..............
containing class IIa, II,
IIIa, lasers7
[[Page 494]]
Class IIa, II, IIIa lasers X X ............... X X X X
and products other than
class I products containing
such lasers7
Class IIIb and IV lasers and X X ............... X X X X
products containing such
lasers7
Sunlamp products (Sec. ............... ............... ............... ............... .................. .................. ..............
1040.20)
Lamps only X ............... ............... ............... .................. .................. ..............
Sunlamp products X X ............... X X X X
Mercury vapor lamps (Sec. ............... ............... ............... ............... .................. .................. ..............
1040.30)
T lamps X X ............... X .................. .................. ..............
R lamps ............... ............... X ............... .................. .................. ..............
ACOUSTIC ............... ............... ............... ............... .................. .................. ..............
Ultrasonic therapy (1050.10) X X ............... X X X X
Diagnostic ultrasound ............... ............... X ............... .................. .................. ..............
Medical ultrasound other X X ............... ............... .................. .................. ..............
than therapy or diagnostic
Nonmedical ultrasound ............... ............... X ............... .................. .................. ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\However, authority to inspect all appropriate documents supporting the adequacy of a manufacturer's compliance testing program is retained.
\2\The requirement includes Secs. 1002.31 and 1002.42, if applicable.
\3\Report of Assembly (Form FDA 2579) is required for diagnostic x-ray components; see 21 CFR 1020.30(d)(1) through (d)(3).
\4\Systems records and reports are required if a manufacturer exercises the option and certifies the system as permitted in 21 CFR 1020.30(c).
\5\Determined using the isoexposure rate limit curve (IRLC) under phase III test conditions (1020.10(c)(3)(iii)).
\6\Annual report is for production status information only.
\7\Determination of the applicable reporting category for a laser product shall be based on the worst-case hazard present within the laser product.
[[Page 495]]
[60 FR 48382, Sept. 19, 1995; 61 FR 13423, Mar. 27, 1996]
Sec. 1002.2 [Reserved]
Sec. 1002.3 Notification to user of performance and technical data.
As authorized by Sec. 5.90 of this chapter, the Director and Deputy
Director of the Center for Devices and Radiological Health may require a
manufacturer of a radiation emitting electronic product to provide to
the ultimate purchaser, at the time of original purchase, such
performance data and other technical data related to safety of the
product as the Director or Deputy Director finds necessary.
[60 FR 48385, Sept. 19, 1995; 61 FR 13424, Mar. 27, 1996]
Sec. 1002.4 Confidentiality of information.
The Secretary or his representative shall not disclose any
information reported to or otherwise obtained by him, pursuant to this
part, which concerns or relates to a trade secret or other matter
referred to in section 1905 of title 18 of the United States Code,
except that such information may be disclosed to other officers or
employees of the Department and of the other agencies concerned with
carrying out the requirements of the Act. Nothing in this section shall
authorize the withholding of information by the Secretary, or by any
officers or employees under his control, from the duly authorized
committees of the Congress.
Sec. 1002.7 Submision of data and reports.
All submissions such as reports, test data, product descriptions,
and other information required by this part, or voluntarily submitted to
the Director, Center for Devices and Radiological Health, shall be filed
with the number of copies as prescribed by the Director, Center for
Devices and Radiological Health, and shall be signed by the person
making the submission. The submissions required by this part shall be
addressed to the Center for Devices and Radiological Health, Electronic
Product Reports, Office of Compliance (HFZ-307), 2098 Gaither Rd.,
Rockville, MD 20850.
(a) In addition to the requirements of this part, all material
submitted to the Director, Center for Devices and Radiological Health,
shall be submitted pursuant to the provisions of Part 20--Public
Information, of this chapter.
(b) Where guides or instructions have been issued by the Director
for the submission of material required by this part, such as test data,
product reports, abbreviated reports, supplemental reports, and annual
reports, the material submitted shall conform to the applicable
reporting guides or instructions. Where it is not feasible or where it
would not be appropriate to conform to any portion of a prescribed
reporting guide or instruction, an alternate format for providing the
information requested by that portion of the guide or instruction may be
used provided the submitter of such information submits adequate
explanation and justification for use of an alternate format. If the
Director, Center for Devices and Radiological Health, determines that
such justification is inadequate and that it is feasible or appropriate
to conform to the prescribed reporting guide or instruction, he may
require resubmission of the information in conformance with the
reporting guide or instruction.
(c) Where the submission of quality control and testing information
is common to more than one model, or model family of the same product
category, a ``common aspects report'' consolidating similar information
may be provided, if applicable.
[42 FR 18062, Apr. 5, 1977, as amended at 53 FR 11254, Apr. 6, 1988; 60
FR 48385, Sept. 19, 1995]
Subpart B--Required Manufacturers' Reports for Listed Electronic
Products
Source: 60 FR 48386, Sept. 19, 1995, unless otherwise noted.
Sec. 1002.10 Product reports.
Every manufacturer of a product or component requiring aproduct
report as set forth in Table 1 of Sec. 1002.1 shall submit a product
report to the Center for Devices and Radiological Health, Electronic
Product Reports, Office of Compliance (HFZ-307), 2098 Gaither Rd.,
Rockville, MD 20850, prior to the
[[Page 496]]
introduction of such product into commerce. The report shall be
distinctly marked ``Radiation Safety Product Report of (name of
manufacturer)'' and shall:
(a) Identify which listed product is being reported.
(b) Identify each model of the listed product together with
sufficient information concerning the manufacturer's code or other
system of labeling to enable the Director to determine the place of
manufacture.
(c) Include information on all components and accessories provided
in, on, or with the listed product that may affect the quantity,
quality, or direction of the radiation emissions.
(d) Describe the function, operational characteristics affecting
radiation emissions, and intended and known uses of each model of the
listed product.
(e) State the standard or design specifications, if any, for each
model with respect to electronic product radiation safety. Reference may
be made to a Federal standard, if applicable.
(f) For each model, describe the physical or electrical
characteristics, such as shielding or electronic circuitry, incorporated
into the product in order to meet the standards or specifications
reported pursuant to paragraph (e) of this section.
(g) Describe the methods and procedures employed, if any, in testing
and measuring each model with respect to electronic product radiation
safety, including the control of unnecessary, secondary, or leakage
electronic product radiation, the applicable quality control procedures
used for each model, and the basis for selecting such testing and
quality control procedures.
(h) For those products which may produce increased radiation with
aging, describe the methods and procedures used, and frequency of
testing of each model for durability and stability with respect to
electronic product radiation safety. Include the basis for selecting
such methods and procedures, or for determining that such testing and
quality control procedures are not necessary.
(i) Provide sufficient results of the testing, measuring, and
quality control procedures described in accordance with paragraphs (g)
and (h) of this section to enable the Director to determine the
effectiveness of those test methods and procedures.
(j) Report for each model all warning signs, labels, and
instructions for installation, operation, and use that relate to
electronic product radiation safety.
(k) Provide, upon request, such other information as the Director
may reasonably require to enable him/her to determine whether the
manufacturer has acted or is acting in compliance with the Act and any
standards prescribed thereunder, and to enable the Director to carry out
the purposes of the Act.
Sec. 1002.11 Supplemental reports.
Prior to the introduction into commerce of a new or modified model
within a model or chassis family of a product listed in Table 1 of
Sec. 1002.1 for which a report under Sec. 1002.10 is required, each
manufacturer shall submit a report with respect to such new or modified
model describing any changes in the information previously submitted in
the product report. Reports will be required for changes that:
(a) Affect actual or potential radiation emission.
(b) Affect the manner of compliance with a standard or manner of
testing for radiation safety.
Sec. 1002.12 Abbreviated reports.
Manufacturers of products requiring abbreviated reports as specified
in Table 1 of Sec. 1002.1 shall submit, prior to the introduction of
such product, a report distinctly marked ``Radiation Safety Abbreviated
Report'' which shall include:
(a) Firm and model identification.
(b) A brief description of operational characteristics that affect
radiation emissions, transmission, or leakage or that control exposure.
(c) A list of applications or uses.
(d) Radiation emission, transmission, or leakage levels.
(e) If necessary, additional information as may be requested to
determine compliance with the Act and this part.
[[Page 497]]
Sec. 1002.13 Annual reports.
(a) Every manufacturer of products requiring an annual report as
specified in Table 1 of Sec. 1002.1 shall submit an annual report
summarizing the contents of the records required to be maintained by
Sec. 1002.30(a) and providing the volume of products produced, sold, or
installed.
(b) Reports are due annually by September 1. Such reports shall
cover the 12-month period ending on June 30 preceding the due date of
the report.
(c) New models of a model family that do not involve changes in
radiation emission or requirements of a performance standard do not
require supplemental reports prior to introduction into commerce. These
model numbers should be reported in quarterly updates to the annual
report.
Subpart C--Manufacturers' Reports on Accidental Radiation Occurrences
Sec. 1002.20 Reporting of accidental radiation occurrences.
(a) Manufacturers of electronic products shall, where reasonable
grounds for suspecting that such an incident has occurred, immediately
report to the Director, Center for Devices and Radiological Health, all
accidental radiation occurrences reported to or otherwise known to the
manufacturer and arising from the manufacturing, testing, or use of any
product introduced or intended to be introduced into commerce by such
manufacturer. Reasonable grounds include, but are not necessarily
limited to, professional, scientific, or medical facts or opinions
documented or otherwise, that conclude or lead to the conclusion that
such an incident has occurred.
(b) Such reports shall be addressed to the Director, Center for
Devices and Radiological Health, 5600 Fishers Lane, Rockville, MD 20857,
and the reports and their envelopes shall be distinctly marked ``Report
on Sec. 1002.20'' and shall contain all of the following information
where known to the manufacturer:
(1) The nature of the accidental radiation occurrence;
(2) The location at which the accidental radiation occurrence
occurred;
(3) The manufacturer, type, and model number of the electronic
product or products involved;
(4) The circumstances surrounding the accidental radiation
occurrence, including causes;
(5) The number of persons involved, adversely affected, or exposed
during the accidental radiation occurrence, the nature and magnitude of
their exposure and/or injuries and, if requested by the Director, Center
for Devices and Radiological Health, the names of the persons involved;
(6) The actions, if any, which may have been taken by the
manufacturer, to control, correct, or eliminate the causes and to
prevent reoccurrence; and
(7) Any other pertinent information with respect to the accidental
radiation occurrence.
(c) If a manufacturer is required to report to the Director under
paragraph (a) of this section and also is required to report under Part
803 of this chapter, the manufacturer shall report in accordance with
Part 803. If a manufacturer is required to report to the Director under
paragraph (a) of this section and is not required to report under Part
803, the manufacturer shall report in accordance with paragraph (a) of
this section. A manufacturer need not file a separate report under this
section if an incident involving an accidental radiation occurrence is
associated with a defect or noncompliance and is reported pursuant to
Sec. 1003.10 of this chapter.
[38 FR 28625, Oct. 15, 1973, as amended at 49 FR 36351, Sept. 14, 1984;
53 FR 11254, Apr. 6, 1988; 60 FR 48386, Sept. 19, 1995]
Subpart D--Manufacturers' Records
Sec. 1002.30 Records to be maintained by manufacturers.
(a) Manufacturers of products listed under Table 1 of Sec. 1002.1
shall establish and maintain the following records with respect to such
products:
(1) Description of the quality control procedures with respect to
electronic product radiation safety.
(2) Records of the results of tests for electronic product radiation
safety, including the control of unnecessary, sec-
[[Page 498]]
ondary or leakage electronic product radiation, the methods, devices,
and procedures used in such tests, and the basis for selecting such
methods, devices, and procedures.
(3) For those products displaying aging effects which may increase
electronic product radiation emission, records of the results of tests
for durability and stability of the product, and the basis for selecting
these tests.
(4) Copies of all written communications between the manufacturer
and dealers, distributors, and purchasers concerning radiation safety
including complaints, investigations, instructions, or explanations
affecting the use, repair, adjustment, maintenance, or testing of the
listed product.
(5) Data on production and sales volume levels if available.
(b) In addition to the records required by paragraph (a) of this
section, manufacturers of products listed in paragraph (c) of
Sec. 1002.61 shall establish and maintain the following records with
respect to such products:
(1) A record of the manufacturer's distribution of products in a
form which will enable the tracing of specific products or production
lots to distributors or to dealers in those instances in which the
manufacturer distributes directly to dealers.
(2) Records received from dealers or distributors pursuant to
Sec. 1002.41.
[38 FR 28625, Oct. 15, 1973, as amended at 60 FR 48386, Sept. 19, 1995]
Sec. 1002.31 Preservation and inspection of records.
(a) Every manufacturer required to maintain records pursuant to this
part, including records received pursuant to Sec. 1002.41, shall
preserve such records for a period of 5 years from the date of the
record.
(b) Upon reasonable notice by an officer or employee duly designated
by the Department, manufacturers shall permit such officer or employee
to inspect appropriate books, records, papers, and documents as are
relevant to determining whether the manufacturer has acted or is acting
in compliance with Federal standards.
(c) Upon request of the Director, Center for Devices and
Radiological Health, a manufacturer of products listed in Table 1 of
Sec. 1002.1 shall submit to the Director, copies of the records required
to be maintained by paragraph (b) of Sec. 1002.30.
[38 FR 28625, Oct. 15, 1973, as amended at 53 FR 11254, Apr. 6, 1988; 60
FR 48386, Sept. 19, 1995]
Subpart E--Dealer and Distributor Records
Sec. 1002.40 Records to be obtained by dealers and distributors.
(a) Dealers and distributors of electronic products for which there
are performance standards and for which the retail price is $50 or more
shall obtain such information as is necessary to identify and locate
first purchasers if the product is subject to this section by virtue of
Table 1 of Sec. 1002.1.
(b) Such information shall include:
(1) The name and mailing address of the distributor, dealer, or
purchaser to whom the product was transferred.
(2) Identification and brand name of the product.
(3) Model number and serial or other identification number of the
product.
(4) Date of sale, award, or lease.
(c) The information obtained pursuant to this section shall be
forwarded immediately to the appropriate manufacturer of the electronic
product, or preserved as prescribed in Sec. 1002.41.
[38 FR 28625, Oct. 15, 1973, as amended at 42 FR 18063, Apr. 5, 1977; 60
FR 48386, Sept. 19, 1995]
Sec. 1002.41 Disposition of records obtained by dealers and distributors.
(a) Information obtained by dealers and distributors pursuant to
Sec. 1002.40 shall immediately be forwarded to the appropriate
manufacturer unless:
(1) The dealer or distributor elects to hold and preserve such
information and to immediately furnish it to the manufacturer when
advised by the manufacturer or the Director, Center for Devices and
Radiological Health, that such information is required for purposes of
section 359 of the Act; and
(2) The dealer or distributor, upon making the election under
paragraph (a)(1) of this section, promptly notifies the manufacturer of
such election; such notification shall be in writing and shall identify
the dealer or dis-
[[Page 499]]
tributor and the electronic product or products for which the
information is being accumulated and preserved.
(b) Every dealer or distributor who elects to hold and preserve
information required pursuant to Sec. 1002.40 shall preserve the
information for a period of 5 years from the date of the sale, award, or
lease of the product, or until the dealer or distributor discontinues
dealing in, or distributing the product, whichever is sooner. If the
dealer or distributor discontinues dealing in, or distributing the
product, such information as obtained pursuant to Sec. 1002.40 shall be
furnished at that time, or before, to the manufacturer of the product.
[38 FR 28625, Oct. 15, 1973, as amended at 42 FR 18063, Apr. 5, 1977; 53
FR 11254, Apr. 6, 1988]
Sec. 1002.42 Confidentiality of records furnished by dealers and distributors.
All information furnished to manufacturers by dealers and
distributors pursuant to this part shall be treated by such
manufacturers as confidential information which may be used only as
necessary to notify persons pursuant to section 359 of the Act.
Subpart F--Exemptions from Records and Reports Requirements
Sec. 1002.50 Special exemptions.
(a) Manufacturers of electronic products may submit to the Director
a request, together with accompanying justification, for exemption from
any requirements listed in Table 1 of Sec. 1002.1. The request must
specify each requirement from which an exemption is requested. In
addition to other information that is required, the justification must
contain documented evidence showing that the product or product type for
which the exemption is requested does not pose a public health risk and
meets at least one of the following criteria:
(1) The products cannot emit electronic product radiation in
sufficient intensity or of such quality, under any conditions of
operation, maintenance, service, or product failure, to be hazardous;
(2) The products are produced in small quantities;
(3) The products are used by trained individuals and are to be used
by the same manufacturing corporation or for research, investigation, or
training.
(4) The products are custom designed and used by trained individuals
knowledgeable of the hazards; or
(5) The products are produced in such a way that the requirements
are inappropriate or unnecessary.
(b) The Director may, subject to any conditions that the Director
deems necessary to protect the public health, exempt manufacturers from
all or part of the record and reporting requirements of this part on the
basis of information submitted in accordance with paragraph (a) of this
section or such other information which the Director may possess if the
Director determines that such exemption is in keeping with the purposes
of the Act.
(c) The Director will provide written notification of the reason for
any denial. If the exemption is granted, the Director will provide
written notification of:
(1) The electronic product or products for which the exemption has
been granted;
(2) The requirements from which the product is exempted; and
(3) Such conditions as are deemed necessary to protect the public
health and safety. Copies of exemptions shall be available upon request
from the Office of Compliance (HFZ-307), Center for Devices and
Radiological Health, 2098 Gaither Rd., Rockville, MD 20850.
(d) The Director may, on the Director's own motion, exempt certain
classes of products from the reporting requirements listed in Table 1 of
Sec. 1002.1, provided that the Director finds that such exemption is in
keeping with the purposes of the act.
(e) Manufacturers of products for which there is no applicable
performance standard under parts 1020 through 1050 of this chapter and
for which an investigational device exemption has been approved under
Sec. 812.30 of this chapter or for which a premarket approval
application has been approved in accordance with Sec. 814.44(d) of this
chap-
[[Page 500]]
ter are exempt from submitting all reports listed in Table 1 of
Sec. 1002.1.
[60 FR 48387, Sept. 19, 1995]
Sec. 1002.51 Exemptions for manufacturers of products intended for the U.S. Government.
Upon application therefor by the manufacturer, the Director, Center
for Devices and Radiological Health, may exempt from the provisions of
this part a manufacturer of any electronic product intended for use by
departments or agencies of the United States provided such department or
agency has prescribed procurement specifications governing emissions of
electronic product radiation and provided further that such product is
of a type used solely or predominantly by departments or agencies of the
United States.
[38 FR 28625, Oct. 15, 1973, as amended at 53 FR 11254, Apr. 6, 1988]
PART 1003--NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY--Table of Contents
Subpart A--General Provisions
Sec.
1003.1 Applicability.
1003.2 Defect in an electronic product.
1003.5 Effect of regulations on other laws.
Subpart B--Discovery of Defect or Failure to Comply
1003.10 Discovery of defect or failure of compliance by manufacturer;
notice requirements.
1003.11 Determination by Secretary that product fails to comply or has
a defect.
Subpart C--Notification
1003.20 Notification by the manufacturer to the Secretary.
1003.21 Notification by the manufacturer to affected persons.
1003.22 Copies of communications sent to purchasers, dealers, or
distributors.
Subpart D--Exemptions from Notification Requirements
1003.30 Application for exemption from notification requirements.
1003.31 Granting the exemption.
Authority: Secs. 354-360F of the Public Health Service Act (42
U.S.C. 263b-263n).
Source: 38 FR 28628, Oct. 15, 1973, unless otherwise noted.
Subpart A--General Provisions
Sec. 1003.1 Applicability.
The provisions of this part are applicable to electronic products
which were manufactured after October 18, 1968.
Sec. 1003.2 Defect in an electronic product.
For the purpose of this part, an electronic product shall be
considered to have a defect which relates to the safety of use by reason
of the emission of electronic product radiation if:
(a) It is a product which does not utilize the emission of
electronic product radiation in order to accomplish its purpose, and
from which such emissions are unintended, and as a result of its design,
production or assembly;
(1) It emits electronic product radiation which creates a risk of
injury, including genetic injury, to any person, or
(2) It fails to conform to its design specifications relating to
electronic radiation emissions; or
(b) It is a product which utilizes electronic product radiation to
accomplish its primary purpose and from which such emissions are
intended, and as a result of its design, production or assembly it;
(1) Fails to conform to its design specifications relating to the
emission of electronic product radiation; or
(2) Without regard to the design specifications of the product,
emits electronic product radiation unnecessary to the accomplishment of
its primary purpose which creates a risk of injury, including genetic
injury to any person; or
(3) Fails to accomplish the intended purpose.
Sec. 1003.5 Effect of regulations on other laws.
The remedies provided for in this subchapter shall be in addition to
and not in substitution for any other remedies provided by law and shall
not relieve any person from liability at common law or under statutory
law.
[[Page 501]]
Subpart B--Discovery of Defect or Failure to Comply
Sec. 1003.10 Discovery of defect or failure of compliance by manufacturer; notice requirements.
Any manufacturer who discovers that any electronic product produced,
assembled, or imported by him, which product has left its place of
manufacture, has a defect or fails to comply with an applicable Federal
standard shall:
(a) Immediately notify the Secretary in accordance with
Sec. 1003.20, and
(b) Except as authorized by Sec. 1003.30, furnish notification with
reasonable promptness to the following persons:
(1) The dealers or distributors to whom such product was delivered
by the manufacturer; and
(2) The purchaser of such product and any subsequent transferee of
such product (where known to the manufacturer or where the manufacturer
upon reasonable inquiry to dealers, distributors, or purchasers can
identify the present user).
(c) If a manufacturer is required to notify the Secretary under
paragraph (a) of this section and also is required to report to the Food
and Drug Administration under Part 803 of this chapter, the manufacturer
shall report in accordance with Part 803. If a manufacturer is required
to notify the Secretary under paragraph (a) of this section and is not
required to report to the Food and Drug Administration under Part 803,
the manufacturer shall notify the Secretary in accordance with paragraph
(a) of this section.
[38 FR 28628, Oct. 15, 1973 and 49 FR 36351, Sept. 14, 1984]
Sec. 1003.11 Determination by Secretary that product fails to comply or has a defect.
(a) If, the Secretary, through testing, inspection, research, or
examination of reports or other data, determines that any electronic
product does not comply with an applicable Federal standard issued
pursuant to the Act or has a defect, he shall immediately notify the
manufacturer of the product in writing specifying:
(1) The defect in the product or the manner in which the product
fails to comply with the applicable Federal standard;
(2) The Secretary's findings, with references to the tests,
inspections, studies, or reports upon which such findings are based;
(3) A reasonable period of time during which the manufacturer may
present his views and evidence to establish that there is no failure of
compliance or that the alleged defect does not exist or does not relate
to safety of use of the product by reason of the emission of electronic
product radiation.
The manufacturer shall have an opportunity for a regulatory hearing
before the Food and Drug Administration pursuant to Part 16 of this
chapter.
(b) Every manufacturer who receives a notice under paragraph (a) of
this section shall immediately advise the Secretary in writing of the
total number of such product units produced and the approximate number
of such product units which have left the place of manufacture.
(c) If, after the expiration of the period of time specified in the
notice, the Secretary determines that the product has a defect or does
not comply with an applicable Federal standard and the manufacturer has
not applied for an exemption, he shall direct the manufacturer to
furnish the notification to the persons specified in Sec. 1003.10(b) in
the manner specified in Sec. 1003.21. The manufacturer shall within 14
days from the date of receipt of such directive furnish the required
notification.
[38 FR 28628, Oct. 15, 1973, as amended at 41 FR 48269, Nov. 2, 1976; 42
FR 15676, Mar. 22, 1977]
Subpart C--Notification
Sec. 1003.20 Notification by the manufacturer to the Secretary.
The notification to the Secretary required by Sec. 1003.10(a) shall
be confirmed in writing and, in addition to other relevant information
which the Secretary may require, shall include the following:
(a) Identification of the product or products involved;
(b) The total number of such product units so produced, and the
approximate
[[Page 502]]
number of such product units which have left the place of manufacture;
(c) The expected usage for the product if known to the manufacturer;
(d) A description of the defect in the product or the manner in
which the product fails to comply with an applicable Federal standard;
(e) An evaluation of the hazards reasonably related to defect or the
failure to comply with the Federal standard;
(f) A statement of the measures to be taken to repair such defect or
to bring the product into compliance with the Federal standard;
(g) The date and circumstances under which the defect was
discovered; and
(h) The identification of any trade secret information which the
manufacturer desires kept confidential.
Sec. 1003.21 Notification by the manufacturer to affected persons.
(a) The notification to the persons specified in Sec. 1003.10(b)
shall be in writing and, in addition to other relevant information which
the Secretary may require, shall include:
(1) The information prescribed by Sec. 1003.20 (a), (d), and
instructions with respect to the use of the product pending the
correction of the defect;
(2) A clear evaluation in nontechnical terms of the hazards
reasonably related to any defect or failure to comply; and
(3) The following statement:
The manufacturer will, without charge, remedy the defect or bring
the product into compliance with each applicable Federal standard in
accordance with a plan to be approved by the Secretary of Health and
Human Services, the details of which will be included in a subsequent
communication to you.
Provided, That if at the time the notification is sent, the Secretary
has approved a plan for the repair, replacement or refund of the
product, the notification may include the details of the approved plan
in lieu of the above statement.
(b) The envelope containing the notice shall not contain advertising
or other extraneous material, and such mailings will be made in
accordance with this section.
(1) No. 10 white envelopes shall be used, and the name and address
of the manufacturer shall appear in the upper left corner of the
envelope.
(2) The following statement is to appear in the far left third of
the envelope in the type and size indicated and in reverse printing,
centered in a red rectangle 3\3/4\ inches wide and 2\1/4\ inches high:
Important--Electronic Product Radiation Warning
The statement shall be in three lines, all capitals, and centered.
``Important'' shall be in 36-point Gothic Bold type. ``Electronic
Product'' and ``Radiation Warning'' shall be in 36-point Gothic
Condensed type.
(3) Envelopes with markings similar to those prescribed in this
section shall not be used by manufacturers for mailings other than those
required by this part.
(c) The notification shall be sent:
(1) By certified mail to purchasers of the product and to subsequent
transferees.
(2) By certified mail or other more expeditious means to dealers and
distributors.
(d) Where products were sold under a name other than that of the
manufacturer of the product, the name of the individual or company under
whose name the product was sold may be used in the notification required
by this section.
Sec. 1003.22 Copies of communications sent to purchasers, dealers or distributors.
(a) Every manufacturer of electronic products shall furnish to the
Secretary a copy of all notices, bulletins, or other communications sent
to the dealers or distributors of such manufacturers or to purchasers
(or subsequent transferees) of electronic products of such manufacturer
regarding any defect in such product or any failure of such product to
comply with an applicable Federal standard.
(b) In the event the Secretary deems the content of such notices to
be insufficient to protect the public health and safety, the Secretary
may require additional notice to such recipients, or may elect to make
or cause to be made such notification by whatever means he deems
appropriate.
[[Page 503]]
Subpart D--Exemptions From Notification Requirements
Sec. 1003.30 Application for exemption from notification requirements.
(a) A manufacturer may at the time of giving the written
confirmation required by Sec. 1003.20 or within 15 days of the receipt
of any notice from the Secretary pursuant to Sec. 1003.11(a), apply for
an exemption from the requirement of notice to the persons specified in
Sec. 1003.10(b).
(b) The application for exemption shall contain the information
required by Sec. 1003.20 and in addition shall set forth in detail the
grounds upon which the exemption is sought.
Sec. 1003.31 Granting the exemption.
(a) If, in the judgment of the Secretary, the application filed
pursuant to Sec. 1003.30 states reasonable grounds for an exemption from
the requirement of notice, the Secretary shall give the manufacturer
written notice specifying a reasonable period of time during which he
may present his views and evidence in support of the application.
(b) Such views and evidence shall be confined to matters relevant to
whether the defect in the product or its failure to comply with an
applicable Federal standard is such as to create a significant risk of
injury, including genetic injury, to any person and shall be presented
in writing unless the Secretary determines that an oral presentation is
desirable. Where such evidence includes nonclinical laboratory studies,
the data submitted shall include, with respect to each such study,
either a statement that the study was conducted in compliance with the
requirements set forth in Part 58 of this chapter, or, if the study was
not conducted in compliance with such regulations, a brief statement of
the reason for the noncompliance. When such evidence includes clinical
investigations involving human subjects, the data submitted shall
include, with respect to each clinical investigation either a statement
that each investigation was conducted in compliance with the
requirements set forth in Part 56 of this chapter, or a statement that
the investigation is not subject to such requirements in accordance with
Sec. 56.104 or Sec. 56.105, and a statement that each investigation was
conducted in compliance with the requirements set forth in Part 50 of
this chapter.
(c) If, during the period of time afforded the manufacturer to
present his views and evidence, the manufacturer proves to the
Secretary's satisfaction that the defect or failure to comply does not
create a significant risk of injury, including genetic injury, to any
person, the Secretary shall issue an exemption from the requirement of
notification to the manufacturer and shall notify the manufacturer in
writing specifying:
(1) The electronic product or products for which the exemption has
been issued; and
(2) Such conditions as the Secretary deems necessary to protect the
public health and safety.
(d) Any person who contests denial of an exemption shall have an
opportunity for a regulatory hearing before the Food and Drug
Administration pursuant to Part 16 of this chapter.
[38 FR 28628, Oct. 15, 1973, as amended at 41 FR 48269, Nov. 2, 1976; 42
FR 15676, Mar. 22, 1977; 50 FR 7518, Feb. 22, 1985]
PART 1004--REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS--Table of Contents
Sec.
1004.1 Manufacturer's obligation to repair, replace, or refund cost of
electronic products.
1004.2 Plans for the repair of electronic products.
1004.3 Plans for the replacement of electronic products.
1004.4 Plans for refunding the cost of electronic products.
1004.6 Approval of plans.
Authority: Secs. 354-360F of the Public Health Service Act (42
U.S.C. 263b-263n).
Source: 38 FR 28629, Oct. 15, 1973, unless otherwise noted.
Sec. 1004.1 Manufacturer's obligation to repair, replace, or refund cost of electronic products.
(a) If any electronic product fails to comply with an applicable
Federal standard or has a defect and the notification specified in
Sec. 1003.10(b) of this chapter is required to be furnished, the
manufacturer of such product shall;
[[Page 504]]
(1) Without charge, bring such product into conformity with such
standard or remedy such defect and provide reimbursement for any
expenses for transportation of such product incurred in connection with
having such product brought into conformity or having such defect
remedied; or
(2) Replace such product with a like or equivalent product which
complies with each applicable Federal standard and which has no defect
relating to the safety of its use; or
(3) Make a refund of the cost of the product to the purchaser.
(b) The manufacturer shall take the action required by this section
in accordance with a plan approved by the Secretary pursuant to
Sec. 1004.6.
Sec. 1004.2 Plans for the repair of electronic products.
Every plan for bringing an electronic product into conformity with
applicable Federal standards or for remedying any defect in such product
shall be submitted to the Secretary in writing, and in addition to other
relevant information which the Secretary may require, shall include:
(a) Identification of the product involved.
(b) The approximate number of defective product units which have
left the place of manufacture.
(c) The specific modifications, alterations, changes, repairs,
corrections, or adjustments to be made to bring the product into
conformity or remedy any defect.
(d) The manner in which the operations described in paragraph (c)
will be accomplished, including the procedure for obtaining access to,
or possession of, the products and the location where such operations
will be performed.
(e) The technical data, test results or studies demonstrating the
effectiveness of the proposed remedial action.
(f) A time limit, reasonable in light of the circumstances, for
completion of the operations.
(g) The system by which the manufacturer will provide reimbursement
for any transportation expenses incurred in connection with having such
product brought into conformity or having any defect remedied.
(h) The text of the statement which the manufacturer will send to
the persons specified in Sec. 1003.10(b) of this chapter informing such
persons;
(1) That the manufacturer, at his expense, will repair the
electronic product involved,
(2) Of the method by which the manufacturer will obtain access to or
possession of the product to make such repairs,
(3) That the manufacturer will reimburse such persons for any
transportation expenses incurred in connection with making such repairs,
and
(4) Of the manner in which such reimbursement will be effected.
(i) An assurance that the manufacturer will provide the Secretary
with progress reports on the effectiveness of the plan, including the
number of electronic products repaired.
Sec. 1004.3 Plans for the replacement of electronic products.
Every plan for replacing an electronic product with a like or
equivalent product shall be submitted to the Secretary in writing, and
in addition to other relevant information which the Secretary may
require, shall include:
(a) Identification of the product to be replaced.
(b) A description of the replacement product in sufficient detail to
support the manufacturer's contention that the replacement product is
like or equivalent to the product being replaced.
(c) The approximate number of defective product units which have
left the place of manufacture.
(d) The manner in which the replacement operation will be effected
including the procedure for obtaining possession of the product to be
replaced.
(e) A time limit, reasonable, in light of the circumstances for
completion of the replacement.
(f) The steps which the manufacturer will take to insure that the
defective product will not be reintroduced into commerce, until it
complies with each applicable Federal standard and has no defect
relating to the safety of its use.
(g) The system by which the manufacturer will provide reimbursement
for any expenses for transportation of such product incurred in
connection with effecting the replacement.
[[Page 505]]
(h) The text of the statement which the manufacturer will send to
the persons specified in Sec. 1003.10(b) of this chapter informing such
persons;
(1) That the manufacturer, at its expense, will replace the
electronic product involved,
(2) Of the method by which the manufacturer will obtain possession
of the product and effect the replacement,
(3) That the manufacturer will reimburse such persons for any
transportation expenses incurred in connection with effecting such
replacement, and
(4) Of the manner in which such reimbursement will be made.
(i) An assurance that the manufacturer will provide the Secretary
with progress reports on the effectiveness of the plan, including the
number of electronic products replaced.
Sec. 1004.4 Plans for refunding the cost of electronic products.
Every plan for refunding the cost of an electronic product shall be
submitted to the Secretary in writing, and in addition to other relevant
information which the Secretary may require, shall include:
(a) Identification of the product involved.
(b) The approximate number of defective product units which have
left the place of manufacture.
(c) The manner in which the refund operation will be effected
including the procedure for obtaining possession of the product for
which the refund is to be made.
(d) The steps which the manufacturer will take to insure that the
defective products will not be reintroduced into commerce, until it
complies with each applicable Federal standard and has no defect
relating to the safety of its use.
(e) A time limit, reasonable in light of the circumstances, for
obtaining the product and making the refund.
(f) A statement that the manufacturer will refund the cost of such
product together with the information the manufacturer has used to
determine the amount of the refund.
(g) The text of the statement which the manufacturer will send to
the persons specified in Sec. 1003.10(b) of this chapter informing such
persons;
(1) That the manufacturer, at his expense, will refund the cost of
the electronic product plus any transportation costs,
(2) Of the amount to be refunded exclusive of transportation costs,
(3) Of the method by which the manufacturer will obtain possession
of the product and make the refund.
(h) An assurance that the manufacturer will provide the Secretary
with progress reports on the effectiveness of the plan, including the
number of refunds made.
Sec. 1004.6 Approval of plans.
If, after review of any plan submitted pursuant to this subchapter,
the Secretary determines that the action to be taken by the manufacturer
will expeditiously and effectively fulfill the manufacturer's obligation
under Sec. 1004.1 in a manner designed to encourage the public to
respond to the proposal, the Secretary will send written notice of his
approval of such plan to the manufacturer. Such approval may be
conditioned upon such additional terms as the Secretary deems necessary
to protect the public health and safety. Any person who contests denial
of a plan shall have an opportunity for a regulatory hearing before the
Food and Drug Administration pursuant to Part 16 of this chapter.
[38 FR 28629, Oct. 15, 1973, as amended at 41 FR 48269, Nov. 2, 1976; 42
FR 15676, Mar. 22, 1977]
PART 1005--IMPORTATION OF ELECTRONIC PRODUCTS--Table of Contents
Subpart A--General Provisions
Sec.
1005.1 Applicability.
1005.2 Definitions.
1005.3 Importation of noncomplying goods prohibited.
Subpart B--Inspection and Testing
1005.10 Notice of sampling.
1005.11 Payment for samples.
Subpart C--Bonding and Compliance Procedures
1005.20 Hearing.
1005.21 Application for permission to bring product into compliance.
[[Page 506]]
1005.22 Granting permission to bring product into compliance.
1005.23 Bonds.
1005.24 Costs of bringing product into compliance.
1005.25 Service of process on manufacturers.
Authority: Secs. 356, 360 of the Public Health Service Act (42
U.S.C. 263d, 263h).
Source: 38 FR 28630, Oct. 15, 1973, unless otherwise noted.
Subpart A--General Provisions
Sec. 1005.1 Applicability.
(a) The provisions of Secs. 1005.1 through 1005.24 are applicable to
electronic products which are subject to the standards prescribed under
this subchapter and are offered for importation into the United States.
(b) Section 1005.25 is applicable to every manufacturer of
electronic products offering an electronic product for importation into
the United States.
[38 FR 28630, Oct. 15, 1973, as amended at 45 FR 81739, Dec. 12, 1980]
Sec. 1005.2 Definitions.
As used in this part:
The term owner or consignee means the person who has the rights of a
consignee under the provisions of sections 483, 484, and 485 of the
Tariff Act of 1930, as amended (19 U.S.C. 1483, 1484, 1485).
Sec. 1005.3 Importation of noncomplying goods prohibited.
The importation of any electronic product for which standards have
been prescribed under section 358 of the Act (42 U.S.C. 263f) shall be
refused admission into the United States unless there is affixed to such
product a certification in the form of a label or tag in conformity with
section 358(h) of the Act (42 U.S.C. 263f(h)). Merchandise refused
admission shall be destroyed or exported under regulations prescribed by
the Secretary of the Treasury unless a timely and adequate petition for
permission to bring the product into compliance is filed and granted
under Secs. 1005.21 and 1005.22.
Subpart B--Inspection and Testing
Sec. 1005.10 Notice of sampling.
When a sample of a product to be offered for importation has been
requested by the Secretary, the District Director of Customs having
jurisdiction over the shipment shall, upon the arrival of the shipment,
procure the sample and shall give to its owner or consignee prompt
notice of the delivery or of the intention to deliver such sample to the
Secretary. If the notice so requires, the owner or consignee will hold
the shipment of which the sample is typical and not release such
shipment until he receives notice of the results of the tests of the
sample from the Secretary, stating that the product is in compliance
with the requirements of the Act. The District Director of Customs will
be given the results of the tests. If the Secretary notifies the
District Director of Customs that the product does not meet the
requirements of the Act, the District Director of Customs shall require
the exportation or destruction of the shipment in accordance with
customs laws.
Sec. 1005.11 Payment for samples.
The Department of Health and Human Services will pay for all import
samples of electronic products rendered unsalable as a result of
testing, or will pay the reasonable costs of repackaging such samples
for sale, if the samples are found to be in compliance with the
requirements of the Radiation Control for Health and Safety Act of 1968.
Billing for reimbursement shall be made by the owner or consignee to the
Center for Devices and Radiological Health, 5600 Fishers Lane,
Rockville, MD 20857. Payment for samples will not be made if the sample
is found to be in violation of the Act, even though subsequently brought
into compliance pursuant to terms specified in a notice of permission
issued under Sec. 1005.22.
[38 FR 28630, Oct. 15, 1973, as amended at 53 FR 11254, Apr. 6, 1988]
[[Page 507]]
Subpart C--Bonding and Compliance Procedures
Sec. 1005.20 Hearing.
(a) If, from an examination of the sample or otherwise, it appears
that the product may be subject to a refusal of admission, the Secretary
shall give the owner or consignee a written notice to that effect,
stating the reasons therefor. The notice shall specify a place and a
period of time during which the owner or consignee shall have an
opportunity to introduce testimony unless the owner or consignee
indicates his intention to bring the product into compliance. Upon
timely request, such time and place may be changed. Such testimony shall
be confined to matters relevant to the admissibility of the article and
may be introduced orally or in writing.
(b) If the owner or consignee submits or indicates his intention to
submit an application for permission to perform such action as is
necessary to bring the product into compliance with the Act, such
application shall include the information required by Sec. 1005.21.
(c) If the application is not submitted at or prior to the hearing,
the Secretary may allow a reasonable time for filing such application.
Sec. 1005.21 Application for permission to bring product into compliance.
Application for permission to perform such action as is necessary to
bring the product into compliance with the Act may be filed only by the
owner, consignee, or manufacturer and, in addition to any other
information which the Secretary may reasonably require, shall:
(a) Contain a detailed proposal for bringing the product into
compliance with the Act;
(b) Specify the time and place where such operations will be
effected and the approximate time for their completion; and
(c) Identify the bond required to be filed pursuant to Sec. 1005.23.
Sec. 1005.22 Granting permission to bring product into compliance.
(a) When permission contemplated by Sec. 1005.21 is granted, the
Secretary shall notify the applicant in writing, specifying:
(1) The procedure to be followed;
(2) The disposition of the rejected articles or portions thereof;
(3) That the operations are to be carried out under the supervision
of a representative of the Department of Health and Human Services;
(4) A reasonable time limit for completing the operations; and
(5) Such other conditions as he finds necessary to maintain adequate
supervision and control over the product.
(b) Upon receipt of a written request for an extension of time to
complete the operations necessary to bring the product into compliance,
the Secretary may grant such additional time as he deems necessary.
(c) The notice of permission may be amended upon a showing of
reasonable grounds thereof and the filing of an amended application for
permission with the Secretary.
(d) If ownership of a product included in a notice of permission
changes before the operations specified in the notice have been
completed, the original owner will remain responsible under its bond,
unless the new owner has executed a superseding bond on customs Form
7601 and obtained a new notice.
(e) The Secretary will notify the District Director of Customs
having jurisdiction over the shipment involved, of the determination as
to whether or not the product has in fact been brought into compliance
with the Act.
Sec. 1005.23 Bonds.
The bond required under section 360(b) of the Act shall be executed
by the owner or consignee on the appropriate form of a customs single-
entry bond, customs Form 7551 or term bond, customs Form 7553 or 7595,
containing a condition for the redelivery of the shipment or any part
thereof not complying with the laws and regulations governing its
admission into the commerce of the United States upon demand of the
District Director of Customs and containing a provision for the
performance of any action necessary to bring the product into compliance
with all applicable laws and regulations. The bond shall be filed with
the District Director of Customs.
[[Page 508]]
Sec. 1005.24 Costs of bringing product into compliance.
The costs of supervising the operations necessary to bring a product
into compliance with the Act shall be paid by the owner or consignee who
files an application pursuant to Sec. 1005.21 and executes a bond under
section 360(b) of the Act. Such costs shall include:
(a) Travel expenses of the supervising officer;
(b) Per diem in lieu of subsistence of the supervising officer when
away from his home station, as provided by law;
(c) Service fees: (1) The charge for the services of the supervising
officer, which shall include administrative support, shall be computed
at a rate per hour equal to 266 percent of the hourly rate of regular
pay of a grade GS-11/4 employee, except that such services performed by
a customs officer and subject to the provisions of the act of February
13, 1911, as amended (sec. 5, 36 Stat. 901, as amended (19 U.S.C. 267)),
shall be calculated as provided in that act.
(2) The charge for the services of the analyst, which shall include
administrative and laboratory support, shall be computed at a rate per
hour equal to 266 percent of the hourly rate of regular pay of a grade
GS-12/4 employee.
(3) The rate per hour equal to 266 percent of the equivalent hourly
rate of regular pay of the supervising officer (GS-11/4) and the analyst
(GS-12/4) is computed as follows:
------------------------------------------------------------------------
Hours
------------------------------------------------------------------------
Gross number of working hours in 52 40-hour weeks............. 2,080
Less:
Nine legal public holidays--New Years Day, Washington's
Birthday, Memorial Day, Independence Day, Labor Day,
Columbus Day, Veterans Day, Thanksgiving Day, and Christmas
Day........................................................ 72
Annual Leave--26 days....................................... 208
Sick Leave--13 days......................................... 104
---------
Total................................................... 384
=========
Net number of working hours............................. 1,696
=========
Gross number of working hours in 52 40-hour weeks............. 2,080
Working hour equivalent of Government contributions for
employee retirement, life insurance, and health benefits
computed at 8\1/2\% of annual rate of pay of employee........ 176
---------
Equivalent annual working hours............................... 2,256
Support required to equal to 1 man-year....................... 2,256
---------
Equivalent gross annual working hours charged to Food and Drug
appropriation................................................ 4,512
------------------------------------------------------------------------
Note: Ratio of equivalent gross annual number of working hours
charged to Food and Drug appropriation to net number of annual working
hours (4512/1696)=266 pct.
(d) The minimum charge for services of supervising officers shall be
not less than the charge for 1 hour and time after the first hour shall
be computed in multiples of 1 hour, disregarding fractional parts less
than one-half hour.
[38 FR 28630, Oct. 15, 1973, as amended at 42 FR 55207, Oct. 14, 1977;
42 FR 62130, Dec. 9, 1977]
Sec. 1005.25 Service of process on manufacturers.
(a) Every manufacturer of electronic products, prior to offering
such product for importation into the United States, shall designate a
permanent resident of the United States as the manufacturer's agent upon
whom service of all processes, notices, orders, decisions, and
requirements may be made for and on behalf of the manufacturer as
provided in section 360(d) of the Radiation Control for Health and
Safety Act of 1968 (42 U.S.C. 263h(d)) and this section. The agent may
be an individual, a firm, or a domestic corporation. For purposes of
this section, any number of manufacturers may designate the same agent.
(b) The designation shall be addressed to the Center for Devices and
Radiological Health, 5600 Fishers Lane, Rockville, MD 20857. It shall be
in writing and dated; all signatures shall be in ink. The designation
shall be made in the legal form required to make it valid and binding on
the manufacturer under the laws, corporate bylaws, or other requirements
governing the making of the designation by the manufacturer at the place
and time where it is made, and the persons or person signing the
designation shall certify that it is so made. The designation shall
disclose the manufacturer's full legal name and the name(s) under which
he conducts his business, if applicable, his principal place of
business, and mailing
[[Page 509]]
address. If any of the products of the manufacturer do not bear his
legal name, the designation shall identify the marks, trade names, or
other designations of origin which these products bear. The designation
shall provide that it will remain in effect until withdrawn or replaced
by the manufacturer and shall bear a declaration of acceptance duly
signed by the designated agent. The full legal name and mailing address
of the agent shall be stated. Until rejected by the Secretary,
designations are binding on the manufacturer even when not in compliance
with all the requirements of this section. The designated agent may not
assign performance of his function under the designation to another.
(c) Service of any process, notice, order, requirement, or decision
specified in section 360(d) of the Radiation Control for Health and
Safety Act of 1968 may be made by registered or certified mail addressed
to the agent with return receipt requested, or in any other manner
authorized by law. In the absence of such a designation or if for any
reason service on the designated agent cannot be effected, service may
be made as provided in section 360(d) by posting such process, notice,
order, requirement, or decision in the Office of the Director, Center
for Devices and Radiological Health and publishing a notice that such
service was made in the Federal Register.
[38 FR 28630, Oct. 15, 1973, as amended at 53 FR 11254, Apr. 6, 1988]
PART 1010--PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL--Table of Contents
Subpart A--General Provisions
Sec.
1010.1 Scope.
1010.2 Certification.
1010.3 Identification.
1010.4 Variances.
1010.5 Exemptions for products intended for United States Government
use.
Subpart B--Alternate Test Procedures
1010.13 Special test procedures.
Subpart C--Exportation of Electronic Products
1010.20 Electronic products intended for export.
Authority: Secs. 501, 502, 510, 515-520, 701, 801 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360, 360e-360j, 371,
381); secs. 354-360F of the Public Health Service Act (42 U.S.C. 263b-
263n).
Source: 38 FR 28631, Oct. 15, 1973, unless otherwise noted.
Subpart A--General Provisions
Sec. 1010.1 Scope.
The standards listed in this subchapter are prescribed pursuant to
section 358 of the Radiation Control for Health and Safety Act of 1968
(42 U.S.C. 263f) and are applicable to electronic products as specified
herein, to control electronic product radiation from such products.
Standards so prescribed are subject to amendment or revocation and
additional standards may be prescribed as are determined necessary for
the protection of the public health and safety.
[40 FR 32257, July 31, 1975]
Sec. 1010.2 Certification.
(a) Every manufacturer of an electronic product for which an
applicable standard is in effect under this subchapter shall furnish to
the dealer or distributor, at the time of delivery of such product, the
certification that such product conforms to all applicable standards
under this subchapter.
(b) The certification shall be in the form of a label or tag
permanently affixed to or inscribed on such product so as to be legible
and readily accessible to view when the product is fully assembled for
use, unless the applicable standard prescribes some other manner of
certification. All such labels or tags shall be in the English language.
(c) Such certification shall be based upon a test, in accordance
with the standard, of the individual article to which it is attached or
upon a testing program which is in accordance with good manufacturing
practices. The Director, Center for Devices and Radiological Health may
disapprove such a testing program on the grounds that it does not assure
the adequacy of safe-
[[Page 510]]
guards against hazardous electronic product radiation or that it does
not assure that electronic products comply with the standards prescribed
under this subchapter.
(d) In the case of products for which it is not feasible to certify
in accordance with paragraph (b) of this section, upon application by
the manufacturer, the Director, Center for Devices and Radiological
Health may approve an alternate means by which such certification may be
provided.
[38 FR 28631, Oct. 15, 1973, as amended at 40 FR 32257, July 31, 1975;
42 FR 18063, Apr. 5, 1977; 53 FR 11254, Apr. 6, 1988]
Sec. 1010.3 Identification.
(a) Every manufacturer of an electronic product to which a standard
under this subchapter is applicable shall set forth the information
specified in paragraphs (a)(1) and (2) of this section. This information
shall be provided in the form of a tag or label permanently affixed or
inscribed on such product so as to be legible and readily accessible to
view when the product is fully assembled for use or in such other manner
as may be prescribed in the applicable standard. Except for foreign
equivalent abbreviations as authorized in paragraph (a)(1) of this
section all such labels or tags shall be in the English language.
(1) The full name and address of the manufacturer of the product;
abbreviations such as ``Co.,'' ``Inc.,'' or their foreign equivalents
and the first and middle initials of individuals may be used. Where
products are sold under a name other than that of the manufacturer of
the product, the full name and address of the individual or company
under whose name the product was sold may be set forth, provided such
individual or company has previously suppled the Director, Center for
Devices and Radiological Health with sufficient information to identify
the manufacturer of the product.
(2) The place and month and year of manufacture:
(i) The place of manufacture may be expressed in code provided the
manufacturer has previously supplied the Director, Center for Devices
and Radiological Health with the key to such code.
(ii) The month and year of manufacture shall be provided clearly and
legibly, without abbreviation, and with the year shown as a four-digit
number as follows:
Manufactured: (Insert Month and Year of Manufacture.)
(b) In the case of products for which it is not feasible to affix
identification labeling in accordance with paragraph (a) of this
section, upon application by the manufacturer, the Director, Center for
Devices and Radiological Health may approve an alternate means by which
such identification may be provided.
(c) Every manufacturer of an electronic product to which a standard
under this subchapter is applicable shall provide to the Director,
Center for Devices and Radiological Health a list identifying each brand
name which is applied to the product together with the full name and
address of the individual or company for whom each product so branded is
manufactured.
[40 FR 32257, July 31, 1975, as amended at 42 FR 18063, Apr. 5, 1977; 53
FR 11254, Apr. 6, 1988]
Sec. 1010.4 Variances.
(a) Criteria for variances. (1) Upon application by a manufacturer
(including an assembler), the Director, Center for Devices and
Radiological Health, Food and Drug Administration, may grant a variance
from one or more provisions of any performance standard under Subchapter
J of this chapter for an electronic product subject to such standard
when the Director determines that granting such a variance is in keeping
with the purposes of the Radiation Control for Health and Safety Act of
1968, and:
(i) The scope of the requested variance is so limited in its
applicability as not to justify an amendment to the standard, or
(ii) There is not sufficient time for the promulgation of an
amendment to the standard.
(2) The issuance of the variance shall be based upon a determination
that:
(i) The product utilizes an alternate means for providing radiation
safety or protection equal to or greater than that provided by products
meeting all
[[Page 511]]
requirements of the applicable standard, or
(ii) The product performs a function or is intended for a purpose
which could not be performed or accomplished if required to meet the
applicable standards, and suitable means for assuring radiation safety
or protection are provided, or
(iii) One or more requirements of the applicable standard are not
appropriate, and suitable means for assuring radiation safety or
protection are provided.
(b) Applications for variances. Applications for variances or for
amendments or extensions thereof shall be submitted in an original and
two copies to the Dockets Management Branch (HFA-305), Food and Drug
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
(1) The application for variance shall include the following
information:
(i) A description of the product and its intended use.
(ii) An explanation of how compliance with the applicable standard
would restrict or be inappropriate for this intended use.
(iii) A description of the manner in which it is proposed to deviate
from the requirements of the applicable standard.
(iv) A description of the advantages to be derived from such
deviation.
(v) An explanation of how alternate or suitable means of radiation
protection will be provided.
(vi) The period of time it is desired that the variance be in
effect, and, if appropriate, the number of units the applicant wishes to
manufacture.
(vii) In the case of prototype or experimental equipment, the
proposed location of each unit.
(viii) Such other information required by regulation or by the
Director, Center for Devices and Radiological Health, to evaluate and
act on the application.
(ix) With respect to each nonclinical laboratory study contained in
the application, either a statement that the study was conducted in
compliance with the good laboratory practice regulations set forth in
Part 58 of this chapter, or, if the study was not conducted in
compliance with such regulations, a brief statement of the reason for
the noncompliance.
(x) [Reserved]
(xi) If the electronic product is used in a clinical investigation
involving human subjects, is subject to the requirements for
institutional review set forth in Part 56 of this chapter, and is
subject to the requirements for informed consent set forth in Part 50 of
this chapter, the investigation shall be conducted in compliance with
such requirements.
(2) The application for amendment or extension of a variance shall
include the following information:
(i) The variance number and expiration date.
(ii) The amendment or extension requested and basis for the
amendment or extension.
(iii) A description of the effect of the amendment or extension on
protection from radiation produced by the product.
(iv) An explanation of how alternate or suitable means of protection
will be provided.
(c) Ruling on applications. (1) The Director, Center for Devices and
Radiological Health, may approve or deny, in whole or in part, a
requested variance or any amendment or extension thereof, and the
director shall inform the applicant in writing of this action on a
requested variance or amendment or extension. The written notice will
state the manner in which the variance differs from the standard, the
effective date and the termination date of the variance, a summary of
the requirements and conditions attached to the variance, any other
information that may be relevant to the application or variance, and, if
appropriate, the number of units or other similar limitations for which
the variance is approved. Each variance will be assigned an identifying
number.
(2) The Director, Center for Devices and Radiological Health, shall
amend or withdraw a variance whenever the Director determines that this
action is necessary to protect the public health or otherwise is
justified by this subchapter. Such action will become effective on the
date specified in the written notice of the action sent to the
applicant, except that it will become ef-
[[Page 512]]
fective immediately upon notification to the applicant when the Director
determines that such action is necessary to prevent an imminent health
hazard.
(3) All applications for variances and for amendments and extensions
thereof and all correspondence (including written notices of approval)
on these applications will be available for public disclosure in the
office of the Dockets Management Branch, except for information regarded
as confidential under section 360A(e) of the act.
(d) Certification of equipment covered by variance. The manufacturer
of any product for which a variance is granted shall modify the tag,
label, or other certification required by Sec. 1010.2 to state:
(1) That the product is in conformity with the applicable standard,
except with respect to those characteristics covered by the variance;
(2) That the product is in conformity with the provisions of the
variance; and
(3) The assigned number and effective date of the variance.
[39 FR 13879, Apr. 18, 1974, as amended at 44 FR 48191, Aug. 17, 1979;
50 FR 7518, Feb. 22, 1985; 50 FR 13565, Apr. 5, 1985; 53 FR 11254, Apr.
6, 1988; 53 FR 52683, Dec. 29, 1988; 59 FR 14365, Mar. 28, 1994]
Sec. 1010.5 Exemptions for products intended for United States Government use.
(a) Criteria for exemption. Upon application by a manufacturer
(including assembler) or by a U.S. department or agency, the Director,
Center for Devices and Radiological Health, Food and Drug
Administration, may grant an exemption from any performance standard
under subchapter J of this chapter for an electronic product, or class
of products, otherwise subject to such standard when he determines that
such electronic product or class is intended for use by departments or
agencies of the United States and meets the criteria set forth in
paragraph (a) (1) or (2) of this section.
(1) The procuring agency shall prescribe procurement specifications
for the product or class of products governing emissions of electronic
product radiation, and the product or class shall be of a type used
solely or predominantly by a department or agency of the United States.
(2) The product or class of products is intended for research,
investigations, studies, demonstration, or training, or for reasons of
national security.
(b) Consultation between the procuring agency and the Food and Drug
Administration. The United States department or agency that intends to
procure or manufacture a product or class of products subject to
electronic product radiation safety standards contained in this
subchapter should consult with the Center for Devices and Radiological
Health, Food and Drug Administration, whenever it is anticipated that
the specifications for the product or class must deviate from, or be in
conflict with, such applicable standards. Such consultation should occur
as early as possible during development of such specifications. The
department or agency should include in the specifications all
requirements of such standards that are not in conflict with, or are not
inappropriate for, the special or unique uses for which the product is
intended. The procuring agency should indicate to the Center for Divices
and Radiological Health if it desires to be notified of the approval,
amendment, or withdrawal of the exemption.
(c) Application for exemption. An original and two copies of any
application for exemption, or for amendment or extension thereof, shall
be submitted to the Dockets Management Branch (HFA-305), Food and Drug
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857. For
an exemption pursuant to the criteria prescribed in paragraph (a)(1) of
this section, the application shall include the information prescribed
in paragraphs (c)(1) through (13) of this section. For an exemption
pursuant to the criteria prescribed in paragraph (a)(2) of this section,
the application shall include the information prescribed in paragraphs
(c)(3) through (13) of this section. An application for exemption, or
for amendment or extension thereof, and correspondence relating to such
application shall be made available for public disclosure in the Dockets
Management Branch except for confidential or proprietary information
submitted in accordance with Part 20 of this chapter. Information
[[Page 513]]
classified for reasons of national security shall not be included in the
application. Except as indicated above, the application for exemption
shall include the following:
(1) The procurement specifications for the product or class of
products that govern emissions of electronic product radiation.
(2) Evidence that the product or class of products is of a type used
solely or predominantly by departments or agencies of the United States.
(3) Evidence that such product or class of products is intended for
use by a department or agency of the United States.
(4) A description of the product or class of products and its
intended use.
(5) An explanation of how compliance with the applicable standard
would restrict or be inappropriate for this intended use.
(6) A description of the manner in which it is proposed that the
product or class of products shall deviate from the requirements of the
applicable standard.
(7) An explanation of the advantages to be derived from such
deviation.
(8) An explanation of how means of radiation protection will be
provided where the product or class of products deviates from the
requirements of the applicable standard.
(9) The period of time it is desired that the exemption be in
effect, and, if appropriate, the number of units to be manufactured
under the exemption.
(10) The name, address, and telephone number of the manufacturer or
his agent.
(11) The name, address, and telephone number of the appropriate
office of the United States department or agency purchasing the product
or class of products.
(12) Such other information required by regulation or by the
Director, Center for Devices and Radiological Health, to evaluate and
act on the application. Where such information includes nonclinical
laboratory studies, the information shall include, with respect to each
nonclinical study, either a statement that each study was conducted in
compliance with the requirements set forth in part 58 of this chapter,
or, if the study was not conducted in compliance with such regulations,
a statement that describes in detail all differences between the
practices used in the study and those required in the regulations. When
such information includes clinical investigations involving human
subjects, the information shall include, with respect to each clinical
investigation, either a statement that each investigation was conducted
in compliance with the requirements set forth in part 56 of this
chapter, or a statement that the investigation is not subject to such
requirements in accordance with Sec. 56.104 or Sec. 56.105 and a
statement that each investigation was conducted in compliance with the
requirements set forth in part 50 of this chapter.
(13) With respect to each nonclinical laboratory study contained in
the application, either a statement that the study was conducted in
compliance with the requirements set forth in Part 58 of this chapter,
or, if the study was not conducted in compliance with such regulations,
a brief statement of the reason for the noncompliance.
(d) Amendment or extension of an exemption. An exemption is granted
on the basis of the information contained in the orginal applicaion.
Therefore, if changes are needed in the radiation safety specifications
for the product, or its use, or related radiation control procedures
such that the information in the original application would no longer be
correct with respect to radiation safety, the applicant shall submit in
advance of such changes a request for an amendment to the exemption. He
also shall submit a request for extension of the exemption, if needed,
at least 60 days before the expiration date. The application for
amendment or extension of an exemption shall include the following
information:
(1) The exemption number and expiration date.
(2) The amendment or extension requested and basis for the amendment
or extension.
(3) If the radiation safety specifications for the product or class
of products or the product's or class of products' use or related
radiation control procedures differ from the description provided in the
original application, a description of such changes.
[[Page 514]]
(e) Ruling on an application. (1) The Director, Center for Devices
and Radiological Health, may grant an exemption including in the written
notice of exemption such conditions or terms as may be necessary to
protect the public health and safety and shall notify the applicant in
writing of his action. The conditions or terms of the exemption may
include specifications concerning the manufacture, use, control, and
disposal of the excess or surplus exempted product of class of products
as provided in the Code of Federal Regulations, title 41, subtitle C.
Each exemption will be assigned an identifying number.
(2) The Director, Center for Devices and Radiological Health, shall
amend or withdraw an exemption whenever he determines that such action
is necessary to protect the public health or otherwise is justified by
provisions of the act or this subchapter. Such action shall become
effective on the date specified in the written notice of the action sent
to the applicant, except that it shall become effective immediately when
the Director determines that it is necessary to prevent an imminent
health hazard.
(f) Identification of equipment covered by exemption. The
manufacturer of any product for which an exemption is granted shall
provide the following identification in the form of a tag or label
permanently affixed or inscribed on such product so as to be legible and
readily accessible to view when the product is fully assembled for use
or in such other manner as may be prescribed in the exemption:
Caution
This electronic product has been exempted from Food and Drug
Administration radiation safety performance standards prescribed in the
Code of Federal Regulations, Title 21, Chapter I, Subchapter J, pursuant
to Exemption No. 2/32/32/3, granted on 2/32/32/32/32/32/32/3
[42 FR 44229, Sept. 2, 1977; 42 FR 61257, Dec. 2, 1977, as amended at 44
FR 17657, Mar. 23, 1979; 46 FR 8460, 8958, Jan. 27, 1981; 50 FR 7518,
Feb. 22, 1985; 50 FR 13564, Apr. 5, 1985; 53 FR 11254, Apr. 6, 1988; 59
FR 14365, Mar. 28, 1994]
Subpart B--Alternate Test Procedures
Sec. 1010.13 Special test procedures.
The Director, Center for Devices and Radiological Health, may, on
the basis of a written application by a manufacturer, authorize test
programs other than those set forth in the standards under this
subchapter for an electronic product if he determines that such products
are not susceptible to satisfactory testing by the procedures set forth
in the standard and that the alternative test procedures assure
compliance with the standard.
[40 FR 32257, July 31, 1975, as amended at 53 FR 11254, Apr. 6, 1988]
Subpart C--Exportation of Electronic Products
Sec. 1010.20 Electronic products intended for export.
The performance standards prescribed in this subchapter shall not
apply to any electronic product which is intended solely for export if:
(a) Such product and the outside of any shipping container used in
the export of such product are labeled or tagged to show that such
product is intended for export, and
(b) Such product meets all the applicable requirements of the
country to which such product is intended for export.
[40 FR 32257, July 31, 1975]
PART 1020--PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS--Table of Contents
Sec.
1020.10 Television receivers.
1020.20 Cold-cathode gas discharge tubes.
1020.30 Diagnostic x-ray systems and their major components.
1020.31 Radiographic equipment.
1020.32 Fluoroscopic equipment.
1020.33 Computed tomography (CT) equipment.
1020.40 Cabinet x-ray systems.
Authority: Secs. 501, 502, 515-520, 530-542, 701, 801 of the Federal
Food, Drug, and Cos-
[[Page 515]]
metic Act (21 U.S.C. 351, 352, 360e-360j, 360gg-360ss, 371, 381).
Source: 38 FR 28632, Oct. 15, 1973, unless otherwise noted.
Sec. 1020.10 Television receivers.
(a) Applicability. The provisions of this section are applicable to
television receivers manufactured subsequent to January 15, 1970.
(b) Definitions. (1) External surface means the cabinet or enclosure
provided by the manufacturer as part of the receiver. If a cabinet or
enclosure is not provided as part of the receiver, the external surface
shall be considered to be a hypothetical cabinet, the plane surfaces of
which are located at those minimum distances from the chassis sufficient
to enclose all components of the receiver except that portion of the
neck and socket of the cathode-ray tube which normally extends beyond
the plane surfaces of the enclosure.
(2) Maximum test voltage means 130 root mean square volts if the
receiver is designed to operate from nominal 110 to 120 root mean square
volt power sources. If the receiver is designed to operate from a power
source having some voltage other than from nominal 110 to 120 root mean
square volts, maximum test voltage means 110 percent of the nominal root
mean square voltage specified by the manufacturer for the power source.
(3) Service controls means all of those controls on a television
receiver provided by the manufacturer for purposes of adjustment which,
under normal usage, are not accessible to the user.
(4) Television receiver means an electronic product designed to
receive and display a television picture through broadcast, cable, or
closed circuit television.
(5) Usable picture means a picture in synchronization and
transmitting viewable intelligence.
(6) User controls means all of those controls on a television
receiver, provided by the manufacturer for purposes of adjustment, which
on a fully assembled receiver under normal usage, are accessible to the
user.
(c) Requirements--(1) Exposure rate limit. Radiation exposure rates
produced by a television receiver shall not exceed 0.5 milliroentgens
per hour at a distance of five (5) centimeters from any point on the
external surface of the receiver, as measured in accordance with this
section.
(2) Measurements. Compliance with the exposure rate limit defined in
paragraph (c)(1) of this section shall be determined by measurements
made with an instrument, the radiation sensitive volume of which shall
have a cross section parallel to the external surface of the receiver
with an area of ten (10) square centimeters and no dimension larger than
five (5) centimeters. Measurements made with instruments having other
areas must be corrected for spatial nonuniformity of the radiation field
to obtain the exposure rate average over a ten (10) square centimeter
area.
(3) Test conditions. All measurements shall be made with the
receiver displaying a usable picture and with the power source operated
at supply voltages up to the maximum test voltage of the receiver and,
as applicable, under the following specific conditions:
(i) On television receivers manufactured subsequent to January 15,
1970, measurements shall be made with all user controls adjusted so as
to produce maximum x-radiation emissions from the receiver.
(ii) On television receivers manufactured subsequent to June 1,
1970, measurements shall be made with all user controls and all service
controls adjusted to combinations which result in the production of
maximum x-radiation emissions.
(iii) On television receivers manufactured subsequent to June 1,
1971, measurements shall be made under the conditions described in
paragraph (c)(3) (ii) of this section, together with conditions
identical to those which result from that component or circuit failure
which maximizes x-radiation emissions.
(4) Critical component warning. The manufacturer shall permanently
affix or inscribe a warning label, clearly legible under conditions of
service, on all television receivers which could produce radiation
exposure rates in excess of the requirements of this section as a result
of failure or improper adjustment or improper replacement of a circuit
or shield component. The warn-
[[Page 516]]
ing label shall include the specification of operating high voltage and
an instruction for adjusting the high voltage to the specified value.
Sec. 1020.20 Cold-cathode gas discharge tubes.
(a) Applicability. The provisions of this section are applicable to
cold-cathode gas discharge tubes designed to demonstrate the effects of
a flow of electrons or the production of x-radiation as specified
herein.
(b) Definitions. Beam blocking device means a movable or removable
portion of any enclosure around a cold-cathode gas discharge tube, which
may be opened or closed to permit or prevent the emergence of an exit
beam.
Cold-cathode gas discharge tube means an electronic device in which
electron flow is produced and sustained by ionization of contained gas
atoms and ion bombardment of the cathode.
Exit beam means that portion of the radiation which passes through
the aperture resulting from the opening of the beam blocking device.
Exposure means the sum of the electrical charges on all of the ions
of one sign produced in air when all electrons liberated by photons in a
volume element of air are completely stopped in air divided by the mass
of the air in the volume element. The special unit of exposure is the
roentgen. One (1) roentgen equals 2.58 x 10-4 coulombs/kilogram.
(c) Requirements--(1) Exposure rate limit. (i) Radiation exposure
rates produced by cold-cathode gas discharge tubes shall not exceed 10
mR./hr. at a distance of thirty (30) centimeters from any point on the
external surface of the tube, as measured in accordance with this
section.
(ii) The divergence of the exit beam from tubes designed primarily
to demonstrate the effects of x radiation, with the beam blocking device
in the open position, shall not exceed (Pi) steradians.
(2) Measurements. (i) Compliance with the exposure rate limit
defined in paragraph (c)(1)(i) of this section shall be determined by
measurements averaged over an area of one hundred (100) square
centimeters with no linear dimension greater than twenty (20)
centimeters.
(ii) Measurements of exposure rates from tubes in enclosures from
which the tubes cannot be removed without destroying the function of the
tube may be made at a distance of thirty (30) centimeters from any point
on the external surface of the enclosure, provided:
(a) In the case of enclosures containing tubes designed primarily to
demonstrate the production of x radiation, measurements shall be made
with any beam blocking device in the beam blocking position, or
(b) In the case of enclosures containing tubes designed primarily to
demonstrate the effects of a flow of electrons, measurements shall be
made with all movable or removable parts of such enclosure in the
position which would maximize external exposure levels.
(3) Test conditions. (i) Measurements shall be made under the
conditions of use specified in instructions provided by the
manufacturer.
(ii) Measurements shall be made with the tube operated under forward
and reverse polarity.
(4) Instructions, labels, and warnings. (i) Manufacturers shall
provide, or cause to be provided, with each tube to which this section
is applicable, appropriate safety instructions, together with
instructions for the use of such tube, including the specification of a
power source for use with the tube.
(ii) Each enclosure or tube shall have inscribed on or permanently
affixed to it, tags or labels, which identify the intended polarity of
the terminals and:
(a) In the case of tubes designed primarily to demonstrate the heat
effect, fluorescence effect, or magnetic effect, a warning that
application of power in excess of that specified may result in the
production of x-rays in excess of allowable limits; and (b) in the case
of tubes designed primarily to demonstrate the production of x-
radiation, a warning that this device produces x-rays when energized.
(iii) The tag or label required by this paragraph shall be located
on the tube or enclosure so as to be readily visible and legible when
the product is fully assembled for use.
[[Page 517]]
Sec. 1020.30 Diagnostic x-ray systems and their major components.
(a) Applicability--(1) The provisions of this section are applicable
to:
(i) The following components of diagnostic x-ray systems:
(A) Tube housing assemblies, x-ray controls, x-ray high-voltage
generators, x-ray tables, cradles, film changers, vertical cassette
holders mounted in a fixed location and cassette holders with front
panels, and beam-limiting devices manufactured after August 1, 1974.
(B) Fluoroscopic imaging assemblies manufactured after August 1,
1974, and before April 26, 1977.
(C) Spot-film devices and image intensifiers manufactured after
April 26, 1977.
(D) Cephalometric devices manufactured after February 25, 1978.
(E) Image receptor support devices for mammographic x-ray systems
manufactured after September 5, 1978.
(ii) Diagnostic x-ray systems, except computed tomography x-ray
systems, incorporating one or more of such components; however, such x-
ray systems shall be required to comply only with those provisions of
this section and Secs. 1020.31 and 1020.32 which relate to the
components certified in accordance with paragraph (c) of this section
and installed into the systems.
(iii) Computed tomography (CT) x-ray systems manufactured before
November 29, 1984.
(iv) CT gantries manufactured after September 3, 1985.
(2) The following provisions of this section and Sec. 1020.33 are
applicable to CT x-ray systems manufactured or remanufactured on or
after November 29, 1984:
(i) Section 1020.30(a);
(ii) Section 1020.30(b) ``Technique factors'';
(iii) Section 1020.30(b) ``CT,'' ``Dose,'' ``Scan,'' ``Scan time,''
and ``Tomogram'';
(iv) Section 1020.30 (h)(3)(vi) through (h)(3)(viii);
(v) Section 1020.30(n);
(vi) Section 1020.33 (a) and (b);
(vii) Section 1020.33(c)(1) as it affects Sec. 1020.33(c)(2); and
(viii) Section 1020.33(c)(2).
(3) The provisions of this section and Sec. 1020.33 in its entirety,
including those provisions in paragraph (a)(2) of this section, are
applicable to CT x-ray systems manufactured or remanufactured on or
after September 3, 1985. The date of manufacture of the CT system is the
date of manufacture of the CT gantry.
(b) Definitions. As used in this section and Secs. 1020.31, 1020.32,
and 1020.33, the following definitions apply:
Accessible surface means the external surface of the enclosure or
housing provided by the manufacturer.
Accessory component means:
(1) A component used with diagnostic x-ray systems, such as a cradle
or film changer, that is not necessary for the compliance of the system
with applicable provisions of this subchapter but which requires an
initial determination of compatibility with the system; or
(2) A component necessary for compliance of the system with
applicable provisions of this subchapter but which may be interchanged
with similar compatible components without affecting the system's
compliance, such as one of a set of interchangeable beam-limiting
devices; or
(3) A component compatible with all x-ray systems with which it may
be used and that does not require compatibility or installation
instructions, such as a tabletop cassette holder.
Aluminum equivalent means the thickness of aluminum (type 1100
alloy) \1\ affording the same attenuation, under specified conditions as
the material in question.
---------------------------------------------------------------------------
\1\ The nominal chemical composition of type 1100 aluminum alloy is
99.00 percent minimum aluminum, 0.12 percent copper, as given in
``Aluminum Standards and Data'' (1969). Copies may be obtained from: The
Aluminum Association, New York, NY.
---------------------------------------------------------------------------
Articulated joint means a joint between two separate sections of a
tabletop which joint provides the capacity for one of the sections to
pivot on the line segment along which the sections join.
Assembler means any person engaged in the business of assembling,
replacing, or installing one or more components into a diagnostic x-ray
system or subsystem. The term includes the owner of an x-ray system or
his or her employee or agent who assembles com-
[[Page 518]]
ponents into an x-ray system that is subsequently used to provide
professional or commercial services.
Attenuation block means a block or stack of type 1100 aluminum alloy
or aluminum alloy having equivalent attenuation with dimensions 20
centimeters by 20 centimeters by 3.8 centimeters.
Automatic exposure control means a device which automatically
controls one or more technique factors in order to obtain at a
preselected location(s) a required quantity of radiation.
Beam axis means a line from the source through the centers of the x-
ray fields.
Beam-limiting device means a device which provides a means to
restrict the dimensions of the x-ray field.
Cantilevered tabletop means a tabletop designed such that the
unsupported portion can be extended at least 100 centimeters beyond the
support.
Cassette holder means a device, other than a spot-film device, that
supports and/or fixes the position of an x-ray film cassette during an
x-ray exposure.
Cephalometric device means a device intended for the radiographic
visualization and measurement of the dimensions of the human head.
Coefficient of variation means the ratio of the standard deviation
to the mean value of a population of observations. It is estimated using
the following equation:
[GRAPHIC] [TIFF OMITTED] TR01FE93.030
where
s = Estimated standard deviation of the population.
X = Mean value of observations in sample.
Xi = ith observation sampled.
n = Number of observations sampled.
Computed tomography (CT) means the production of a tomogram by the
acquisition and computer processing of x-ray transmission data.
Control panel means that part of the x-ray control upon which are
mounted the switches, knobs, pushbuttons, and other hardware necessary
for manually setting the technique factors.
Cooling curve means the graphical relationship between heat units
stored and cooling time.
Cradle means:
(1) A removable device which supports and may restrain a patient
above an x-ray table; or
(2) A device;
(i) Whose patient support structure is interposed between the
patient and the image receptor during normal use;
(ii) Which is equipped with means for patient restraint; and
(iii) Which is capable of rotation about its long (longitudinal)
axis.
CT gantry means tube housing assemblies, beam-limiting devices,
detectors, and the supporting structures, frames, and covers which hold
and/or enclose these components.
Diagnostic source assembly means the tube housing assembly with a
beam-limiting device attached.
Diagnostic x-ray system means an x-ray system designed for
irradiation of any part of the human body for the purpose of diagnosis
or visualization.
Dose means the absorbed dose as defined by the International
Commission on Radiation Units and Measurements. The absorbed dose, D, is
the quotient of de by dm, where de is the mean energy imparted by
ionizing radiation to matter of mass dm.
Equipment means x-ray equipment.
Exposure means the quotient of dQ by dm where dQ is the absolute
value of the total charge of the ions of one sign produced in air when
all the electrons (negatrons and positrons) liberated by photons in a
volume element of air having mass dm are completely stopped in air.
Field emission equipment means equipment which uses an x-ray tube in
[[Page 519]]
which electron emission from the cathode is due solely to action of an
electric field.
Fluoroscopic imaging assembly means a subsystem in which x-ray
photons produce a fluoroscopic image. It includes the image receptor(s)
such as the image intensifier and spot-film device, electrical
interlocks, if any, and structural material providing linkage between
the image receptor and diagnostic source assembly.
General purpose radiographic x-ray system means any radiographic x-
ray system which, by design, is not limited to radiographic examination
of specific anatomical regions.
Half-value layer (HVL) means the thickness of specified material
which attenuates the beam of radiation to an extent such that the
exposure rate is reduced to one-half of its original value. In this
definition the contribution of all scattered radiation, other than any
which might be present initially in the beam concerned, is deemed to be
excluded.
Image intensifier means a device, installed in its housing, which
instantaneously converts an x-ray pattern into a corresponding light
image of higher energy density.
Image receptor means any device, such as a fluorescent screen,
radiographic film, solid-state detector, or gaseous detector, which
transforms incident x-ray photons either into a visible image or into
another form which can be made into a visible image by further
transformations. In those cases where means are provided to preselect a
portion of the image receptor, the term ``image receptor'' shall mean
the preselected portion of the device.
Image receptor support means, for mammographic systems, that part of
the system designed to support the image receptor in a horizontal plane
during a mammographic examination.
Leakage radiation means radiation emanating from the diagnostic
source assembly except for:
(1) The useful beam; and
(2) Radiation produced when the exposure switch or timer is not
activated.
Leakage technique factors means the technique factors associated
with the diagnostic source assembly which are used in measuring leakage
radiation. They are defined as follows:
(1) For diagnostic source assemblies intended for capacitor energy
storage equipment, the maximum-rated peak tube potential and the
maximum-rated number of exposures in an hour for operation at the
maximum-rated peak tube potential with the quantity of charge per
exposure being 10 millicoulombs (or 10 mAs) or the minimum obtainable
from the unit, whichever is larger;
(2) For diagnostic source assemblies intended for field emission
equipment rated for pulsed operation, the maximum-rated peak tube
potential and the maximum-rated number of x-ray pulses in an hour for
operation at the maximum-rated peak tube potential; and
(3) For all other diagnostic source assemblies, the maximum-rated
continuous tube current for the maximum-rated continuous tube current
for the maximum-rated peak tube potential.
Light field means that area of the intersection of the light beam
from the beam-limiting device and one of the set of planes parallel to
and including the plane of the image receptor, whose perimeter is the
locus of points at which the illuminance is one-fourth of the maximum in
the intersection.
Line-voltage regulation means the difference between the no-load and
the load line potentials expressed as a percent of the load line
potential; that is, Percent line-voltage regulation
100(Vn-Vi)
= -----------------
Vi
where
Vn = No-load line potential and
Vi = Load line potential.
Maximum line current means the root mean square current in the
supply line of an x-ray machine operating at its maximum rating.
Movable tabletop means a tabletop which, when assembled for use, is
capable of movement with respect to its supporting structure within the
plane of the tabletop.
Peak tube potential means the maximum value of the potential
difference across the x-ray tube during an exposure.
[[Page 520]]
Primary protective barrier means the material, excluding filters,
placed in the useful beam to reduce the radiation exposure for
protection purposes.
Pulsed mode means operation of the x-ray system such that the x-ray
tube current is pulsed by the x-ray control to produce one or more
exposure intervals of duration less than one-half second.
Quick change x-ray tube means an x-ray tube designed for use in its
associated tube housing such that:
(1) The tube cannot be inserted in its housing in a manner that
would result in noncompliance of the system with the requirements of
paragraphs (k) and (m) of this section;
(2) The focal spot position will not cause noncompliance with the
provisions of this section or Sec. 1020.31 or Sec. 1020.32;
(3) The shielding within the tube housing cannot be displaced; and
(4) Any removal and subsequent replacement of a beam-limiting device
during reloading of the tube in the tube housing will not result in
noncompliance of the x-ray system with the applicable field limitation
and alignment requirements of Secs. 1020.31 and 1020.32.
Radiation therapy simulation system means a radiographic or
fluoroscopic x-ray system intended for localizing the volume to be
exposed during radiation therapy and confirming the position and size of
the therapeutic irradiation field.
Rated line voltage means the range of potentials, in volts, of the
supply line specified by the manufacturer at which the x-ray machine is
designed to operate.
Rated output current means the maximum allowable load current of the
x-ray high-voltage generator.
Rated output voltage means the allowable peak potential, in volts,
at the output terminals of the x-ray high-voltage generator.
Rating means the operating limits specified by the manufacturer.
Recording means producing a permanent form of an image resulting
from x-ray photons (e.g., film, videotape).
Scan means the complete process of collecting x-ray transmission
data for the production of a tomogram. Data may be collected
simultaneously during a single scan for the production of one or more
tomograms.
Scan time means the period of time between the beginning and end of
x-ray transmission data accumulation for a single scan.
Source means the focal spot of the x-ray tube.
Source-image receptor distance (SID) means the distance from the
source to the center of the input surface of the image receptor.
Spot-film device means a device intended to transport and/or
position a radiographic image receptor between the x-ray source and
fluoroscopic image receptor. It includes a device intended to hold a
cassette over the input end of an image intensifier for the purpose of a
radiograph.
Stationary tabletop means a tabletop which, when assembled for use,
is incapable of movement with respect to its supporting structure within
the plane of the tabletop.
Technique factors means the following conditions of operation:
(1) For capacitor energy storage equipment, peak tube potential in
kilovolts (kV) and quantity of charge in milliamperes-seconds (mAs);
(2) For field emission equipment rated for pulsed operation, peak
tube potential in kV and number of x-ray pulses;
(3) For CT equipment designed for pulsed operation, peak tube
potential in kV, scan time in seconds, and either tube current in
milliamperes (mA), x-ray pulse width in seconds, and the number of x-ray
pulses per scan, or the product of the tube current, x-ray pulse width,
and the number of x-ray pulses in mAs;
(4) For CT equipment not designed for pulsed operation, peak tube
potential in kV, and either tube current in mA and scan time in seconds,
or the product of tube current and exposure time in mAs and the scan
time when the scan time and exposure time are equivalent; and
(5) For all other equipment, peak tube potential in kV, and either
tube current in mA and exposure time in seconds, or the product of tube
current and exposure time in mAs.
[[Page 521]]
Tomogram means the depiction of the x-ray attenuation properties of
a section through a body.
Tube means an x-ray tube, unless otherwise specified.
Tube housing assembly means the tube housing with tube installed. It
includes high-voltage and/or filament transformers and other appropriate
elements when they are contained within the tube housing.
Tube rating chart means the set of curves which specify the rated
limits of operation of the tube in terms of the technique factors.
Useful beam means the radiation which passes through the tube
housing port and the aperture of the beam-limiting device when the
exposure switch or timer is activated.
Variable-aperture beam-limiting device means a beam-limiting device
which has the capacity for stepless adjustment of the x-ray field size
at a given SID.
Visible area means the portion of the input surface of the image
receptor over which incident x-ray photons are producing a visible
image.
X-ray control means a device which controls input power to the x-ray
high-voltage generator and/or the x-ray tube. It includes equipment such
as timers, phototimers, automatic brightness stabilizers, and similar
devices, which control the technique factors of an x-ray exposure.
X-ray equipment means an x-ray system, subsystem, or component
thereof. Types of x-ray equipment are as follows:
(1) Mobile x-ray equipment means x-ray equipment mounted on a
permanent base with wheels and/or casters for moving while completely
assembled;
(2) Portable x-ray equipment means x-ray equipment designed to be
hand-carried; and
(3) Stationary x-ray equipment means x-ray equipment which is
installed in a fixed location.
X-ray field means that area of the intersection of the useful beam
and any one of the set of planes parallel to and including the plane of
the image receptor, whose perimeter is the locus of points at which the
exposure rate is one-fourth of the maximum in the intersection.
X-ray high-voltage generator means a device which transforms
electrical energy from the potential supplied by the x-ray control to
the tube operating potential. The device may also include means for
transforming alternating current to direct current, filament
transformers for the x-ray tube(s), high-voltage switches, electrical
protective devices, and other appropriate elements.
X-ray system means an assemblage of components for the controlled
production of x-rays. It includes minimally an x-ray high-voltage
generator, an x-ray control, a tube housing assembly, a beam-limiting
device, and the necessary supporting structures. Additional components
which function with the system are considered integral parts of the
system.
X-ray subsystem means any combination of two or more components of
an x-ray system for which there are requirements specified in this
section and Secs. 1020.31 and 1020.32.
X-ray table means a patient support device with its patient support
structure (tabletop) interposed between the patient and the image
receptor during radiography and/or fluoroscopy. This includes, but is
not limited to, any stretcher equipped with a radiolucent panel and any
table equipped with a cassette tray (or bucky), cassette tunnel, image
intensifier, or spot-film device beneath the tabletop.
X-ray tube means any electron tube which is designed for the
conversion of electrical energy into x-ray energy.
(c) Manufacturers' responsibility. Manufacturers of products subject
to Secs. 1020.30 through 1020.33 shall certify that each of their
products meet all applicable requirements when installed into a
diagnostic x-ray system according to instructions. This certification
shall be made under the format specified in Sec. 1010.2 of this chapter.
Manufacturers may certify a combination of two or more components if
they obtain prior authorization in writing from the Director of the
Office of Compliance and Surveillance of the Center for Devices and
Radiological Health. Manufacturers shall not be held responsible for
noncompliance of their products if
[[Page 522]]
that noncompliance is due solely to the improper installation or
assembly of that product by another person; however, manufacturers are
responsible for providing assembly instructions adequate to assure
compliance of their components with the applicable provisions of
Secs. 1020.30 through 1020.33.
(d) Assemblers' responsibility. An assembler who installs one or
more components certified as required by paragraph (c) of this section
shall install certified components that are of the type required by
Secs. 1020.31, 1020.32, or 1020.33 and shall assemble, install, adjust,
and test the certified components according to the instructions of their
respective manufacturers. Assemblers shall not be liable for
noncompliance of a certified component if the assembly of that component
was according to the component manufacturer's instruction.
(1) Reports of assembly. All assemblers who install certified
components shall file a report of assembly, except as specified in
paragraph (d)(2) of this section. The report will be construed as the
assembler's certification and identification under Secs. 1010.2 and
1010.3 of this chapter. The assembler shall affirm in the report that
the manufacturer's instructions were followed in the assembly or that
the certified components as assembled into the system meet all
applicable requirements of Secs. 1020.30 through 1020.33. All assembler
reports must be on a form prescribed by and available from the Director,
Center for Devices and Radiological Health, 5600 Fishers Lane,
Rockville, MD 20857. Completed reports must be submitted to the
Director, the purchaser, and, where applicable, to the State agency
responsible for radiation protection within 15 days following completion
of the assembly.
(2) Exceptions to reporting requirements. Reports of assembly need
not be submitted for any of the following:
(i) Reloaded or replacement tube housing assemblies that are
reinstalled in or newly assembled into an existing x-ray system;
(ii) Certified accessory components that have been identified as
such to the Center for Devices and Radiological Health in the report
required under Sec. 1002.10 of this chapter;
(iii) Repaired components, whether or not removed from the system
and reinstalled during the course of repair, provided the original
installation into the system was reported; or
(iv) Components installed temporarily in an x-ray system in place of
components removed temporarily for repair, provided the temporarily
installed component is identified by a tag or label bearing the
following information:
Temporarily Installed Component
This certified component has been assembled, installed, adjusted,
and tested by me according to the instructions provided by the
manufacturer.
Signature
Company Name
Street Address, P.O. Box
City, State, Zip Code
Date of Installation
The replacement of the temporarily installed component by a
component other than the component originally removed for repair shall
be reported as specified in paragraph (d)(1) of this section.
(e) Identification of x-ray components. In addition to the
identification requirements specified in Sec. 1010.3 of this chapter,
manufacturers of components subject to this section and Secs. 1020.31,
1020.32, and 1020.33, except high-voltage generators contained within
tube housings and beam-limiting devices that are integral parts of tube
housings, shall permanently inscribe or affix thereon the model number
and serial number of the product so that they are legible and accessible
to view. The word ``model'' or ``type'' shall appear as part of the
manufacturer's required identification of certified x-ray components.
Where the certification of a system or subsystem, consisting of two or
more components, has been authorized pursuant to paragraph (c) of this
section, a single inscription, tag, or label bearing the model number
and serial number may be used to identify the product.
(1) Tube housing assemblies. In a similar manner, manufacturers of
tube housing assemblies shall also inscribe or affix thereon the name of
the manufacturer, model number, and serial number of the x-ray tube
which the tube housing assembly incorporates.
[[Page 523]]
(2) Replacement of tubes. Except as specified in paragraph (e)(3) of
this section, the replacement of an x-ray tube in a previously
manufactured tube housing assembly certified pursuant to paragraph (c)
of this section constitutes manufacture of a new tube housing assembly,
and the manufacturer is subject to the provisions of paragraph (e)(1) of
this section. The manufacturer shall remove, cover, or deface any
previously affixed inscriptions, tags, or labels, that are no longer
applicable.
(3) Quick-change x-ray tubes. The requirements of paragraph (e)(2)
of this section shall not apply to tube housing assemblies designed and
designated by their original manufacturer to contain quick change x-ray
tubes. The manufacturer of quick-change x-ray tubes shall include with
each replacement tube a label with the tube manufacturer's name, the
model, and serial number of the x-ray tube. The manufacturer of the tube
shall instruct the assembler who installs the new tube to attach the
label to the tube housing assembly and to remove, cover, or deface the
previously affixed inscriptions, tags, or labels that are described by
the tube manufacturer as no longer applicable.
(f) [Reserved]
(g) Information to be provided to assemblers. Manufacturers of
components listed in paragraph (a)(1) of this section shall provide to
assemblers subject to paragraph (d) of this section and, upon request,
to others at a cost not to exceed the cost of publication and
distribution, instructions for assembly, installation, adjustment, and
testing of such components adequate to assure that the products will
comply with applicable provisions of this section and Secs. 1020.31,
1020.32, and 1020.33, when assembled, installed, adjusted, and tested as
directed. Such instructions shall include specifications of other
components compatible with that to be installed when compliance of the
system or subsystem depends on their compatibility. Such specifications
may describe pertinent physical characteristics of the components and/or
may list by manufacturer model number the components which are
compatible. For x-ray controls and generators manufactured after May 3,
1994, manufacturers shall provide:
(1) A statement of the rated line voltage and the range of line-
voltage regulation for operation at maximum line current;
(2) A statement of the maximum line current of the x-ray system
based on the maximum input voltage and current characteristics of the
tube housing assembly compatible with rated output voltage and rated
output current characteristics of the x-ray control and associated high-
voltage generator. If the rated input voltage and current
characteristics of the tube housing assembly are not known by the
manufacturer of the x-ray control and associated high-voltage generator,
he shall provide necessary information to allow the assembler to
determine the maximum line current for the particular tube housing
assembly(ies);
(3) A statement of the technique factors that constitute the maximum
line current condition described in paragraph (g)(2) of this section.
(h) Information to be provided to users. Manufacturers of x-ray
equipment shall provide to purchasers and, upon request, to others at a
cost not to exceed the cost of publication and distribution, manuals or
instruction sheets which shall include the following technical and
safety information:
(1) All x-ray equipment. For x-ray equipment to which this section
and Secs. 1020.31, 1020.32, and 1020.33 are applicable, there shall be
provided:
(i) Adequate instructions concerning any radiological safety
procedures and precautions which may be necessary because of unique
features of the equipment; and
(ii) A schedule of the maintenance necessary to keep the equipment
in compliance with this section and Secs. 1020.31, 1020.32, and 1020.33.
(2) Tube housing assemblies. For each tube housing assembly, there
shall be provided:
(i) Statements of the leakage technique factors for all combinations
of tube housing assemblies and beam-limiting devices for which the tube
housing assembly manufacturer states compatibility, the minimum
filtration permanently in the useful beam expressed as millimeters of
aluminum equiva-
[[Page 524]]
lent, and the peak tube potential at which the aluminum equivalent was
obtained;
(ii) Cooling curves for the anode and tube housing; and
(iii) Tube rating charts. If the tube is designed to operate from
different types of x-ray high-voltage generators (such as single-phase
self rectified, single-phase half-wave rectified, single-phase full-wave
rectified, 3-phase 6-pulse, 3-phase 12-pulse, constant potential,
capacitor energy storage) or under modes of operation such as alternate
focal spot sizes or speeds of anode rotation which affect its rating,
specific identification of the difference in ratings shall be noted.
(3) X-ray controls and generators. For the x-ray control and
associated x-ray high-voltage generator, there shall be provided:
(i) A statement of the rated line voltage and the range of line-
voltage regulation for operation at maximum line current;
(ii) A statement of the maximum line current of the x-ray system
based on the maximum input voltage and output current characteristics of
the tube housing assembly compatible with rated output voltage and rated
current characteristics of the x-ray control and associated high-voltage
generator. If the rated input voltage and current characteristics of the
tube housing assembly are not known by the manufacturer of the x-ray
control and associated high-voltage generator, the manufacturer shall
provide necessary information to allow the purchaser to determine the
maximum line current for his particular tube housing assembly(ies);
(iii) A statement of the technique factors that constitute the
maximum line current condition described in paragraph (h)(3)(ii) of this
section;
(iv) In the case of battery-powered generators, a specification of
the minimum state of charge necessary for proper operation;
(v) Generator rating and duty cycle;
(vi) A statement of the maximum deviation from the preindication
given by labeled technique factor control settings or indicators during
any radiographic or CT exposure where the equipment is connected to a
power supply as described in accordance with this paragraph. In the case
of fixed technique factors, the maximum deviation from the nominal fixed
value of each factor shall be stated;
(vii) A statement of the maximum deviation from the continuous
indication of x-ray tube potential and current during any fluoroscopic
exposure when the equipment is connected to a power supply as described
in accordance with this paragraph; and
(viii) A statement describing the measurement criteria for all
technique factors used in paragraphs (h)(3)(iii), (h)(3)(vi), and
(h)(3)(vii) of this section; for example, the beginning and endpoints of
exposure time measured with respect to a certain percentage of the
voltage waveform.
(4) Beam-limiting device. For each variable-aperture beam-limiting
device, there shall be provided;
(i) Leakage technique factors for all combinations of tube housing
assemblies and beam-limiting devices for which the beam-limiting device
manufacturer states compatibility; and
(ii) A statement including the minimum aluminum equivalent of that
part of the device through which the useful beam passes and including
the x-ray tube potential at which the aluminum equivalent was obtained.
When two or more filters are provided as part of the device, the
statement shall include the aluminum equivalent of each filter.
(i) [Reserved]
(j) Warning label. The control panel containing the main power
switch shall bear the warning statement, legible and accessible to view:
``Warning: This x-ray unit may be dangerous to patient and operator
unless safe exposure factors and operating instructions are observed.''
(k) Leakage radiation from the diagnostic source assembly. The
leakage radiation from the diagnostic source assembly measured at a
distance of 1 meter in any direction from the source shall not exceed
2.58 x 10-5 coulombs per kilogram (C/kg) (100 milliroentgens (mR))
in 1 hour when the x-ray tube is operated at the leakage technique
factors. If the maximum rated peak tube potential of the tube housing
assembly is greater than the maximum rated peak tube potential for the
diagnostic source assembly, positive means shall
[[Page 525]]
be provided to limit the maximum x-ray tube potential to that of the
diagnostic source assembly. Compliance shall be determined by
measurements averaged over an area of 100 square centimeters with no
linear dimension greater than 20 centimeters.
(l) Radiation from components other than the diagnostic source
assembly. The radiation emitted by a component other than the diagnostic
source assembly shall not exceed 5.16 x 10-7 C/kg (2 mR) in 1 hour
at 5 centimeters from any accessible surface of the component when it is
operated in an assembled x-ray system under any conditions for which it
was designed. Compliance shall be determined by measurements averaged
over an area of 100 square centimeters with no linear dimension greater
than 20 centimeters.
(m) Beam quality--(1) Half-value layer. The half-value layer (HVL)
of the useful beam for a given x-ray tube potential shall not be less
than the appropriate value shown in Table I under ``Specified dental
systems,'' for any dental x-ray system designed for use with intraoral
image receptors and manufactured after December 1, 1980; and under
``Other x-ray systems,'' for all other x-ray systems subject to this
section. If it is necessary to determine such HVL at an x-ray tube
potential which is not listed in Table I, linear interpolation or
extrapolation may be made. Positive means \2\ shall be provided to
insure that at least the minimum filtration needed to achieve the above
beam quality requirements is in the useful beam during each exposure.
---------------------------------------------------------------------------
\2\ In the case of a system which is to be operated with more than
one thickness of filtration, this requirement can be met by a filter
interlock with the kilovoltage selector which will prevent x-ray
emission if the minimum required filtration is not in place.
Table I
------------------------------------------------------------------------
X-ray tube voltage (kilovolt peak) Minimum HVL
--------------------------------------------------- (millimeters of
aluminum)
Measured ---------------------
Designed operating range operating Specified Other X-
potential dental ray
systems systems
------------------------------------------------------------------------
Below 51............................... 30 1.5 0.3
40 1.5 0.4
50 1.5 0.5
51 to 70............................... 51 1.5 1.2
60 1.5 1.3
70 1.5 1.5
Above 70............................... 71 2.1 2.1
80 2.3 2.3
90 2.5 2.5
100 2.7 2.7
110 3.0 3.0
120 3.2 3.2
130 3.5 3.5
140 3.8 3.8
150 4.1 4.1
------------------------------------------------------------------------
(2) Measuring compliance. For capacitor energy storage equipment,
compliance shall be determined with the maximum selectable quantity of
charge per exposure.
(n) Aluminum equivalent of material between patient and image
receptor. Except when used in a CT x-ray system, the aluminum equivalent
of each of the items listed in Table II, which are used between the
patient and image receptor, may not exceed the indicated limits.
Compliance shall be determined by x-ray measurements made at a potential
of 100 kilovolts peak and with an x-ray beam that has a HVL of 2.7
millimeters of aluminum. This requirement applies to front panel(s) of
cassette holders and film changers provided by the manufacturer for
patient support or for prevention of foreign object intrusions. It does
not apply to screens and their associated mechanical support panels or
grids.
Table II
------------------------------------------------------------------------
Aluminum
Item equivalent
(millimeters)
------------------------------------------------------------------------
Front panel(s) of cassette holder (total of all)........ 1.0
Front panel(s) of film changer (total of all)........... 1.0
Cradle.................................................. 2.0
Tabletop, stationary, without articulated joint(s)...... 1.0
Tabletop, movable, without articulated joint(s)
(including stationary subtop).......................... 1.5
Tabletop, with radiolucent panel having one articulated
joint.................................................. 1.5
[[Page 526]]
Tabletop, with radiolucent panel having two or more
articulated joints..................................... 2.0
Tabletop, cantilevered.................................. 2.0
Tabletop, radiation therapy simulator................... 5.0
------------------------------------------------------------------------
(o) Battery charge indicator. On battery-powered generators, visual
means shall be provided on the control panel to indicate whether the
battery is in a state of charge adequate for proper operation.
(p) [Reserved]
(q) Modification of certified diagnostic x-ray components and
systems--(1) Diagnostic x-ray components and systems certified in
accordance with Sec. 1010.2 of this chapter shall not be modified such
that the component or system fails to comply with any applicable
provision of this chapter unless a variance in accordance with
Sec. 1010.4 of this chapter or an exemption under sections 358(a)(5) or
360B(b) of the Public Health Service Act has been granted.
(2) The owner of a diagnostic x-ray system who uses the system in a
professional or commercial capacity may modify the system, provided the
modification does not result in the failure of the system or component
to comply with the applicable requirements of this section or of
Sec. 1020.31, Sec. 1020.32, or Sec. 1020.33. The owner who causes such
modification need not submit the reports required by subpart B of part
1002 of this chapter, provided the owner records the date and the
details of the modification, and provided the modification of the x-ray
system does not result in a failure to comply with Sec. 1020.31,
Sec. 1020.32, or Sec. 1020.33.
[58 FR 26396, May 3, 1993, as amended at 59 FR 26403, May 19, 1994]
Sec. 1020.31 Radiographic equipment.
The provisions of this section apply to equipment for the recording
of images, except equipment involving use of an image intensifier or
computed tomography x-ray systems manufactured on or after November 28,
1984.
(a) Control and indication of technique factors--(1) Visual
indication. The technique factors to be used during an exposure shall be
indicated before the exposure begins, except when automatic exposure
controls are used, in which case the technique factors which are set
prior to the exposure shall be indicated. On equipment having fixed
technique factors, this requirement may be met by permanent markings.
Indication of technique factors shall be visible from the operator's
position except in the case of spot films made by the fluoroscopist.
(2) Timers. Means shall be provided to terminate the exposure at a
preset time interval, a preset product of current and time, a preset
number of pulses, or a preset radiation exposure to the image receptor.
(i) Except during serial radiography, the operator shall be able to
terminate the exposure at any time during an exposure of greater than
one-half second. Termination of exposure shall cause automatic resetting
of the timer to its initial setting or to zero. It shall not be possible
to make an exposure when the timer is set to a zero or off position if
either position is provided.
(ii) During serial radiography, the operator shall be able to
terminate the x-ray exposure(s) at any time, but means may be provided
to permit completion of any single exposure of the series in process.
(3) Automatic exposure controls. When an automatic exposure control
is provided:
(i) Indication shall be made on the control panel when this mode of
operation is selected;
(ii) When the x-ray tube potential is equal to or greater than 51
kilovolts peak (kVp), the minimum exposure time for field emission
equipment rated for pulsed operation shall be equal to or less than a
time interval equivalent to two pulses and the minimum exposure time for
all other equipment shall be equal to or less than 1/60 second or a time
interval required to deliver 5 milliamperes-seconds (mAs), whichever is
greater;
(iii) Either the product of peak x-ray tube potential, current, and
exposure time shall be limited to not more than 60 kilowatt-seconds
(kW's) per exposure
[[Page 527]]
or the product of x-ray tube current and exposure time shall be limited
to not more than 600 mAs per exposure, except when the x-ray tube
potential is less than 51 kVp, in which case the product of x-ray tube
current and exposure time shall be limited to not more than 2,000 mAs
per exposure; and
(iv) A visible signal shall indicate when an exposure has been
terminated at the limits described in paragraph (a)(3)(iii) of this
section, and manual resetting shall be required before further
automatically timed exposures can be made.
(4) Accuracy. Deviation of technique factors from indicated values
shall not exceed the limits given in the information provided in
accordance with Sec. 1020.30(h)(3);
(b) Reproducibility. The following requirements shall apply when the
equipment is operated on an adequate power supply as specified by the
manufacturer in accordance with the requirements of Sec. 1020.30(h)(3);
(1) Coefficient of variation. For any specific combination of
selected technique factors, the estimated coefficient of variation of
radiation exposures shall be no greater than 0.05.
(2) Measuring compliance. Determination of compliance shall be based
on 10 consecutive measurements taken within a time period of 1 hour.
Equipment manufactured after September 5, 1978, shall be subject to the
additional requirement that all variable controls for technique factors
shall be adjusted to alternate settings and reset to the test setting
after each measurement. The percent line-voltage regulation shall be
determined for each measurement. All values for percent line-voltage
regulation shall be within 1 of the mean value for all
measurements. For equipment having automatic exposure controls,
compliance shall be determined with a sufficient thickness of
attenuating material in the useful beam such that the technique factors
can be adjusted to provide individual exposures of a minimum of 12
pulses on field emission equipment rated for pulsed operation or no less
than one-tenth second per exposure on all other equipment.
(c) Linearity. The following requirements apply when the equipment
is operated on a power supply as specified by the manufacturer in
accordance with the requirements of Sec. 1020.30(h)(3) for any fixed x-
ray tube potential within the range of 40 percent to 100 percent of the
maximum rated.
(1) Equipment having independent selection of x-ray tube current
(mA). The average ratios of exposure to the indicated milliampere-
seconds product (C/kg/mAs (or mR/mAs)) obtained at any two consecutive
tube current settings shall not differ by more than 0.10 times their
sum. This is: |X1-X2|0.10(X1+X2); where
X1 and X2 are the average C/kg/mAs (or mR/mAs) values obtained
at each of two consecutive tube current settings or at two settings
differing by no more than a factor of 2 where the tube current selection
is continuous.
(2) Equipment having selection of x-ray tube current-exposure time
product (mAs). For equipment manufactured after May 3, 1994 the average
ratios of exposure to the indicated milliampere-seconds product (C/kg/
mAs (or mR/mAs)) obtained at any two consecutive mAs selector settings
shall not differ by more than 0.10 times their sum. This is:
|X1-X2|0.10(X1+X2); where X1 and
X2 are the average C/kg/mAs (or mR/mAs) values obtained at each of
two consecutive mAs selector settings or at two settings differing by no
more than a factor of 2 where the mAs selector provides continuous
selection.
(3) Measuring compliance. Determination of compliance will be based
on 10 exposures, made within 1 hour, at each of the two
settings. These two settings may include any two focal spot sizes except
where one is equal to or less than 0.45 millimeters and the other is
greater than 0.45 millimeters. For purposes of this requirement, focal
spot size is the focal spot size specified by the x-ray tube
manufacturer. The percent line-voltage regulation shall be determined
for each measurement. All values for percent line-voltage regulation at
any one combination of technique factors shall be within 1 of the mean
value for all measurements at these technique factors.
(d) Field limitation and alignment for mobile, portable, and
stationary general purpose x-ray systems. Except when spot-film devices
or special attachments for mammography are in serv-
[[Page 528]]
ice, mobile, portable, and stationary general purpose radiographic x-ray
systems shall meet the following requirements:
(1) Variable x-ray field limitation. A means for stepless adjustment
of the size of the x-ray field shall be provided. Each dimension of the
minimum field size at an SID of 100 centimeters shall be equal to or
less than 5 centimeters.
(2) Visual definition. (i) Means for visually defining the perimeter
of the x-ray field shall be provided. The total misalignment of the
edges of the visually defined field with the respective edges of the x-
ray field along either the length or width of the visually defined field
shall not exceed 2 percent of the distance from the source to the center
of the visually defined field when the surface upon which it appears is
perpendicular to the axis of the x-ray beam.
(ii) When a light localizer is used to define the x-ray field, it
shall provide an average illuminance of not less than 160 lux (15
footcandles) at 100 centimeters or at the maximum SID, whichever is
less. The average illuminance shall be based upon measurements made in
the approximate center of each quadrant of the light field. Radiation
therapy simulation systems are exempt from this requirement.
(iii) The edge of the light field at 100 centimeters or at the
maximum SID, whichever is less, shall have a contrast ratio, corrected
for ambient lighting, of not less than 4 in the case of beam-limiting
devices designed for use on stationary equipment, and a contrast ratio
of not less than 3 in the case of beam-limiting devices designed for use
on mobile and portable equipment. The contrast ratio is defined as
I1 I2, where I1 is the illuminance 3 millimeters from the
edge of the light field toward the center of the field; and I2 is
the illuminance 3 millimeters from the edge of the light field away from
the center of the field. Compliance shall be determined with a measuring
aperture of 1 millimeter.
(e) Field indication and alignment on stationary general purpose x-
ray equipment. Except when spot-film devices or special attachments for
mammography are in service, stationary general purpose x-ray systems
shall meet the following requirements in addition to those prescribed in
paragraph (d) of this section:
(1) Means shall be provided to indicate when the axis of the x-ray
beam is perpendicular to the plane of the image receptor, to align the
center of the x-ray field with respect to the center of the image
receptor to within 2 percent of the SID, and to indicate the SID to
within 2 percent;
(2) The beam-limiting device shall numerically indicate the field
size in the plane of the image receptor to which it is adjusted;
(3) Indication of field size dimensions and SID's shall be specified
in centimeters and/or inches and shall be such that aperture adjustments
result in x-ray field dimensions in the plane of the image receptor
which correspond to those indicated by the beam-limiting device to
within 2 percent of the SID when the beam axis is indicated to be
perpendicular to the plane of the image receptor; and
(4) Compliance measurements will be made at discrete SID's and image
receptor dimensions in common clinical use (such as SID's of 100, 150,
and 200 centimeters and/or 36, 40, 48, and 72 inches and nominal image
receptor dimensions of 13, 18, 24, 30, 35, 40, and 43 centimeters and/or
5, 7, 8, 9, 10, 11, 12, 14, and 17 inches) or at any other specific
dimensions at which the beam-limiting device or its associated
diagnostic x-ray system is uniquely designed to operate.
(f) Field limitation on radiographic x-ray equipment other than
general purpose radiographic systems--(1) Equipment for use with
intraoral image receptors. Radiographic equipment designed for use with
an intraoral image receptor shall be provided with means to limit the x-
ray beam such that:
(i) If the minimum source-to-skin distance (SSD) is 18 centimeters
or more, the x-ray field at the minimum SSD shall be containable in a
circle having a diameter of no more than 7 centimeters; and
(ii) If the minimum SSD is less than 18 centimeters, the x-ray field
at the minimum SSD shall be containable in a circle having a diameter of
no more than 6 centimeters.
[[Page 529]]
(2) X-ray systems designed for one image receptor size. Radiographic
equipment designed for only one image receptor size at a fixed SID shall
be provided with means to limit the field at the plane of the image
receptor to dimensions no greater than those of the image receptor, and
to align the center of the x-ray field with the center of the image
receptor to within 2 percent of the SID or shall be provided with means
to both size and align the x-ray field such that the x-ray field at the
plane of the image receptor does not extend beyond any edge of the image
receptor.
(3) Systems designed for or provided with special attachments for
mammography. Radiographic systems designed only for mammography and
general purpose radiographic systems, when special attachments for
mammography are in service, shall be provided with means to limit the
useful beam such that the x-ray field at the plane of the image receptor
does not extend beyond any edge of the image receptor at any designated
SID except the edge of the image receptor designed to be adjacent to the
chest wall where the x-ray field may not extend beyond this edge by more
than 2 percent of the SID. This requirement can be met with a system
which performs as prescribed in paragraphs (f)(4)(i), (f)(4)(ii), and
(f)(4)(iii) of this section. When the beam-limiting device and image
receptor support device are designed to be used to immobilize the breast
during a mammographic procedure and the SID may vary, the SID indication
specified in paragraphs (f)(4)(ii) and (f)(4)(iii) of this section shall
be the maximum SID for which the beam-limiting device or aperture is
designed. In addition, each image receptor support intended for
installation on a system designed only for mammography shall have clear
and permanent markings to indicate the maximum image receptor size for
which it is designed.
(4) Other x-ray systems. Radiographic systems not specifically
covered in paragraphs (d), (e), (f)(2), (f)(3), and (h) of this section
and systems covered in paragraph (f)(1) of this section, which are also
designed for use with extraoral image receptors and when used with an
extraoral image receptor, shall be provided with means to limit the x-
ray field in the plane of the image receptor so that such field does not
exceed each dimension of the image receptor by more than 2 percent of
the SID, when the axis of the x-ray beam is perpendicular to the plane
of the image receptor. In addition, means shall be provided to align the
center of the x-ray field with the center of the image receptor to
within 2 percent of the SID, or means shall be provided to both size and
align the x-ray field such that the x-ray field at the plane of the
image receptor does not extend beyond any edge of the image receptor.
These requirements may be met with:
(i) A system which performs in accordance with paragraphs (d) and
(e) of this section; or when alignment means are also provided, may be
met with either;
(ii) An assortment of removable, fixed-aperture, beam-limiting
devices sufficient to meet the requirement for each combination of image
receptor size and SID for which the unit is designed. Each such device
shall have clear and permanent markings to indicate the image receptor
size and SID for which it is designed; or
(iii) A beam-limiting device having multiple fixed apertures
sufficient to meet the requirement for each combination of image
receptor size and SID for which the unit is designed. Permanent, clearly
legible markings shall indicate the image receptor size and SID for
which each aperture is designed and shall indicate which aperture is in
position for use.
(g) Positive beam limitation (PBL). The requirements of this
paragraph shall apply to radiographic systems which contain PBL.
(1) Field size. When a PBL system is provided, it shall prevent x-
ray production when:
(i) Either the length or width of the x-ray field in the plane of
the image receptor differs from the corresponding image receptor
dimension by more than 3 percent of the SID; or
(ii) The sum of the length and width differences as stated in
paragraph (g)(1)(i) of this section without regard to sign exceeds 4
percent of the SID.
[[Page 530]]
(iii) The beam limiting device is at an SID for which PBL is not
designed for sizing.
(2) Conditions for PBL. When provided, the PBL system shall function
as described in paragraph (g)(1) of this section whenever all the
following conditions are met:
(i) The image receptor is inserted into a permanently mounted
cassette holder;
(ii) The image receptor length and width are less than 50
centimeters;
(iii) The x-ray beam axis is within 3 degrees of
vertical and the SID is 90 centimeters to 130 centimeters inclusive; or
the x-ray beam axis is within 3 degrees of horizontal and
the SID is 90 centimeters to 205 centimeters inclusive;
(iv) The x-ray beam axis is perpendicular to the plane of the image
receptor to within 3 degrees; and
(v) Neither tomographic nor stereoscopic radiography is being
performed.
(3) Measuring compliance. Compliance with the requirements of
paragraph (g)(1) of this section shall be determined when the equipment
indicates that the beam axis is perpendicular to the plane of the image
receptor and the provisions of paragraph (g)(2) of this section are met.
Compliance shall be determined no sooner than 5 seconds after insertion
of the image receptor.
(4) Operator initiated undersizing. The PBL system shall be capable
of operation such that, at the discretion of the operator, the size of
the field may be made smaller than the size of the image receptor
through stepless adjustment of the field size. Each dimension of the
minimum field size at an SID of 100 centimeters shall be equal to or
less than 5 centimeters. Return to PBL function as described in
paragraph (g)(1) of this section shall occur automatically upon any
change of image receptor size or SID.
(5) Override of PBL. A capability may be provided for overriding PBL
in case of system failure and for servicing the system. This override
may be for all SID's and image receptor sizes. A key shall be required
for any override capability that is accessible to the operator. It shall
not be possible to remove the key while PBL is overridden. Each such key
switch or key shall be clearly and durably labeled as follows:
For X-ray Field Limitation System Failure
The override capability is considered accessible to the operator if
it is referenced in the operator's manual or in other material intended
for the operator or if its location is such that the operator would
consider it part of the operational controls.
(h) Field limitation and alignment for spot-film devices. The
following requirements shall apply to spot-film devices, except when the
spot-film device is provided for use with a radiation therapy simulation
system:
(1) Means shall be provided between the source and the patient for
adjustment of the x-ray field size in the plane of the image receptor to
the size of that portion of the image receptor which has been selected
on the spot-film selector. Such adjustment shall be accomplished
automatically when the x-ray field size in the plane of the image
receptor is greater than the selected portion of the image receptor. If
the x-ray field size is less than the size of the selected portion of
the image receptor, the field size shall not open automatically to the
size of the selected portion of the image receptor unless the operator
has selected that mode of operation.
(2) Neither the length nor the width of the x-ray field in the plane
of the image receptor shall differ from the corresponding dimensions of
the selected portion of the image receptor by more than 3 percent of the
SID when adjusted for full coverage of the selected portion of the image
receptor. The sum, without regard to sign, of the length and width
differences shall not exceed 4 percent of the SID. On spot-film devices
manufactured after February 25, 1978, if the angle between the plane of
the image receptor and beam axis is variable, means shall be provided to
indicate when the axis of the x-ray beam is perpendicular to the plane
of the image receptor, and compliance shall be determined with the beam
axis indicated to be perpendicular to the plane of the image receptor.
(3) The center of the x-ray field in the plane of the image receptor
shall be aligned with the center of the selected
[[Page 531]]
portion of the image receptor to within 2 percent of the SID.
(4) Means shall be provided to reduce the x-ray field size in the
plane of the image receptor to a size smaller than the selected portion
of the image receptor such that:
(i) For spot-film devices used on fixed-SID fluoroscopic systems
which are not required to, and do not provide stepless adjustment of the
x-ray field, the minimum field size, at the greatest SID, does not
exceed 125 square centimeters; or
(ii) For spot-film devices used on fluoroscopic systems that have a
variable SID and/or stepless adjustment of the field size, the minimum
field size, at the greatest SID, shall be containable in a square of 5
centimeters by 5 centimeters.
(5) A capability may be provided for overriding the automatic x-ray
field size adjustment in case of system failure. If it is so provided, a
signal visible at the fluoroscopist's position shall indicate whenever
the automatic x-ray field size adjustment override is engaged. Each such
system failure override switch shall be clearly labeled as follows:
For X-ray Field Limitation System Failure
(i) Source-skin distance--(1) X-ray systems designed for use with an
intraoral image receptor shall be provided with means to limit the
source-skin distance to not less than:
(i) Eighteen centimeters if operable above 50 kVp; or
(ii) Ten centimeters if not operable above 50 kVp.
(2) Mobile and portable x-ray systems other than dental shall be
provided with means to limit the source-skin distance to not less than
30 centimeters.
(j) Beam-on indicators. The x-ray control shall provide visual
indication whenever x-rays are produced. In addition, a signal audible
to the operator shall indicate that the exposure has terminated.
(k) Multiple tubes. Where two or more radiographic tubes are
controlled by one exposure switch, the tube or tubes which have been
selected shall be clearly indicated before initiation of the exposure.
This indication shall be both on the x-ray control and at or near the
tube housing assembly which has been selected.
(l) Radiation from capacitor energy storage equipment. Radiation
emitted from the x-ray tube shall not exceed:
(1) 8.6 x 10-9 C/kg (0.03 mR) in 1 minute at 5 centimeters from
any accessible surface of the diagnostic source assembly, with the beam-
limiting device fully open, the system fully charged, and the exposure
switch, timer, or any discharge mechanism not activated. Compliance
shall be determined by measurements averaged over an area of 100 square
centimeters, with no linear dimension greater than 20 centimeters; and
(2) 2.58 x 10-5 C/kg (100 mR) in 1 hour at 100 centimeters from
the x-ray source, with the beam-limiting device fully open, when the
system is discharged through the x-ray tube either manually or
automatically by use of a discharge switch or deactivation of the input
power. Compliance shall be determined by measurements of the maximum
exposure per discharge multiplied by the total number of discharges in 1
hour (duty cycle). The measurements shall be averaged over an area of
100 square centimeters with no linear dimension greater than 20
centimeters.
(m) Transmission limit for image receptor supporting devices used
for mammography. For x-ray systems manufactured after September 5, 1978,
which are designed only for mammography, the transmission of the primary
beam through any image receptor support provided with the system shall
be limited such that the exposure 5 centimeters from any accessible
surface beyond the plane of the image receptor supporting device does
not exceed 2.58 x 10-8 C/kg (0.1 mR) for each activation of the
tube. Exposure shall be measured with the system operated at the minimum
SID for which it is designed. Compliance shall be determined at the
maximum rated peak tube potential for the system and at the maximum
rated product of the tube current and exposure time (mAs) for that peak
tube potential. Compliance shall be determined by measurements averaged
over an area of 100 square centimeters
[[Page 532]]
with no linear dimension greater than 20 centimeters.
[58 FR 26401, May 3, 1993; 58 FR 31067, May 28, 1993]
Sec. 1020.32 Fluoroscopic equipment.
The provisions of this section apply to equipment for fluoroscopy
and for the recording of images through an image intensifier except
computed tomography x-ray systems manufactured on or after November 29,
1984.
(a) Primary protective barrier--(1) Limitation of useful beam. The
fluoroscopic imaging assembly shall be provided with a primary
protective barrier which intercepts the entire cross section of the
useful beam at any SID. The x-ray tube used for fluoroscopy shall not
produce x-rays unless the barrier is in position to intercept the entire
useful beam. The exposure rate due to transmission through the barrier
with the attenuation block in the useful beam combined with radiation
from the image intensifier if provided, shall not exceed
3.34 x 10-3 percent of the entrance exposure rate, at a distance of
10 centimeters from any accessible surface of the fluoroscopic imaging
assembly beyond the plane of the image receptor. Radiation therapy
simulation systems shall be exempt from this requirement provided the
systems are intended only for remote control operation and the
manufacturer sets forth instructions for assemblers with respect to
control location as part of the information required in Sec. 1020.30(g).
Additionally, the manufacturer shall provide to users, pursuant to
Sec. 1020.30(h)(1)(i), precautions concerning the importance of remote
control operation.
(2) Measuring compliance. The entrance exposure rate shall be
measured in accordance with paragraph (d) of this section. The exposure
rate due to transmission through the primary barrier combined with
radiation from the image intensifier shall be determined by measurements
averaged over an area of 100 square centimeters with no linear dimension
greater than 20 centimeters. If the source is below the tabletop, the
measurement shall be made with the input surface of the fluoroscopic
imaging assembly positioned 30 centimeters above the tabletop. If the
source is above the tabletop and the SID is variable, the measurement
shall be made with the end of the beam-limiting device or spacer as
close to the tabletop as it can be placed, provided that it shall not be
closer than 30 centimeters. Movable grids and compression devices shall
be removed from the useful beam during the measurement. For all
measurements, the attenuation block shall be positioned in the useful
beam 10 centimeters from the point of measurement of entrance exposure
rate and between this point and the input surface of the fluoroscopic
imaging assembly.
(b) Field limitation--(1) Nonimage-intensified fluoroscopy. (i) The
x-ray field produced by nonimage-intensified fluoroscopic equipment
shall not extend beyond the entire visible area of the image receptor.
Means shall be provided for stepless adjustment of the field size. The
minimum field size, at the greatest SID, shall be containable in a
square of 5 centimeters by 5 centimeters.
(ii) For equipment manufactured after February 25, 1978, when the
angle between the image receptor and the beam axis of the x-ray beam is
variable, means shall be provided to indicate when the axis of the x-ray
beam is perpendicular to the plane of the image receptor. Compliance
with paragraph (b)(1)(i) of this section shall be determined with the
beam axis indicated to be perpendicular to the plane of the image
receptor.
(2) Image-intensified fluoroscopy. (i) For image-intensified
fluoroscopic equipment other than radiation therapy simulation systems,
neither the length nor the width of the x-ray field in the plane of the
image receptor shall exceed that of the visible area of the image
receptor by more than 3 percent of the SID. The sum of the excess length
and the excess width shall be no greater than 4 percent of the SID.
(ii) For rectangular x-ray fields used with circular image
receptors, the error in alignment shall be determined along the length
and width dimensions of the x-ray field which pass through the center of
the visible area of the image receptor.
(iii) For equipment manufactured after February 25, 1978, when the
angle
[[Page 533]]
between the image receptor and beam axis is variable, means shall be
provided to indicate when the axis of the x-ray beam is perpendicular to
the plane of the image receptor. Compliance with paragraph (b)(2)(i) of
this section shall be determined with the beam axis indicated to be
perpendicular to the plane of the image receptor.
(iv) Means shall be provided to permit further limitation of the
field. Beam-limiting devices manufactured after May 22, 1979, and
incorporated in equipment with a variable SID and/or the capability of a
visible area of greater than 300 square centimeters shall be provided
with means for stepless adjustment of the x-ray field. Equipment with a
fixed SID and the capability of a visible area of no greater than 300
square centimeters shall be provided with either stepless adjustment of
the x-ray field or with a means to further limit the x-ray field size at
the plane of the image receptor to 125 square centimeters or less.
Stepless adjustment shall, at the greatest SID, provide continuous field
sizes from the maximum obtainable to a field size containable in a
square of 5 centimeters by 5 centimeters.
(3) If the fluoroscopic x-ray field size is adjusted automatically
as the SID or image receptor size is changed, a capability may be
provided for overriding the automatic adjustment in case of system
failure. If it is so provided, a signal visible at the fluoroscopist's
position shall indicate whenever the automatic field adjustment is
overridden. Each such system failure override switch shall be clearly
labeled as follows:
For X-ray Field Limitation System Failure
(c) Activation of tube. X-ray production in the fluoroscopic mode
shall be controlled by a device which requires continuous pressure by
the operator for the entire time of any exposure. When recording serial
fluoroscopic images, the operator shall be able to terminate the x-ray
exposure(s) at any time, but means may be provided to permit completion
of any single exposure of the series in process.
(d) Entrance exposure rates. For fluoroscopic equipment manufactured
before May 19, 1995, the following requirements apply:
(1) Equipment with automatic exposure rate control (AERC).
Fluoroscopic equipment that is provided with AERC shall not be operable
at any combination of tube potential and current that will result in an
exposure rate in excess of 2.58x10-3 coulomb per kilogram (C/kg)
per minute (10 roentgens per minute (10 R/min)) at the point where the
center of the useful beam enters the patient, except:
(i) During recording of fluoroscopic images, or
(ii) When an optional high-level control is provided. When so
provided, the equipment shall not be operable at any combination of tube
potential and current that will result in an exposure rate in excess of
1.29x10-3 C/kg per minute (5 R/min) at the point where the center
of the useful beam enters the patient, unless the high-level control is
activated. Special means of activation of high-level controls shall be
required. The high-level control shall be operable only when continuous
manual activation is provided by the operator. A continuous signal
audible to the fluoroscopist shall indicate that the high-level control
is being employed.
(2) Equipment without AERC (manual mode). Fluoroscopic equipment
that is not provided with AERC shall not be operable at any combination
of tube potential and current that will result in an exposure rate in
excess of 1.29x10-3 C/kg per minute (5 R/min) at the point where
the center of the useful beam enters the patient, except:
(i) During recording of fluoroscopic images, or
(ii) When an optional high-level control is activated. Special means
of activation of high-level controls shall be required. The high-level
control shall be operable only when continuous manual activation is
provided by the operator. A continuous signal audible to the
fluoroscopist shall indicate that the high-level control is being
employed.
(3) Equipment with both an AERC mode and a manual mode. Fluoroscopic
equipment that is provided with both an AERC mode and a manual mode
shall not be operable at any combination of tube potential and current
that will result in an exposure rate in excess of
[[Page 534]]
2.58x10-3 C/kg per minute (10 R/min) in either mode at the point
where the center of the useful beam enters the patient except:
(i) During recording of fluoroscopic images, or
(ii) When the mode or modes have an optional high-level control, in
which case that mode or modes shall not be operable at any combination
of tube potential and current that will result in an exposure rate in
excess of 1.29x10-3 C/kg per minute (5 R/min) at the point where
the center of the useful beam enters the patient, unless the high-level
control is activated. Special means of activation of high-level controls
shall be required. The high-level control shall be operable only when
continuous manual activation is provided by the operator. A continuous
signal audible to the fluoroscopist shall indicate that the high-level
is being employed.
(4) Measuring compliance. Compliance with paragraph (d) of this
section shall be determined as follows:
(i) If the source is below the x-ray table, the exposure rate shall
be measured at 1 centimeter above the tabletop or cradle.
(ii) If the source is above the x-ray table, the exposure rate shall
be measured at 30 centimeters above the tabletop with the end of the
beam-limiting device or spacer positioned as closely as possible to the
point of measurement.
(iii) In a C-arm type of fluoroscope, the exposure rate shall be
measured at 30 centimeters from the input surface of the fluoroscopic
imaging assembly, with the source positioned at any available SID,
provided that the end of the beam-limiting device or spacer is no closer
than 30 centimeters from the input surface of the imaging assembly.
(iv) In a lateral type of fluoroscope, the exposure rate shall be
measured at a point 15 centimeters from the centerline of the x-ray
table and in the direction of the x-ray source with the end of the beam-
limiting device or spacer positioned as closely as possible to the point
of measurement. If the tabletop is movable, it shall be positioned as
closely as possible to the lateral x-ray source, with the end of the
beam-limiting device or spacer no closer than 15 centimeters to the
centerline of the x-ray table.
(5) Exemptions. Fluoroscopic radiation therapy simulation systems
are exempt from the requirements set forth in paragraph (d) of this
section.
(e) Entrance exposure rate limits. For fluoroscopic equipment
manufactured on and after May 19, 1995, the following requirements
apply:
(1) Fluoroscopic equipment operable at any combination of tube
potential and current that results in an exposure rate greater than
1.29x10-3 C/kg per minute (5 R/min) at the point where the center
of the useful beam enters the patient shall be equipped with AERC.
Provision for manual selection of technique factors may be provided.
(2) Fluoroscopic equipment shall not be operable at any combination
of tube potential and current that will result in an exposure rate in
excess of 2.58x10-3 C/kg per minute (10 R/min) at the point where
the center of the useful beam enters the patient except:
(i) During the recording of images from an x-ray image-intensifier
tube using photographic film or a video camera when the x-ray source is
operated in a pulsed mode.
(ii) When an optional high-level control is activated. When the
high-level control is activated, the equipment shall not be operable at
any combination of tube potential and current that will result in an
exposure rate in excess of 5.16x10-3 C/kg per minute (20 R/min) at
the point where the center of the useful beam enters the patient.
Special means of activation of high-level controls shall be required.
The high-level control shall only be operable when continuous manual
activation is provided by the operator. A continuous signal audible to
the fluoroscopist shall indicate that the high-level control is being
employed.
(3) Measuring compliance. Compliance with paragraph (e) of this
section shall be determined as follows:
(i) If the source is below the x-ray table, the exposure rate shall
be measured at 1 centimeter above the tabletop or cradle.
(ii) If the source is above the x-ray table, the exposure rate shall
be measured at 30 centimeters above the tabletop with the end of the
beam-limiting
[[Page 535]]
device or spacer positioned as closely as possible to the point of
measurement.
(iii) In a C-arm type of fluoroscope, the exposure rate shall be
measured at 30 centimeters from the input surface of the fluoroscopic
imaging assembly, with the source positioned at any available SID,
provided that the end of the beam-limiting device or spacer is no closer
than 30 centimeters from the input surface of the fluoroscopic imaging
assembly.
(iv) In a lateral type of fluoroscope, the exposure rate shall be
measured at a point 15 centimeters from the centerline of the x-ray
table and in the direction of the x-ray source with the end of the beam-
limiting device or spacer positioned as closely as possible to the point
of measurement. If the tabletop is movable, it shall be positioned as
closely as possible to the lateral x-ray source, with the end of the
beam-limiting device or spacer no closer than 15 centimeters to the
centerline of the x-ray table.
(4) Exemptions. Fluoroscopic radiation therapy simulation systems
are exempt from the requirements set forth in paragraph (e) of this
section.
(f) Indication of potential and current. During fluoroscopy and
cinefluorography, x-ray tube potential and current shall be continuously
indicated. Deviation of x-ray tube potential and current from the
indicated values shall not exceed the maximum deviation as stated by the
manufacturer in accordance with Sec. 1020.30(h)(3).
(g) Source-skin distance. Means shall be provided to limit the
source-skin distance to not less than 38 centimeters on stationary
fluoroscopes and to not less than 30 centimeters on mobile and portable
fluoroscopes. In addition, for image-intensified fluoroscopes intended
for specific surgical application that would be prohibited at the
source-skin distances specified in this paragraph, provisions may be
made for operation at shorter source-skin distances but in no case less
than 20 centimeters. When provided, the manufacturer must set forth
precautions with respect to the optional means of spacing, in addition
to other information as required in Sec. 1020.30(h).
(h) Fluoroscopic timer. Means shall be provided to preset the
cumulative on-time of the fluoroscopic tube. The maximum cumulative time
of the timing device shall not exceed 5 minutes without resetting. A
signal audible to the fluoroscopist shall indicate the completion of any
preset cumulative on-time. Such signal shall continue to sound while x-
rays are produced until the timing device is reset. As an alternative to
the requirements of this paragraph, radiation therapy simulation systems
may be provided with a means to indicate the total cumulative exposure
time during which x-rays were produced, and which is capable of being
reset between x-ray examinations.
(i) Mobile and portable fluoroscopes. In addition to the foregoing
requirements of this section, mobile and portable fluoroscopes shall
provide intensified imaging.
[58 FR 26404, May 3, 1993, as amended at 59 FR 26404, May 19, 1994]
Sec. 1020.33 Computed tomography (CT) equipment.
(a) Applicability. (1) The provisions of this section, except for
paragraphs (b), (c)(1), and (c)(2) are applicable as specified herein to
CT x-ray systems manufactured or remanufactured on or after September 3,
1985.
(2) The provisions of paragraphs (b), (c)(1), and (c)(2) are
applicable to CT x-ray systems manufactured or remanufactured on or
after November 29, 1984.
(b) Definitions. As used in this section, the following definitions
apply:
(1) Computed tomography dose index (CTDI) means the integral of the
dose profile along a line perpendicular to the tomographic plane divided
by the product of the nominal tomographic section thickness and the
number of tomograms produced in a single scan; that is:
+7
CTDI = 1/nT D (z) dz
-7
Where:
z=position along a line perpendicular to the tomographic plane.
D(z)=Dose at position z.
[[Page 536]]
T=Nominal tomographic section thickness.
n=Number of tomograms produced in a single scan.
This definition assumes that the dose profile is centered around z=0 and
that, for a multiple tomogram system, the scan increment between
adjacent scans is nT.
(2) Contrast scale means the change in linear attenuation
coefficient per CT number relative to water; that is:
x-w
Contrast scale= -----------------------
(CT)x-(CT)w
Where:
w=Linear attenuation coefficient of water.
x=Linear attenuation coefficient of material of interest.
(CT)w=CT number of water.
(CT)x=CT number of material of interest.
(3) CT conditions of operation means all selectable parameters
governing the operation of a CT x-ray system including nominal
tomographic section thickness, filtration, and the technique factors as
defined in Sec. 1020.30(b)(36).
(4) CT number means the number used to represent the x-ray
attenuation associated with each elemental area of the CT image.
(5) [Reserved]
(6) CT dosimetry phantom means the phantom used for determination of
the dose delivered by a CT x-ray system. The phantom shall be a right
circular cylinder of polymethl-methacrylate of density
1.190.01 grams per cubic centimeter. The phantom shall be at
least 14 centimeters in length and shall have diameters of 32.0
centimeters for testing any CT system designed to image any section of
the body (whole body scanners) and 16.0 centimeters for any system
designed to image the head (head scanners) or for any whole body scanner
operated in the head scanning mode. The phantom shall provide means for
the placement of a dosimeter(s) along its axis of rotation and along a
line parallel to the axis of rotation 1.0 centimeter from the outer
surface and within the phantom. Means for the placement of a
dosimeter(s) or alignment device at other locations may be provided for
convenience. The means used for placement of a dosimeter(s) (i.e., hole
size) and the type of dosimeter(s) used is at the discretion of the
manufacturer. Any effect on the doses measured due to the removal of
phantom material to accommodate dosimeters shall be accounted for
through appropriate corrections to the reported data or included in the
statement of maximum deviation for the values obtained using the
phantom.
(7) Dose profile means the dose as a function of position along a
line.
(8) Modulation transfer function means the modulus of the Fourier
transform of the impulse response of the system.
(9) Multiple tomogram system means a CT x-ray system which obtains
x-ray transmission data simultaneously during a single scan to produce
more than one tomogram.
(10) Noise means the standard deviation of the fluctuations in CT
number expressed as a percent of the attenuation coefficient of water.
Its estimate (Sn) is calculated using the following expression:
100 x CS x s
Sn= --------------
w
Where:
CS=Contrast scale.
w=Linear attenuation coefficient of water.
s=Estimated standard deviation of the CT numbers of picture elements in
a specified area of the CT image.
(11) Nominal tomographic section thickness means the full-width at
half-maximum of the sensitivity profile taken at the center of the
cross-sectional volume over which x-ray transmission data are collected.
(12) Picture element means an elemental area of a tomogram.
(13) Remanufacturing means modifying a CT system in such a way that
the resulting dose and imaging performance become substantially
equivalent to any CT x-ray system manufactured by the original
manufacturer on or after November 29, 1984. Any reference in this
section to ``manufacture'', ``manufacturer'', or ``manufacturing''
includes remanufacture, remanufacturer, or remanufacturing,
respectively.
(14) Scan increment means the amount of relative displacement of the
patient with respect to the CT x-ray system between successive scans
measured along the direction of such displacement.
[[Page 537]]
(15) Scan sequence means a preselected set of two or more scans
performed consecutively under preselected CT conditions of operations.
(16) Sensitivity profile means the relative response of the CT x-ray
system as a function of position along a line perpendicular to the
tomographic plane.
(17) Single tomogram system means a CT x-ray system which obtains x-
ray transmission data during a scan to produce a single tomogram.
(18) Tomographic plane means that geometric plane which the
manufacturer identifies as corresponding to the output tomogram.
(19) Tomographic section means the volume of an object whose x-ray
attenuation properties are imaged in a tomogram.
(c) Information to be provided for users. Each manufacturer of a CT
x-ray system shall provide the following technical and safety
information, in addition to that required under Sec. 1020.30(h), to
purchasers and, upon request, to others at a cost not to exceed the cost
of publication and distribution of such information. This information
shall be identified and provided in a separate section of the user's
instruction manual or in a separate manual devoted only to this
information.
(1) Conditions of operation. A statement of the CT conditions of
operation used to provide the information required by paragraph (c) (2)
and (3) of this section.
(2) Dose information. The following dose information obtained by
using the CT dosimetry phantom. For any CT x-ray system designed to
image both the head and body, separate dose information shall be
provided for each application. All dose measurements shall be performed
with the CT dosimetry phantom placed on the patient couch or support
device without additional attenuating materials present.
(i) The CTDI at the following locations in the dosimetry phantom:
(a) Along the axis of rotation of the phantom.
(b) Along a line parallel to the axis of rotation and 1.0 centimeter
interior to the surface of the phantom with the phantom positioned so
that CTDI is the maximum obtainable at this depth.
(c) Along lines parallel to the axis of rotation and 1.0 centimeter
interior to the surface of the phantom at positions 90, 180, and 270
degrees from the position in paragraph (c)(2)(i)(b) of this section. The
CT conditions of operation shall be the typical values suggested by the
manufacturer for CT of the head or body. The location of the position
where the CTDI is maximum as specified in paragraph (c)(2)(i)(b) of this
section shall be given by the manufacturer with respect to the housing
of the scanning mechanism or other readily identifiable feature of the
CT x-ray system in such a manner as to permit placement of the dosimetry
phantom in this orientation.
(ii) The CTDI in the center location of the dosimetry phantom for
each selectable CT condition of operation that varies either the rate or
duration of x-ray exposure. This CTDI shall be presented as a value that
is normalized to the CTDI in the center location of the dosimetry
phantom from paragraph (c)(2)(i) of this section, with the CTDI of
paragraph (c)(2)(i) of this section having a value of one. As each
individual CT condition of operation is changed, all other independent
CT conditions of operation shall be maintained at the typical values
described in paragraph (c)(2)(i) of this section. These data shall
encompass the range of each CT condition of operation stated by the
manufacturer as appropriate for CT of the head or body. When more than
three selections of a CT condition of operation are available, the
normalized CTDI shall be provided, at least, for the minimum, maximum,
and mid-range value of the CT condition of operation.
(iii) The CTDI at the location coincident with the maximum CTDI at 1
centimeter interior to the surface of the dosimetry phantom for each
selectable peak tube potential. When more than three selections of peak
tube potential are available, the normalized CTDI shall be provided, at
least, for the minimum, maximum, and a typical value of peak tube
potential. The CTDI shall be presented as a value that is normalized to
the maximum CTDI located at 1 centimeter interior to the surface of
[[Page 538]]
the dosimetry phantom from paragraph (c)(2)(i) of this section, with the
CTDI of paragraph (c)(2)(i) of this section having a value of one.
(iv) The dose profile in the center location of the dosimetry
phantom for each selectable nominal tomographic section thickness. When
more than three selections of nominal tomographic section thicknesses
are available, the information shall be provided, at least, for the
minimum, maximum, and midrange value of nominal tomographic section
thickness. The dose profile shall be presented on the same graph and to
the same scale as the corresponding sensitivity profile required by
paragraph (c)(3)(iv) of this section.
(v) A statement of the maximum deviation from the values given in
the information provided according to paragraph (c)(2) (i), (ii), (iii),
and (iv) of this section. Deviation of actual values may not exceed
these limits.
(3) Imaging performance information. The following performance data
shall be provided for the CT conditions of operation used to provide the
information required by paragraph (c)(2)(i) of this section. All other
aspects of data collection, including the x-ray attenuation properties
of the material in the tomographic section, shall be similar to those
used to provide the dose information required by paragraph (c)(2)(i) of
this section. For any CT x-ray system designed to image both the head
and body, separate imaging performance information shall be provided for
each application.
(i) A statement of the noise.
(ii) A graphical presentation of the modulation transfer function
for the same image processing and display mode as that used in the
statement of the noise.
(iii) A statement of the nominal tomographic section thickness(es).
(iv) A graphical presentation of the sensitivity profile, at the
location corresponding to the center location of the dosimetry phantom,
for each selectable nominal tomographic section thickness for which the
dose profile is given according to paragraph (c)(2)(iv) of this section.
(v) A description of the phantom or device and test protocol or
procedure used to determine the specifications and a statement of the
maximum deviation from the specifications provided in accordance with
paragraphs (c)(3) (i), (ii), (iii), and (iv) of this section. Deviation
of actual values may not exceed these limits.
(d) Quality assurance. The manufacturer of any CT x-ray system shall
provide the following with each system. All information required by this
subsection shall be provided in a separate section of the user's
instructional manual.
(1) A phantom(s) capable of providing an indication of contrast
scale, noise, nominal tomographic section thickness, the spatial
resolution capability of the system for low and high contrast objects,
and measuring the mean CT number of water or a reference material.
(2) Instructions on the use of the phantom(s) including a schedule
of testing appropriate for the system, allowable variations for the
indicated parameters, and a method to store as records, quality
assurance data.
(3) Representative images obtained with the phantom(s) using the
same processing mode and CT conditions of operation as in paragraph
(c)(3) of this section for a properly functioning system of the same
model. The representative images shall be of two forms as follows:
(i) Photographic copies of the images obtained from the image
display device.
(ii) Images stored in digital form on a storage medium compatible
with the CT x-ray system. The CT x-ray system shall be provided with the
means to display these images on the image display device.
(e) [Reserved]
(f) Control and indication of conditions of operation--(1) Visual
indication. The CT conditions of operation to be used during a scan or a
scan sequence shall be indicated prior to initiation of a scan or a scan
sequence. On equipment having all or some of these conditions of
operation at fixed values, this requirement may be met by permanent
markings. Indication of the CT conditions of operation shall be visible
from any position from which scan initiation is possible.
[[Page 539]]
(2) Timers. (i) Means shall be provided to terminate the x-ray
exposure automatically by either deenergizing the x-ray source or
shuttering the x-ray beam in the event of equipment failure affecting
data collection. Such termination shall occur within an interval that
limits the total scan time to no more than 110 percent of its preset
value through the use of either a backup timer or devices which monitor
equipment function. A visible signal shall indicate when the x-ray
exposure has been terminated through these means and manual resetting of
the CT conditions of operation shall be required prior to the initiation
of another scan.
(ii) Means shall be provided so that the operator can terminate the
x-ray exposure at any time during a scan, or series of scans under x-ray
system control, of greater than one-half second duration. Termination of
the x-ray exposure shall necessitate resetting of the CT conditions of
operation prior to the initiation of another scan.
(g) Tomographic plane indication and alignment. (1) For any single
tomogram system, means shall be provided to permit visual determination
of the tomographic plane or a reference plane offset from the
tomographic plane.
(2) For any multiple tomogram system, means shall be provided to
permit visual determination of the location of a reference plane. The
relationship of the reference plane to the planes of the tomograms shall
be provided to the user in addition to other information provided
according to Sec. 1020.30(h). This reference plane can be offset from
the location of the tomographic planes.
(3) The distance between the indicated location of the tomographic
plane or reference plane and its actual location may not exceed 5
millimeters.
(4) For any offset alignment system, the manufacturer shall provide
specific instructions with respect to the use of this system for patient
positioning, in addition to other information provided according to
Sec. 1020.30(h).
(5) If a mechanism using a light source is used to satisfy the
requirements of paragraphs (g) (1) and (2) of this section, the light
source shall allow visual determination of the location of the
tomographic plane or reference plane under ambient light conditions of
up to 500 lux.
(h) Beam-on and shutter status indicators. (1) Means shall be
provided on the control and on or near the housing of the scanning
mechanism to provide visual indication when and only when x rays are
produced and, if applicable, whether the shutter is open or closed. If
the x-ray production period is less than one-half second, the indication
of x-ray production shall be actuated for one-half second. Indicators at
or near the housing of the scanning mechanism shall be discernible from
any point external to the patient opening where insertion of any part of
the human body into the primary beam is possible.
(2) For systems that allow high voltage to be applied to the x-ray
tube continuously and that control the emission of x rays with a
shutter, the radiation emitted may not exceed 100 milliroentgens
(2.58 x 10-5 coulomb/kilogram) in 1 hour at any point 5 centimeters
outside the external surface of the housing of the scanning mechanism
when the shutter is closed. Compliance shall be determined by
measurements averaged over an area of 100 square centimeters with no
linear dimensions greater than 20 centimeters.
(i) Scan increment accuracy. The deviation of indicated scan
increment from actual scan increment may not exceed 1 millimeter.
Compliance shall be measured as follows: The determination of the
deviation of indicated versus actual scan increment shall be based on
measurements taken with a mass 100 kilograms or less, on the patient
support device. The patient support device shall be incremented from a
typical starting position to the maximum incrementation distance or 30
centimeters, whichever is less, and then returned to the starting
position. Measurement of actual versus indicated scan increment may be
taken anywhere along this travel.
(j) CT number mean and standard deviation. (1) A method shall be
provided to calculate the mean and standard deviation of CT numbers for
an array of picture elements about any location in the image. The number
of elements in this array shall be under user control.
(2) The manufacturer shall provide specific instructions concerning
the
[[Page 540]]
use of the method provided for calculation of CT number mean and
standard deviation in addition to other information provided according
to Sec. 1020.30(h).
(The information collection requirements in paragraphs (c), (d), (g),
and (j) were approved by the Office of Management and Budget under
control number 0910-0025)
[49 FR 34712, Aug. 31, 1984; 49 37381, Sept. 24, 1984, as amended at 49
FR 47388, Dec. 4, 1984; 56 FR 36098, Aug. 1, 1991]
Sec. 1020.40 Cabinet x-ray systems.
(a) Applicability. The provisions of this section are applicable to
cabinet x-ray systems manufactured or assembled on or after April 10,
1975, except that the provisions as applied to x-ray systems designed
primarily for the inspection of carry-on baggage are applicable to such
systems manufactured or assembled on or after April 25, 1974. The
provisions of this section are not applicable to systems which are
designed exclusively for microscopic examination of material, e.g., x-
ray diffraction, spectroscopic, and electron microscope equipment or to
systems for intentional exposure of humans to x-rays.
(b) Definitions. As used in this section the following definitions
apply:
(1) Access panel means any barrier or panel which is designed to be
removed or opened for maintenance or service purposes, requires tools to
open, and permits access to the interior of the cabinet.
(2) Aperture means any opening in the outside surface of the
cabinet, other than a port, which remains open during generation of x
radiation.
(3) Cabinet x-ray system means an x-ray system with the x-ray tube
installed in an enclosure (hereinafter termed cabinet) which,
independently of existing architectural structures except the floor on
which it may be placed, is intended to contain at least that portion of
a material being irradiated, provide radiation attenuation, and exclude
personnel from its interior during generation of x radiation. Included
are all x-ray systems designed primarily for the inspection of carry-on
baggage at airline, railroad, and bus terminals, and in similar
facilities. An x-ray tube used within a shielded part of a building, or
x-ray equipment which may temporarily or occasionally incorporate
portable shielding is not considered a cabinet x-ray system.
(4) Door means any barrier which is designed to be movable or opened
for routine operation purposes, does not generally require tools to
open, and permits access to the interior of the cabinet. For the
purposes of paragraph (c)(4)(i) of this section, inflexible hardware
rigidly affixed to the door shall be considered part of the door.
(5) Exposure means the quotient of dQ by dm where dQ is the absolute
value of the total charge of the ions of one sign produced in air when
all the electrons (negatrons and positrons) liberated by photons in a
volume element of air having mass dm are completely stopped in air.
(6) External surface means the outside surface of the cabinet x-ray
system, including the high-voltage generator, doors, access panels,
latches, control knobs, and other permanently mounted hardware and
including the plane across any aperture or port.
(7) Floor means the underside external surface of the cabinet.
(8) Ground fault means an accidental electrical grounding of an
electrical conductor.
(9) Port means any opening in the outside surface of the cabinet
which is designed to remain open, during generation of x-rays, for the
purpose of conveying material to be irradiated into and out of the
cabinet, or for partial insertion for irradiation of an object whose
dimensions do not permit complete insertion into the cabinet.
(10) Primary beam means the x radiation emitted directly from the
from the target and passing through the window of the x-ray tube.
(11) Safety interlock means a device which is intended to prevent
the generation of x radiation when access by any part of the human body
to the interior of the cabinet x-ray system through a door or access
panel is possible.
(12) X-ray system means an assemblage of components for the
controlled generation of x-rays.
(13) X-ray tube means any electron tube which is designed for the
conversion of electrical energy into x-ray energy.
[[Page 541]]
(c) Requirements--(1) Emission limit. (i) Radiation emitted from the
cabinet x-ray system shall not exceed an exposure of 0.5 milliroentgen
in one hour at any point five centimeters outside the external surface.
(ii) Compliance with the exposure limit in paragraph (c)(1)(i) of
this section shall be determined by measurements averaged over a cross-
sectional area of ten square centimeters with no linear dimension
greater than 5 centimeters, with the cabinet x-ray system operated at
those combinations of x-ray tube potential, current, beam orientation,
and conditions of scatter radiation which produce the maximum x-ray
exposure at the external surface, and with the door(s) and access
panel(s) fully closed as well as fixed at any other position(s) which
will allow the generation of x radiation.
(2) Floors. A cabinet x-ray system shall have a permanent floor. Any
support surface to which a cabinet x-ray system is permanently affixed
may be deemed the floor of the system.
(3) Ports and apertures. (i) The insertion of any part of the human
body through any port into the primary beam shall not be possible.
(ii) The insertion of any part of the human body through any
aperture shall not be possible.
(4) Safety interlocks. (i) Each door of a cabinet x-ray system shall
have a minimum of two safety interlocks. One, but not both of the
required interlocks shall be such that door opening results in physical
disconnection of the energy supply circuit to the high-voltage
generator, and such disconnection shall not be dependent upon any moving
part other than the door.
(ii) Each access panel shall have at least one safety interlock.
(iii) Following interruption of x-ray generation by the functioning
of any safety interlock, use of a control provided in accordance with
paragraph (c)(6)(ii) of this section shall be necessary for resumption
of x-ray generation.
(iv) Failure of any single component of the cabinet x-ray system
shall not cause failure of more than one required safety interlock.
(5) Ground fault. A ground fault shall not result in the generation
of x-rays.
(6) Controls and indicators for all cabinet x-ray systems. For all
systems to which this section is applicable there shall be provided:
(i) A key-actuated control to insure that x-ray generation is not
possible with the key removed.
(ii) A control or controls to initiate and terminate the generation
of x-rays other than by functioning of a safety interlock or the main
power control.
(iii) Two independent means which indicate when and only when x-rays
are being generated, unless the x-ray generation period is less than
one-half second, in which case the indicators shall be activated for
one-half second, and which are discernible from any point at which
initiation of x-ray generation is possible. Failure of a single
component of the cabinet x-ray system shall not cause failure of both
indicators to perform their intended function. One, but not both, of the
indicators required by this subdivision may be a milliammeter labeled to
indicate x-ray tube current. All other indicators shall be legibly
labeled ``X-RAY ON''.
(iv) Additional means other than milliammeters which indicate when
and only when x-rays are being generated, unless the x-ray generation
period is less than one-half second in which case the indicators shall
be activated for one-half second, as needed to insure that at least one
indicator is visible from each door, access panel, and port, and is
legibly labeled ``X-RAY ON''.
(7) Additional controls and indicators for cabinet x-ray systems
designed to admit humans. For cabinet x-ray systems designed to admit
humans there shall also be provided:
(i) A control within the cabinet for preventing and terminating x-
ray generation, which cannot be reset, overridden or bypassed from the
outside of the cabinet.
(ii) No means by which x-ray generation can be initiated from within
the cabinet.
(iii) Audible and visible warning signals within the cabinet which
are actuated for at least 10 seconds immediately prior to the first
initiation of x-ray generation after closing any door designed to admit
humans. Failure of any single component of the cabinet x-
[[Page 542]]
ray system shall not cause failure of both the audible and visible
warning signals.
(iv) A visible warning signal within the cabinet which remains
actuated when and only when x-rays are being generated, unless the x-ray
generation period is less than one-half second in which case the
indicators shall be activated for one-half second.
(v) Signs indicating the meaning of the warning signals provided
pursuant to paragraphs (c)(7) (iii) and (iv) of this section and
containing instructions for the use of the control provided pursuant to
paragraph (c)(7)(i) of this section. These signs shall be legible,
accessible to view, and illuminated when the main power control is in
the ``on'' position.
(8) Warning labels. (i) There shall be permanently affixed or
inscribed on the cabinet x-ray system at the location of any controls
which can be used to initiate x-ray generation, a clearly legible and
visible label bearing the statement:
Caution: X-Rays Produced When Energized
(ii) There shall be permanently affixed or inscribed on the cabinet
x-ray system adjacent to each port a clearly legible and visible label
bearing the statement:
caution: Do Not Insert Any Part of the Body Ehen System is Energized--X-
ray Hazard
(9) Instructions. (i) Manufacturers of cabinet x-ray systems shall
provide for purchasers, and to others upon request at a cost not to
exceed the cost of preparation and distribution, manuals and
instructions which shall include at least the following technical and
safety information: Potential, current, and duty cycle ratings of the x-
ray generation equipment; adequate instructions concerning any
radiological safety procedures and precautions which may be necessary
because of unique features of the system; and a schedule of maintenance
necessary to keep the system in compliance with this section.
(ii) Manufacturers of cabinet x-ray systems which are intended to be
assembled or installed by the purchaser shall provide instructions for
assembly, installation, adjustment and testing of the cabinet x-ray
system adequate to assure that the system is in compliance with
applicable provisions of this section when assembled, installed,
adjusted and tested as directed.
(10) Additional requirements for x-ray baggage inspection systems.
X-ray systems designed primarily for the inspection of carry-on baggage
at airline, railroad, and bus terminals, and at similar facilities,
shall be provided with means, pursuant to paragraphs (c)(10) (i) and
(ii) of this section, to insure operator presence at the control area in
a position which permits surveillance of the ports and doors during
generation of x-radiation.
(i) During an exposure or preset succession of exposures of one-half
second or greater duration, the means provided shall enable the operator
to terminate the exposure or preset succession of exposures at any time.
(ii) During an exposure or preset succession of exposures of less
than one-half second duration, the means provided may allow completion
of the exposure in progress but shall enable the operator to prevent
additional exposures.
(d) Modification of a certified system. The modification of a
cabinet x-ray system, previously certified pursuant to Sec. 1010.2 by
any person engaged in the business of manufacturing, assembling or
modifying cabinet x-ray systems shall be construed as manufacturing
under the act if the modification affects any aspect of the system's
performance for which this section has an applicable requirement. The
manufacturer who performs such modification shall recertify and
reidentify the system in accordance with the provisions of Secs. 1010.2
and 1010.3 of this chapter.
[39 FR 12986, Apr. 10, 1974]
PART 1030--PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS--Table of Contents
Authority: Secs. 501, 502, 510, 515-520, 701, 801 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360, 360e-360j, 371,
381); secs. 354-360F of the Public Health Service Act (42 U.S.C. 263b-
263n).
[[Page 543]]
Sec. 1030.10 Microwave ovens.
(a) Applicability. The provisions of this standard are applicable to
microwave ovens manufactured after October 6, 1971.
(b) Definitions. (1) Microwave oven means a device designed to heat,
cook, or dry food through the application of electromagnetic energy at
frequencies assigned by the Federal Communications Commission in the
normal ISM heating bands ranging from 890 megahertz to 6,000 megahertz.
As defined in this standard, ``microwave ovens'' are limited to those
manufactured for use in homes, restaurants, food vending, or service
establishments, on interstate carriers, and in similar facilities.
(2) Cavity means that portion of the microwave oven in which food
may be heated, cooked, or dried.
(3) Door means the movable barrier which prevents access to the
cavity during operation and whose function is to prevent emission of
microwave energy from the passage or opening which provides access to
the cavity.
(4) Safety interlock means a device or system of devices which is
intended to prevent generation of microwave energy when access to the
cavity is possible.
(5) Service adjustments or service procedures means those servicing
methods prescribed by the manufacturer for a specific product model.
(6) Stirrer means that feature of a microwave oven which is intended
to provide uniform heating of the load by constantly changing the
standing wave pattern within the cavity or moving the load.
(7) External surface means the outside surface of the cabinet or
enclosure provided by the manufacturer as part of the microwave oven,
including doors, door handles, latches, and control knobs.
(8) Equivalent plane-wave power density means the square of the
root-mean-square (rms) electric field strength divided by the impedance
of free space (377 ohms).
(c) Requirements--(1) Power density limit. The equivalent plane-wave
power density existing in the proximity of the external oven surface
shall not exceed 1 milliwatt per square centimeter at any point 5
centimeters or more from the external surface of the oven, measured
prior to acquisition by a purchaser, and, thereafter, 5 milliwatts per
square centimeter at any such point.
(2) Safety interlocks. (i) Microwave ovens shall have a minimum of
two operative safety interlocks. At least one operative safety interlock
on a fully assembled microwave oven shall not be operable by any part of
the human body, or any object with a straight insertable length of 10
centimeters. Such interlock must also be concealed, unless its actuation
is prevented when access to the interlock is possible. Any visible
actuator or device to prevent actuation of this safety interlock must
not be removable without disassembly of the oven or its door. A
magnetically operated interlock is considered to be concealed, or its
actuation is considered to be prevented, only if a test magnet held in
place on the oven by gravity or its own attraction cannot operate the
safety interlock. The test magnet shall be capable of lifting vertically
at zero air gap at least 4.5 kilograms, and at 1 centimeter air gap at
least 450 grams when the face of the magnet, which is toward the
interlock when the magnet is in the test position, is pulling against
one of the large faces of a mild steel armature having dimensions of 80
millimeters by 50 millimeters by 8 millimeters.
(ii) Failure of any single mechanical or electrical component of the
microwave oven shall not cause all safety interlocks to be inoperative.
(iii) Service adjustments or service procedures on the microwave
oven shall not cause the safety interlocks to become inoperative or the
microwave radiation emission to exceed the power density limits of this
section as a result of such service adjustments or procedures.
(iv) Microwave radiation emission in excess of the limits specified
in paragraph (c)(1) of this section shall not be caused by insertion of
an insulated wire through any opening in the external surfaces of a
fully assembled oven into the cavity, waveguide, or other microwave-
energy-containing spaces while the door is closed, provided the wire,
when inserted, could consist of two straight segments forming an obtuse
angle of not less than 170 degrees.
[[Page 544]]
(v) One (the primary) required safety interlock shall prevent
microwave radiation emission in excess of the requirement of paragraph
(c)(1) of this section; the other (secondary) required safety interlock
shall prevent microwave radiation emission in excess of 5 milliwatts per
square centimeter at any point 5 centimeters or more from the external
surface of the oven. The two required safety interlocks shall be
designated as primary or secondary in the service instructions for the
oven.
(vi) A means of monitoring one or both of the required safety
interlocks shall be provided which shall cause the oven to become
inoperable and remain so until repaired if the required safety
interlock(s) should fail to perform required functions as specified in
this section. Interlock failures shall not disrupt the monitoring
function.
(3) Measurement and test conditions. (i) Compliance with the power
density limit in paragraph (c)(1) of this section shall be determined by
measurement of the equivalent plane-wave power density made with an
instrument which reaches 90 percent of its steady-state reading within 3
seconds, when the system is subjected to a step-function input signal.
Tests for compliance shall account for all measurement errors and
uncertainties to ensure that the equivalent plane-wave power density
does not exceed the limit prescribed by paragraph (c)(1) of this
section.
(ii) Microwave ovens shall be in compliance with the power density
limits if the maximum reading obtained at the location of greatest
microwave radiation emission, taking into account all measurement errors
and uncertainties, does not exceed the limit specified in paragraph
(c)(1) of this section, when the emission is measured through at least
one stirrer cycle. As provided in Sec. 1010.13 of this chapter, a
manufacturer may request alternative test procedures if, as a result of
the stirrer characteristics of a microwave oven, such oven is not
susceptible to testing by the procedures described in this paragraph.
(iii) Measurements shall be made with the microwave oven operating
at its maximum output and containing a load of 275plus-minus15
milliliters of tap water initially at 20 deg.plus-minus5 deg.
centigrade placed within the cavity at the center of the load-carrying
surface provided by the manufacturer. The water container shall be a low
form 600-milliliter beaker having an inside diameter of approximately
8.5 centimeters and made of an electrically nonconductive material such
as glass or plastic.
(iv) Measurements shall be made with the door fully closed as well
as with the door fixed in any other position which allows the oven to
operate.
(4) User instructions. Manufacturers of microwave ovens to which
this section is applicable shall provide, or cause to be provided, with
each oven, radiation safety instructions which:
(i) Occupy a separate section and are an integral part of the
regularly supplied users' manual and cookbook, if supplied separately,
and are located so as to elicit the attention of the reader.
(ii) Are as legible and durable as other instructions with the title
emphasized to elicit the attention of the reader by such means as bold-
faced type, contrasting color, a heavy-lined border, or by similar
means.
(iii) Contain the following wording:
Precautions To Avoid Possible Exposure To Excessive Microwave Energy
(a) Do not attempt to operate this oven with the door open since
open-door operation can result in harmful exposure to microwave energy.
It is important not to defeat or tamper with the safety interlocks.
(b) Do not place any object between the oven front face and the door
or allow soil or cleaner residue to accumulate on sealing surfaces.
(c) Do not operate the oven if it is damaged. It is particularly
important that the oven door close properly and that there is no damage
to the: (1) Door (bent), (2) hinges and latches (broken or loosened),
(3) door seals and sealing surfaces.
(d) The oven should not be adjusted or repaired by anyone except
properly qualified service personnel.
(iv) Include additional radiation safety precautions or instructions
which may be necessary for particular oven designs or models, as
determined by the Director, Center for Devices and Radiological Health
or the manufacturer.
(5) Service instructions. Manufacturers of microwave ovens to which
this section is applicable shall provide or cause to be provided to
servicing dealers and
[[Page 545]]
distributors and to others upon request, for each oven model, adequate
instructions for service adjustments and service procedures, and, in
addition, radiation safety instructions which:
(i) Occupy a separate section and are an integral part of the
regularly supplied service manual and are located so as to elicit the
attention of the reader.
(ii) Are as legible and durable as other instructions with the title
emphasized so as to elicit the attention of the reader by such means as
bold-faced type, contrasting color, a heavy-lined border, or by similar
means.
(iii) Contain the following wording:
Precautions To Be Observed Before And During Servicing To Avoid Possible
Exposure To Excessive Microwave Energy
(a) Do not operate or allow the oven to be operated with the door
open.
(b) Make the following safety checks on all ovens to be serviced
before activating the magnetron or other microwave source, and make
repairs as necessary: (1) Interlock operation, (2) proper door closing,
(3) seal and sealing surfaces (arcing, wear, and other damage), (4)
damage to or loosening of hinges and latches, (5) evidence of dropping
or abuse.
(c) Before turning on microwave power for any service test or
inspection within the microwave generating compartments, check the
magnetron, wave guide or transmission line, and cavity for proper
alignment, integrity, and connections.
(d) Any defective or misadjusted components in the interlock,
monitor, door seal, and microwave generation and transmission systems
shall be repaired, replaced, or adjusted by procedures described in this
manual before the oven is released to the owner.
(e) A Microwave leakage check to verify compliance with the Federal
performance standard should be performed on each oven prior to release
to the owner.
(iv) Include additional radiation safety precautions or instructions
which may be necessary for particular oven designs or models, as
determined by the Director, Center for Devices and Radiological Health
or the manufacturer.
(6) Warning labels. Except as provided in paragraph (c)(6)(iv) of
this section, microwave ovens shall have the following warning labels:
(i) A label, permanently attached to or inscribed on the oven, which
shall be legible and readily viewable during normal oven use, and which
shall have the title emphasized and be so located as to elicit the
attention of the user. The label shall bear the following warning
statement:
Precautions For Safe Use To Avoid Possible Exposure To Excessive
Microwave Energy
DO NOT Attempt to Operate This Oven With:
(a) Object Caught in Door.
(b) Door That Does Not Close Properly.
(c) Damaged Door, Hinge, Latch, or Sealing Surface.
(ii) A label, permanently attached to or inscribed on the external
surface of the oven, which shall be legible and readily viewable during
servicing, and which shall have the word ``CAUTION'' emphasized and be
so located as to elicit the attention of service personnel. The label
shall bear the following warning statement:
Caution: This Device is to be Serviced Only by Properly Qualified
Service Personnel. Consult the Service Manual for Proper Service
Procedures to Assure Continued Compliance with the Federal Performance
Standard for Microwave Ovens and for Precautions to be Taken to Avoid
Possible Exposure to Excessive Microwave Energy.
(iii) The labels provided in accordance with paragraphs (c)(6)(i)
and (ii) of this section shall bear only the statements specified in
that paragraph, except for additional radiation safety warnings or
instructions which may be necessary for particular oven designs or
models, as determined by the Director, Center for Devices and
Radiological Health or the manufacturer.
(iv) Upon application by a manufacturer, the Director, Center for
Devices and Radiological Health, Food and Drug Administration, may grant
an exemption from one or more of the statements (radiation safety
warnings) specified in paragraph (c)(6)(i) of this section. Such
exemption shall be based upon a determination by the Director that the
microwave oven model for which the exemption is sought should continue
to comply with paragraphs (c) (1), (2), and (3) of this section under
the adverse condition of use addressed by such precautionary
statement(s). An original and two copies of applications shall be
submitted to the Dockets Management Branch (HFA-305), Food and
[[Page 546]]
Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
Copies of the written portion of the application, including supporting
data and information, and the Director's action on the application will
be maintained by the Branch for public review. The application shall
include:
(a) The specific microwave oven model(s) for which the exemption is
sought.
(b) The specific radiation safety warning(s) from which exemption is
sought.
(c) Data and information which clearly establish that one or more of
the radiation safety warnings in paragraph (c)(6)(i) of this section is
not necessary for the specified microwave oven model(s).
(d) Such other information and a sample of the applicable product if
required by regulation or by the Director, Center for Devices and
Radiological Health, to evaluate and act on the application.
[38 FR 28640, Oct. 15, 1973, as amended at 40 FR 14752, Apr. 4, 1975; 40
FR 52007, Nov. 7, 1975; 46 FR 8461, Jan. 27, 1981; 48 FR 57482, Dec. 30,
1983; 50 FR 13566, Apr. 5, 1985; 53 FR 11254, Apr. 6, 1988; 59 FR 14365,
Mar. 28, 1994]
PART 1040--PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS--Table of Contents
Sec.
1040.10 Laser products.
1040.11 Specific purpose laser products.
1040.20 Sunlamp products and ultraviolet lamps intended for use in
sunlamp products.
1040.30 High-intensity mercury vapor discharge lamps.
Authority: Secs. 501, 502, 510, 515-520, 701, 801 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360, 360e-360j, 371,
381); secs. 354-360F of the Public Health Service Act (42 U.S.C. 263b-
263n).
Sec. 1040.10 Laser products.
(a) Applicability. The provisions of this section and Sec. 1040.11,
as amended, are applicable as specified to all laser products
manufactured or assembled after August 1, 1976, except when:
(1) Such a laser product is either sold to a manufacturer of an
electronic product for use as a component (or replacement) in such
electronic product, or
(2) Sold by or for a manufacturer of an electronic product for use
as a component (or replacement) in such electronic product, provided
that such laser product:
(i) Is accompanied by a general warning notice that adequate
instructions for the safe installation of the laser product are provided
in servicing information available from the complete laser product
manufacturer under paragraph (h)(2)(ii) of this section, and should be
followed,
(ii) Is labeled with a statement that it is designated for use
solely as a component of such electronic product and therefore does not
comply with the appropriate requirements of this section and
Sec. 1040.11 for complete laser products, and
(iii) Is not a removable laser system as described in paragraph
(c)(2) of this section; and
(3) The manufacturer of such a laser product, if manufactured after
August 20, 1986:
(i) Registers, and provides a listing by type of such laser products
manufactured that includes the product name, model number and laser
medium or emitted wavelength(s). The registration and listing shall
include the name and address of the manufacturer and shall be submitted
to the Director, Office of Compliance (HFZ-300), Center for Devices and
Radiological Health, 5600 Fishers Lane, Rockville, MD 20857.
(ii) Maintains and allows access to any sales, shipping, or
distribution records that identify the purchaser of such a laser product
by name and address, the product by type, the number of units sold, and
the date of sale (shipment). These records shall be maintained and made
available as specified in Sec. 1002.31.
(b) Definitions. As used in this section and Sec. 1040.11, the
following definitions apply:
(1) Accessible emission level means the magnitude of accessible
laser or collateral radiation of a specific wavelength and emission
duration at a particular point as measured according to paragraph (e) of
this section. Accessible laser or collateral radiation is radiation to
which human access is pos-
[[Page 547]]
sible, as defined in paragraphs (b) (12), (15), and (22) of this
section.
(2) Accessible emission limit means the maximum accessible emission
level permitted within a particular class as set forth in paragraphs
(c), (d), and (e) of this section.
(3) Aperture means any opening in the protective housing or other
enclosure of a laser product through which laser or collateral radiation
is emitted, thereby allowing human access to such radiation.
(4) Aperture stop means an opening serving to limit the size and to
define the shape of the area over which radiation is measured.
(5) Class I laser product means any laser product that does not
permit access during the operation to levels of laser radiation in
excess of the accessible emission limits contained in Table I of
paragraph (d) of this section.\1\
---------------------------------------------------------------------------
\1\ Class I levels of laser radiation are not considered to be
hazardous.
---------------------------------------------------------------------------
(6) Class IIa laser product means any laser product that permits
human access during operation to levels of visible laser radiation in
excess of the accessible emission limits contained in Table I, but does
not permit human access during operation to levels of laser radiation in
excess of the accessible emission limits contained in Table II-A of
paragraph (d) of this section.\2\
---------------------------------------------------------------------------
\2\ Class IIa levels of laser radiation are not considered to be
hazardous if viewed for any period of time less than or equal to 1 x
10\3\ seconds but are considered to be a chronic viewing hazard for any
period of time greater than 1 x 10\3\ seconds.
---------------------------------------------------------------------------
(7) Class II laser product means any laser product that permits
human access during operation to levels of visible laser radiation in
excess of the accessible emission limits contained in Table II-A, but
does not permit human access during operation to levels of laser
radiation in excess of the accessible emission limits contained in Table
II of paragraph (d) of this section.\3\
---------------------------------------------------------------------------
\3\ Class II levels of laser radiation are considered to be a
chronic viewing hazard.
---------------------------------------------------------------------------
(8) Class IIIa laser product means any laser product that permits
human access during operation to levels of visible laser radiation in
excess of the accessible emission limits contained in Table II, but does
not permit human access during operation to levels of laser radiation in
excess of the accessible emission limits contained in Table III-A of
paragraph (d) of this section.\4\
---------------------------------------------------------------------------
\4\ Class IIIa levels of laser radiation are considered to be,
depending upon the irradiance, either an acute intrabeam viewing hazard
or chronic viewing hazard, and an acute viewing hazard if viewed
directly with optical instruments.
---------------------------------------------------------------------------
(9) Class IIIb laser product means any laser product that permits
human access during operation to levels of laser radiation in excess of
the accessible emission limits of Table III-A, but does not permit human
access during operation to levels of laser radiation in excess of the
accessible emission limits contained in Table III-B of paragraph (d) of
this section.\5\
---------------------------------------------------------------------------
\5\ Class IIIb levels of laser radiation are considered to be an
acute hazard to the skin and eyes from direct radiation.
---------------------------------------------------------------------------
(10) Class III laser product means any Class IIIa or Class IIIb
laser product.
(11) Class IV laser product means any laser that permits human
access during operation to levels of laser radiation in excess of the
accessible emission limits contained in Table III-B of paragraph (d) of
this section.\6\
---------------------------------------------------------------------------
\6\ Class IV levels of laser radiation are considered to be an acute
hazard to the skin and eyes from direct and scattered radiation.
---------------------------------------------------------------------------
(12) Collateral radiation means any electronic product radiation,
except laser radiation, emitted by a laser product as a result of the
operation of the laser(s) or any component of the laser product that is
physically necessary for the operation of the laser(s).
(13) Demonstration laser product means any laser product
manufactured, designed, intended, or promoted for purposes of
demonstration, entertainment, advertising display, or artistic
composition. The term ``demonstration laser product'' does not apply to
laser products which are not manufactured, designed, intended, or
promoted for such purposes, even though they may be used for those
purposes or are intended to demonstrate other applications.
(14) Emission duration means the temporal duration of a pulse, a
series of
[[Page 548]]
pulses, or continuous operation, expressed in seconds, during which
human access to laser or collateral radiation could be permitted as a
result of operation, maintenance, or service of a laser product.
(15) Human access means the capacity to intercept laser or
collateral radiation by any part of the human body. For laser products
that contain Class IIIb or IV levels of laser radiation, ``human
access'' also means access to laser radiation that can be reflected
directly by any single introduced flat surface from the interior of the
product through any opening in the protective housing of the product.
(16) Integrated radiance means radiant energy per unit area of a
radiating surface per unit solid angle of emission, expressed in joules
per square centimeter per steradian (Jcm-2 sr-1).
(17) Invisible radiation means laser or collateral radiation having
wavelengths of equal to or greater than 180 nm but less than or equal to
400 nm or greater than 710 nm but less than or equal to 1.0 X 106
nm (1 millimeter).
(18) Irradiance means the time-averaged radiant power incident on an
element of a surface divided by the area of that element, expressed in
watts per square centimeter (W cm-2).
(19) Laser means any device that can be made to produce or amplify
electromagnetic radiation at wavelenghts greater than 250 nm but less
than or equal to 13,000 nm or, after August 20, 1986, at wavelengths
equal to or greater than 180 nm but less than or equal to 1.0X106
nm primarily by the process of controlled stimulated emission.
(20) Laser energy source means any device intended for use in
conjunction with a laser to supply energy for the operation of the
laser. General energy sources such as electrical supply mains or
batteries shall not be considered to constitute laser energy sources.
(21) Laser product means any manufactured product or assemblage of
components which constitutes, incorporates, or is intended to
incorporate a laser or laser system. A laser or laser system that is
intended for use as a component of an electronic product shall itself be
considered a laser product.
(22) Laser radiation means all electromagnetic radiation emitted by
a laser product within the spectral range specified in paragraph (b)(19)
of this section that is produced as a result of controlled stimulated
emission or that is detectable with radiation so produced through the
appropriate aperture stop and within the appropriate solid angle of
acceptance, as specified in paragraph (e) of this section.
(23) Laser system means a laser in combination with an appropriate
laser energy source with or without additional incorporated components.
See paragraph (c)(2) of this section for an explanation of the term
``removable laser system.''
(24) Maintenance means performance of those adjustments or
procedures specified in user information provided by the manufacturer
with the laser product which are to be performed by the user for the
purpose of assuring the intended performance of the product. It does not
include operation or service as defined in paragraph (b) (27) and (38)
of this section.
(25) Maximum output means the maximum radiant power and, where
applicable, the maximum radiant energy per pulse of accessible laser
radiation emitted by a laser product during operation, as determined
under paragraph (e) of this section.
(26) Medical laser product means any laser product which is a
medical device as defined in 21 U.S.C. 321(h) and is manufactured,
designed, intended or promoted for in vivo laser irradiation of any part
of the human body for the purpose of: (i) Diagnosis, surgery, or
therapy; or (ii) relative positioning of the human body.
(27) Operation means the performance of the laser product over the
full range of its functions. It does not include maintenance or service
as defined in paragraphs (b) (24) and (38) of this section.
(28) Protective housing means those portions of a laser product
which are designed to prevent human access to laser or collateral
radiation in excess of the prescribed accessible emission limits under
conditions specified in this section and in Sec. 1040.11.
(29) Pulse duration means the time increment measured between the
half-
[[Page 549]]
peak-power points at the leading and trailing edges of a pulse.
(30) Radiance means time-averaged radiant power per unit area of a
radiating surface per unit solid angle of emission, expressed in watts
per square centimeter per steradian (W cm-2sr-1).
(31) Radiant energy means energy emitted, transferred or received in
the form of radiation, expressed in joules (J).
(32) Radiant exposure means the radiant energy incident on an
element of a surface divided by the area of the element, expressed in
joules per square centimeter (Jcm-2)
(33) Radiant power means time-averaged power emitted, transferred or
received in the form of radiation, expressed in watts (W).
(34) Remote interlock connector means an electrical connector which
permits the connection of external remote interlocks.
(35) Safety interlock means a device associated with the protective
housing of a laser product to prevent human access to excessive
radiation in accordance with paragraph (f)(2) of this section.
(36) Sampling interval means the time interval during which the
level of accessible laser or collateral radiation is sampled by a
measurement process. The magnitude of the sampling interval in units of
seconds is represented by the symbol (t).
(37) Scanned laser radiation means laser radiation having a time-
varying direction, origin or pattern of propagation with respect to a
stationary frame of reference.
(38) Service means the performance of those procedures or
adjustments described in the manufacturer's service instructions which
may affect any aspect of the product's performance for which this
section and Sec. 1040.11 have applicable requirements. It does not
include maintenance or operation as defined in paragraphs (b) (24) and
(27) of this section.
(39) Surveying, leveling, or alignment laser product means a laser
product manufactured, designed, intended or promoted for one or more of
the following uses:
(i) Determining and delineating the form, extent, or position of a
point, body, or area by taking angular measurement.
(ii) Positioning or adjusting parts in proper relation to one
another.
(iii) Defining a plane, level, elevation, or straight line.
(40) Visible radiation means laser or collateral radiation having
wavelengths of greater than 400 nm but less than or equal to 710 nm.
(41) Warning logotype means a logotype as illustrated in either
Figure 1 or Figure 2 of paragraph (g) of this section.
(42) Wavelength means the propagation wavelength in air of
electromagnetic radiation.
(c) Classification of laser products-- (1) All laser products. Each
laser product shall be classified in Class I, IIa, II, IIIa, IIIb, or IV
in accordance with definitions set forth in paragraphs (b) (5) through
(11) of this section. The product classification shall be based on the
highest accessible emission level(s) of laser radiation to which human
access is possible during operation in accordance with paragraphs (d),
(e), and (f)(1) of this section.
(2) Removable laser systems. Any laser system that is incorporated
into a laser product subject to the requirements of this section and
that is capable, without modification, of producing laser radiation when
removed from such laser product, shall itself be considered a laser
product and shall be separately subject to the applicable requirements
in this subchapter for laser products of its class. It shall be
classified on the basis of accessible emission of laser radiation when
so removed.
(d) Accessible emission limits. Accessible emission limits for laser
radiation in each class are specified in Tables I, II-A, II, III-A, and
III-B of this paragraph. The factors, k1 and k2 vary with
wavelength and emission duration. These factors are given in Table IV of
this paragraph, with selected numerical values in Table V of this
paragraph. Accessible emission limits for collateral radiation are
specified in Table VI of this paragraph.
[[Page 550]]
Notes applicable to Tables I, II-A, II, III-A and III-B:
(1) The factors k1 and k2 are wavelength-dependent
correction factors determined from Table IV.
(2) The variable t in the expressions of emission limits is the
magnitude of the sampling interval in units of seconds.
[[Page 551]]
[GRAPHIC] [TIFF OMITTED] TR01FE93.031
[[Page 552]]
[GRAPHIC] [TIFF OMITTED] TR01FE93.032
[[Page 553]]
[GRAPHIC] [TIFF OMITTED] TR01FE93.033
[[Page 554]]
[GRAPHIC] [TIFF OMITTED] TR01FE93.034
[[Page 555]]
[GRAPHIC] [TIFF OMITTED] TR01FE93.035
[[Page 556]]
[GRAPHIC] [TIFF OMITTED] TR01FE93.036
[[Page 557]]
(1) Beam of a single wavelength. Laser or collateral radiation of a
single wavelength exceeds the accessible emission limits of a class if
its accessible emission level is greater than the accessible emission
limit of that class within any of the ranges of emission duration
specified in Tables I, II-A, II, III-A, and III-B of this paragraph.
(2) Beam of multiple wavelengths in same range. Laser or collateral
radiation having two or more wavelengths within any one of the
wavelength ranges specified in Tables I, II-A, II, III-A, and III-B of
this paragraph exceeds the accessible emission limits of a class if the
sum of the ratios of the accessible emission level to the corresponding
accessible emission limit at each such wavelength is greater than unity
for that combination of emission duration and wavelength distribution
which results in the maximum sum.
(3) Beam with multiple wavelengths in different ranges. Laser or
collateral radiation having wavelengths within two or more of the
wavelength ranges specified in Tables I, II-A, II, III-A, and III-B of
this paragraph exceeds the accessible emission limits of a class if it
exceeds the applicable limits within any one of those wavelength ranges.
This determination is made for each wavelength range in accordance with
paragraph (d) (1) or (2) of this section.
(4) Class I dual limits. Laser or collateral radiation in the
wavelength range of greater than 400 nm but less than or equal to 1.400
nm exceeds the accessible emission limits of Class I if it exceeds both:
(i) The Class I accessible emission limits for radiant energy within
any range of emission duration specified in Table I of this paragraph,
and
(ii) The Class I accessible emission limits for integrated radiance
within any range of emission duration specified in Table I of this
paragraph.
(e) Tests for determination of compliance--(1) Tests for
certification. Tests on which certification under Sec. 1010.2 is based
shall account for all errors and statistical uncertainties in the
measurement process. Because compliance with the standard is required
for the useful life of a product such tests shall also account for
increases in emission and degradation in radiation safety with age.
(2) Test conditions. Except as provided in Sec. 1010.13, tests for
compliance with each of the applicable requirements of this section and
Sec. 1040.11 shall be made during operation, maintenance, or service as
appropriate:
(i) Under those conditions and procedures which maximize the
accessible emission levels, including start-up, stabilized emission, and
shut-down of the laser product; and
(ii) With all controls and adjustments listed in the operation,
maintenance, and service instructions adjusted in combination to result
in the maximum accessible emission level of radiation; and
(iii) At points in space to which human access is possible in the
product configuration which is necessary to determine compliance with
each requirement, e.g., if operation may require removal of portions of
the protective housing and defeat of safety interlocks, measurements
shall be made at points accessible in that product configuration; and
(iv) With the measuring instrument detector so positioned and so
oriented with respect to the laser product as to result in the maximum
detection of radiation by the instrument; and
(v) For a laser product other than a laser system, with the laser
coupled to that type of laser energy source which is specified as
compatible by the laser product manufacturer and which produces the
maximum emission level of accessible radiation from that product.
(3) Measurement parameters. Accessible emission levels of laser and
collateral radiation shall be based upon the following measurements as
appropriate, or their equivalent:
(i) For laser products intended to be used in a locale where the
emitted laser radiation is unlikely to be viewed with optical
instruments, the radiant power (W) or radiant energy (J) detectable
through a circular aperture stop having a diameter of 7 millimeters and
within a circular solid angle of acceptance of 1 X 10-3 steradian
with collimating optics of 5 diopters or less. For scanned laser
radiation, the direction of the solid angle of acceptance shall change
as needed to maximize de-
[[Page 558]]
tectable radiation, with an angular speed of up to 5 radians/second. A
50 millimeter diameter aperture stop with the same collimating optics
and acceptance angle stated above shall be used for all other laser
products (except that a 7 millimeter diameter aperture stop shall be
used in the measurement of scanned laser radiation emitted by laser
products manufactured on or before August 20, 1986.
(ii) The irradiance (W cm-2) or radiant exposure (J cm-2
equivalent to the radiant power (W) or radiant energy (J) detectable
through a circular aperture stop having a diameter of 7 millimeters and,
for irradiance, within a circular solid angle of acceptance of 1 x
10-3 steradian with collimating optics of 5 diopters or less,
divided by the area of the aperture stop (cm-2).
(iii) The radiance (W cm-2 sr-1) or integrated radiance (J
cm-2 sr-1) equivalent to the radiant power (W) or radiant
energy (J) detectable through a circular aperture stop having a diameter
of 7 millimeters and within a circular solid angle of acceptance of 1 X
10-5 steradian with collimating optics of 5 diopters or less,
divided by that solid angle (sr) and by the area of the aperture stop
(cm-2).
(f) Performance requirements--(1) Protective housing. Each laser
product shall have a protective housing that prevents human access
during operation to laser and collateral radiation that exceed the
limits of Class I and Table VI, respectively, wherever and whenever such
human access is not necessary for the product to perform its intended
function. Wherever and whenever human access to laser radiation levels
that exceed the limits of Class I is necessary, these levels shall not
exceed the limits of the lowest class necessary to perform the intended
function(s) of the product.
(2) Safety interlocks. (i) Each laser product, regardless of its
class, shall be provided with at least one safety interlock for each
portion of the protective housing which is designed to be removed or
displaced during operation or maintenance, if removal or displacement of
the protective housing could permit, in the absence of such
interlock(s), human access to laser or collateral radiation in excess of
the accessible emission limit applicable under paragraph (f)(1) of this
section.
(ii) Each required safety interlock, unless defeated, shall prevent
such human access to laser and collateral radiation upon removal or
displacement of such portion of the protective housing
(iii) Either multiple safety interlocks or a means to preclude
removal or displacement of the interlocked portion of the protective
housing shall be provided, if failure of a single interlock would allow;
(a) Human access to a level of laser radiation in excess of the
accessible emission limits of Class IIIa; or
(b) Laser radiation in excess of the accessible emission limits of
Class II to be emitted directly through the opening created by removal
or displacement of the interlocked portion of the protective housing.
(iv) Laser products that incorporate safety interlocks designed to
allow safety interlock defeat shall incorporate a means of visual or
aural indication of interlock defeat. During interlock defeat, such
indication shall be visible or audible whenever the laser product is
energized, with and without the associated portion of the protective
housing removed or displaced.
(v) Replacement of a removed or displaced portion of the protective
housing shall not be possible while required safety interlocks are
defeated.
(3) Remote interlock connector. Each laser system classified as a
Class IIIb or IV laser product shall incorporate a readily available
remote interlock connector having an electrical potential difference of
no greater than 130 root-mean-square volts between terminals. When the
terminals of the connector are not electrically joined, human access to
all laser and collateral radiation from the laser product in excess of
the accessible emission limits of Class I and Table VI shall be
prevented.
(4) Key control. Each laser system classified as a Class IIIb or IV
laser product shall incorporate a key-actuated master control. The key
shall be removable and the laser shall not be operable when the key is
removed.
(5) Laser radiation emission indicator. (i) Each laser system
classified as a Class II or IIIa laser product shall in-
[[Page 559]]
corporate an emission indicator that provides a visible or audible
signal during emission of accessible laser radiation in excess of the
accessible emission limits of Class I.
(ii) Each laser system classified as a Class IIIb or IV laser
product shall incorporate an emission indicator which provides a visible
or audible signal during emission of accessible laser radiation in
excess of the accessible emission limits of Class I, and sufficiently
prior to emission of such radiation to allow appropriate action to avoid
exposure to the laser radiation.
(iii) For laser systems manufactured on or before August 20, 1986,
if the laser and laser energy source are housed separately and can be
operated at a separation distance of greater than 2 meters, both laser
and laser energy source shall incorporate an emission indicator as
required in accordance with paragraph (f)(5) (i) or (ii) of this
section. For laser systems manufactured after August 20, 1986, each
separately housed laser and operation control of a laser system that
regulates the laser or collateral radiation emitted by a product during
operation shall incorporate an emission indicator as required in
accordance with paragraph (f)(5) (i) or (ii) of this section, if the
laser or operation control can be operated at a separation distance
greater than 2 meters from any other separately housed portion of the
laser product incorporating an emission indicator.
(iv) Any visible signal required by paragraph (f)(5) (i) or (ii) of
this section shall be clearly visible through protective eyewear
designed specifically for the wavelength(s) of the emitted laser
radiation.
(v) Emission indicators required by paragraph (f)(5) (i) or (ii) of
this section shall be located so that viewing does not require human
exposure to laser or collateral radiation in excess of the accessible
emission limits of Class I and Table VI.
(6) Beam attenuator. (i) Each laser system classified as a Class II,
III, or IV laser product shall be provided with one or more permanently
attached means, other than laser energy source switch(es), electrical
supply main connectors, or the key-actuated master control, capable of
preventing access by any part of the human body to all laser and
collateral radiation in excess of the accessible emission limits of
Class I and Table VI.
(ii) If the configuration, design, or function of the laser product
would make unnecessary compliance with the requirement in paragraph
(f)(6)(i) of this section, the Director, Office of Compliance (HFZ-300),
Center for Devices and Radiological Health, may, upon written
application by the manufacturer, approve alternate means to accomplish
the radiation protection provided by the beam attenuator.
(7) Location of controls. Each Class IIa, II, III, or IV laser
product shall have operational and adjustment controls located so that
human exposure to laser or collateral radiation in excess of the
accessible emission limits of Class I and Table VI is unnecessary for
operation or adjustment of such controls.
(8) Viewing optics. All viewing optics, viewports, and display
screens incorporated into a laser product, regardless of its class,
shall limit the levels of laser and collateral radiation accessible to
the human eye by means of such viewing optics, viewports, or display
screens during operation or maintenance to less than the accessible
emission limits of Class I and Table VI. For any shutter or variable
attenuator incorporated into such viewing optics, viewports, or display
screens, a means shall be provided:
(i) To prevent access by the human eye to laser and collateral
radiation in excess of the accessible emission limits of Class I and
Table VI whenever the shutter is opened or the attenuator varied.
(ii) To preclude, upon failure of such means as required in
paragraph (f)(8)(i) of this section, opening the shutter or varying the
attenuator when access by the human eye is possible to laser or
collateral radiation in excess of the accessible emission limits of
Class I and Table VI.
(9) Scanning safeguard. Laser products that emit accessible scanned
laser radiation shall not, as a result of any failure causing a change
in either scan velocity or amplitude, permit human access to laser
radiation in excess of:
[[Page 560]]
(i) The accessible emission limits of the class of the product, or
(ii) The accessible emission limits of the class of the scanned
laser radiation if the product is Class IIIb or IV and the accessible
emission limits of Class IIIa would be exceeded solely as result of such
failure.
(10) Manual reset mechanism. Each laser system manufactured after
August 20, 1986, and classified as a Class IV laser product shall be
provided with a manual reset to enable resumption of laser radiation
emission after interruption of emission caused by the use of a remote
interlock or after an interruption of emission in excess of 5 seconds
duration due to the unexpected loss of main electrical power.
(g) Labeling requirements. In addition to the requirements of
Secs. 1010.2 and 1010.3, each laser product shall be subject to the
applicable labeling requirements of this paragraph.
(1) Class IIa and II designations and warnings. (i) Each Class IIa
laser product shall have affixed a label bearing the following wording:
``Class IIa Laser Product--Avoid Long-Term Viewing of Direct Laser
Radiation.''
(ii) Each Class II laser product shall have affixed a label bearing
the warning logotype A (Figure 1 in this paragraph) and including the
following wording:
[Position I on the logotype]
``LASER RADIATION--DO NOT STARE INTO BEAM''; and
[Position 3 on the logotype]
``CLASS II LASER PRODUCT''.
[GRAPHIC] [TIFF OMITTED] TR01FE93.037
(2) Class IIIa and IIIb designations and warnings. (i) Each Class
IIIa laser product with an irradiance less than or equal to
2.5 x 10-3 W cm2- shall have affixed a label bearing the
warning logotype A (Figure 1 of paragraph (g)(1)(ii) of this section)
and including the following wording:
[[Page 561]]
[Position 1 on the logotype]
``LASER RADIATION--DO NOT STARE INTO BEAM OR VIEW DIRECTLY WITH OPTICAL
INSTRUMENTS''; and,
[Position 3 on the logotype]
``CLASS IIIa LASER PRODUCT''.
(ii) Each Class IIIa laser product with an irradiance greater than
2.5 x 10-3 W cm-2 shall have affixed a label bearing the
warning logotype B (Figure 2 in this paragraph) and including the
following wording:
[Position 1 on the logotype]
``LASER RADIATION--AVOID DIRECT EYE EXPOSURE''; and,
[Position 3 on the logotype]
``CLASS IIIa LASER PRODUCT''.
[GRAPHIC] [TIFF OMITTED] TR01FE93.038
(iii) Each Class IIIb laser product shall have affixed a label
bearing the warning logotype B (Figure 2 of paragraph (g)(2)(ii) of this
section) and including the following wording:
[Position 1 on the logotype]
``LASER RADIATION--AVOID DIRECT EXPOSURE TO BEAM''; and,
[Position 3 on the logotype]
``CLASS IIIb LASER PRODUCT''.
(3) Class IV designation and warning. Each Class IV laser product
shall have affixed a label bearing the warning logotype B (Figure 2 of
paragraph (g)(2)(ii) of this section), and including the following
wording:
[Position 1 on the logotype]
``LASER RADIATION--AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED
RADIATION''; and,
[Position 3 on the logotype]
``CLASS IV LASER PRODUCT''.
(4) Radiation output information on warning logotype. Each Class II,
III, and
[[Page 562]]
IV laser product shall state in appropriate units, at position 2 on the
required warning logotype, the maximum output of laser radiation, the
pulse duration when appropriate, and the laser medium or emitted
wavelength(s).
(5) Aperture label. Each laser product, except medical laser
products and Class IIa laser products, shall have affixed, in close
proximity to each aperture through which is emitted accessible laser or
collateral radiation in excess of the accessible emission limits of
Class I and Table VI of paragraph (d) of this section, a label(s)
bearing the following wording as applicable.
(i) ``AVOID EXPOSURE--Laser radiation is emitted from this
aperture,'' if the radiation emitted through such aperture is laser
radiation.
(ii) ``AVOID EXPOSURE--Hazardous electromagnetic radiation is
emitted from this aperture,'' if the radiation emitted through such
aperture is collateral radiation described in Table VI, item 1.
(iii) ``AVOID EXPOSURE--Hazardous x-rays are emitted from this
aperture,'' if the radiation emitted through such aperture is collateral
radiation described in Table VI, item 2.
(6) Labels for noninterlocked protective housings. For each laser
product, labels shall be provided for each portion of the protective
housing which has no safety interlock and which is designed to be
displaced or removed during operation, maintenance, or service, and
thereby could permit human access to laser or collateral radiation in
excess of the limits of Class I and Table VI. Such labels shall be
visible on the protective housing prior to displacement or removal of
such portion of the protective housing and visible on the product in
close proximity to the opening created by removal or displacement of
such portion of the protective housing, and shall include the wording:
(i) ``CAUTION--Laser radiation when open. DO NOT STARE INTO BEAM.''
for Class II accessible laser radiation.
(ii) ``CAUTION--Laser radiation when open. DO NOT STARE INTO BEAM OR
VIEW DIRECTLY WITH OPTICAL INSTRUMENTS.'' for Class IIIa accessible
laser radiation with an irradiance less than or equal to 2.5 x 10-3
W cm-2.
(iii) ``DANGER--Laser radiation when open. AVOID DIRECT EYE
EXPOSURE.'' for Class IIIa accessible laser radiation with an irradiance
greater than 2.5 x 10-3 W cm-2.
(iv) ``DANGER--Laser radiation when open. AVOID DIRECT EXPOSURE TO
BEAM.'' for Class IIIb accessible laser radiation.
(v) ``DANGER--Laser radiation when open. AVOID EYE OR SKIN EXPOSURE
TO DIRECT OR SCATTERED RADIATION.'' for Class IV accessible laser
radiation.
(vi) ``CAUTION--Hazardous electromagnetic radiation when open.'' for
collateral radiation in excess of the accessible emission limits in
Table VI, item 1 of paragraph (d) of this section.
(vii) ``CAUTION--Hazardous x-rays when open.'' for collateral
radiation in excess of the accessible emission limits in Table VI, item
2 of paragraph (d) of this section.
(7) Labels for defeatably interlocked protective housings. For each
laser product, labels shall be provided for each defeatably interlocked
(as described in paragraph (f)(2)(iv) of this section) portion of the
protective housing which is designed to be displaced or removed during
operation, maintenance, or service, and which upon interlock defeat
could permit human access to laser or collateral radiation in excess of
the limits of Class I or Table VI. Such labels shall be visible on the
product prior to and during interlock defeat and in close proximity to
the opening created by the removal or displacement of such portion of
the protective housing, and shall include the wording:
(i) ``CAUTION--Laser radiation when open and interlock defeated. DO
NOT STARE INTO BEAM.'' for Class II accessible laser radiation.
(ii) ``CAUTION--Laser radiation when open and interlock defeated. DO
NOT STARE INTO BEAM OR VIEW DIRECTLY WITH OPTICAL INSTRUMENTS.'' for
Class IIIa accessible laser radiation with an irradiance less than or
equal to 2.5 x 10-3 W cm-2.
(iii) ``DANGER--Laser radiation when open and interlock defeated.
AVOID DIRECT EYE EXPOSURE.'' for Class IIIa accessible laser radiation
when an irradiance greater than 2.5 x 10-3 W cm-2.
[[Page 563]]
(iv) ``DANGER--Laser radiation when open and interlock defeated.
AVOID DIRECT EXPOSURE TO BEAM.'' for Class IIIb accessible laser
radiation.
(v) ``DANGER--Laser radiation when open and interlock defeated.
AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION.'' for Clas
IV accessible laser radiation.
(vi) ``CAUTION--Hazardous electromagnetic radiation when open and
interlock defeated.'' for collateral radiation in excess of the
accessible emission limits in Table VI. item 1 of paragraph (d) of this
section.
(vii) ``CAUTION--Hazardous x-rays when open and interlock
defeated.'' for collateral radiation in excess of the accesible emission
limits in Table VI. item 2 of paragraph (d) of this section.
(8) Warning for visible and/or invisible radiation. On the labels
specified in this paragraph, if the laser or collateral radiation
referred to is:
(i) Invisible radiation, the word ``invisible'' shall appropriately
precede the word ``radiation''; or
(ii) Visible and invisible radiation, the words ``visible and
invisible'' or ``visible and/or invisible'' shall appropriately precede
the word ``radiation.''
(iii) Visible laser radiation only, the phrase ``laser light'' may
replace the phrase ``laser radiation.''
(9) Positioning of labels. All labels affixed to a laser product
shall be positioned so as to make unnecessary, during reading, human
exposure to laser radiation in excess of the accessible emission limits
of Class I radiation or the limits of collateral radiation established
to Table VI of paragraph (d) of this section.
(10) Label specifications. Labels required by this section and
Sec. 1040.11 shall be permanently affixed to, or inscribed on, the laser
product, legible, and clearly visible during operation, maintenance, or
service, as appropriate. If the size, configuration, design, or function
of the laser product would preclude compliance with the requirements for
any required label or would render the required wording of such label
inappropriate or ineffective, the Director, Office of Compliance (HFZ-
300), Center for Devices and Radiological Health, on the Director's own
initiative or upon written application by the manufacturer, may approve
alternate means of providing such label(s) or alternate wording for such
label(s) as applicable.
(h) Informational requirements--(1) User information. Manufacturers
of laser products shall provide as an integral part of any user
instruction or operation manual which is regularly supplied with the
product, or, if not so supplied, shall cause to be provided with each
laser product:
(i) Adequate instructions for assembly, operation, and maintenance,
including clear warnings concerning precautions to avoid possible
exposure to laser and collateral radiation in excess of the accessible
emission limits in Tables I, II-A, II, III-A, III-B, and VI of paragraph
(d) of this section, and a schedule of maintenance necessary to keep the
product in compliance with this section and Sec. 1040.11.
(ii) A statement of the magnitude, in appropriate units, of the
pulse durations(s), maximum radiant power and, where applicable, the
maximum radiant energy per pulse of the accessible laser radiation
detectable in each direction in excess of the accessible emission limits
in Table I of paragraph (d) of this section determined under paragraph
(e) of this section.
(iii) Legible reproductions (color optional) of all labels and
hazard warnings required by paragraph (g) of this section and
Sec. 1040.11 to be affixed to the laser product or provided with the
laser product, including the information required for positions 1, 2,
and 3 of the applicable logotype (Figure 1 of paragraph (g)(1)(ii) or
Figure 2 or paragraph (g)(2)(ii) of this section). The corresponding
position of each label affixed to the product shall be indicated or, if
provided with the product, a statement that such labels could not be
affixed to the product but were supplied with the product and a
statement of the form and manner in which they were supplied shall be
provided.
(iv) A listing of all controls, adjustments, and procedures for
operation and maintenance, including the warning ``Caution--use of
controls or adjustments or performance of procedures other than those
specified herein
[[Page 564]]
may result in hazardous radiation exposure.''
(v) In the case of laser products other than laser systems, a
statment of the compatibility requirements for a laser energy source
that will assure compliance of the laser product with this section and
Sec. 1040.11.
(vi) In the case of laser products classified with a 7 millimeter
diameter aperture stop as provided in paragraph (e)(3)(i) of this
section, if the use of a 50 millimeter diameter aperture stop would
result in a higher clsssification of the product, the following warning
shall be included in the user information: ``CAUTION--The use of optical
instruments with this product will increase eye hazard.''
(2) Purchasing and servicing information. Manufacturers of laser
products shall provide or cause to be provided:
(i) In all catalogs, specification sheets, and descriptive brochures
pertaining to each laser product, a legible reproduction (color
optional) of the class designation and warning required by paragraph (g)
of this section to be affixed to that product, including the information
required for positions 1, 2, and 3 of the applicable logotype (Figure 1
of paragraph (g)(1)(ii) or Figure 2 of paragraph (g)(2)(ii) of this
section).
(ii) To servicing dealers and distributors and to others upon
request at a cost not to exceed the cost of preparation and
distribution, adequate instructions for service adjustments and service
procedures for each laser product model, including clear warnings and
precautions to be taken to avoid possible exposure to laser and
collateral radiation in excess of the accessible emission limits in
Tables I, II-A, II, III-A, III-B, and VI of paragraph (d) of this
section, and a schedule of maintenance necessary to keep the product in
compliance with this section and Sec. 1040.11; and in all such service
instructions, a listing of those controls and procedures that could be
utilized by persons other than the manufacturers or the manufacturer's
agents to increase accessible emission levels of radiation and a clear
description of the location of displaceable portions of the protective
housing that could allow human access to laser or collateral radiation
in excess of the accessible emission limits in Tables I, II-A, II, III-
A, III-B, and VI of paragraph (d) of this section. The instructions
shall include protective procedures for service personnel to avoid
exposure to levels of laser and collateral radiation known to be
hazardous for each procedure or sequence of procedures to be
accomplished, and legible reproductions (color optional) of required
labels and hazard warnings.
(i) Modification of a certified product. The modification of a laser
product, previously certified under Sec. 1010.2, by any person engaged
in the business of manufacturing, assembling, or modifying laser
products shall be construed as manufacturing under the act if the
modification affects any aspect of the product's performance or intended
function(s) for which this section and Sec. 1040.11 have an applicable
requirement. The manufacturer who performs such modification shall
recertify and reidentify the product in accordance with the provisions
of Secs. 1010.2. and 1010.3.
[The information collection requirements contained in paragraph
(a)(3)(ii) were approved by the Office of Management and Budget under
control number 0910-0176]
[50 FR 33688, Aug. 20, 1985; 50 FR 42156, Oct. 18, 1985]
Sec. 1040.11 Specific purpose laser products.
(a) Medical laser products. Each medical laser product shall comply
with all of the applicable requirements of Sec. 1040.10 for laser
products of its class. In addition, the manufacturer shall:
(1) Incorporate in each Class III or IV medical laser product a
means for the measurement of the level of that laser radiation intended
for irradiation of the human body. Such means may have an error in
measurement of no more than 20 percent when calibrated in accordance
with paragraph (a)(2) of this section. Indication of the measurement
shall be in International System Units. The requirements of this
paragraph do not apply to any laser radiation that is all of the
following:
(i) Of a level less than the accessible limits of Class IIIa; and
(ii) Used for relative positioning of the human body; and
[[Page 565]]
(iii) Not used for irradiation of the human eye for ophthalmic
purposes.
(2) Supply with each Class III or IV medical laser product
instructions specifying a procedure and schedule for calibration of the
measurement system required by paragraph (a)(1) of this section.
(3) Affix to each medical laser product, in close proximity to each
aperture through which is emitted accessible laser radiation in excess
of the accessible emission limits of Class I, a label bearing the
wording: ``Laser aperture.''
(b) Surveying, leveling, and alignment laser products. Each
surveying, leveling. or alignment laser product shall comply with all of
the applicable requirements of Sec. 1040.10 for a Class I, IIa, II or
IIIa laser product and shall not permit human access to laser radiation
in excess of the accessible emission limits of Class IIIa.
(c) Demonstration laser products. Each demonstration laser product
shall comply with all of the applicable requirements of Sec. 1040.10 for
a Class I, IIa, II, or IIIa laser product and shall not permit human
access to laser radiation in excess of the accessible emission limits of
Class I and, if applicable, Class IIa, Class II, or Class IIIa.
[50 FR 33702, Aug. 20, 1985]
Sec. 1040.20 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
(a) Applicability. (1) The provisions of this section, as amended,
are applicable as specified herein to the following products
manufactured on or after September 8, 1986.
(i) Any sunlamp product.
(ii) Any ultraviolet lamp intended for use in any sunlamp product.
(2) Sunlamp products and ultraviolet lamps manufactured on or after
May 7, 1980, but before September 8, 1986, are subject to the provisions
of this section as published in the Federal Register of November 9, 1979
(44 FR 65357).
(b) Definitions. As used in this section the following definitions
apply:
(1) Exposure position means any position, distance, orientation, or
location relative to the radiating surfaces of the sunlamp product at
which the user is intended to be exposed to ultraviolet radiation from
the product, as recommended by the manufacturer.
(2) Intended means the same as ``intended uses'' in Sec. 801.4.
(3) Irradiance means the radiant power incident on a surface at a
specified location and orientation relative to the radiating surface
divided by the area of the surface, as the area becomes vanishingly
small, expressed in units of watts per square centimeter (W/cm2).
(4) Maximum exposure time means the greatest continuous exposure
time interval recommended by the manufacturer of the product.
(5) Maximum timer interval means the greatest time interval setting
on the timer of a product.
(6) Protective eyewear means any device designed to be worn by users
of a product to reduce exposure of the eyes to radiation emitted by the
product.
(7) Spectral irradiance means the irradiance resulting from
radiation within a wavelength range divided by the wavelength range as
the range becomes vanishingly small, expressed in units of watts per
square centimeter per nanometer (W/(cm2/nm)).
(8) Spectral transmittance means the spectral irradiance transmitted
through protective eyewear divided by the spectral irradiance incident
on the protective eyewear.
(9) Sunlamp product means any electronic product designed to
incorporate one or more ultraviolet lamps and intended for irradiation
of any part of the living human body, by ultraviolet radiation with
wavelengths in air between 200 and 400 nanometers, to induce skin
tanning.
(10) Timer means any device incorporated into a product that
terminates radiation emission after a preset time interval.
(11) Ultraviolet lamp means any lamp that produces ultraviolet
radiation in the wavelength interval of 200 to 400 nanometers in air and
that is intended for use in any sunlamp product.
(c) Performance requirements--(1) Irradiance ratio limits. For each
sunlamp product and ultraviolet lamp, the ratio of the irradiance within
the wavelength range of greater than 200 nanometers through 260
nanometers to the irradiance within the wavelength
[[Page 566]]
range of greater than 260 nanometers through 320 nanometers may not
exceed 0.003 at any distance and direction from the product or lamp.
(2) Timer system. (i) Each sunlamp product shall incorporate a timer
system with multiple timer settings adequate for the recommended
exposure time intervals for different exposure positions and expected
results of the products as specified in the label required by paragraph
(d) of this section.
(ii) The maximum timer interval(s) may not exceed the manufacturer's
recommended maximum exposure time(s) that is indicated on the label
required by paragraph (d)(1)(iv) of this section.
(iii) No timer interval may have an error greater than 10 percent of
the maximum timer interval of the product.
(iv) The timer may not automatically reset and cause radiation
emission to resume for a period greater than the unused portion of the
timer cycle, when emission from the sunlamp product has been terminated.
(v) The timer requirements do not preclude a product from allowing a
user to reset the timer before the end of the preset time interval.
(3) Control for termination of radiation emission. Each sunlamp
product shall incorporate a control on the product to enable the person
being exposed to terminate manually radiation emission from the product
at any time without disconnecting the electrical plug or removing the
ultraviolet lamp.
(4) Protective eyewear. (i) Each sunlamp product shall be
accompanied by the number of sets of protective eyewear that is equal to
the maximum number of persons that the instructions provided under
paragraph (e)(1)(ii) of this section recommend to be exposed
simultaneously to radiation from such product.
(ii) The spectral transmittance to the eye of the protective eyewear
required by paragraph (c)(4)(i) of this section shall not exceed a value
of 0.001 over the wavelength range of greater than 200 nanometers 320
nanometers and an value of 0.01 over the wavelength range of greater
than 320 nanometers through 400 nanometers, and shall be sufficient over
the wavelength greater than 400 nanometers to enable the user to see
clearly enough to reset the timer.
(5) Compatibility of lamps. An ultraviolet lamp may not be capable
of insertion and operation in either the ``single-contact medium screw''
or the ``double-contact medium screw'' lampholders described in American
National Standard C81.10-1976, Specifications for Electric Lamp Bases
and Holders--Screw-Shell Types, which is incorporated by reference.
Copies are available from the American National Standards Institute,
1430 Broadway, New York, NY 10018, or available for inspection at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(d) Label requirements. In addition to the labeling requirements in
part 801 and the certification and identification requirements of
Secs. 1010.2 and 1010.3, each sunlamp product and ultraviolet lamp shall
be subject to the labeling requirements prescribed in this paragraph and
paragraph (e) of this section.
(1) Labels for sunlamp products. Each sunlamp product shall have a
label(s) which contains:
(i) A warning statement with the words ``DANGER--Ultraviolet
radiation. Follow instructions. Avoid overexposure. As with natural
sunlight, overexposure can cause eye and skin injury and allergic
reactions. Repeated exposure may cause premature aging of the skin and
skin cancer. WEAR PROTECTIVE EYEWEAR; FAILURE TO MAY RESULT IN SEVERE
BURNS OR LONG-TERM INJURY TO THE EYES. Medications or cosmetics may
increase your sensitivity to the ultraviolet radiation. Consult
physician before using sunlamp if you are using medications or have a
history of skin problems or believe yourself especially sensitive to
sunlight. If you do not tan in the sun, you are unlikely to tan from the
use of this product.''
(ii) Recommended exposure position(s). Any exposure position may be
expressed either in terms of a distance specified both in meters and in
feet (or in inches) or through the use of markings or other means to
indicate clearly the recommended exposure position.
(iii) Directions for achieving the recommended exposure position(s)
and a
[[Page 567]]
warning that the use of other positions may result in overexposure.
(iv) A recommended exposure schedule including duration and spacing
of sequential exposures and maximum exposure time(s) in minutes.
(v) A statement of the time it may take before the expected results
appear.
(vi) Designation of the ultraviolet lamp type to be used in the
product.
(2) Labels for ultraviolet lamps. Each ultraviolet lamp shall have a
label which contains:
(i) The words ``Sunlamp--DANGER--Ultraviolet radiation. Follow
instructions.''
(ii) The model identification.
(iii) The words ``Use ONLY in fixture equipped with a timer.''
(3) Label specifications. (i) Any label prescribed in this paragraph
for sunlamp products shall be permanently affixed or inscribed on an
exterior surface of the product when fully assembled for use so as to be
legible and readily accessible to view by the person being exposed
immediately before the use of the product.
(ii) Any label prescribed in this paragraph for ultraviolet lamps
shall be permanently affixed or inscribed on the product so as to be
legible and readily accessible to view.
(iii) If the size, configuration, design, or function of the sunlamp
product or ultraviolet lamp would preclude compliance with the
requirements for any required label or would render the required wording
of such label inappropriate or ineffective, or would render the required
label unnecessary, the Director, Office of Compliance (HFZ-300), Center
for Devices and Radiological Health, on the Center's own initiative or
upon written application by the manufacturer, may approve alternate
means of providing such label(s), alernate wording for such label(s), or
deletion, as applicable.
(iv) In lieu of permanently affixing or inscribing tags or labels on
the ultraviolet lamp as required by Secs. 1010.2(b) and 1010.3(a), the
manfacturer of the ultraviolet lamp may permanently affix or inscribe
such required tags or labels on the lamp packaging uniquely associated
with the lamp, if the name of the manufacturer and month and year of
manufacture are permanently affixed or inscribed on the exterior surface
of the ultraviolet lamp so as to be legible and readily accessible to
view. The name of the manufacturer and month and year of manufacture
affixed or inscribed on the exterior surface of the lamp may be
expressed in code or symbols, if the manufacturer has previously
supplied the Director, Office of Compliance (HFZ-300), Center for
Devices and Radiological Health, with the key to such code or symbols
and the location of the coded information or symbols on the ultraviolet
lamp. The label or tag affixed or inscribed on the lamp packaging may
provide either the month and year of manufacture without abbreviation,
or information to allow the date to be readily decoded.
(v) A label may contain statements or illustrations in addition to
those required by this paragraph if the additional statements are not
false or misleading in any particular; e.g., if they do not diminish the
impact of the required statements; and are not prohibited by this
chapter.
(e) Instructions to be provided to users. Each manufacturer of a
sunlamp product and ultraviolet lamp shall provide or cause to be
provided to purchasers and, upon request, to others at a cost not to
exceed the cost of publication and distribution, adequate instructions
for use to avoid or to minimize potential injury to the user, including
the following technical and safety information as applicable:
(1) Sunlamp products. The users' instructions for a sunlamp product
shall contain:
(i) A reproduction of the label(s) required in paragraph (d)(1) of
this section prominently displayed at the beginning of the instructions.
(ii) A statement of the maximum number of people who may be exposed
to the product at the same time and a warning that only that number of
protective eyewear has been provided.
(iii) Instructions for the proper operation of the product including
the function, use, and setting of the timer and other controls, and the
use of protective eyewear.
(iv) Instructions for determining the correct exposure time and
schedule for persons according to skin type.
[[Page 568]]
(v) Instructions for obtaining repairs and recommended replacement
components and accessories which are compatible with the product,
including compatible protective eyewear, ultraviolet lamps, timers,
reflectors, and filters, and which will, if installed or used as
instructed, result in continued compliance with the standard.
(2) Ultraviolet lamps. The users' instructions for an ultraviolet
lamp not accompanying a sunlamp product shall contain:
(i) A reproduction of the label(s) required in paragraphs (d)(1)(i)
and (2) of this section, prominently displayed at the beginning of the
instructions.
(ii) A warning that the instructions accompanying the sunlamp
product should always be followed to avoid or to minimize potential
injury.
(iii) A clear identification by brand and model designation of all
lamp models for which replacement lamps are promoted, if applicable.
(f) Test for determination of compliance. Tests on which
certification pursuant to Sec. 1010.2 is based shall account for all
errors and statistical uncertainties in the process and, wherever
applicable, for changes in radiation emission or degradation in
radiation safety with age of the product. Measurements for certification
purposes shall be made under those operational conditions, lamp voltage,
current, and position as recommended by the manufacturer. For these
measurements, the measuring instrument shall be positioned at the
recommended exposure position and so oriented as to result in the
maximum detection of the radiation by the instrument.
(The information collection requirements contained in paragraphs (d) and
(e) were approved by the Office of Management and Budget under control
number 0910-0195)
[50 FR 36550, Sept. 6, 1985]
Sec. 1040.30 High-intensity mercury vapor discharge lamps.
(a) Applicability. The provisions of this section apply to any high-
intensity mercury vapor discharge lamp that is designed, intended, or
promoted for illumination purposes and is manufactured or assembled
after March 7, 1980, except as described in paragraph (d)(1)(ii) of this
section.
(b) Definitions. (1) High-intensity mercury vapor discharge lamp
means any lamp including any ``mercury vapor'' and ``metal halide''
lamp, with the exception of the tungsten filament self-ballasted mercury
vapor lamp, incorporating a high-pressure arc discharge tube that has a
fill consisting primarily of mercury and that is contained within an
outer envelope.
(2) Advertisement means any catalog, specification sheet, price
list, and any other descriptive or commercial brochure and literature,
including videotape and film, pertaining to high-intensity mercury vapor
discharge lamps.
(3) Packaging means any lamp carton, outer wrapping, or other means
of containment that is intended for the storage, shipment, or display of
a high-intensity mercury vapor lamp and is intended to identify the
contents or recommend its use.
(4) Outer envelope means the lamp element, usually glass,
surrounding a high-pressure arc discharge tube, that, when intact,
attenuates the emission of shortwave ultraviolet radiation.
(5) Shortwave ultraviolet radiation means ultraviolet radiation with
wavelengths shorter than 320 nanometers.
(6) Cumulative operating time means the sum of the times during
which electric current passes through the high-pressure arc discharge.
(7) Self-extinguishing lamp means a high-intensity mercury vapor
discharge lamp that is intended to comply with the requirements of
paragraph (d)(1) of this section as applicable.
(8) Reference ballast is an inductive reactor designed to have the
operating characteristics as listed in Section 7 in the American
National Standard Specifications for High-Intensity Discharge Lamp
Reference Ballasts (ANSI C82.5-1977)1 or its equivalent.
---------------------------------------------------------------------------
1 Copies are available from American National Standards
Institute, 1430 Broadway, New York, NY 10018.
---------------------------------------------------------------------------
(c) General requirements for all lamps. (1) Each high-intensity
mercury vapor discharge lamp shall:
(i) Meet the requirements of either paragraph (d) or paragraph (e)
of this section; and
(ii) Be permanently labeled or marked in such a manner that the
[[Page 569]]
name of the manufacturer and the month and year of manufacture of the
lamp can be determined on an intact lamp and after the outer envelope of
the lamp is broken or removed. The name of the manufacturer and month
and year of manufacture may be expressed in code or symbols, provided
the manufacturer has previously supplied the Director, Center for
Devices and Radiological Health, with the key to the code or symbols and
the location of the coded information or symbols on the lamp.
(2) In lieu of permanently affixing or inscribing tags or labels on
the product as required by Secs. 1010.2(b) and 1010.3(a) of this
chapter, the manufacturer of any high-intensity mercury vapor discharge
lamp may permanently affix or inscribe such required tags or labels on
the lamp packaging uniquely associated with the applicable lamp.
(d) Requirements for self-extinguishing lamps--(1) Maximum
cumulative operating time. (i) Each self-extinguishing lamp manufactured
after March 7, 1980 shall cease operation within a cumulative operating
time not to exceed 15 minutes following complete breakage or removal of
the outer envelope (with the exception of fragments extending 50
millimeters or less from the base shell); and
(ii) Each self-extinguishing lamp manufactured after September 7,
1981, shall cease operation within a cumulative operating time not to
exceed 15 minutes following breakage or removal of at least 3 square
centimeters of contiguous surface of the outer envelope.
(2) Lamp labeling. Each self-extinguishing lamp shall be clearly
marked with the letter ``T'' on the outer envelope and on another part
of the lamp in such a manner that it is visible after the outer envelope
of the lamp is broken or removed.
(3) Lamp packaging. Lamp packaging for each self-extinguishing lamp
shall clearly and prominently display:
(i) The letter ``T''; and
(ii) The words ``This lamp should self-extinguish within 15 minutes
after the outer envelope is broken or punctured. If such damage occurs,
TURN OFF AND REMOVE LAMP to avoid possible injury from hazardous
shortwave ultraviolet radiation.''
(e) Requirements for lamps that are not self-extinguishing lamps--
(1) Lamp labeling. Any high-intensity mercury vapor discharge lamp that
does not comply with paragraph (d)(1) of this section shall be clearly
and legibly marked with the letter ``R'' on the outer envelope and on
another part of the lamp in such a manner that it is visible after the
outer envelope of the lamp is broken or removed.
(2) Lamp packaging. Lamp packaging for each high-intensity mercury
vapor discharge lamp that does not comply with paragraph (d)(1) of this
section shall clearly and prominently display:
(i) The letter ``R''; and
(ii) The words ``WARNING: This lamp can cause serious skin burn and
eye inflammation from shortwave ultraviolet radiation if outer envelope
of the lamp is broken or punctured. Do not use where people will remain
for more than a few minutes unless adequate shielding or other safety
precautions are used. Lamps that will automatically extinguish when the
outer envelope is broken or punctured are commercially available.''
(3) Lamp advertisement. Advertising for any high-intensity mercury
vapor discharge lamp that does not comply with paragraph (d)(1) of this
section shall prominently display the following wording: ``WARNING: This
lamp can cause serious skin burn and eye inflammation from shortwave
ultraviolet radiation if outer envelope of the lamp is broken or
punctured. Do not use where people will remain for more than a few
minutes unless adequate shielding or other safety precautions are used.
Lamps that will automatically extinguish when the outer envelope is
broken or punctured are commercially available.''
(f) Test conditions. Any high-intensity mercury vapor discharge lamp
under test for compliance with the requirements set forth in paragraph
(d)(1) of this section shall be started and operated under the following
conditions as applicable:
(1) Lamp voltage, current, and orientation shall be those indicated
or recommended by the manufacturer for operation of the intact lamp.
(2) The lamp shall be operated on a reference ballast.
[[Page 570]]
(3) The lamp shall be started in air that has a temperature of
25plus-minus5 deg. C. Heating and movement of the air surrounding
the lamp shall be that produced by the lamp and ballast alone.
(4) If any test is performed in an enclosure, the enclosure shall be
not less than 0.227 cubic meter (8 cubic feet).
(5) Any lamp designed to be operated only in a specific fixture or
luminaire that the lamp manufacturer supplies or specifies shall be
tested in that fixture or luminaire. Any other lamp shall be tested with
no reflector or other surrounding material.
[44 FR 52195, Sept. 7, 1979, as amended at 53 FR 11254, Apr. 6, 1988]
PART 1050--PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS--Table of Contents
Authority: Secs. 501, 502, 510, 515-520, 701, 801 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360, 360e-360j, 371,
381); secs. 354-360F of the Public Health Service Act (42 U.S.C. 263b-
263n).
Sec. 1050.10 Ultrasonic therapy products.
(a) Applicability. The provisions of this section are applicable as
specified herein to any ultrasonic therapy product for use in physical
therapy manufactured on or after February 17, 1979.
(b) Definitions. The following definitions apply to words and
phrases used in this section:
(1) Amplitude modulated waveform means a waveform in which the ratio
of the temporal-maximum pressure amplitude spatially averaged over the
effective radiating surface to the root-mean-square pressure amplitude
spatially averaged over the effective radiating surface is greater than
1.05.
(2) Applicator means that portion of a fully assembled ultrasonic
therapy product that is designed to emit ultrasonic radiation and which
includes one or more ultrasonic transducers and any associated housing.
(3) Beam cross-section means the surface in any plane consisting of
the points at which the intensity is greater than 5 percent of the
spatial-maximum intensity in that plane.
(4) Beam nonuniformity ratio means the ratio of the temporal-average
spatial-maximum intensity to the temporal-average effective intensity.
(5) Centroid of a surface means the point whose coordinates are the
mean values of the coordinates of the points of the surface.
(6) Collimating applicator means an applicator that does not meet
the definition of a focusing applicator as specified in paragraph
(b)(15) of this section and for which the ratio of the area of at least
one beam cross-section, whose centroid is 12 centimeters from the
centroid of the effective radiating surface, to the area of the
effective radiating surface is less than two.
(7) Continuous-wave waveform means a waveform in which the ratio of
the temporal-maximum pressure amplitude spatially averaged over the
effective radiating surface to the root-mean-square pressure amplitude
spatially averaged over the effective radiating surface is less than or
equal to 1.05.
(8) Diverging applicator means an applicator that does not meet the
definition of a collimating applicator or a focusing applicator as
specified in paragraphs (b) (6) and (15) of this section.
(9) Effective intensity means the ratio of the ultrasonic power to
the focal area for a focusing applicator. For all other applicators, the
effective intensity is the ratio of the ultrasonic power to the
effective radiating area. Effective intensity is expressed in watts per
square centimeter (W cm-2).
(10) Effective radiating area means the area consisting of all
points of the effective radiating surface at which the intensity is 5
percent or more of the maximum intensity at the effective radiating
surface, expressed in square centimeters (cm