[Federal Register Volume 64, Number 56 (Wednesday, March 24, 1999)]
[Proposed Rules]
[Pages 14180-14200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-7158]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1010 and 1040
[Docket No. 93N-0044]
Laser Products; Proposed Amendment to Performance Standard
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the performance standard for laser products to achieve harmonization
between the current standard and the International Electrotechnical
Commission (IEC) standard for laser products and medical laser
products. FDA is proposing additional changes that reflect FDA's
understanding of how photobiological and behavioral factors, such as
involuntary eye and body motion, affect the risk of injury from
exposure. In addition, FDA is clarifying the requirement that
manufacturers provide certain information to servicers. Generally, the
proposed amendments will reduce the regulatory burden on affected
manufacturers and improve the effectiveness of FDA's regulation of
laser products. This action is being taken under the Federal Food,
Drug, and Cosmetic Act as amended by Radiation Control for Health and
Safety Act of 1968.
DATES: Written comments on the proposed rule should be submitted by
June 22, 1999. See section IV of this document for the proposed
effective date of a final rule based on this document.
ADDRESSES: Submit written comments on the proposed rule to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
[[Page 14181]]
FOR FURTHER INFORMATION CONTACT: Jerome E. Dennis, Center for Devices
and Radiological Health (HFZ-342), Food and Drug Administration, 2094
Oak Grove Rd., Rockville, MD 20850, 301-594-4654, ext. 135.
SUPPLEMENTARY INFORMATION:
I. Background
On September 23, 1992, FDA's Center for Devices and Radiological
Health (CDRH) mailed to all listed manufacturers and importers of laser
products and interested persons a notice that FDA was considering
amendments to the Federal performance standard for laser products
(Secs. 1040.10 and 1040.11) (21 CFR 1040.10 and 1040.11). Accordingly,
in the Federal Register of May 10, 1993 (58 FR 27495), FDA published a
notice of intent (NOI) that informed interested persons that FDA was
considering amending the performance standard for laser products to:
(1) Achieve greater consistency between the performance standard and
the IEC standards for laser products and medical laser products (IEC
825-1 and IEC 601-2-22); (2) improve compliance; and (3) develop a more
efficient enforcement program. The NOI explained that the impetus for
many of the changes under consideration stemmed largely from extensive
FDA involvement in international standardization efforts for laser
products with IEC, an international standards development organization
with participants from many countries. The NOI also informed interested
persons that additional changes to the current standard that are
unrelated to harmonization were being considered as a result of FDA's
continuing effort to evaluate new information and experience enforcing
the present laser standard and processing variance applications.
At this time, the agency is proposing specific amendments discussed
in the NOI and is also proposing additional items responding to
amendments to the IEC 825-1 standard. A significant amendment to the
IEC standard, which was approved in 1993, expanded the scope of the IEC
825-1 standard to include light emitting diodes (LED's) and products
incorporating LED's. This amendment was approved because LED's are: (1)
Very similar to semiconductor laser diodes, (2) often electrically and
mechanically interchangeable with laser diodes, and (3) considered to
represent similar hazards to the eyes. After the publication of IEC
825-1, considerable controversy developed because manufacturers of
LED's became aware that the conditions for measuring radiant power and
energy to enable product hazard classification resulted in an
exaggeration of the hazard of many LED's. Unlike lasers, LED's are
often extended sources (i.e., have relatively large physical
dimensions) and therefore are not capable of being focussed to as small
and intense a retinal image as comparable lasers. At this time, it
appears that the IEC will be publishing an amendment that will
partially address this concern. However, FDA is not aware of any
injuries that have occurred from LED radiation. In consideration of the
economic impact of including LED's in the applicability of its
standard, the FDA has reconsidered its former notifications and is
eliminating LED products from this proposed rulemaking. The agency
believes that other remedies exist that can be used if needed and can,
in the future, propose additional amendments if warranted.
FDA recognizes its responsibility not only to participate in the
development of radiation safety standards for electronic products, but
also to use its role in the development of the standard to demonstrate
leadership and to exert influence. Although harmonization with the IEC
standard is in itself a worthwhile goal, FDA disagrees with certain
parts of the IEC standard. Specifically, under the IEC standard, the
conditions for the measurement of radiant energy and power for the
purpose of product classification contain a requirement that assumes
that the output of diverging laser sources will be collected by large
aperture optical instruments at a short distance from the source, and
that optical components to collimate the diverging sources are
currently commercially offered as accessories. FDA believes that the
present IEC approach fails to allow for realistic factors of risk
likely in the use of the products. FDA also believes that when
collimators are offered as accessories, the classification measurements
are to be made using the collimators; this situation is equivalent to
offering the collimated laser product in a kit form. The entire laser
product industry, however, should not be burdened with excessive
classification and requirements for controls, indicators, and warnings.
Therefore, FDA is proposing that measurements of radiant energy and
power be made in accordance with the scheme developed by Working Group
1 of the IEC Technical Committee 76 (IEC TC76/WG1) at its meeting in
Washington, DC, in February, 1995, which does not require the use of
large aperture optical instruments in all cases. The IEC TC76/WG1:1995
scheme is described in section II of this document.
Another departure from the requirements of IEC 825-1 relates to the
criterion for human access that applies to levels of laser radiation
that are less than the accessible emission limit (AEL) of Class 2
(Class II under FDA's current standard). Such levels of radiation are
considered to be ocular hazards only for exposures longer than 0.25
seconds. However, the criterion for human access is based on skin
exposure, i.e., interception by any part of the human body. FDA has
recently identified laser products that are classified as Class 2 but
have configurations that prevent direct eye exposure. The present
classification is based upon the ability to insert a part of a hand or
finger into a laser field that is not recognized to be a skin hazard.
FDA recognizes that the classification of an eye hazard based on the
possibility of skin exposure is unnecessarily burdensome on such
products and is therefore proposing to amend this criterion. Although
it is acknowledged that the possibility exists for a person to insert a
mirror and extract the beam, this is not considered to be a realistic
risk upon which all such products need be evaluated.
II. Contents of the Proposed Regulation
Proposed Secs. 1010.2(d) and 1010.3(b) (21 CFR 1010.2(d) and
1010.3(b)) authorize the Director, Office of Compliance, CDRH, to
approve alternate means of providing certification and identification
information. The 1985 amendments to the standard authorized the
Director, Office of Compliance, to give similar approvals for labeling
required by part 1040 (21 CFR part 1040). FDA is now proposing to give
the Director, Office of Compliance, similar authority under
Secs. 1010.2 and 1010.3.
In proposed Sec. 1040.10(d)(4), FDA is introducing the concept of
reduced emission duration for classification of products for which
viewing of the radiation is not intended within the range of their
applications. This is to harmonize with IEC 825-1 and to reduce the
burden on manufacturers of products that have been in higher classes
because of the use of emission durations for classification that are
unrealistically long given the use of the products. Therefore, the
current Class IIa would no longer be needed, and its definition, table
of AEL, and warning label requirements would be eliminated.
Under proposed Sec. 1040.10(b), FDA would change to the use of
Arabic numerals for class designations because Arabic numerals are less
ambiguous. Also, changing to Arabic numerals will
[[Page 14182]]
harmonize with IEC 825-1 and the American National Standard Institute
(ANSI) Z136.1 standards. However, FDA would not object to continued use
of Roman numerals providing that the classification is correct as of
the date of manufacture of the product as shown on the identification
label required by Sec. 1010.3.
Proposed Sec. 1040.10(b)(7) redefines Class 3A (IIIa). The proposed
new definition would expand the range of wavelengths included in the
class and have an AEL for radiant power and energy that is five times
that of Class 1 in addition to an AEL for radiant exposure and
irradiance to account for increased hazard as a result of the use of
collecting optics. Although the new Class 3A would exclude visible
radiation if the irradiance exceeds 2.5 milliwatts per square
centimeter (mW/cm2), the performance and labeling
requirement currently applicable to Class IIIa would apply to the new
class.
Under proposed Sec. 1040.10(d) and Table 1, FDA is deleting the
Class 1 AEL for integrated radiance and replacing these limits with
correction factors to the AEL for radiant energy and power based on the
angular subtense of the radiation source. This concept is in accord
with the current bioeffects science and will harmonize with IEC 825-1.
Current bioeffects science indicates that repetitive pulse exposures
have an increased hazard compared either to a simple summation of the
individual pulses or to a continuous exposure to the same average power
for the same duration. For this reason, the AEL for Class 1 should be
reduced by a factor of the number of pulses raised to the negative one
fourth power (N-1/4).
The measurement parameters for radiant energy and power are those
proposed by IEC TC76/WG1:1995 and endorsed by the U.S. Technical
Advisory Group for that standards committee. This proposal would
require two measurements for visible or near-infrared wavelengths, a 50
millimeters (mm) aperture at 2 meters (m) from the apparent source, and
a 7 mm aperture at 100 mm. The measurement yielding the greater result
is to be used for classification. For sources that have a high degree
of divergence, the 7 mm aperture at a close distance is believed to
accurately represent a worst practical viewing condition without the
use of optical aides. This proposal by WG1 received a majority of the
votes within IEC TC-76, but not a high enough number for acceptance.
The TC-76 has, since approved, a more conservative proposal for the
purpose of providing relief for LED's that can be considered to be
extended sources. This more conservative approach, however, uses a 50
mm aperture at 100 mm from the apparent source and reflects the
assumption that the classification will be based upon the hazard
associated with viewing highly divergent sources through collecting
optics, which increase the hazard. In addition, the use of the 7 mm
aperture with sources that subtend greater than
permits the aperture to
be placed at a distance greater than 100 mm from the apparent source.
In order to be in further agreement with IEC 825-1, the aperture
diameter over which the power or energy is averaged to determine the
radiant exposure or irradiance is determined from a table (Table 6) and
is determined by the wavelength and emission duration.
Under proposed Sec. 1040.10(f)(5) and (f)(6), FDA would eliminate
the requirements for an emission indicator and beam attenuator for
systems in Class 2, 3A, and for systems in Class 3B having a visible
output power of 5 mW or less. Because such systems present minimal
hazard or, by virtue of the visibility of their output, give adequate
warning of its presence, this relaxation is considered to be
appropriate.
FDA is proposing to eliminate the requirement in
Sec. 1040.10(f)(9)(ii) that requires a scanning safeguard to determine
if a change in scan parameters results from a failure or is
intentional, and to react only to those changes resulting from failure.
This requirement has not been invoked by the agency and has been found
very difficult for the industry to understand.
Proposed Sec. 1040.10(g) allows the use of warning logotype labels
and protective housing labels that comply with IEC 825-1. The logotype
labels in current Sec. 1040.10(g) are of a design specified by ANSI. It
is noted that the ANSI standard for laser safety allows use of the IEC
style labels. The IEC labels for protective housings use the word
``CAUTION'' in all cases. In permitting use of the IEC labels, for
consistency purposes, FDA will also permit this wording change.
The agency is not proposing significant changes to
Sec. 1040.10(h)(2)(ii); however, FDA is using this preamble to clarify
the agency's interpretation of that provision in response to the
evident confusion among manufacturers and servicers.
Finally, FDA is proposing to eliminate the quoted caution statement
in Sec. 1040.10(h)(1)(iv), while retaining the requirement in general
terms. This proposed change will avoid otherwise unnecessary approvals
or notifications and allow manufacturers to fulfill the requirement by
using their own wordings for this warning.
III. Summary and Analysis of Comments and FDA's Response
The NOI set out the proposed changes to Secs. 1040.10 and 1040.11
and invited comments and recommendations on such changes. Interested
persons were given until August 9, 1993, to comment on the NOI. FDA
received a total of 13 comments from laser product manufacturers,
government organizations, a consultant, an industry association, and a
professional medical association. These comments generally supported
the proposed changes and the concept of harmonization with
international requirements, except for the comments that follow.
1. Several comments suggested clarifying the proposed amendments to
Sec. 1040.10(d), which proposed reducing the emission durations to be
used for the classification of Class 1 laser products that emit visible
or infrared (IR) laser radiation not intended to be viewed, as
determined from the design of the product or its intended function.
These comments included the following:
A. Long-Term Viewing or Exposure
Four comments requested that FDA clarify the amendment as being
applicable to products for which ``long-term'' viewing or exposure is
intended or inherent in the design of the product, to differentiate
between products in which viewing or exposure would only occur for
short periods.
B. Products Emitting in the Near-IR Range
Four comments assumed that products which emit in the near-IR range
that are classified on the basis of 100 seconds of emission would
continue to be so classified, even if they are general purpose
products. The comments noted that it would help to clarify the proposal
by adding ``general construction'' to the applications listed for use
with the 100 seconds classification time.
C. Surveying Lasers
Six comments stated that surveying lasers should not be included in
the category with laboratory laser systems for a 10,000 seconds
classification because they are not intended to be viewed for long
durations. One comment noted that the purpose of the design of
surveying lasers is to permit the beam to be viewed by electronic or
mechanical devices. Two comments cited the existence of the
Occupational Safety and Health Administration
[[Page 14183]]
regulations promoting safe use of surveying lasers. One manufacturer
submitted an analysis stipulating that the current standard provides an
adequate safety margin for its laser surveying products and noted that
the proposed amendment would mandate a large reduction of output power
for such products, which would render the technology useless.
FDA agrees with comments 1.A and 1.B of section III of this
document. The proposed amendments have been drafted to incorporate the
concepts and language of IEC 825-1, 1993. Although FDA agrees with the
point in comment 1.C of section III of this document that invisible
radiation intended for detection only by electronic means is not
considered to be intended to be viewed, FDA notes that visible
radiation emitted by surveying lasers that is used for leveling must be
assumed to be intended to be viewed by the eyes. Further, viewing for
more than 100 seconds cannot be considered to be unlikely. Therefore,
the proposed 30,000 second maximum sampling interval is retained.
2. Four comments noted that the amendments to reduce the AEL for
repetitively pulsed lasers should only be made if the change to reduce
the time period for classification discussed in comment 1 of section
III of this document is also made. If the proposed reduction in the AEL
were made without reducing the time period for classification, the
result would be a lowering of the allowable power for some products and
an inconsistency with the IEC 825 standard. The comments also suggested
that ``repetitively pulsed lasers'' be changed to ``products with
scanning or repetitively pulsed outputs,'' to clarify that the
requirement would also apply to scanning products.
FDA agrees with these comments and believes that the wording of the
proposed amendments addresses the concern relating to the time period
for classification. The clarification that the requirement applies both
to repetitive pulses and scanned radiation has been made.
3. One comment suggested use of the revised ANSI AEL in the 1,150
to 2,800 nanometers (nm) spectral band rather than merely revising the
AEL in the 1,535 to 1,540 nm spectral band. The comment noted that the
revisions, which relate to both fiber optic exposure and so-called
``eye-safe'' laser exposure, are important to consider because of the
greatly expanding technology in that spectral region.
FDA agrees that a revision of the AEL is appropriate to incorporate
up-to-date understanding of the biological effects of exposure to
certain spectral bands. The method used in the ANSI standard to
determine the AEL is to calculate using the maximum permissible
exposure. Although this is appropriate in the ANSI standard, which is
primarily concerned with the safe use of lasers, FDA believes that it
is appropriate to employ tables of AEL in a product standard. In
addition, in the interests of global harmonization, the AEL in the
proposed amendments to the standard are identical to those of IEC 825-
1, which is accepted in most other countries.
4. One comment disagreed with FDA's approach in its proposal to
amend the tables in Sec. 1040.10(d) for the purpose of making the
resulting classifications agree more nearly with the IEC and ANSI
classifications. The comment disagreed with FDA's contention that the
present structure of these tables should be retained because the
existing structure is simpler than the corresponding ANSI and IEC
tables. The comment stated that although the ANSI calculations are more
complex, if more simplified tables (such as those in the FDA standard)
result in some systems being considered more hazardous than they would
be under the ANSI or IEC methods, then the more complex method should
be used.
FDA partially agrees with this comment. Upon further consideration,
it became clear that reformatting the IEC tables of AEL to conform to
those in the present standard was practically unworkable. Therefore,
the proposal contains tables of AEL that are identical to those of IEC
825-1. Further, FDA agrees that the standard should not result in an
exaggeration of the hazard; therefore, the specified conditions for
measurement of radiant energy and power for classification are more
relaxed than those of IEC 825-1. FDA recognizes that this is a
potential obstacle to harmonization and hopes that the IEC TC-76 will
follow the agency's lead in this area.
5. Four comments stated that it would be helpful to clarify the
amendment regarding relaxation of the laser radiation levels for which
the requirements of Sec. 1040.10(f)(2) for safety interlocks are
applicable. These comments requested that FDA clarify that the
relaxation discussed with regard to ``radiation emitted directly
through the opening created by removal or displacement of the
interlocked portion of the protective housing'' refers only to Class 3A
radiation that is ``emitted out, not just any radiation level.''
FDA agrees with this comment and has inserted an explanatory note
in the performance requirement for protective housing.
6. Five comments noted that the proposed interlock requirement
(Sec. 1040.10(f)(2)) exceeds the requirements in Amendment 2 to IEC
825. One comment noted that safety interlocks are not now required by
IEC 825 on Class 4 lasers and suggested a requirement that the lids of
laser boxes be interlocked so that the laser turns off when the lid is
lifted, or a requirement that the laser beam be fully enclosed within
the box, inside a cover which is either interlocked itself or that
requires a tool for removal.
FDA disagrees with this comment and notes that this performance
requirement was made identical to that in the current CDRH standard in
the amendments of the IEC standard that were approved in 1993. FDA has
always maintained that interlock protection during operation or
maintenance that entails human access to hazardous levels of laser
radiation is equally appropriate for all classes of laser products.
7. Four comments noted that the proposed amendment of
Sec. 1040.10(f)(5) to require ``visible indications of actual emission
from remote laser apertures of Class 3B and 4 laser systems'' exceeds
the requirements of the IEC amendments, which only require such
indications when the aperture could be emitting energy. The comments
expressed concern that the proposed amendment, as worded, would be
difficult to implement and may not provide additional safety for the
user. FDA has considered these comments and decided that the proposed
amendment would provide additional safety for the user and that any
difficulty in implementation would be outweighed by the increase in
safety. The proposed change addresses concern about some industrial
workstations where the laser aperture is located at a considerable
distance from either the laser or the control station. The concern is
even greater for those situations in which the output of a single high
power laser is shared by a number of workstations. The proposed
requirements are in agreement with those under consideration by the IEC
TC-76.
8. Several comments addressed the proposed amendments to warning
labels, signal words, and labels for noninterlocked and defeatably
interlocked protective housings. These comments are as follows:
[[Page 14184]]
A. Acceptance of IEC Labels
Five comments believed that the acceptance of IEC labels will ease
the burden on manufacturers. Several of these comments expressed
concern, however, that the differences in measurement criteria for
classification between the IEC and FDA standards may cause problems and
confusion. The comments noted that these problems might be addressed in
the third set of amendments to the IEC standard.
B. Signal Words
One comment disagreed with eliminating the signal words ``CAUTION''
and ``DANGER'' because U.S. consumers are accustomed to the type of
markings that include a signal word. The use of signal words resulted
from consensus agreements between consumer and legal interests in the
United States a number of years ago, and the standard 3-part marking
specified in most U.S. product safety standards, which are ANSI
approved, requires the use of a signal word.
C. Permission of the Word ``CAUTION'' in Place of the Word ``DANGER''
Three comments that agreed with the proposed amendment to
Sec. 1040.10(g)(6) permitting the word ``CAUTION'' in place of the word
``DANGER'' believed that this amendment should also apply to
Sec. 1040.10(g)(7).
D. Proposed Simplification
Four comments agreed with the proposed simplification of the
requirements in Sec. 1040.10(g)(6) and (g)(7) applicable to labels for
noninterlocked and defeatably interlocked protective housings.
FDA is in general agreement with comment 8.A of section III of this
document. Although it is true that differences in measurement criteria
will cause problems and confusion for a small number of products, FDA
believes that the disadvantages of adopting the present measurement
criteria of IEC 825-1 outweigh the disadvantages of having different
FDA and IEC criteria.
In response to comment 8.B of section III of this document, FDA
believes that the benefit resulting from the use of ``CAUTION'' or
``DANGER'' is outweighed, in this case, by that of averting
noncompliance through harmonized requirements.
FDA agrees with comment 8.C of section III of this document as it
applies to Class 2 and certain Class 3A accessible laser radiation and
collateral radiation. Proposed Sec. 1040.10(g)(6) and (g)(7) permit use
of the word ``CAUTION'' on labels for the protective housing on
products emitting these levels of radiation.
Proposed Sec. 1040.10(g)(6) and (g)(7) are simplified in accordance
with the NOI and with comment 8.D of section III of this document.
9. One comment requested clarification of the proposed amendment to
Sec. 1040.11(a) requiring optical or electrical monitoring of the
operation of lasers in Class 3B and 4 medical laser products. The
proposed amendment states that ``an electrical or optical quantity that
is directly related to the laser or LED level generated shall be
continually monitored during operation.'' The comment noted that for
very low repetition rate pulsed laser systems, the energy is usually
measured before a procedure begins or between patient exposures.
According to this comment, if an additional means of monitoring is
required beyond the level of normal compliance, the ``additional
means'' would be a ``significant engineering feat.'' This is because
``real-time'' monitoring of the pulsed energy during an actual
treatment pulse requires an instantaneous shuttering or shutoff of the
laser pulse while the specified energy level is reached. FDA believes
that monitoring the voltage of a charged capacitor could satisfy this
requirement for a pulsed laser system. The comment concluded that the
cost of new pulsed laser systems would be increased substantially if
this engineering change were required for new or existing laser
systems.
FDA agrees with this comment and has clarified its intent in
proposed Sec. 1040.11(a). The item was intended to harmonize with the
requirements of IEC 601-2-22 for medical laser and LED products. The
present standard requires that Class 3B and 4 medical laser products
incorporate a means of optical measurement of the level of laser
radiation intended to be incident upon the target tissue. FDA has
determined that this requirement can be met by a measurement at a
location within the product or prior to emission from the distal
aperture. IEC 601-2-22 addresses the same intent by imposing an
accuracy specification relative to the preset or selected level. IEC
601-2-22 further requires that the operation of the laser be monitored
electrically or optically, that there be an alarm if the actual
monitored value differs by more than 20 percent from the
preset value, and that the user instructions specify how and when to
actually measure the delivered output. Proposed Sec. 1040.11(a) adopts
these requirements.
10. One comment requested that a section be included in the
amendment that certain low-power laser products be exempt from
reporting. This section would condense and clarify provisions set forth
in exemptions granted by Laser Notices 36, 41, and 42 and other notices
as applicable. The author of the comment believes that inclusion of
such a section would make this information available to the broad
audience, and reduce misunderstandings associated with the
administration of the regulation.
FDA agrees with this comment and believes the question has already
been addressed in the amendments to part 1002 (21 CFR part 1002)
published in the Federal Register of September 19, 1995 (60 FR 48374).
11. One comment believed that the lasers in compact disk (CD)
players should be exempt from FDA regulation and should only be subject
to general safety certification (UL, CSA, etc.)
FDA believes that the amendments to part 1002 have addressed this
concern, but notes that the lasers themselves that are in CD players
are generally Class 3B. However, when the laser is incorporated into a
cell with a focusing lens, this assembly becomes the smallest component
that is replaceable in service and is Class 1. Because of the low cost
of such components, it is unlikely that any individual or firm would be
motivated to disassemble the components and then to attempt to cause
them to emit. FDA has determined that the level of laser radiation that
could be accessible during service may be considered to be the maximum
level accessible from the smallest replaceable component.
12. In addition, FDA has recently received inquiries, suggestions,
and one trade complaint concerning the interpretation of
Sec. 1040.10(h)(2)(ii), which requires manufacturers of laser products
to provide adequate instructional information to servicers and others
upon request. Although the correspondence does not directly relate to
the advanced notice of proposed rulemaking, the agency believes this
proposal is an appropriate forum for presenting its construction of the
current regulation and inviting comment from interested persons.
The correspondence FDA has received has reflected disagreement
between manufacturers and independent servicers of laser products about
whether the regulation authorizes manufacturers to interpret
``adequate'' to include training provided by the manufacturer. The
agency believes that it is appropriate for the manufacturer to decide,
in the first instance, what constitutes ``adequate'' servicing
instructions. If the agency learns, however, through the inspection of
laser
[[Page 14185]]
manufacturing facilities or otherwise, that manufacturers are using the
requirement of ``adequate'' as a pretext for making the provision of
servicing instructions contingent upon costly or burdensome training,
FDA will deem the manufacturer's product to be noncompliant with the
laser performance standard and will take appropriate regulatory action.
IV. Effective Date
FDA proposes that any final rule that may issue based on this
proposal become effective 1 year after the date of publication of the
final rule in the Federal Register.
V. Environmental Impact
The agency has determined under 21 CFR 25.34(c) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VI. Analysis of Impacts
FDA has examined the impact of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as
amended by subtitle D of the Small Regulatory Fairness Act of 1966
(Pub. L. 104-121)), and the Unfunded Mandates Reform Act of 1995 (Pub.
L. 104-4). Executive Order 12866 directs agencies to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity).
The agency believes that this proposed rule is consistent with the
regulatory philosophy and principles identified in the Executive Order.
In addition, the proposed rule is not a significant regulatory action
as defined by the Executive Order and so is not subject to review under
the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this rule in many instances decreases the
regulatory burden from that imposed by the current regulations and
increases the level of consistency between Federal law and
international law to which small entities may be subject, the agency
certifies that the proposed rule will not have a significant economic
impact on a substantial number of small entities. In addition, this
proposed rule will not impose costs of $100 million or more in either
the private sector or State, local, and tribal governments in the
aggregate, and therefore a summary statement of analysis under section
202(a) of the Unfunded Mandates Reform Act is not required.
VII. Paperwork Reduction Act of 1995
This proposed rule contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
burden hours required for Sec. 1040.10(a)(4)(i), (h)(1)(i) through
(h)(1)(vi), (h)(2)(i) and (h)(2)(ii), (i), and Sec. 1040.11(a)(2)(iv)
are reported and approved under OMB control number 0910-0213.
VIII. Comments
Interested persons may, on or before June 22, 1999, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in the brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
List of Subjects
21 CFR Part 1010
Administrative practice and procedures, Electronic products,
Exports, Radiation protection.
21 CFR Part 1040
Electronic products, Labeling, Lasers, Medical devices, Radiation
protection, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR parts 1010 and 1040 be amended as follows:
PART 1010--PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL
1. The authority citation for 21 CFR part 1010 is revised to read
as follows:
Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss, 371,
381.
2. Section 1010.2 is amended by revising paragraph (d) to read as
follows:
Sec. 1010.2 Certification.
* * * * *
(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 or upon his or her initiative, the Director, Office of
Compliance, Center for Devices and Radiological Health, may approve an
alternate means by which such certification may be provided.
3. Section 1010.3 is amended by revising paragraph (b) to read as
follows:
Sec. 1010.3 Identification.
* * * * *
(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 or upon his or her
initiative, the Director, Office of Compliance, Center for Devices and
Radiological Health, may approve an alternate means by which such
identification may be provided.
* * * * *
PART 1040--PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS
4. The authority citation for 21 CFR part 1040 continues to read as
follows:
Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 371, 381; 42
U.S.C. 263b-263n.
5. Section 1040.10 is revised to read as follows:
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 (date 1 year after date of publication
in the Federal Register of any final rule that issues based on this
proposed rule), except when:
(1) Such a laser cannot under any conditions of operation,
maintenance, service, or single failure emit radiation in excess of the
accessible emission limits of a Class 1 laser product, or
(2) Such a laser is sold to a manufacturer of an electronic product
for use as a component (or replacement) in such electronic product, or
(3) Such a laser is 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:
(i) Is accompanied by a general warning notice that adequate
instructions for the safe installation of the product are provided in
servicing information available from the complete product manufacturer
under paragraph (h)(2)(ii) of this section, and should be followed,
[[Page 14186]]
(ii) Is labeled with a statement that it is designated for use
solely as a component of such electronic product and therefore is not
required to 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
(4) 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-342), Center for Devices and
Radiological Health, 2098 Gaither Rd., Rockville, MD 20850; and
(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 of this
chapter.
(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 possible.
(2) Accessible emission limit means the maximum accessible emission
level permitted within a particular class as set forth in paragraphs
(c) and (d) of this section when measured according to paragraph (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 1 laser means any laser that does not permit access
during the operation to levels of laser radiation in excess of the
accessible emission limits contained in Table 1 of paragraph (d) of
this section.\1\
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\1\ Class 1 levels of laser or radiation are not considered to
be hazardous.
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(6) Class 2 laser means any laser that permits human access during
operation to levels of visible laser radiation in excess of the
accessible emission limits contained in Table 1 in paragraph (d) of
this section, but does not permit human access during operation to
levels of laser radiation in excess of the accessible emission limits
contained in Table 2 of paragraph (d) of this section.\2\
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\2\ Class 2 levels of laser radiation are considered to be a
chronic viewing hazard.
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(7) Class 3A laser means any laser that permits human access during
operation to levels of visible laser radiation in excess of the
accessible emission limits contained in Table 2 of paragraph (d) of
this section, but does not permit human access during operation to
levels of laser radiation in excess of the accessible emission limits
contained in Table 3 of paragraph (d) of this section.\3\
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\3\ Class 3A levels of laser radiation are considered to be
either an acute viewing hazard at visible or near-infrared (700 to
1,400 nanometers (nm)) wavelengths if viewed directly with optical
instruments, or a nominal hazard at wavelengths outside these
ranges.
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(8) Class 3B 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 3 of paragraph (d) of this
section, but does not permit human access during operation to levels of
laser radiation in excess of the accessible emission limits contained
in Table 4 of paragraph (d) of this section.\4\
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\4\ Class 3B levels of laser radiation are considered to be an
acute hazard to the skin and eyes from direct radiation.
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(9) Class 3 laser product means any Class 3A or Class 3B laser
product.
(10) Class 4 laser product means any laser product that permits
human access during operation to levels of laser radiation in excess of
the accessible emission limits contained in Table 4 of paragraph (d) of
this section.\5\
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\5\ Class 4 levels of laser radiation are considered to be an
acute hazard to the skin and eyes from direct and scattered
radiation.
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(11) 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).
(12) 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.
(13) Emission duration means the temporal duration of a pulse, a
series of pulses, or continuous operation, expressed in seconds, during
which human access to laser or collateral radiation could be possible
as a result of operation, maintenance, or service of a laser product.
(14) Human access means the capacity to intercept laser or
collateral radiation by any part of the human body. For laser products
that contain Class 3B or 4 levels of laser radiation, ``human access''
also means access to laser radiation that can be reflected directly
onto any part of the human body by any single introduced flat surface
from the interior of the product through any opening in the protective
housing of the product.
(15) 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 700 nm but less than or equal to 1,000,000 nm
(1 millimeter).
(16) 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.
(17) Laser means any device that can be made to produce or amplify
electromagnetic radiation at wavelengths greater than 180 nm but less
than or equal to 1,000,000 nm (1 millimeter) primarily by the process
of controlled stimulated emission.
(18) 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.
(19) 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.
(20) Laser radiation means all electromagnetic radiation emitted by
a laser product within the spectral range specified in paragraph
(b)(17) 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 as
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specified in paragraph (e) of this section.
(21) 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.''
(22) 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 paragraphs (b)(27) and
(b)(37) of this section.
(23) 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.
(24) Maximum angular subtense means the value of angular subtense
of the apparent source above which the AEL's are independent of the
source size ( = 0.1 rad
(100 mrad)).
(25) Medical laser 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.
(26) Minimum angular subtense means the value of angular subtense
of the apparent source above which the source is considered to be an
extended source. Maximum permissible exposures (MPE's) and AEL's are
independent of source size for angles less than the minimum angular
subtense ().
= 0.0015 rad t
0.7s
0.002t3/4 rad 0.7s t 10s
0.01rad t 10s
(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)(22) and (b)(37) 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-peak-power points at the leading and trailing edges of a pulse.
(30) Radiant energy means energy emitted, transferred or received
in the form of radiation, expressed in joules (J).
(31) 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).
(32) Radiant power means time-averaged power emitted, transferred
or received in the form of radiation, expressed in watts (W).
(33) Remote interlock connector means an electrical connector which
permits the connection of external remote interlocks.
(34) 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.
(35) 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).
(36) Scanned laser radiation means laser radiation having a time-
varying direction, origin or pattern of propagation with respect to a
stationary frame of reference.
(37) 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)(22) and
(b)(27) of this section.
(38) 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; and
(iii) Defining a plane, level, elevation, or straight line.
(39) Visible radiation means laser or collateral radiation having
wavelengths of greater than 400 nm but less than or equal to 700 nm.
(40) Warning logotype means a logotype as illustrated in either
Figure 1 or Figure 2 of paragraph (g) of this section.
(41) Wavelength means the propagation wavelength in air of
electromagnetic radiation.
(c) Classification of laser--(1) All laser products. Each laser
shall be classified in Class 1, 2, 3A, 3B, or 4 in accordance with
definitions set forth in paragraphs (b)(5) through (b)(10) 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 the accessible emission level of
laser radiation the system is capable of producing when so removed.
(d) Accessible emission limits. Accessible emission limits for
laser radiation in each class are specified in Tables 1, 2, 3, and 4 of
this paragraph. Accessible emission limits for collateral radiation are
specified in Table 7 of this paragraph.
NOTE APPLICABLE TO TABLES 1, 2, 3, 4, AND 6
The variable t in the expressions of emission limits is the
magnitude of the sampling interval in units of seconds.
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(1) Beam of a single wavelength. Laser or collateral radiation
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 1, 2, 3, and 4 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 1, 2, 3, and 4 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 1, 2, 3, and 4 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 (d)(2) of this section.
(4) Maximum sampling interval. Three maximum sampling intervals are
used for the classification of laser. Which interval applies depends
upon the accessible emission level of the product and whether viewing
the radiation is an inherent feature of the product. The accessible
emission limits of a class are exceeded, if exceeded within any
emission duration less than or equal to the following maximum sampling
intervals:
(i) 30,000 seconds for wavelengths less than or equal to 400 nm and
for wavelengths greater than 400 nm if intentional viewing of the
radiation is inherent in the design or function of the product, or
(ii) 100 seconds for wavelengths greater than 400 nm unless
intentional viewing of the radiation is inherent in the design or
function of the product.
(iii) 0.25 seconds for Class 2 and for Class 3A laser radiation
within the wavelength range from 400 to 700 nm.
(5) Repetitively pulsed or scanned laser radiation. For
repetitively pulsed or scanned laser radiation in the wavelength range
from 400 nm to 1,000,000 nm (1 millimeter) the AEL is determined by
using the most restrictive of requirements in paragraphs (d)(4)(i),
(d)(4)(ii), and (d)(4)(iii) of this section as appropriate. For
wavelengths less than 400 nm, the AEL is determined by using the most
restrictive of requirements in paragraphs (d)(4)(i) and (d)(4)(ii) of
this section.
(i) The emission level of any single pulse within a pulse train
shall not exceed the AEL for a single pulse.
(ii) The average power of a pulse train of duration t shall not
exceed the power corresponding to the AEL given in Tables 1, 2, 3, and
4 of this paragraph, respectively, for a single pulse of duration t.
(iii) The emission level of any single pulse within a pulse train
shall not exceed the AEL for a single pulse multiplied by the
correction factor C5:
AELtrain = AELsingle x C5
NOTE: C5 is only applicable to pulse durations shorter
than 0.25 sec. where:
AELtrain = AEL for any single pulse in the pulse train
AELsingle = AEL for a single pulse
C5 = N-1/4
N = number of pulses in the pulse train during the sampling
interval.
NOTE: In some cases, AELtrain this value may fall below the
AEL that would apply for continuous operation at the same peak power
using the same time base. Under these circumstances, the AEL for
continuous operation may be used.
(e) Tests for determination of compliance--(1) Tests for
certification. Tests on which certification under
[[Page 14195]]
Sec. 1010.2 of this chapter 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 of this
chapter, tests for compliance with each of the applicable requirements
of this section and Sec. 1040.11 shall be made as appropriate during
operation, maintenance, service, or single failure as follows:
(i) Under those conditions and procedures that 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 locations where human access to laser radiation is
possible, 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
connected to that type of laser energy source that is specified as
compatible by the laser product manufacturer and that 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 measurements in paragraph
(e)(3)(i) of this section as appropriate, or their equivalent. For the
purposes of the measurements in paragraphs (e)(3)(i)(A) through
(e)(3)(i)(D), and paragraph (e)(3)(ii) of this section, the 50-
millimeter aperture will be the limiting case with collimated beams,
and the measurement distances referring to the apparent source are
measured from the apparent source irrespective of any optical element
placed between the source and the measurement aperture.
(i) Radiant power (W) or radiant energy (J) measurable under the
following conditions:
(A) Within a circular aperture stop of 50-millimeter diameter
placed at a distance of 2 meters from the closest point of human
access. In general, the 50-millimeter aperture will be the limiting
case with collimated beams, or
(B) In the wavelength range from 400 nm to 1,400 nm within a
circular aperture stop of 7-millimeter diameter placed at a distance of
100 millimeters from the apparent source.
(C) For apparent sources subtending an angle () (measured
at a minimum distance of 100 millimeters) less than
and within the
wavelength range from 400 nm to 1,400 nm, within a circular aperture
stop of 7-millimeter diameter positioned at a distance (r) from the
source depending upon the angular subtense (between a minimum
of 1.5 mrad and a maximum of
) of the source. The
distance (r) of the 7-millimeter measurement aperture from the source
is determined by:
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NOTE: In cases where the apparent source is recessed within the product
at a distance greater than that specified in paragraph (e)(3)(i)(B) or
(e)(3)(i)(C) of this section, the minimum measurement distance should
be at the closest point of human access, such as the exit window or
lens. This measurement is needed to determine the user information
required for Class 1 laser products (see paragraph (h)(1)(vi) of this
section).
(D) For wavelengths less than 400 nm and greater than 1,400 nm,
within a circular aperture stop of 7-millimeter diameter (or as
otherwise specified) placed at a distance of 14 millimeters from the
closest point of human access.
(E) For the calculation of the AEL expressed in terms of radiant
power, radiant energy, irradiance, or radiant exposure, the value of
the angular subtense of a rectangular or linear source is determined by
the arithmetic mean of the two angular dimensions of the source. Any
angular dimension that is greater than
or less than
shall be limited to
or
, respectively, prior to
calculating the mean.
(F) For scanned laser radiation, the direction of the solid angle
of acceptance shall change as needed to maximize detectable radiation,
with an angular speed of up to 5 radians/second.
(ii) The irradiance (Wcm-2) or radiant exposure
(Jcm-2) equivalent to the radiant power (W) or radiant
energy (J) measurable through a circular aperture stop having a
diameter as specified in Table 6 of paragraph (d) of this section shall
be divided by the area of the aperture stop.
(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 Tables 1 or 7 of paragraph (d) of this section 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 1 is necessary, these
levels shall not exceed the limits of the lowest class necessary to
perform the intended function(s) of the product.
NOTE: If there is an opening or openings, such as for cooling, in a
protective housing that encloses Class 3B or 4 levels of laser
radiation, the adequacy of the protective housing shall be determined
by whether the level of radiation that can be reflected out through the
opening(s) by a single flat reflector exceeds the accessible emission
limits of Class 1.
(2) Safety interlocks--(i) Each laser, 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
[[Page 14196]]
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:
(A) Laser radiation in excess of the accessible emission limits of
Class 3A; or
(B) Laser radiation in excess of the accessible emission limits of
Class 2 to be emitted directly through the opening created by removal
or displacement of the interlocked portion of the protective housing.
(ii) Each required safety interlock, unless defeated, shall prevent
human access to laser radiation as described in paragraphs (f)(2)(i)(A)
through (f)(2)(i)(B) of this section 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 3A; or
(B) Laser radiation in excess of the accessible emission limits of
Class 2 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 3B or 4 laser product, except for Class 3B with not more than
five times the AEL of Class 2 in the wavelength range of 400 to 700 nm,
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 1 and Table 7 of paragraph (d) of this section shall be
prevented.
(4) Key control. Each laser system classified as a Class 3B or 4
laser product, except for Class 3B with not more than five times the
AEL of Class 2 in the wavelength range of 400 to 700 nm, 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 3B or 4 laser product, except for Class 3B with
not more than five times the AEL of Class 2 in the wavelength range of
400 to 700 nm, 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 1, and
sufficiently prior to emission of such radiation to allow appropriate
action to avoid exposure to the laser radiation.
(ii) 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) of this section.
(iii) Any visible signal required by paragraph (f)(5)(i) or
(f)(5)(ii) of this section shall be clearly visible through protective
eyewear designed specifically for the wavelength(s) of the emitted
laser radiation.
(iv) Emission indicators required by paragraph (f)(5)(i) or
(f)(5)(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 1 and Table 7 of paragraph (d)
of this section.
(6) Beam attenuator--(i) Each laser system classified as a Class 3B
or 4 laser product, except for Class 3B with not more than five times
the AEL of Class 2 in the wavelength range of 400 to 700 nm, 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 1 and Table 7 of paragraph (d)
of this section.
(ii) Upon written application by the manufacturer or on the
initiative of the Director, Office of Compliance, Center for Devices
and Radiological Health, the Director may, upon determination that the
configuration, design, or function of the laser product would make
unnecessary compliance with the requirement in paragraph (f)(6)(i) of
this section, approve alternate means to accomplish the radiation
protection provided by the beam attenuator.
(7) Location of controls. Each Class 2, 3, or 4 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 1 and Table 7 of paragraph (d) of this section 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 1 and Table 7 of paragraph (d) of this
section. 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 1 and
Table 7 of paragraph (d) of this section 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 1 and Table 7 of paragraph (d) of this section.
(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 the accessible emission limits of the class of
the product.
(10) Manual reset mechanism. Each laser system manufactured after
August 20, 1986, classified as a Class 4 laser 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 of this chapter, each laser product shall be
subject to the applicable labeling requirements of this paragraph.
Labeling in accordance with the International Electrotechnical
Commission (IEC) Document 825-1 will
[[Page 14197]]
satisfy the requirements of paragraphs (g)(1) through (g)(10) of this
section.
(1) Class 2 designation and warnings. Each Class 2 laser product
shall have affixed a label bearing the warning logotype A (Figure 1 in
this paragraph) that includes the following wording:
[Position 1 on the logotype]
``LASER RADIATION--DO NOT STARE INTO BEAM''; and
[Position 3 on the logotype]
``CLASS 2 LASER PRODUCT''.
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(2) Class 3A and 3B designations and warnings. (i) Each Class 3
laser product that does not exceed the accessible emission limits of
Table 3A shall have affixed a label bearing the warning logotype A
(Figure 1 of paragraph (g)(1) of this section) that includes the
following wording:
[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 3A LASER PRODUCT''.
(ii) Each Class 3 laser product that exceeds the accessible
emission limits of Table 3A in the wavelength range of 400 to 700 nm
and less than the AEL of Class 3A at other wavelengths 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 3B LASER PRODUCT''.
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(iii) Each Class 3B laser product except as specified in (g)(2)(ii)
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 3B LASER PRODUCT''.
(3) Class 4 designation and warning. Each Class 4 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 4 LASER PRODUCT''.
(4) Radiation output information on warning logotype. Each Class 2,
3, and 4 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, except medical lasers, 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 1 and Table 7 of paragraph (d) of this
section, a label or labels 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 7, item 1 of
paragraph (d) of this section.
(iii) ``AVOID EXPOSURE--Hazardous x-rays are emitted from this
aperture,'' if the radiation emitted through such aperture is
collateral radiation described in Table 7, item 2 of paragraph (d) of
this section.
(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 1 and Table 7 of paragraph (d) of this
section. 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 2 accessible laser radiation.
(ii) ``CAUTION--Laser radiation when open. DO NOT STARE INTO BEAM
OR VIEW DIRECTLY WITH OPTICAL INSTRUMENTS.'' for Class 3A accessible
laser radiation.
(iii) ``DANGER--Laser radiation when open. AVOID DIRECT EYE
EXPOSURE.'' for Class 3B accessible
[[Page 14199]]
laser radiation with an irradiance greater than 0.0025 W/
cm-2 and with not more than five times the AEL of Class 2 in
the wavelength range of 400 to 700 nm.
(iv) ``DANGER Laser radiation when open. AVOID DIRECT EXPOSURE TO
BEAM.'' for Class 3B accessible laser radiation other than that
described in paragraph (g)(6)(iii) of this section.
(v) ``DANGER Laser radiation when open. AVOID EYE OR SKIN EXPOSURE
TO DIRECT OR SCATTERED RADIATION.'' for Class 4 accessible laser
radiation.
(vi) ``CAUTION Hazardous electromagnetic radiation when open.'' for
collateral radiation in excess of the accessible emission limits in
Table 7, 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 7, 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 1 or Table 7 of paragraph (d) of this section. Such
labels shall be visible on the product prior to and during interlock
defeat and shall be 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 2 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 3A accessible laser radiation with an irradiance less than or
equal to 0.0025 W/cm-2.
(iii) ``DANGER Laser radiation when open and interlock defeated.
AVOID DIRECT EYE EXPOSURE.'' for Class 3B accessible laser radiation
with an irradiance greater than 0.0025 W/cm-2 and with not
more than five times the AEL of Class 2 in the wavelength range of 400
to 700 nm.
(iv) ``DANGER Laser radiation when open and interlock defeated.
AVOID DIRECT EXPOSURE TO BEAM.'' for Class 3B accessible laser
radiation other than that described in paragraph (g)(7)(iii) of this
section.
(v) ``DANGER Laser radiation when open and interlock defeated.
AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION.'' for
Class 4 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 7 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 accessible
emission limits in Table 7, 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 1 radiation or the limits of collateral radiation established
to Table 7 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, and service, as appropriate. Upon written application by
the manufacturer, or on the initiative of the Director, Office of
Compliance, Center for Devices and Radiological Health, the Director
may, upon determination that 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, 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:
(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 1, 2, 3, 4, and 7 of paragraph (d) of this
section determined under paragraph (e) of this section, and a schedule
of maintenance necessary to keep the product in compliance with this
section and, if applicable, Sec. 1040.11.
(ii) A statement of the magnitude, in appropriate units, of the
pulse duration(s), maximum radiant power and, where applicable, the
maximum radiant energy per pulse of the accessible laser detectable in
each direction in excess of the accessible emission limits in Table 1
of paragraph (d) of this section.
(iii) Legible reproductions (color optional) of all labels and
hazard warnings required by paragraph (g) of this section and, if
applicable, Sec. 1040.11, to be affixed to the laser product or
provided with the laser product, including the information and warnings
required for positions 1, 2, and 3 of the applicable logotype (Figure 1
of paragraph (g)(1) or Figure 2 of 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 a cautionary warning that the use
of controls or adjustments or performance of procedures other than
specified may result in hazardous radiation exposure.
(v) In the case of laser products other than laser systems, a
statement of the compatibility requirements for a laser energy source
that will assure compliance of the laser product with this section and,
if applicable, Sec. 1040.11.
(vi) For Class 1 laser products, if the output power (or energy)
measured according to paragraph (e)(3)(i)(D) of this section is greater
than that measured in accordance with paragraph (e)(3)(i)(A) or
(e)(3)(i)(B) of this section and that level exceeds the Class 1 limit,
an additional warning is required. This warning shall state that
viewing the laser output with optical instruments having a magnifying
power greater than
[[Page 14200]]
2.5 (e.g., eye loupes) may pose an 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) 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 1, 2, 3, 4, and 7 of paragraph (d) of this section, and a
schedule of maintenance necessary to keep the product in compliance
with this section and, if applicable, Sec. 1040.11. All such service
instructions shall include a listing of those controls and procedures
that could be used by persons other than the manufacturers or their
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 1, 2, 3, 4, and 7
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 of this chapter,
by any person engaged in the business of manufacturing, assembling, or
modifying laser products constitutes manufacturing under the Federal
Food, Drug, and Cosmetic Act if the modification affects any aspect of
the product's performance or intended function(s) for which this
section or Sec. 1040.11 have an applicable requirement. The person who
performs such modification shall recertify and reidentify the product
in accordance with the provisions of Secs. 1010.2 and 1010.3 of this
chapter.
5. Section 1040.11 is revised to read as follows:
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:
(1) A label bearing the wording: ``Laser aperture.'' shall be
affixed in close proximity to each aperture through which is emitted
accessible laser radiation in excess of the accessible emission limits
of Class 1, and
(2) For each Class 3B or 4 medical laser system, except those of
Class 3B not exceeding 5 milliwatts at visible wavelengths and not
intended for ocular exposure:
(i) The accessible emission level, shall not deviate from the
preset or selected level by more than 20 percent,
(ii) An electrical or optical quantity that is directly related to
the laser level generated shall be continually monitored during
operation,
(iii) A visible or audible indication shall be given whenever the
monitored quantity denotes deviation from the preset or selected level
by more than 20 percent,
(iv) The user instructions shall specify an instrument, procedure,
and schedule for calibration of the accessible emission level,
(v) If the system emits either continuously or a series of pulses
for longer than 0.25 seconds, the system shall incorporate a visual or
audible indication of actual emission in addition to the emission
indicator required by Sec. 1040.10(f)(5),
(vi) The system shall include a hand or foot operated control to
stop the emission of laser radiation. The switch shall be colored red
and be located so that it is clearly visible and quickly accessible to
the operator from the operating position. If it is a push-button type,
it shall be of the ``mushroom-head'' type.
(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 1, 2 or 3A
laser product and shall not permit human access to laser radiation in
excess of the accessible emission limits of Class 3A.
(c) Demonstration laser products. Each demonstration laser product
shall comply with all of the applicable requirements of Sec. 1040.10
for a Class 1, 2, 3A or Class 3B laser, except for Class 3B with not
more than five times the AEL of Class 2 in the wavelength range of 400
to 700 nanometers, and shall not permit human access to laser radiation
in excess of the accessible emission limits of such classes.
Dated: March 17, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-7158 Filed 3-23-99; 8:45 am]
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