[Federal Register Volume 72, Number 97 (Monday, May 21, 2007)]
[Notices]
[Pages 28500-28511]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-9718]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0226]
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 017
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a
publication containing modifications the agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
recognized consensus standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 017'' (Recognition List Number: 017), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: Submit written or electronic comments concerning this document
at any time. See section VII of this document for the effective date of
the recognition of standards announced in this document.
ADDRESSES: Submit written requests for single copies of
``Modifications to the List of Recognized Standards, Recognition List
Number: 017'' to the Division of Small Manufacturers, International and
Consumer Assistance, Center for Devices and Radiological Health (HFZ-
220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD
20850. Send two self-addressed adhesive labels to assist that office in
processing your requests, or fax your request to 240-276-3151. Submit
written comments concerning this document, or recommendations for
additional standards for recognition, to the contact person (see FOR
FURTHER INFORMATION CONTACT). Submit electronic comments by e-mail:
[email protected]. This document may also be accessed on FDA's
Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm. See section VI of this document for electronic
access to the searchable database for the current list of FDA
recognized consensus standards, including Recognition List Number: 017
modifications and other standards related information.
FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices
and Radiological Health (HFZ-84), Food and Drug Administration, 2098
Gaither Road, Rockville, MD 20850, 240-276-0533.
I. Background
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended
section 514 allows FDA to recognize consensus standards developed by
international and national organizations for use in satisfying portions
of device premarket review submissions or other requirements.
In a notice published in the Federal Register of February 25, 1998
(63 FR 9561), FDA announced the availability of a guidance entitled
``Guidance on the Recognition and Use of Consensus Standards.'' The
notice described how FDA would implement its standard recognition
program and provided the initial list of recognized standards.
Modifications to the initial list of recognized standards, as published
in the Federal Register, are identified in table 1 of this document.
Table 1.
------------------------------------------------------------------------
Federal Register Cite
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October 16, 1998 (63 FR 55617)
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July 12, 1999 (64 FR 37546)
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November 15, 2000 (65 FR 69022)
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May 7, 2001 (66 FR 23032)
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January 14, 2002 (67 FR 1774)
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October 2, 2002 (67 FR 61893)
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April 28, 2003 (68 FR 22391)
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March 8, 2004 (69 FR 10712)
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June 18, 2004 (69 FR 34176)
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October 4, 2004 (69 FR 59240)
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May 27, 2005 (70 FR 30756)
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November 8, 2005 (70 FR 67713)
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March 31, 2006 (71 FR 16313)
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June 23, 2006 (71 FR 36121)
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November 3, 2006 (71 FR 64718)
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These notices describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The agency maintains ``hypertext
markup language (HTML)'' and ``portable document format (PDF)''
versions of the list of ``FDA Recognized Consensus Standards.'' Both
versions are publicly accessible at the agency's Internet site. See
section VI of this document for electronic access information.
Interested persons should review the supplementary information sheet
for the standard to understand fully the extent to which FDA recognizes
the standard.
II. Modifications to the List of Recognized Standards, Recognition List
Number: 017
FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the agency will recognize for
use in satisfying premarket reviews and other requirements for devices.
FDA will incorporate these modifications in the list of FDA Recognized
Consensus Standards in the agency's searchable database. FDA will use
the term ``Recognition List Number: 017 to identify these current
modifications.
In Table 2 of this document, FDA describes the following
modifications: (1) The withdrawal of standards and their replacement by
others, (2) the correction of errors made by FDA in listing previously
recognized standards, and (3) the changes to the supplementary
information sheets of recognized standards that describe revisions to
the applicability of the standards.
In section III of this document, FDA lists modifications the agency
is making that involve the initial addition of standards not previously
recognized by FDA.
[[Page 28501]]
Table 2.
------------------------------------------------------------------------
Old Item Replacement
No. Standard Change Item No.
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
19 ISO 8382:1988: Resuscitators Withdrawn 71
Intended for Use With Humans
------------------------------------------------------------------------
48 ASTM F1246-91(2005): Standard Withdrawn and 70
Specification for replaced with
Electrically Powered Home newer version
Care Ventilators, Part 1--
Positive-Pressure
Ventilators and Ventilator
Circuits
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
57 ASTM F895-84(2006): Standard Withdrawn and 115
Test Method for Agar replaced with
Diffusion Cell Culture newer version
Screening for Cytotoxicity
------------------------------------------------------------------------
72 ASTM F1439-03: Standard Guide Withdrawn and 116
for Performance of Lifetime replaced with
Bioassay for the Tumorigenic newer version
Potential of Implant
Materials
------------------------------------------------------------------------
86 AAMI/ANSI/ISO 10993- Withdrawn--dup 87
10:2002(E): Biological licate
Evaluation of Medical
Devices--Part 10: Tests for
Irritation and Sensitization
------------------------------------------------------------------------
87 AAMI/ANSI/ISO 10993-10:2002: Title ...............
Biological Evaluation of
Medical Devices--Part 10:
Tests for Irritation and
Delayed-type
Hypersensitivity
------------------------------------------------------------------------
99 ASTM F1904-98(2003): Standard Title ...............
Practice for Testing the
Biological Responses to
Particles In Vivo
------------------------------------------------------------------------
C. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
60 ANSI/ADA Specification No. Withdrawn and 143
96:2000: Dental Water-Based replaced with
Cements newer version
------------------------------------------------------------------------
72 ISO 6877-2006: Dentistry-- Withdrawn and 137
Root-canal Obturating Points replaced with
newer version
------------------------------------------------------------------------
85 ANSI/ADA Specification No. Withdrawn and 138
15:2000, Synthetic Polymer replaced with
Teeth newer version
------------------------------------------------------------------------
91 ANSI/ADA Specification No. Title ...............
80:2001, Dental Materials--
Determination of Color
Stability
------------------------------------------------------------------------
114 ANSI/ADA Specification No. Withdrawn and 139
48:2004, Visible Light replaced with
Curing Units newer version
------------------------------------------------------------------------
D. General
------------------------------------------------------------------------
2 IEC 60601-1, Medical Contact Person ...............
Electrical Equipment--Part
1:General Requirements for
Safety
------------------------------------------------------------------------
11 ISO 2859/1995, Sampling Contact Person ...............
Procedures and Tables for
Inspection By Attributes
------------------------------------------------------------------------
12 ISO 10012/1993, Quality Contact Person ...............
Assurance Requirements for
Measuring Equipment Part 1:
Metrological Confirmation
System for Measuring
Equipment
------------------------------------------------------------------------
14 ANSI Z1.4/1993, Inspection by Contact Person ...............
Attributes
------------------------------------------------------------------------
15 ANSI Z1.9/1993, Inspection by Contact Person ...............
Variables
------------------------------------------------------------------------
18 ASTM D-4332/1991, Standard Contact Person ...............
Practice for Conditioning
Containers, Packages, or
Packaging Components for
Testing
------------------------------------------------------------------------
19 ASTM E-876/1995, Standard Contact Person ...............
Practice for Use of
Statistics in the Evaluation
of Spectrometric Data
------------------------------------------------------------------------
20 ASTM F-1140/1988, Standard Contact Person ...............
Test Method for Failure
Resistance of Unrestrained
and Nonrigid Packages for
Medical Applications
------------------------------------------------------------------------
27 IEC 60601-1-1:2000, Medical Contact Person ...............
Electrical Equipment--Part
1: General Requirement for
Safety; Safety Requirements
for Medical Electrical
Systems
------------------------------------------------------------------------
[[Page 28502]]
28 IEC 60601-1-2, (Second Extent of ...............
Edition, 2001), Medical Recognition
Electrical Equipment--Part 1-
2: General Requirements for
Safety; Electromagnetic
Compatibility--Requirements
and Tests
------------------------------------------------------------------------
29 AAMI/ANSI HE74-2001, Human Contact Person ...............
Factors Design Process for
Medical Devices
------------------------------------------------------------------------
31 ISO 15223, Medical Devices-- Contact Person ...............
Symbols to be Used With
Medical Device Labels,
Labeling and Information to
be Supplied
------------------------------------------------------------------------
32 EN 980:1996+1:1999+A2:2001, Contact Person ...............
Graphical Symbols for use in
the Labeling of Medical
Devices
------------------------------------------------------------------------
35 AAMI/ANSI/IEC 60601-1-2, Standard ...............
Medical Electrical Organizations
Equipment--Part 1-2: General
Requirements for Safety--
Collateral standard:
Electromagnetic
Compatibility--Requirements
and Tests (Edition 2:2001
with Amendment 1:2004) (AAMI/
ANSI/IEC 60601-1--2:2001 is
the U.S. version of IEC
60601-1-2:2001, with
identical requirements for
electromagnetic
compatibility (EMC) of
medical electrical
equipment.)
------------------------------------------------------------------------
E. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
114 ISO 11608-1:2000 Pen- Contact Person ...............
injectors for Medical Use--
Part 1: Pen-injectors--
Requirements and Test
Methods
------------------------------------------------------------------------
115 ISO 11608-2:2000 Pen- Contact Person ...............
injectors for Medical Use--
Part 2: Needles--
Requirements and Test
Methods
------------------------------------------------------------------------
116 ISO 11608-3:2000 Pen- Contact Person ...............
injectors for Medical Use--
Part 3: Finished Cartridges--
Requirements and Test
Methods
------------------------------------------------------------------------
66 and ISO 8536-1:2006 Infusion Withdrawn and 172
162 Equipment for Medical Use-- replaced with
Part 1: Infusion Glass newer version
Bottles
------------------------------------------------------------------------
53 ASTM D5151-99 (2006) Standard Withdrawn and 175
Test Method for Detection of replaced with
Holes in Medical Gloves newer version
------------------------------------------------------------------------
77 ASTM F1862-05 Standard Test Withdrawn and 181
Method for Resistance of replaced with
Medical Face Masks to newer version
Penetration by Synthetic
Blood (Horizontal Projection
of Fixed Volume at a Known
Velocity)
------------------------------------------------------------------------
80 ASTM E1112-00 (2006) Standard Withdrawn and 177
Specification for Electronic replaced with
Thermometer for Intermittent newer version
Determination of Patient
Temperature
------------------------------------------------------------------------
84 ASTM D6124-06 Standard Test Withdrawn and 178
Method for Residual Powder replaced with
on Medical Gloves newer version
------------------------------------------------------------------------
161 ISO 10555-1:1995/ Amendment Title ...............
1:1999, Amendment 2:2004
Sterile, Single-use
Intravascular Catheters--
Part 1: General Requirements
------------------------------------------------------------------------
85 ASTM 5250-06 Standard Withdrawn and 183
Specification for Poly(vinyl replaced with
chloride) Gloves for Medical newer version
Application
------------------------------------------------------------------------
E. In Vitro Diagnostics
------------------------------------------------------------------------
91 CLSI EP7-A2, Interference Withdrawn and 127
Testing in Clinical replaced with
Chemistry; Approved newer version
Guidelines--Second Edition
------------------------------------------------------------------------
F. Materials
------------------------------------------------------------------------
1 ASTM F67-06: Standard Withdrawn and 129
Specification for Unalloyed replaced with
Titanium for Surgical newer version
Implant Applications (UNS
R50250, UNS R50400, UNS
R50550, UNS R50700)
------------------------------------------------------------------------
2 ASTM F75-01: Standard Contact Person ...............
Specification for Cobalt-28
Chromium-6 Molybdenum Alloy
Castings and Casting Alloy
for Surgical Implants (UNS
R30075)
------------------------------------------------------------------------
3 ASTM F90-01: Standard Contact Person ...............
Specification for Wrought
Cobalt-20 Chromium-15
Tungsten-10 Nickel Alloy for
Surgical Implant
Applications (UNS R30605)
------------------------------------------------------------------------
[[Page 28503]]
10 ASTM F603-00: Standard Contact Person ...............
Specification for High-
Purity Dense Aluminum Oxide
for Surgical Implant
Application
------------------------------------------------------------------------
11 ASTM F620-06: Standard Withdrawn and 130
Specification for Alpha Plus replaced with
Beta Titanium Alloy Forgings newer version
for Surgical Implants
------------------------------------------------------------------------
15 ASTM F745-00: Standard Contact Person ...............
Specification for 18
Chromium-12.5 Nickel-2.5
Molybdenum Stainless Steel
for Cast and Solution-
Annealed Surgical Implant
Applications
------------------------------------------------------------------------
26 ASTM F1314-01: Standard Contact Person ...............
Specification for Wrought
Nitrogen Strengthened 22
Chromium--13 Nickel--5
Manganese--2.5 Molybdenum
Stainless Steel Alloy Bar
and Wire for Surgical
Implants (UNS S20910)
------------------------------------------------------------------------
27 ASTM F1341-99: Standard Withdrawn ...............
Specification for Unalloyed
Titanium Wire UNS R50250,
UNS R50400, UNS R50550, UNS
R50700, for Surgical Implant
Applications
------------------------------------------------------------------------
30 ASTM F1537-00: Standard Contact Person ...............
Specification for Wrought
Cobalt-28-Chromium-6-Molybde
num Alloy for Surgical
Implants (UNS R31537, UNS
R31538, and UNS R31539)
------------------------------------------------------------------------
32 ASTM F1586-02: Standard Contact Person ...............
Specification for Wrought
Nitrogen Strengthened 21
Chromium-10 Nickel-3
Manganese-2.5 Molybdenum
Stainless Steel Bar for
Surgical Implants (UNS
S31675)
------------------------------------------------------------------------
37 ASTM F1813-01: Standard Contact Person ...............
Specification for Wrought
Titanium--12 Molybdenum--6
Zirconium--2 Iron Alloy for
Surgical Implant (UNS
R58120)
------------------------------------------------------------------------
41 ASTM F2066-01: Standard Contact Person ...............
Specification for Wrought
Titanium-15 Molybdenum Alloy
for Surgical Implant
Applications (UNS R58150)
------------------------------------------------------------------------
43 ASTM F2146-01: Standard Contact Person ...............
Specification for Wrought
Titanium-3Aluminum-2.5Vanadi
um Alloy Seamless Tubing for
Surgical Implant
Applications (UNS R56320)
------------------------------------------------------------------------
44 ASTM F136-02a: Standard Contact Person ...............
Specification for Wrought
Titanium-6 Aluminum-4
Vanadium ELI (Extra Low
Interstitial) Alloy for
Surgical Implant
Applications (UNS R56401)
------------------------------------------------------------------------
45 ASTM F562-02: Standard Contact Person ...............
Specification for Wrought
35Cobalt-35Nickel-20Chromium
-10Molybdenum Alloy for
Surgical Implant
Applications (UNS R30035)
------------------------------------------------------------------------
46 ASTM F621-02: Standard Contact Person ...............
Specification for Stainless
Steel Forgings for Surgical
Implants
------------------------------------------------------------------------
47 ASTM F799-06: Standard Withdrawn and 131
Specification for Cobalt-28 replaced with
Chromium-6 Molybdenum Alloy newer version
Forgings for Surgical
Implants (UNS R31537,
R31538, R31539)
------------------------------------------------------------------------
48 ASTM F899-02: Standard Contact Person ...............
Specification for Stainless
Steel for Surgical
Instruments
------------------------------------------------------------------------
49 ASTM F1058-02: Standard Contact Person ...............
Specification for Wrought
40Cobalt-20Chromium-16Iron-1
5Nickel-7Molybdenum Alloy
Wire and Strip for Surgical
Implant Applications (UNS
R30003 and UNS R30008)
------------------------------------------------------------------------
50 ASTM F1091-02: Standard Contact Person ...............
Specification for Wrought
Cobalt-20 Chromium-15
Tungsten-10 Nickel Alloy
Surgical Fixation Wire (UNS
R30605)
------------------------------------------------------------------------
52 ASTM F1350-02: Standard Contact Person ...............
Specification for Wrought 18
Chromium-14 Nickel-2.5
Molybdenum Stainless Steel
Surgical Fixation Wire (UNS
S31673)
------------------------------------------------------------------------
53 ASTM F1472-02a: Standard Contact Person ...............
Specification for Wrought
Titanium -6Aluminum -
4Vanadium Alloy for Surgical
Implant Applications (UNS
R56400)
------------------------------------------------------------------------
[[Page 28504]]
54 ASTM F1580-01: Standard Contact Person ...............
Specification for Titanium
and Titanium-6 Aluminum-4
Vanadium Alloy Powders for
Coatings of Surgical
Implants
------------------------------------------------------------------------
56 ISO 5832-1:1997: Implants for Contact Person ...............
Surgery--Metallic materials--
Part 1: Wrought Stainless
Steel
------------------------------------------------------------------------
57 ISO 5832-2:1999: Implants for Contact Person ...............
Surgery--Metallic Materials--
Part 2: Unalloyed Titanium
------------------------------------------------------------------------
58 ISO 5832-3:1996: Implants for Contact Person ...............
Surgery--Metallic Materials--
Part 3: Wrought Titanium 6-
Aluminium 4-Vanadium Alloy
------------------------------------------------------------------------
59 ISO 5832-4:1996: Implants for Contact Person ...............
Surgery--Metallic Materials--
Part 4: Cobalt-chromium-
molybdenum Casting Alloy
------------------------------------------------------------------------
61 ISO 5832-6:1997: Implants for Contact Person ...............
Surgery--Metallic Materials--
Part 6: Wrought Cobalt-
nickel-chromium-Molybdenum
alloy
------------------------------------------------------------------------
62 ISO 5832-9:1992: Implants for Contact Person ...............
Surgery--Metallic Materials--
Part 9: Wrought High
Nitrogen Stainless Steel
------------------------------------------------------------------------
63 ISO 5832-11:1994: Implants Contact Person ...............
for Surgery--Metallic
Materials--Part 11: Wrought
Titanium 6-aluminium 7
niobium Alloy
------------------------------------------------------------------------
64 ISO 5832-12:1996: Implants Contact Person ...............
for Surgery--Metallic
Materials--Part 12: Wrought
Cobalt-chromium-molybdenum
Alloy
------------------------------------------------------------------------
66 ISO 6474:1994: Implants for Contact Person ...............
Surgery--Ceramic Materials
Based on High Purity Alumina
------------------------------------------------------------------------
68 ISO 13782:1996: Implants for Contact Person ...............
Surgery--Metallic Materials--
Unalloyed Tantalum for
Surgical Implant
Applications
------------------------------------------------------------------------
76 ASTM F138-03: Standard Contact Person ...............
Specification for Wrought 18
Chromium-14 Nickel-2.5
Molybdenum Stainless Steel
Bar and Wire for Surgical
Implants (UNS S31673)
------------------------------------------------------------------------
77 ASTM F139-03: Standard Contact Person ...............
Specification for Wrought 18
Chromium-14 Nickel-2.5
Molybdenum Stainless Steel
Sheet and Strip for Surgical
Implants (UNS S31673)
------------------------------------------------------------------------
79 ASTM F961-03: Standard Contact Person ...............
Specification for Cobalt-35
Nickel-20 Chromium-10
Molybdenum Alloy Forgings
for Surgical Implants [UNS
R30035]
------------------------------------------------------------------------
80 ASTM F1088-04ae1: Standard Withdrawn and 132
Specification for Beta- replaced with
Tricalcium Phosphate for newer version
Surgical Implantation
------------------------------------------------------------------------
81 ASTM F1609-03: Standard Contact Person ...............
Specification for Calcium
Phosphate Coatings for
Implantable Materials
------------------------------------------------------------------------
82 ASTM F1713-03: Standard Contact Person ...............
Specification for Wrought
Titanium-13 Niobium-13
Zirconium Alloy for Surgical
Implant Applications
------------------------------------------------------------------------
85 ASTM F1854-01: Standard Test Contact Person ...............
Method for Stereological
Evaluation of Porous
Coatings on Medical Implants
------------------------------------------------------------------------
86 ASTM F1926-03: Standard Test Contact Person ...............
Method for Evaluation of the
Environmental Stability of
Calcium Phosphate Coatings
------------------------------------------------------------------------
87 ASTM F1978-00e1: Standard Contact Person ...............
Test Method for Measuring
Abrasion Resistance of
Metallic Thermal Spray
Coatings by Using the Taber
Abraser
------------------------------------------------------------------------
88 ASTM F2024-00: Standard Contact Person ...............
Practice for X-Ray
Diffraction Determination of
Phase Content of Plasma-
Sprayed Hydroxyapatite
Coatings
------------------------------------------------------------------------
89 ASTM F1873-98: Standard Contact Person ...............
Specification for High-
Purity Dense Yttria
Tetragonal Zirconium Oxide
Polycrystal (Y-TZP) for
Surgical Implant
Applications
------------------------------------------------------------------------
[[Page 28505]]
94 ASTM F601-03: Standard Contact Person ...............
Practice for Fluorescent
Penetrant Inspection of
Metallic Surgical Implants
------------------------------------------------------------------------
95 ASTM F629-02: Standard Contact Person ...............
Practice for Radiography of
Cast Metallic Surgical
Implants
------------------------------------------------------------------------
97 ASTM F2129-06: Standard Test Withdrawn and 133
Method for Conducting Cyclic replaced with
Potentiodynamic Polarization newer version
Measurements to Determine
the Corrosion Susceptibility
of Small Implant Devices
------------------------------------------------------------------------
98 ASTM F451-99ae1: Standard Contact Person ...............
Specification for Acrylic
Bone Cement
------------------------------------------------------------------------
102 ASTM F2082-06: Standard Test Withdrawn and 134
Method for Determination of replaced with
Transformation Temperature newer version
of Nickel-Titanium Shape
Memory Alloys by Bend and
Free Recovery
------------------------------------------------------------------------
103 ASTM F1801-97(2004): Standard Contact Person ...............
Practice for Corrosion and Type of
Fatigue Testing of Metallic Standard
Implant Materials
------------------------------------------------------------------------
104 ASTM F1108-04: Standard Contact Person ...............
Specification for Titanium-
6Aluminum-4Vanadium Alloy
Castings for Surgical
Implants (UNS R56406)
------------------------------------------------------------------------
106 ASTM F648-04: Standard Contact Person ...............
Specification for Ultra-High-
Molecular-Weight
Polyethylene Powder and
Fabricated Form for Surgical
Implants
------------------------------------------------------------------------
107 ASTM F746-04: Standard Test Contact Person ...............
Method for Pitting or
Crevice Corrosion of
Metallic Surgical Implant
Materials
------------------------------------------------------------------------
108 ASTM F1295-05: Standard Contact Person ...............
Specification for Wrought
Titanium-6 Aluminum-7
Niobium Alloy for Surgical
Implant Applications (UNS
R56700)
------------------------------------------------------------------------
110 ASTM F1377-04: Standard Contact Person ...............
Specification for Cobalt-28
Chromium-6 Molybdenum Powder
for Coating of Orthopedic
Implants (UNS R30075)
------------------------------------------------------------------------
111 ASTM F1160-05: Standard Test Contact Person ...............
Method for Shear and Bending
Fatigue Testing of Calcium
Phosphate and Metallic
Medical and Composite
Calcium Phosphate/Metallic
Coatings
------------------------------------------------------------------------
112 ASTM F1044-05: Standard Test Contact Person ...............
Method for Shear Testing of
Calcium Phosphate Coatings
and Metallic Coatings
------------------------------------------------------------------------
113 ASTM F1147-05: Standard Test Contact Person ...............
Method for Tension Testing
of Calcium Phosphate and
Metal Coatings
------------------------------------------------------------------------
114 ASTM F2255-05: Standard Test Contact Person ...............
Method for Strength
Properties of Tissue
Adhesives in Lap Shear by
Tension Loading
------------------------------------------------------------------------
115 ASTM F2256-05: Standard Test Contact Person ...............
Method for Strength
Properties of Tissue
Adhesives in T-Peel by
Tension Loading
------------------------------------------------------------------------
116 ASTM F2258-05: Standard Test Contact Person ...............
Method for Strength
Properties of Tissue
Adhesives in Tension
------------------------------------------------------------------------
117 ASTM F86-04: Standard Contact Person ...............
Practice for Surface
Preparation and Marking of
Metallic Surgical Implants
------------------------------------------------------------------------
119 ASTM F688-05: Standard Contact Person ...............
Specification for Wrought
Cobalt-35 Nickel-20 Chromium-
10 Molybdenum Alloy Plate,
Sheet, and Foil for Surgical
Implants (UNS R30035)
------------------------------------------------------------------------
120 ASTM F560-05: Standard Contact Person ...............
Specification for Unalloyed
Tantalum for Surgical
Implant Applications (UNS
R05200, UNS R05400)
------------------------------------------------------------------------
121 ASTM F2005-05: Standard Contact Person ...............
Terminology for Nickel-
Titanium Shape Memory Alloys
------------------------------------------------------------------------
122 ASTM F2063-05: Standard Contact Person ...............
Specification for Wrought
Nickel-Titanium Shape Memory
Alloys for Medical Devices
and Surgical Implants
------------------------------------------------------------------------
[[Page 28506]]
123 ISO 5832-5:2005: Implants for Contact Person ...............
Surgery--Metallic Materials--
Part 5: Wrought Cobalt-
chromium-tungsten-nickel
Alloy
------------------------------------------------------------------------
125 ASTM F2004-05: Standard Test Contact Person ...............
Method for Transformation
Temperature of Nickel-
Titanium Alloys by Thermal
Analysis
------------------------------------------------------------------------
126 ASTM F561-05a: Practice for Contact Person ...............
Retrieval and Analysis of
Implanted Medical Devices,
and Associated Tissues
------------------------------------------------------------------------
127 ISO 5834-2:1998: Implants for Contact Person ...............
Surgery--Ultra-High-
Molecular-Weight
Polyethylene--Part 2:
Moulded Forms
------------------------------------------------------------------------
G. OB-GYN/Gastroenterology
------------------------------------------------------------------------
35 ASTM D6324-05 Standard Test Withdrawn and 41
Methods for Male Condoms replaced with
Made from Synthetic newer version
Materials
------------------------------------------------------------------------
H. Ophthalmic
------------------------------------------------------------------------
3 ISO 9340:1996 Optics and Withdrawn ...............
Optical Instruments--Contact
lenses--Determination of
Strains for Rigid Contact
Lenses
------------------------------------------------------------------------
12 ISO 11980:1997 Ophthalmic Contact Person ...............
Optics--Contact Lenses and
Contact Lens Care Products--
Guidance for Clinical
Investigations
------------------------------------------------------------------------
13 ISO 10942:2006 Ophthalmic Withdrawn and 37
Instruments--Direct replaced with
Ophthalmoscopes newer version
------------------------------------------------------------------------
15 ISO 9394:1998 Ophthalmic Contact Person ...............
Optics--Contact Lenses and
Contact Lens Care Products--
Determination of
Biocompatibility By Ocular
Study Using Rabbit Eyes
------------------------------------------------------------------------
18 ISO 10943:2006 Ophthalmic Withdrawn and 38
Instruments--Indirect replaced with
Ophthalmoscopes newer version
------------------------------------------------------------------------
20 ISO 11979-1:2006 Ophthalmic Withdrawn and 40
implants--Intraocular replaced with
Lenses--Part 1: Vocabulary newer version
------------------------------------------------------------------------
23 ISO 11981:1999 Ophthalmic Contact Person ...............
Optics--Contact Lenses And
Contact Lens Care Products--
Determination of Physical
Compatibility of Contact
Lens Care Products With
Contact Lenses
------------------------------------------------------------------------
24 ISO 11986:1999 Ophthalmic Contact Person ...............
Optics--Contact Lenses and
Contact Lens Care Products--
Guidelines for Determination
of Preservative Uptake and
Release
------------------------------------------------------------------------
34 ANSI Z80.20-2004 Ophthalmics-- Contact Person ...............
Contact Lenses--Standard
Terminology, Tolerances,
Measurements and
Physicochemical Properties
------------------------------------------------------------------------
I. Orthopedic/Physical Medicine
------------------------------------------------------------------------
73 ISO 5838-1:1995: Implants for Contact Person ...............
Surgery--Skeletal Pins and
Wires--Part 1: Material and
Mechanical Requirements
------------------------------------------------------------------------
74 ISO 5838-2:1991: Implants for Contact Person ...............
Surgery--Skeletal Pins and
Wires--Part 2: Steinmann
Skeletal Pins--Dimensions
------------------------------------------------------------------------
75 ISO 5838-3:1993: Implants for Contact Person ...............
Surgery--Skeletal Pins and
Wires--Part 3: Kirschner
Skeletal Wires
------------------------------------------------------------------------
79 ISO 7206-8:1995: Implants for Contact Person ...............
Surgery--Partial and Total
Hip Joint Prostheses--Part
8: Endurance Performance of
Stemmed Femoral Components
With Application of Torsion
------------------------------------------------------------------------
80 ISO 8828:1988: Implants for Contact Person ...............
Surgery--Guidance on Care
and Handling of Orthopaedic
Implants
------------------------------------------------------------------------
81 ISO 9583:1993: Implants for Contact Person ...............
Surgery--Non-destructive
Testing--Liquid Penetrant
Inspection of Metallic
Surgical Implants
------------------------------------------------------------------------
[[Page 28507]]
82 ISO 9584:1993: Implants for Contact Person ...............
Surgery--Non-destructive
Testing--Radiographic
Examination of Cast Metallic
Surgical Implants
------------------------------------------------------------------------
83 ISO 13402:1995: Surgical and Contact Person ...............
Dental Hand Instruments--
Determination of Resistance
Against Autoclaving,
Corrosion and Thermal
Exposure
------------------------------------------------------------------------
121 ISO 7207-1:1994: Implants for Contact Person ...............
Surgery--Components for
Partial and Total Knee Joint
Prostheses--Part 1:
Classification, Definitions
and Designation of
Dimensions
------------------------------------------------------------------------
155 ISO 7207-2:1998: Implants for Contact Person ...............
Surgery--Components for
Partial and Total Knee Joint
Prostheses--Part 2:
Articulating Surfaces Made
of Metal, Ceramic and
Plastics Materials
------------------------------------------------------------------------
163 ASTM F543-02e1, Standard Withdrawn and 202
Specification and Test replaced with
Methods for Metallic Medical newer version
Bone Screws
------------------------------------------------------------------------
166 ASTM F897-02: Standard Test Contact Person ...............
Method for Measuring
Fretting Corrosion of
Osteosynthesis Plates and
Screws
------------------------------------------------------------------------
167 ASTM F1089-02: Standard Test Contact Person ...............
Method for Corrosion of
Surgical Instruments
------------------------------------------------------------------------
168 ASTM F1781-03: Standard Contact Person ...............
Specification for
Elastomeric Flexible Hinge
Finger Total Joint Implants
------------------------------------------------------------------------
171 ASTM F1814-97a(2003): Contact Person ...............
Standard Guide for
Evaluating Modular Hip and
Knee Joint Components
------------------------------------------------------------------------
172 ASTM F1798-97(2003): Standard Contact Person ...............
Guide for Evaluating the
Static and Fatigue
Properties of
Interconnection Mechanisms
and Subassemblies Used in
Spinal Arthrodesis Implants
------------------------------------------------------------------------
175 ASTM F1582-98(2003): Standard Contact Person ...............
Terminology Relating to
Spinal Implants
------------------------------------------------------------------------
177 ASTM F1264-03: Standard Contact Person ...............
Specification and Test
Methods for Intramedullary
Fixation Devices
------------------------------------------------------------------------
178 ASTM F1440-92(2002): Standard Contact Person ...............
Practice for Cyclic Fatigue
Testing of Metallic Stemmed
Hip Arthroplasty Femoral
Components Without Torsion
------------------------------------------------------------------------
179 ASTM F2068-03: Standard Contact Person ...............
Specification for Femoral
Prostheses--Metallic
Implants
------------------------------------------------------------------------
180 ASTM F366-04: Standard Contact Person ...............
Specification for Fixation
Pins and Wires
------------------------------------------------------------------------
181 ASTM F1717-04: Standard Test Contact Person ...............
Methods for Spinal Implant
Constructs in a
Vertebrectomy Model
------------------------------------------------------------------------
182 ASTM F1800-04: Standard Test Contact Person ...............
Method for Cyclic Fatigue
Testing of Metal Tibial Tray
Components of Total Knee
Joint Replacements
------------------------------------------------------------------------
183 ASTM F1875-98(2004): Standard Contact Person ...............
Practice for Fretting
Corrosion Testing of Modular
Implant Interfaces: Hip
Femoral Head-bore and Cone
Taper Interface
------------------------------------------------------------------------
185 ASTM F2267-04: Standard Test Contact Person ...............
Method for Measuring Load
Induced Subsidence of an
Intervertebral Body Fusion
Device Under Static Axial
Compression
------------------------------------------------------------------------
186 ASTM F2077-03: Test Methods Contact Person ...............
for Intervertebral Body
Fusion Devices
------------------------------------------------------------------------
187 ASTM F2193-02: Standard Contact Person ...............
Specifications and Test
Methods for Components Used
in the Surgical Fixation of
the Spinal Skeletal System
------------------------------------------------------------------------
188 ISO 14243-1:2002: Implants Contact Person ...............
for Surgery--Wear of Total
Knee-joint Prostheses--Part
1: Loading and Displacement
Parameters for Wear-testing
Machines with Load Control
and Corresponding
Environmental Conditions for
Test
------------------------------------------------------------------------
[[Page 28508]]
189 ISO 14243-2:2000: Implants Contact Person ...............
for Surgery--Wear of Total
Knee-joint Prostheses--Part
2: Methods of Measurement
------------------------------------------------------------------------
190 ISO 14243-3:2004: Implants Contact Person ...............
for Surgery--Wear of Total
Knee-joint Prostheses--Part
3: Loading and Displacement
Parameters for Wear-Testing
Machines with Displacement
Control and Corresponding
Environmental Conditions for
Test
------------------------------------------------------------------------
191 ISO 14879-1:2000: Implants Contact Person ...............
for Surgery--Total Knee-
joint Prostheses--Part 1:
Determination of Endurance
Properties of Knee Tibial
Trays
------------------------------------------------------------------------
192 ASTM F1223-05: Standard Test Contact Person ...............
Method for Determination of
Total Knee Replacement
Constraint
------------------------------------------------------------------------
J. Radiology
------------------------------------------------------------------------
34 IEC 60601-2-7 (1998) Medical Contact Person ...............
Electrical Equipment--Part 2-
7: Particular Requirements
for the Safety of High-
Voltage Generators of
Diagnostic X-ray Generators
------------------------------------------------------------------------
68 NEMA MS 4-2006 Acoustic Noise Withdrawn and 151
Measurement Procedure for replaced with
Diagnosing Magnetic newer version
Resonance Imaging Devices
------------------------------------------------------------------------
101 ANSI / IESNA RP-27.1-05 Withdrawn and 153
Recommended Practice for replaced with
Photobiological Safety for newer version
Lamps and Lamp Systems--
General Requirements
------------------------------------------------------------------------
104 IEC 60601-2-33 (2006), Withdrawn and 161
Medical Electrical replaced with
Equipment--Part 2-33: newer version
Particular Requirements for
the Safety of Magnetic
Resonance Equipment for
Medical Diagnosis
------------------------------------------------------------------------
111 ISO 11554:2006 Optics and Withdrawn and 155
Photonics--Lasers and Laser- replaced with
Related equipment--Test newer version
Methods for Laser Beam
Power, Energy and Temporal
Characteristics
------------------------------------------------------------------------
K. Software
------------------------------------------------------------------------
1 ISO/IEC 12207:1995 Withdrawn ...............
Information Technology--
Software Life Cycle
Processes
------------------------------------------------------------------------
3 IEEE/EIA 12207.0-1996 Withdrawn ...............
Industry Implementation of
International Standard ISO/
IEC 12207:1995(ISO/IEC
12207) Standard for
Information Technology--
Software Life Cycle
Processes
------------------------------------------------------------------------
5 IEEE 1074-1997 Standard for Withdrawn ...............
Developing a Software
Project Life Cycle Process
------------------------------------------------------------------------
6 IEEE 1012-2004 Standard for Withdrawn ...............
Software Verification and
Validation
------------------------------------------------------------------------
7 AAMI / ANSI SW68:2001 Medical Withdrawn ...............
Device Software--Software
Life Cycle Processes
------------------------------------------------------------------------
L. Sterility
------------------------------------------------------------------------
67 ASTM F1140-2005, Standard Withdrawn and 196
Test Methods for Internal replaced with
Pressurization Failure newer version
Resistance of Unrestrained
Packages for Medical
Applications
------------------------------------------------------------------------
68 ASTM F1585:2000, Standard Withdrawn ...............
Guide for Integrity Testing
of Porous Barrier Medical
Packages
------------------------------------------------------------------------
69 ASTM F1608:2004, Standard Withdrawn and 197
Test Method for Microbial replaced with
Ranking of Porous Packaging newer version
Materials (Exposure Chamber
Method
------------------------------------------------------------------------
89 ASTM F2054-05, Standard Test Withdrawn and 198
Method for Burst Testing of replaced with
Flexible Package Seals Using newer version
Internal Air Pressurization
Within Restraining Plates
------------------------------------------------------------------------
121 ASTM D4169-05, Standard Withdrawn and 199
Practice for Performance replaced with
Testing of Shipping newer version
Containers and Systems
------------------------------------------------------------------------
122 ASTM F88-2006, Standard Test Withdrawn and 200
Method for Seal Strength of replaced with
Flexible Barrier Materials newer version
------------------------------------------------------------------------
[[Page 28509]]
M. Tissue Engineering
------------------------------------------------------------------------
1 ASTM F2064-00(2006): Standard Withdrawn and 8
Guide for Characterization replaced with
and Testing of Alginates as newer version
Starting Materials Intended
for use in Biomedical and
Tissue-Engineered Medical
Products Application
------------------------------------------------------------------------
III. Listing of New Entries
In table 3 of this document, FDA provides the listing of new
entries and consensus standards added as modifications to the list of
recognized standards under Recognition List Number: 017.
Table 3.
----------------------------------------------------------------------------------------------------------------
Item No. Title of Standard Reference No. & Date
----------------------------------------------------------------------------------------------------------------
A. Anesthesia
----------------------------------------------------------------------------------------------------------------
71 Lung Ventilators for Medical use--Particular ISO 10651-5:2006
Requirements for Basic Safety and Essential
Performance--Part 5: Gas-powered Emergency
Resuscitators
----------------------------------------------------------------------------------------------------------------
B. Cardiovascular/Neurology
----------------------------------------------------------------------------------------------------------------
59 Implants for surgery--Cardiac Pacemakers--Part ISO 5841-3:2000
3: Low-profile Connectors (IS-1) for
Implantable Pacemakers
----------------------------------------------------------------------------------------------------------------
C. Dental/ENT
----------------------------------------------------------------------------------------------------------------
140 Dental Base Metal Casting Alloys--Part 2: Nickel- ISO 6871-2:1994/Amd 1:2005
based Alloys
----------------------------------------------------------------------------------------------------------------
141 Dental Base Metal Casting Alloys--Part 1: Cobalt- ISO 6871-1:1994
based Alloys
----------------------------------------------------------------------------------------------------------------
142 Dental Base Metal Casting Alloys--Part 1: Cobalt- ISO 6871-1:1994/Amd 1:2005
based Alloys
----------------------------------------------------------------------------------------------------------------
D. General
----------------------------------------------------------------------------------------------------------------
36 Technical Information Report: Medical Devices-- ANSI/AAMI/ISO TIR 16142:2006
Guidance on the Selection of Standards in
Support of Recognized Essential Principles of
Safety and Performance of Medical Devices,
Second Edition
----------------------------------------------------------------------------------------------------------------
E. General Hospital/General Plastic Surgery
----------------------------------------------------------------------------------------------------------------
170 Sterile hypodermic syringes for single use--Part ISO 7886-1:1993/ Corrigendum 1:1995
1: Syringes for Manual Use
----------------------------------------------------------------------------------------------------------------
171 Sterile, Single-use Intravascular Catheters- ISO 10555-3:1996/ Corrigendum 1:2002
Part 3: Central Venous Catheters
----------------------------------------------------------------------------------------------------------------
173 Infusion Equipment for Medical Use--Part 2: ISO 8536-2:2001/ Corrigendum 1:2003
Closures for Infusion Bottles
----------------------------------------------------------------------------------------------------------------
174 Pen-injectors for Medical Use--Part 4: ISO 11608-4:2006
Requirements and Test Methods for Electronic
and Electromechanical Pen-injectors
----------------------------------------------------------------------------------------------------------------
176 Standard Guide for Assessment of Medical Gloves ASTM D7103-06
----------------------------------------------------------------------------------------------------------------
179 Needle-free Injectors for Medical Use-- ISO 21649:2006
Requirements and Test Methods
----------------------------------------------------------------------------------------------------------------
180 Standard Specification for Surgical Gowns ASTM F2407-06
Intended for Use in Healthcare Facilities
----------------------------------------------------------------------------------------------------------------
182 Medical Electrical Equipment-- Part 2-38: IEC 60601-2-38 1996/Amendment 1:1999
Particular Requirements for the Safety of
Electrically Operated Hospital Beds
----------------------------------------------------------------------------------------------------------------
F. In Vitro Diagnostic
----------------------------------------------------------------------------------------------------------------
128 Evaluation of Matrix Effects; Approved CLSI EP14-A2 2005
Guideline--Second Edition
----------------------------------------------------------------------------------------------------------------
129 Quality Control of Microbiological Transport CLSI M40-A 2003
Systems
----------------------------------------------------------------------------------------------------------------
G. Materials
----------------------------------------------------------------------------------------------------------------
135 Standard Test Method for Burst Strength of ASTM F2392-04
Surgical Sealants
----------------------------------------------------------------------------------------------------------------
136 Standard Test Method for Wound Closure Strength ASTM F2458-05
of Tissue Adhesives and Sealants
----------------------------------------------------------------------------------------------------------------
[[Page 28510]]
H. OB-GYN/Gastroenterology
----------------------------------------------------------------------------------------------------------------
42 Medical electrical equipment--Part 2: Particular IEC 60601-2-18 (1996) Amendment 1
Requirements for the Safety of Endoscopic 2000
Equipment
----------------------------------------------------------------------------------------------------------------
43 Rubber Condoms--Guidance on the Use of ISO 4074 ISO 16038:2005
in the Quality Management of Natural Rubber
Latex Condoms
----------------------------------------------------------------------------------------------------------------
I. Ophthalmic
----------------------------------------------------------------------------------------------------------------
43 Ophthalmic Implants--Intraocular lenses--Part 8: ISO 11979-8:2006
Fundamental Requirements
----------------------------------------------------------------------------------------------------------------
J. Radiology
----------------------------------------------------------------------------------------------------------------
150 Information Technology--Digital Compression and IEC / ISO 10918-1:1994 Technical
Coding of Continuous-tone Still Images--Part 1: Corrigendum 1:2005
Requirements and Guidelines
----------------------------------------------------------------------------------------------------------------
152 Medical Electrical Equipment--Part 2-1: IEC 60601-2-1 (1998-06), Amendment 1
Particular Requirements for the Safety of 2002
Electron Accelerators in the Range 1 MeV to 50
MeV
----------------------------------------------------------------------------------------------------------------
154 Lasers and Laser-related Equipment-- ISO 11254-3:2006
Determination of Laser-induced Damage Threshold
of Optical Surfaces--Part 3: Assurance of Laser
Power (energy) Handling Capabilities
----------------------------------------------------------------------------------------------------------------
156 Lasers and Laser-related Equipment--Test Methods ISO 11670:2003 Technical Corrigendum
for Laser Beam Parameters--Beam Positional 1:2004
Stability
----------------------------------------------------------------------------------------------------------------
157 Optics and Optical Instruments--Lasers and Laser- ISO 13694:2000 Technical Corrigendum
related Equipment--Test Methods for Laser Beam 1:2005
Power (energy) Density Distribution
----------------------------------------------------------------------------------------------------------------
158 Determination of Local Specific Absorption Rate NEMA MS 10-2006
(SAR) in Diagnostic Magnetic Resonance Imaging
----------------------------------------------------------------------------------------------------------------
159 Determination of Gradient-Induced Electric NEMA MS 11-2006
Fields In Diagnostic Magnetic Resonance Imaging
----------------------------------------------------------------------------------------------------------------
160 Quantification and Mapping of Geometric NEMA MS 12-2006
Distortion for Special Applications
----------------------------------------------------------------------------------------------------------------
IV. List of Recognized Standards
FDA maintains the agency's current list of FDA recognized consensus
standards in a searchable database that may be accessed directly at
FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications
and minor revisions described in this notice into the database and,
upon publication in the Federal Register, this recognition of consensus
standards will be effective. FDA will announce additional modifications
and minor revisions to the list of recognized consensus standards, as
needed, in the Federal Register once a year, or more often, if
necessary.
V. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for
recognition under the new provision of section 514 of the act by
submitting such recommendations, with reasons for the recommendation,
to the contact person (See FOR FURTHER INFORMATION CONTACT). To be
properly considered, such recommendations should contain, at a minimum,
the following information: (1) Title of the standard, (2) any reference
number and date, (3) name and address of the national or international
standards development organization, (4) a proposed list of devices for
which a declaration of conformity to this standard should routinely
apply, and (5) a brief identification of the testing or performance or
other characteristics of the device(s) that would be addressed by a
declaration of conformity.
VI. Electronic Access
You may obtain a copy of ``Guidance on the Recognition and Use of
Consensus Standards'' by using the Internet. CDRH maintains a site on
the Internet for easy access to information including text, graphics,
and files that you may download to a personal computer with access to
the Internet. Updated on a regular basis, the CDRH home page includes
the guidance as well as the current list of recognized standards and
other standards related documents. After publication in the Federal
Register, this notice announcing ``Modifications to the List of
Recognized Standards, Recognition List Number: 017'' will be available
on the CDRH home page. You may access the CDRH home page at http://www.fda.gov/cdrh.
You may access ``Guidance on the Recognition and Use of Consensus
Standards,'' and the searchable database for ``FDA Recognized Consensus
Standards'' through the hyperlink at http://www.fda.gov/cdrh/stdsprog.html.
This Federal Register document on modifications in FDA's
recognition of consensus standards is available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm.
VII. Submission of Comments and Effective Date
Interested persons may submit to the contact person (see FOR
FURTHER INFORMATION CONTACT) written or electronic comments regarding
this document. Two copies of any mailed comments are to be submitted,
except that individuals may submit one paper copy. Comments are to be
identified
[[Page 28511]]
with the docket number found in brackets in the heading of this
document. FDA will consider any comments received in determining
whether to amend the current listing of modifications to the list of
recognized standards, Recognition List Number: 017. These modifications
to the list or recognized standards are effective upon publication of
this notice in the Federal Register.
Dated: May 10, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-9718 Filed 5-18-07; 8:45 am]
BILLING CODE 4160-01-S