Food and Drug Administration Modernization Act of 1997:
Federal Register: October 4, 2010 (Volume 75, Number 191)
Notices
Page 61148-61157
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr04oc10-39
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2004-N-0451
(formerly Docket No. 2004N-0226)
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 025
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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: 025'' (Recognition List Number: 025), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
DATES: Submit either electronic or written 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: 025'' to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66,
Silver Spring, MD 20993-0002. Send two self-addressed adhesive labels to assist that office in processing your requests, or fax your request to 301-847-8149. 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 email: standards@cdrh.fda.gov. This document may also be accessed on FDA's Internet site at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/Standards/ucm123792.htm. 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: 025 modifications and other standards related information.
FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 3632, Silver Spring, MD 20993-0002, 301- 796-6574.
SUPPLEMENTARY INFORMATION:
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
``Recognition and Use of Consensus Standards.'' The notice described how FDA would implement its standard recognition
Page 61149
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.--Previous Publications of Standard Recognition Lists
February 25, 1998 (63 FR 9561)
November 8, 2005 (70 FR 67713)
October 16, 1998 (63 FR 55617)
March 31, 2006 (71 FR 16313)
July 12, 1999 (64 FR 37546)
June 23, 2006 (71 FR 36121)
November 15, 2000 (65 FR 69022)
November 3, 2006 (71 FR 64718)
May 7, 2001 (66 FR 23032)
May 21, 2007 (72 FR 28500)
January 14, 2002 (67 FR 1774)
September 12, 2007 (72 FR 52142)
October 2, 2002 (67 FR 61893)
December 19, 2007 (72 FR 71924)
April 28, 2003 (68 FR 22391)
September 9, 2008 (73 FR 52358)
March 8, 2004 (69 FR 10712)
March, 18, 2009 (74 FR 11586)
June 18, 2004 (69 FR 34176)
September 8, 2009 (74 FR 46203)
October 4, 2004 (69 FR 59240)
May 5, 2010 (75 FR 24711)
May 27, 2005 (70 FR 30756)
June 10, 2010 (75 FR 32943)
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: 025
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: 025'' 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.
Table 2.--Modifications to the List of Recognized Standards
Replacement
Old Recognition No.
Recognition No.
Title of Standard\1\
Change
-
Anesthesia
1-61
1-82
IEC 60601-2-13 Edition 3.1 2009-08 Medical Withdrawn and replaced electrical equipment--Part 2-13:
with newer version
Particular requirements for the safety and essential performance of anaesthetic systems
-
Biocompatibility
2-96
..................... ASTM F 1903-98 (Reapproved 2003) Standard Type of standard and
Practice for Testing For Biological
Contact person
Responses to Particles in vitro
2-98
2-156
ANSI/AAMI/ISO 10993-1:2009 Biological
Withdrawn and replaced evaluation of medical devices--Part 1:
with newer version
Evaluation and testing within a risk management process
2-100
..................... ASTM E1372-95 (2003) Standard Test Method Withdrawn for Conducting a 90-Day Oral Toxicity
Study in Rats
2-115
..................... ASTM F 895--84 (Reapproved 2006) Standard Title, Type of
Test Method for Agar Diffusion Cell
standard , Relevant
Culture Screening for Cytotoxicity
guidance and Contact person
2-117
..................... ANSI/AAMI/ISO 10993-3:2003/(R)2009
Reaffirmation, CDRH
Biological evaluation of medical devices - Office(s) and
Part 3: Tests for genotoxicity,
Division(s) carcinogenicity, and reproductive
associated with toxicity
recognized standard and Contact person
2-118
..................... ANSI/AAMI/ISO 10993-11:2006 Biological
Contact person evaluation of medical devices--Part 11:
Tests for systemic toxicity
2-119
..................... ASTM F 813-07 Standard Practice for Direct Title, Type of
Contact Cell Culture Evaluation of
standard and Contact
Materials for Medical Devices
person
2-135
..................... ANSI/AAMI/ISO 10993-12:2007 Biological
Title and Contact evaluation of medical devices--Part 12:
person
Sample preparation and reference materials
Page 61150
2-147
2-157
USP 33--NF 28 2010 Biological Tests Withdrawn and replaced
Biological Reactivity Test, In Vitro--
with newer version
Direct Contact Test
2-148
2-158
USP 33-NF28 2010 Biological Tests Withdrawn and replaced
Biological Reactivity Test, In Vitro--
with newer version
Elution Test
2-149
2-159
USP 33-NF28 2010 Biological Tests Withdrawn and replaced
Biological Reactivity Tests, In Vivo,
with newer version
Procedure--Preparation of Sample
2-150
2-160
USP 33-NF28 2010 Biological Tests Withdrawn and replaced
Biological Reactivity Tests, In Vivo,
with newer version
Classification of Plastics--
Intracutaneous Test
2-151
2-161
USP 33-NF28 2010 Biological Tests Withdrawn and replaced
Biological Reactivity Tests, In Vivo,
with newer version
Classification of Plastics--Systemic
Injection Test
-
Cardiology
3-74
3-79
ASTM F 2079--09 Standard Test Method for
Withdrawn and replaced
Measuring Intrinsic Elastic Recoil of
with newer version
Balloon-Expandable Stents
3-75
..................... ANSI/AAMI SP10:2002/(R)2008 & ANSI/AAMI
Title and Extent of
SP10:2002/A1:2003/(R)2008 & ANSI/AAMI
recognition
SP10:2002/A2:2006/(R)2008 Manual, electronic or automated sphygmomanometers
-
Dental/ENT
4-86
..................... ANSI/ADA Specification No. 38 2000
Reaffirmation
(Reaffirmed 2010) Metal-Ceramic Dental
Restorative Systems
4-91
..................... ANSI/ADA Specification No. 80 2001
Reaffirmation
(Reaffirmed 2007) Dental Materials--
Determination of Color Stability Test
Procedure
4-107
4-188
ISO 9917-2 Second edition 2010-04-15
Withdrawn and replaced
Dentistry--Water-based cements--Part 2:
with newer version
Resin-modified cements
4-117
..................... ANSI/ADA Specification No. 12 2002
Reaffirmation
(Reaffirmed 2007) Denture Base Polymers
4-119
..................... ANSI/ADA Specification No. 82 1998
Reaffirmation
(Reaffirmed 2009)--Dental Reversible/
Irreversible Hydrocolloid Impression
Material Systems
4-139
..................... ANSI/ADA Specification No. 48-Visible
Reaffirmation
Light Curing Units: 2004, Reaffirmed 2009
4-160
..................... ANSI/ASA S3.1-1999 (Reaffirmed 2003)
Reaffirmation
(Reaffirmed 2008) Maximum Permissible
Ambient Noise Levels for Audiometric Test
Rooms
4-164
..................... ANSI/ASA S3.7-1997 (Reaffirmed 2003)
Reaffirmation
(Reaffirmed 2008) Methods for Coupler
Calibration of Earphones
4-166
..................... ANSI/ASA S3.20-1995 (Reaffirmed 2003)
Reaffirmation
(Reaffirmed 2008) Bioacoustical
Terminology
4-167
..................... ANSI/ASA S3.21-2004 (Reaffirmed 2009)
Reaffirmation
Methods for Manual Pure-Tone Threshold
Audiometry
4-169
4-190
ANSI/ASA S3.35-2010 (Revision of ANSI
Withdrawn and replaced
S3.35-2004) Method of Measurement of
with newer version
Performance Characteristics of Hearing
Aids Under Simulated Real-Ear Working
Conditions
-
General
5-31
..................... ISO 15223:2000 Medical device symbols to
Withdrawn be used with medical device labels, labeling and information to be supplied--
First Edition: Amendment 1: 08/01/2002;
Amendment 2: 02/15/2004
5-32
..................... CEN EN 980:1996+A1:1999+A2:2001 Graphical Withdrawn
Symbols for Use in the Labelling of
Medical Devices
Page 61151
5-38
5-62
ANSI/ASQ Z1.4-2008 Sampling Procedures and Withdrawn and replaced
Tables for Inspection by Attributes
with newer version
-
General Hospital/General Plastic Surgery
6-62
6-239
ISO 8536-6 Second edition 2009-11-15
Withdrawn and replaced
Infusion equipment for medical use--Part with newer version 6: Freeze drying closures for infusion bottles
6-64
6-240
ISO 8536-3 Third edition 2009-06-01
Withdrawn and replaced
Infusion equipment for medical use-- Part with newer version 3: Aluminum caps for infusion bottles
6-70
..................... ASTM E825-98 (Reapproved 2009) Standard
Reaffirmation
Specification for Phase Change-Type
Disposable Fever Thermometer for
Intermittent Determination of Human
Temperature
6-110
..................... ASTM F 1441-03 (Reapproved 2009) Standard Reaffirmation
Specification for Soft-Tissue Expander
Devices
6-112
..................... ANSI/AAMI PB70:2003/(R)2009 Liquid barrier Reaffirmation performance and classification of protective apparel and drapes intended for use in health care facilities
6-123
..................... ASTM E667-98 (Reapproved 2009) Standard
Reaffirmation
Specification for Mercury-in-Glass,
Maximum Self-Registering Clinical
Thermometers
6-124
..................... ASTM E1104-98 (Reapproved 2009) Standard
Reaffirmation
Specification for Clinical Thermometer
Probe Covers and Sheaths
6-125
..................... ASTM E1965-98 (Reapproved 2009) Standard
Reaffirmation
Specification for Infrared Thermometers for Intermittent Determination of Patient
Temperature
6-127
6-241
ISO 1135-4 Forth edition 2010-04-15
Withdrawn and replaced
Transfusion equipment for medical use--
with newer version
Part 4: Transfusion sets for single use
6-173
6-242
ISO 8536-2 Third edition 2010-03-15
Withdrawn and replaced
Infusion equipment for medical use--Part with newer version 2: Closures for infusion bottles
-
IVD
7-49
7-210
CLSI H26-A2 Validation, Verification, and Withdrawn and replaced
Quality Assurance of Automated Hematology with newer version
Analyzers; Approved Standard-Second
Edition
7-82
7-211
CLSI C34-A3 Sweat Testing: Sample
Withdrawn and replaced
Collection and Quantitative Chloride
with newer version
Analysis; Approved Guideline-Third
Edition
7-96
7-212
CLSI EP18-A2 Risk Management Techniques to Withdrawn and replaced
Identify and Control Laboratory Error
with newer version
Sources; Approved Guideline-Second
Edition
7-100
..................... ISO 15197 First edition 2003-05-01 In
Title vitro diagnostic test systems--
Requirements for blood-glucose monitoring systems for self testing in managing diabetes mellitus
7-141
7-213
CLSI H18-A4 Procedures for the Handling
Withdrawn and replaced and Processing of Blood Specimens for
with newer version
Common Laboratory Tests; Approved
Guideline-Fourth Edition
7-181
7-214
CLSI M35-A2 Abbreviated Identification of Withdrawn, see 7-197
Bacteria and Yeast; Approved Guideline-
Second Edition
7-186
7-215
CLSI M44-A2 Method for Antifungal Disk
Withdrawn and Replaced
Diffusion Susceptibility Testing of
with newer version
Yeasts; Approved Guideline-Second Edition
7-199
7-216
CLSI M100-S20 Performance Standards for
Withdrawn and Replaced
Antimicrobial Susceptibility Testing;
with newer version
Twentieth Informational Supplement
7-208
7-217
CLSI M44-S3, Zone Diameter Interpretive
Withdrawn and replaced
Standards, Corresponding Minimal
with newer version
Inhibitory Concentration (MIC)
Interpretive Breakpoints, and Quality
Control Limits for Antifungal Disk
Diffusion Susceptibility Testing of
Yeasts; Third Informational Supplement
-
Materials
Page 61152
8-66
8-191
ISO 6474-1 First edition Implants for
Withdrawn and replaced surgery--Ceramic materials--Part 1:
with newer version
Ceramic materials based on high purity alumina
8-71
8-192
ASTM F2182--09 Standard Test Method for
Withdraw and replaced
Measurement of Radio Frequency Induced
with newer version
Heating On or Near Passive Implants
During Magnetic Resonance Imaging
8-85
8-193
ASTM F 1854--09 Standard Test Method for
Withdraw and replaced
Stereological Evaluation of Porous
with newer version
Coatings on Medical Implants
8-88
..................... ASTM F2024-00 Standard Practice for X-ray Type of standard and
Diffraction Determination of Phase
Contact person
Content of Plasma-Sprayed Hydroxyapatite
Coatings
8-130
..................... ASTM F 620--06 Standard Specification for Type of standard
Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants
8-131
..................... ASTM F 799--06 Standard Specification for Type of standard
Cobalt-28Chromium-6Molybdenum Alloy
Forgings for Surgical Implants (UNS
R31537, R31538, R31539)
8-137
..................... ASTM F 75--07, Standard Specification for Type of standard
Cobalt-28 Chromium-6 Molybdenum Alloy
Castings and Casting Alloy for Surgical
Implants (UNS R30075)
8-138
..................... ASTM F 745--07 Standard Specification for Type of standard 18Chromium-12.5Nickel-2.5Molybdenum
Stainless Steel for Cast and Solution-
Annealed Surgical Implant Applications
8-156
..................... ASTM F 139--08 Standard Specification for Type of standard
Wrought 18Chromium-14Nickel-2.5Molybdenum
Stainless Steel Sheet and Strip for
Surgical Implants (UNS S31673)
8-183
..................... ASTM F 560--08 Standard Specification for Type of standard
Unalloyed Tantalum for Surgical Implant
Applications (UNS R05200, UNS R05400)
I. Neurology
17-2
..................... ASTM F1542-94 (2000) Standard
Withdrawn
Specification for the Requirements and
Disclosure of Self-Closing Aneurysm Clips
17-6
17-9
ASTM F 2129-08 Standard Test Method for
Withdrawn and replaced
Conducting Cyclic Potentiodynamic
with newer version
Polarization Measurements to Determine the Corrosion Susceptibility of Small
Implant Devices
-
OB-GYN/Gastroenterology
9-23
..................... ASTM F1518-00 Standard Practice for
Withdrawn
Cleaning and Disinfection of Flexible
Fiberoptic and Video Endoscopes Used in the Examination of the Hollow Viscera
-
Ophthalmic
10-12
10-59
ISO 11980 Second edition 2009-10-15
Withdrawn and replaced
Ophthalmic optics--Contact lenses and
with newer version contact lens care products--Guidance for clinical investigations
10-30
..................... ANSI Z80.7 (2002) Ophthalmics--Intraocular Withdrawn
Lenses
10-34
..................... ANSI Z80.20 (2004) Ophthalmics--Contact
Withdrawn lenses- Standard Terminology, Tolerances,
Measurements and Physicochemical
Properties
10-44
10-60
ISO 11981 Second edition 2009-07-01
Withdrawn and replaced
Ophthalmic optics--Contact lenses and
with newer version contact lens care products- Determination of physical compatibility of contact lens care products with contact lenses
L. Orthopedics
11-171
..................... ASTM F 1814--97a (Reapproved 2009)
Reaffirmation
Standard Guide for Evaluating Modular Hip and Knee Joint Components
Page 61153
11-179
11-220
ASTM F 2068--09 Standard Specification for Withdrawn and replaced
Femoral Prostheses--Metallic Implants
with newer version
11-180
..................... ASTM F 366--04 (Reapproved 2009) Standard Reaffirmation
Specification for Fixation Pins and Wires
11-181
11-221
ASTM F 1717--09 Standard Test Methods for Withdrawn and replaced
Spinal Implant Constructs in a
with newer version
Vertebrectomy Model
11-188
11-222
ISO 14243-1 Second edition 2009-11-15
Withdrawn and replaced
Implants for surgery--Wear of total knee- with newer version joint prostheses--Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test
11-189
11-223
ISO 14243-2 Second edition 2009-11-15
Withdrawn and replaced
Implants for surgery--Wear of total knee- with newer version joint prostheses--Part 2: Methods of measurement
11-197
..................... ASTM F 983--86 (Reapproved 2009) Standard Reaffirmation
Practice for Permanent Marking of
Orthopaedic Implant Components
11-199
..................... ASTM F 565--04 (Reapproved 2009) e
Reaffirmation
Standard Practice for Care and Handling of Orthopedic Implants and Instruments
11-203
..................... ASTM F 1541--02 (Reapproved 2007) e
Title, Type of
Standard Specification and Test Methods
standard and Relevant for External Skeletal Fixation Devices
guidance
11-210
..................... ASTM F 543--07e Standard Specification and Title, Type of
Test Methods for Metallic Medical Bone
standard and Relevant
Screws
guidance
11-214
..................... ASTM F 382--99 (Reapproved 2008) e
Title and Type of
Standard Specification and Test Method
standard for Metallic Bone Plates
-
Sterility
14-54
14-287
ANSI/AAMI/ISO 11737-2:2009 Sterilization
Withdrawn and replaced of medical devices--Microbiological
with newer version methods--Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
14-55
..................... AAMI/ANSI/ISO 14160:1998/(R)2008
Contact person
Sterilization of single-use medical devices incorporating materials of animal origin--Validation and routine control of sterilization by liquid chemical
14-63
14-288
ASTM F1886/F1886M-09 Standard Test Method Withdrawn and replaced for Determining Integrity of Seals for
with newer version
Flexible Packaging by Visual Inspection
14-77
14-290
ANSI/AAMI ST:24:1999/(R)2009 Automatic,
Withdrawn and replaced general purpose ethylene oxide
with newer version sterilizers and ethylene oxide sterilant sources intended for use in health care facilities
14-88
14-291
ANSI/AAMI/ISO 14937:2009 Sterilization of Withdrawn and replaced health care products--General
with newer version requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
14-116
14-292
ANSI/AAMI ST72:2002/(R)2010 Bacterial
Withdrawn and replaced
Endotoxins--Test methodologies, routine
with newer version monitoring, and alternatives to batch testing
14-118
14-293
ANSI/AAMI ST50:2004/(R)2010 Dry heat
Withdrawn and replaced
(heated air) sterilizers
with newer version
14-152
14-294
ANSI/AAMI ST40:2004/(R)2010 Table-top dry Withdrawn and replaced heat (heated air) sterilization and
with newer version sterility assurance in health care facilities
14-164
14-295
ANSI/AAMI ST81:2004/(R)2010 Sterilization Withdrawn and replaced of medical devices--Information to be
with newer version provided by the manufacturer for the processing of resterilizable medical devices
14-181
..................... AAMI/ANSI ST58: 2005 Chemical
Contact person sterilization and high-level disinfection in health care facilities
Page 61154
14-197
..................... ASTM F1608-00 (Reapproved 2009) Standard
Reaffirmation
Test Method for Microbial Ranking of
Porous Packaging Materials (Exposure
Chamber Method)
14-211
..................... AOAC 6.2.01:2006 Official Method 955.14
Contact person
Testing Disinfectants against Salmonella choleraesuis, Use-Dilution Method
14-212
..................... AOAC 6.2.02:2006 Official Method 991.47
Contact person
Testing Disinfectants against Salmonella choleraesuis, Hard Surface Carrier Test
Method
14-213
..................... AOAC 6.2.03:2006 Official Method 991.48
Contact person
Testing Disinfectant against
Staphylococcus aureus, Hard Surface
Carrier Test Method
14-214
..................... AOAC 6.2.04:2006 Official Method 955.15
Contact person
Testing Disinfectants Against
Staphylococcus aureus, Use-Dilution
Method
14-215
..................... AOAC 6.2.05:2006 Official Method 991.49
Contact person
Testing Disinfectants against Pseudomonas aeruginosa, Hard Surface Carrier Test
Method
14-216
..................... AOAC 6.2.06:2006 Official Method 964.02
Contact person
Testing Disinfectants against Pseudomonas aeruginosa, Use-Dilution Method
14-217
..................... AOAC 6.3.02:2006 Official Method 955.17
Contact person
Fungicidal Activity of Disinfectants
Using Trichophyton mentagrophytes
14-218
..................... AOAC 6.3.05:2006 Official Method 966.04
Contact person
Sporicidal Activity of Disinfectants
Method I
14-219
..................... AOAC 6.3.06:2006 Official Method 965.12
Contact person
Tuberculocidal Activity of Disinfectants
14-223
14-296
ANSI/AAMI/ISO 11138-1:2006/(R)2010
Withdrawn and replaced
Sterilization of health care products--
with newer version
Biological indicators--Part 1: General requirements
14-224
14-297
ANSI/AAMI/ISO 11137-1:2006/(R)2010
Withdrawn and replaced
Sterilization of health care products--
with newer version
Radiation--Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
14-226
14-298
ANSI/AAMI/ISO 11137-3:2006/(R)2010
Withdrawn and replaced
Sterilization of health care products--
with newer version
Radiation--Part 3: Guidance on dosimetric aspects
14-234
14-299
ASTM F2097-10 Standard Guide for Design
Withdrawn and replaced and Evaluation of Primary Flexible
with newer version
Packaging for Medical Products
14-265
..................... USP 32:2009 Microbiological
Contact person
Examination of Nonsterile Products:
Microbial Enumeration Tests
14-266
..................... USP 32:2009 Sterility Tests
Contact person
14-267
..................... USP 32:2009 Bacterial Endotoxins Test Contact person
14-268
..................... USP 32:2009 Pyrogen Test
Contact person
14-269
..................... USP 32:2009 Transfusion and Infusion Contact person
Assemblies and Similar Medical Devices
14-270
..................... USP 32:2009 Biological Indicator for Steam Contact person
Sterilization--Self Contained
14-271
..................... USP 32: 2009 Biological Indicator for Dry- Contact person
Heat Sterilization, Paper Carrier
14-272
..................... USP 32:2009 Biological Indicator for
Contact person
Ethylene Oxide Sterilization, Paper
Carrier
14-273
..................... USP 32:2009 Biological Indicator for Steam Contact person
Sterilization, Paper Carrier
14-278
..................... USP 32:2009 Microbiological
Contact person
Examination of Nonsterile Products: Tests for Specified Microorganisms
14-280
..................... AAMI/ANSI ST79:2006 and A1:2008, A2:2009
Contact person
(Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities
Page 61155
14-284
14-300
ASTM D4169-09 Standard Practice for
Withdrawn and replaced
Performance Testing of Shipping
with newer version
Containers and Systems
14-285
..................... AAMI/ANSI/ISO 14161:2009 Sterilization of Contact person health care products--Biological indicators--Guidance for the selection, use and interpretation of results
-
Tissue Engineering
15-16
15-19
ASTM F2450-10 Standard Guide for Assessing Withdrawn and replaced
Microstructure of Polymeric Scaffolds for with newer version
Use in Tissue-Engineered Medical Products
\1\ All standard titles in this table conform to the style requirements of the respective organizations.
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: 025.
Table 3.--New Entries to the List of Recognized Standards
Recognition No.
Title of Standard\1\
Reference No. & Date
-
Anesthesia
1-83
Medical electrical equipment--Particular requirements for
ISO 21647:2004 TECHNICAL the basic safety and essential performance of respiratory
CORRIGENDUM 1 gas monitors
-
Cardiology
3-80
Non-invasive sphygmomanometers--Part 1: Requirements and
ANSI/AAMI/ISO 81060-1:2007 test methods for non-automated measurement type
3-81
Non-invasive sphygmomanometers - Part 2: Clinical validation ANSI/AAMI/ISO 81060-2:2009 of automated measurement type
3-82
Implants for surgery - Cardiac pacemakers - Part 3: Low-
IS0 5841 -3:2000 TECHNICAL profile connectors [IS-I] for implantable pacemakers
CORRIGENDUM 1
TECHNICAL CORRIGENDUM 1
-
Dental/ENT
4-189
Dentistry--Soft lining materials for removable dentures--
ISO 10139-1:2005 TECHNICAL
Part 1: Materials for short-term use
CORRIGENDUM 1 2006-03-01
-
General
5-56
Medical devices--Symbols to be used with medical device
ISO 15223-2 First edition labels, labelling, and information to be supplied--Part 2: 2010-01-15
Symbol development, selection and validation
5-57
Human factors engineering--Design of medical devices
ANSI/AAMI HE75:2009
5-58
Medical electrical equipment--Part 1-11: General
IEC 60601-1-11 Edition 1.0 requirements for basic safety and essential performance--
2010-04
Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
5-59
Medical devices - Symbols to be used with medical device
ISO 15223-1 First Edition labels, labelling and information to be supplied--Part 1:
2007
General requirements
5-60
Medical electrical equipment - Part 1-2: General
IEC 60601-1-2 (2007) Third requirements for basic safety and essential performance -
edition/I-SH 01
Collateral standard: Electromagnetic compatibility -
Requirements and tests, Interpretation Sheet
5-61
Medical devices - Symbols to be used with medical device
ANSI/AAMI/ISO 15223-1:2007 labels, labeling, and information to be supplied--Part 1:
General requirements
-
Materials
8-194
Standard Test Method for Measurement of Camber, Cast, Helix ASTM F 2754/F 2754M--09 and Direction of Helix of Coiled Wire
Page 61156
8-195
Standard Specification for Wrought Seamless Nickel-Titanium ASTM F 2633-07
Shape Memory Alloy Tube for Medical Devices and Surgical
Implants
-
Ophthalmic
10-61
Ophthalmic optics--Contact lenses--Part 1: Vocabulary,
ISO 18369-1 First edition classification system and recommendations for labelling
2006-08-05 AMENDMENT 1 specifications AMENDMENT 1
2009-02-15
-
Orthopedic
11-224
Standard Test Methods for Occipital-Cervical and Occipital- ASTM F 2706--08
Cervical-Thoracic Spinal Implant Constructs in a
Vertebrectomy Model
-
Radiology
12-212
Medical electrical equipment--Characteristics of digital X- IEC 62220-1 First Edition ray imaging devices--Part 1: Determination of the detective 2003-10 quantum efficiency
12-213
Medical electrical equipment--Characteristics of digital X- IEC 62220-1-2 First ray imaging devices--Part 1-2: Determination of the
Edition 2007-06 detective quantum efficiency--Detectors used in mammography
12-214
Medical electrical equipment--Characteristics of digital X- IEC 62220-1-3 Edition 1.0 ray imaging devices--Part 1-3: Determination of the
2008-06 detective quantum efficiency--Detectors used in dynamic imaging
12-215
Medical electrical equipment--Exposure index of digital X-
IEC 62494-1 Edition 1.0 ray imaging systems--Part 1: Definitions and requirements
2008-08 for general radiography
12-216
Medical electrical equipment - Medical image display systems IEC 62563-1 Edition 1.0
- Part 1: Evaluation methods
2009-12
I. Sterility
14-289
Cleanrooms and associated controlled environments--
ISO 14698-2:2003 TECHNICAL
Biocontamination control--Part 2: Evaluation and
CORRIGENDUM 1 interpretation of biocontamination data
-
Tissue Engineering
15-20
Standard Guide for Characterization and Testing of Raw or
ASTM F 2027-08
Starting Biomaterials for Tissue-Engineered Medical
Products
15-21
Standard Guide for Characterization and Testing of
ASTM F 2150-07
Biomaterial Scaffolds Used in Tissue-Engineered Medical
Products
15-22
Standard Guide for Assessment of Surface Texture of Non-
ASTM F 2791-00
Porous Biomaterials in Two Dimensions
15-23
Standard Guide for Quantitating Cell Viability within
ASTM F 2739-08
Biomaterial Scaffolds
15-24
Standard Guide for Pre-clinical in vivo Evaluation in
ASTM F 2721-09
Critical Size Segmental Bone Defects
\1\ All standard titles in this table conform to the style requirements of the respective organizations.
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
Page 61157
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
``Modification to the List of Recognized Standards, Recognition List
Number: 025'' will be available on the CDRH home page. You may access the CDRH home page at http://www.fda.gov/MedicalDevices.
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/MedicalDevices/
DeviceRegulationandGuidance/Standards.
This Federal Register document on modifications in FDA's recognition of consensus standards is available at http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
VII. Submission of Comments and Effective Date
Interested persons may submit to the contact person (see FOR
FURTHER INFORMATION CONTACT) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to sent two copies of mailed comments. Comments are to be identified 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: 025. These modifications to the list or recognized standards are effective upon publication of this notice in the Federal Register.
Dated: September 28, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
FR Doc. 2010-24788 Filed 10-1-10; 8:45 am
BILLING CODE 4160-01-S
