[Federal Register Volume 75, Number 191 (Monday, October 4, 2010)]
[Notices]
[Pages 61148-61157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-24788]


-----------------------------------------------------------------------

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: [email protected]. 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
----------------------------------------------------------------------------------------------------------------
A. 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
----------------------------------------------------------------------------------------------------------------
B. 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 <87>    Withdrawn and replaced
                                               Biological Reactivity Test, In Vitro--      with newer version
                                               Direct Contact Test
----------------------------------------------------------------------------------------------------------------
2-148                  2-158                  USP 33-NF28 2010 Biological Tests <87>      Withdrawn and replaced
                                               Biological Reactivity Test, In Vitro--      with newer version
                                               Elution Test
----------------------------------------------------------------------------------------------------------------
2-149                  2-159                  USP 33-NF28 2010 Biological Tests <88>      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 <88>      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 <88>      Withdrawn and replaced
                                               Biological Reactivity Tests, In Vivo,       with newer version
                                               Classification of Plastics--Systemic
                                               Injection Test
----------------------------------------------------------------------------------------------------------------
C. 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
----------------------------------------------------------------------------------------------------------------
D. 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
----------------------------------------------------------------------------------------------------------------
E. 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
----------------------------------------------------------------------------------------------------------------
F. 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
----------------------------------------------------------------------------------------------------------------
G. 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
----------------------------------------------------------------------------------------------------------------
H. 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
----------------------------------------------------------------------------------------------------------------
J. 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
----------------------------------------------------------------------------------------------------------------
K. 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
----------------------------------------------------------------------------------------------------------------
M. 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 <61> Microbiological            Contact person
                                               Examination of Nonsterile Products:
                                               Microbial Enumeration Tests
----------------------------------------------------------------------------------------------------------------
14-266                 .....................  USP 32:2009 <71> Sterility Tests            Contact person
----------------------------------------------------------------------------------------------------------------
14-267                 .....................  USP 32:2009 <85> Bacterial Endotoxins Test  Contact person
----------------------------------------------------------------------------------------------------------------
14-268                 .....................  USP 32:2009 <151> Pyrogen Test              Contact person
----------------------------------------------------------------------------------------------------------------
14-269                 .....................  USP 32:2009 <161> 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 <62> 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
----------------------------------------------------------------------------------------------------------------
N. 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
----------------------------------------------------------------------------------------------------------------
A. 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
----------------------------------------------------------------------------------------------------------------
B. 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
----------------------------------------------------------------------------------------------------------------
C. 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
----------------------------------------------------------------------------------------------------------------
D. 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
----------------------------------------------------------------------------------------------------------------
E. 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
----------------------------------------------------------------------------------------------------------------
F. 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
----------------------------------------------------------------------------------------------------------------
G. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-224                  Standard Test Methods for Occipital-Cervical and Occipital-   ASTM F 2706--08
                         Cervical-Thoracic Spinal Implant Constructs in a
                         Vertebrectomy Model
----------------------------------------------------------------------------------------------------------------
H. 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
----------------------------------------------------------------------------------------------------------------
J. 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