Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 025

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

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

Old

Recognition No.

Replacement

Recognition No.

Title of Standard

1

Change

A. Anesthesia

1-61

1-82

IEC 60601-2-13 Edition 3.1 2009-08 Medical electrical equipment—Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems

Withdrawn and replaced with newer version

B. Biocompatibility

2-96

ASTM F 1903-98 (Reapproved 2003) Standard Practice for Testing For Biological Responses to Particles in vitro

Type of standard and Contact person

2-98

2-156

ANSI/AAMI/ISO 10993-1:2009 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process

Withdrawn and replaced with newer version

2-100

ASTM E1372-95 (2003) Standard Test Method for Conducting a 90-Day Oral Toxicity Study in Rats

Withdrawn

2-115

ASTM F 895—84 (Reapproved 2006) Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity

Title, Type of standard , Relevant guidance and Contact person

2-117

ANSI/AAMI/ISO 10993-3:2003/(R)2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity

Reaffirmation, CDRH Office(s) and Division(s) associated with recognized standard and Contact person

2-118

ANSI/AAMI/ISO 10993-11:2006 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity

Contact person

2-119

ASTM F 813-07 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

Title, Type of standard and Contact person

2-135

ANSI/AAMI/ISO 10993-12:2007 Biological evaluation of medical devices—Part 12: Sample preparation and reference materials

Title and Contact person

2-147

2-157

USP 33—NF 28 2010 Biological Tests <87> Biological Reactivity Test, In Vitro—Direct Contact Test

Withdrawn and replaced with newer version

2-148

2-158

USP 33-NF28 2010 Biological Tests <87> Biological Reactivity Test, In Vitro—Elution Test

Withdrawn and replaced with newer version

2-149

2-159

USP 33-NF28 2010 Biological Tests <88> Biological Reactivity Tests, In Vivo, Procedure—Preparation of Sample

Withdrawn and replaced with newer version

2-150

2-160

USP 33-NF28 2010 Biological Tests <88> Biological Reactivity Tests, In Vivo, Classification of Plastics—Intracutaneous Test

Withdrawn and replaced with newer version

2-151

2-161

USP 33-NF28 2010 Biological Tests <88> Biological Reactivity Tests, In Vivo, Classification of Plastics—Systemic Injection Test

Withdrawn and replaced with newer version

C. Cardiology

3-74

3-79

ASTM F 2079—09 Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents

Withdrawn and replaced with newer version

3-75

ANSI/AAMI SP10:2002/(R)2008 & ANSI/AAMI SP10:2002/A1:2003/(R)2008 & ANSI/AAMI SP10:2002/A2:2006/(R)2008 Manual, electronic or automated sphygmomanometers

Title and Extent of recognition

D. Dental/ENT

4-86

ANSI/ADA Specification No. 38 2000 (Reaffirmed 2010) Metal-Ceramic Dental Restorative Systems

Reaffirmation

4-91

ANSI/ADA Specification No. 80 2001 (Reaffirmed 2007) Dental Materials—Determination of Color Stability Test Procedure

Reaffirmation

4-107

4-188

ISO 9917-2 Second edition 2010-04-15 Dentistry—Water-based cements—Part 2: Resin-modified cements

Withdrawn and replaced with newer version

4-117

ANSI/ADA Specification No. 12 2002 (Reaffirmed 2007) Denture Base Polymers

Reaffirmation

4-119

ANSI/ADA Specification No. 82 1998 (Reaffirmed 2009)—Dental Reversible/Irreversible Hydrocolloid Impression Material Systems

Reaffirmation

4-139

ANSI/ADA Specification No. 48-Visible Light Curing Units: 2004, Reaffirmed 2009

Reaffirmation

4-160

ANSI/ASA S3.1-1999 (Reaffirmed 2003) (Reaffirmed 2008) Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms

Reaffirmation

4-164

ANSI/ASA S3.7-1997 (Reaffirmed 2003) (Reaffirmed 2008) Methods for Coupler Calibration of Earphones

Reaffirmation

4-166

ANSI/ASA S3.20-1995 (Reaffirmed 2003) (Reaffirmed 2008) Bioacoustical Terminology

Reaffirmation

4-167

ANSI/ASA S3.21-2004 (Reaffirmed 2009) Methods for Manual Pure-Tone Threshold Audiometry

Reaffirmation

4-169

4-190

ANSI/ASA S3.35-2010 (Revision of ANSI S3.35-2004) Method of Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions

Withdrawn and replaced with newer version

E. General

5-31

ISO 15223:2000 Medical device symbols to be used with medical device labels, labeling and information to be supplied—First Edition: Amendment 1: 08/01/2002; Amendment 2: 02/15/2004

Withdrawn

5-32

CEN EN 980:1996+A1:1999+A2:2001 Graphical Symbols for Use in the Labelling of Medical Devices

Withdrawn

5-38

5-62

ANSI/ASQ Z1.4-2008 Sampling Procedures and Tables for Inspection by Attributes

Withdrawn and replaced with newer version

F. General Hospital/General Plastic Surgery

6-62

6-239

ISO 8536-6 Second edition 2009-11-15 Infusion equipment for medical use—Part 6: Freeze drying closures for infusion bottles

Withdrawn and replaced with newer version

6-64

6-240

ISO 8536-3 Third edition 2009-06-01 Infusion equipment for medical use— Part 3: Aluminum caps for infusion bottles

Withdrawn and replaced with newer version

6-70

ASTM E825-98 (Reapproved 2009) Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature

Reaffirmation

6-110

ASTM F 1441-03 (Reapproved 2009) Standard Specification for Soft-Tissue Expander Devices

Reaffirmation

6-112

ANSI/AAMI PB70:2003/(R)2009 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities

Reaffirmation

6-123

ASTM E667-98 (Reapproved 2009) Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers

Reaffirmation

6-124

ASTM E1104-98 (Reapproved 2009) Standard Specification for Clinical Thermometer Probe Covers and Sheaths

Reaffirmation

6-125

ASTM E1965-98 (Reapproved 2009) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

Reaffirmation

6-127

6-241

ISO 1135-4 Forth edition 2010-04-15 Transfusion equipment for medical use—Part 4: Transfusion sets for single use

Withdrawn and replaced with newer version

6-173

6-242

ISO 8536-2 Third edition 2010-03-15 Infusion equipment for medical use—Part 2: Closures for infusion bottles

Withdrawn and replaced with newer version

G. IVD

7-49

7-210

CLSI H26-A2 Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard-Second Edition

Withdrawn and replaced with newer version

7-82

7-211

CLSI C34-A3 Sweat Testing: Sample Collection and Quantitative Chloride Analysis; Approved Guideline-Third Edition

Withdrawn and replaced with newer version

7-96

7-212

CLSI EP18-A2 Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline-Second Edition

Withdrawn and replaced with newer version

7-100

ISO 15197 First edition 2003-05-01 In vitro diagnostic test systems—Requirements for blood-glucose monitoring systems for self testing in managing diabetes mellitus

Title

7-141

7-213

CLSI H18-A4 Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition

Withdrawn and replaced with newer version

7-181

7-214

CLSI M35-A2 Abbreviated Identification of Bacteria and Yeast; Approved Guideline-Second Edition

Withdrawn, see 7-197

7-186

7-215

CLSI M44-A2 Method for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Approved Guideline-Second Edition

Withdrawn and Replaced with newer version

7-199

7-216

CLSI M100-S20 Performance Standards for Antimicrobial Susceptibility Testing; Twentieth Informational Supplement

Withdrawn and Replaced with newer version

7-208

7-217

CLSI M44-S3, Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement

Withdrawn and replaced with newer version

H. Materials

8-66

8-191

ISO 6474-1 First edition Implants for surgery—Ceramic materials—Part 1: Ceramic materials based on high purity alumina

Withdrawn and replaced with newer version

8-71

8-192

ASTM F2182—09 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging

Withdraw and replaced with newer version

8-85

8-193

ASTM F 1854—09 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants

Withdraw and replaced with newer version

8-88

ASTM F2024-00 Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings

Type of standard and Contact person

8-130

ASTM F 620—06 Standard Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants

Type of standard

8-131

ASTM F 799—06 Standard Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)

Type of standard

8-137

ASTM F 75—07, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)

Type of standard

8-138

ASTM F 745—07 Standard Specification for 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications

Type of standard

8-156

ASTM F 139—08 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)

Type of standard

8-183

ASTM F 560—08 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)

Type of standard

I. Neurology

17-2

ASTM F1542-94 (2000) Standard Specification for the Requirements and Disclosure of Self-Closing Aneurysm Clips

Withdrawn

17-6

17-9

ASTM F 2129-08 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices

Withdrawn and replaced with newer version

J. OB-GYN/Gastroenterology

9-23

ASTM F1518-00 Standard Practice for Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes Used in the Examination of the Hollow Viscera

Withdrawn

K. Ophthalmic

10-12

10-59

ISO 11980 Second edition 2009-10-15 Ophthalmic optics—Contact lenses and contact lens care products—Guidance for clinical investigations

Withdrawn and replaced with newer version

10-30

ANSI Z80.7 (2002) Ophthalmics—Intraocular Lenses

Withdrawn

10-34

ANSI Z80.20 (2004) Ophthalmics—Contact lenses- Standard Terminology, Tolerances, Measurements and Physicochemical Properties

Withdrawn

10-44

10-60

ISO 11981 Second edition 2009-07-01 Ophthalmic optics—Contact lenses and contact lens care products- Determination of physical compatibility of contact lens care products with contact lenses

Withdrawn and replaced with newer version

L. Orthopedics

11-171

ASTM F 1814—97a (Reapproved 2009) Standard Guide for Evaluating Modular Hip and Knee Joint Components

Reaffirmation

11-179

11-220

ASTM F 2068—09 Standard Specification for Femoral Prostheses—Metallic Implants

Withdrawn and replaced with newer version

11-180

ASTM F 366—04 (Reapproved 2009) Standard Specification for Fixation Pins and Wires

Reaffirmation

11-181

11-221

ASTM F 1717—09 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

Withdrawn and replaced with newer version

11-188

11-222

ISO 14243-1 Second edition 2009-11-15 Implants for surgery—Wear of total knee-joint prostheses—Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test

Withdrawn and replaced with newer version

11-189

11-223

ISO 14243-2 Second edition 2009-11-15 Implants for surgery—Wear of total knee-joint prostheses—Part 2: Methods of measurement

Withdrawn and replaced with newer version

11-197

ASTM F 983—86 (Reapproved 2009) Standard Practice for Permanent Marking of Orthopaedic Implant Components

Reaffirmation

11-199

ASTM F 565—04 (Reapproved 2009)

e

Standard Practice for Care and Handling of Orthopedic Implants and Instruments

Reaffirmation

11-203

ASTM F 1541—02 (Reapproved 2007)

e

Standard Specification and Test Methods for External Skeletal Fixation Devices

Title, Type of standard and Relevant guidance

11-210

ASTM F 543—07

e

Standard Specification and Test Methods for Metallic Medical Bone Screws

Title, Type of standard and Relevant guidance

11-214

ASTM F 382—99 (Reapproved 2008)

e

Standard Specification and Test Method for Metallic Bone Plates

Title and Type of standard

M. Sterility

14-54

14-287

ANSI/AAMI/ISO 11737-2:2009 Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

Withdrawn and replaced with newer version

14-55

AAMI/ANSI/ISO 14160:1998/(R)2008 Sterilization of single-use medical devices incorporating materials of animal origin—Validation and routine control of sterilization by liquid chemical

Contact person

14-63

14-288

ASTM F1886/F1886M-09 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection

Withdrawn and replaced with newer version

14-77

14-290

ANSI/AAMI ST:24:1999/(R)2009 Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities

Withdrawn and replaced with newer version

14-88

14-291

ANSI/AAMI/ISO 14937:2009 Sterilization of health care products—General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

Withdrawn and replaced with newer version

14-116

14-292

ANSI/AAMI ST72:2002/(R)2010 Bacterial Endotoxins—Test methodologies, routine monitoring, and alternatives to batch testing

Withdrawn and replaced with newer version

14-118

14-293

ANSI/AAMI ST50:2004/(R)2010 Dry heat (heated air) sterilizers

Withdrawn and replaced with newer version

14-152

14-294

ANSI/AAMI ST40:2004/(R)2010 Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities

Withdrawn and replaced with newer version

14-164

14-295

ANSI/AAMI ST81:2004/(R)2010 Sterilization of medical devices—Information to be provided by the manufacturer for the processing of resterilizable medical devices

Withdrawn and replaced with newer version

14-181

AAMI/ANSI ST58: 2005 Chemical sterilization and high-level disinfection in health care facilities

Contact person

14-197

ASTM F1608-00 (Reapproved 2009) Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)

Reaffirmation

14-211

AOAC 6.2.01:2006 Official Method 955.14 Testing Disinfectants against Salmonella choleraesuis, Use-Dilution Method

Contact person

14-212

AOAC 6.2.02:2006 Official Method 991.47 Testing Disinfectants against Salmonella choleraesuis, Hard Surface Carrier Test Method

Contact person

14-213

AOAC 6.2.03:2006 Official Method 991.48 Testing Disinfectant against Staphylococcus aureus, Hard Surface Carrier Test Method

Contact person

14-214

AOAC 6.2.04:2006 Official Method 955.15 Testing Disinfectants Against Staphylococcus aureus, Use-Dilution Method

Contact person

14-215

AOAC 6.2.05:2006 Official Method 991.49 Testing Disinfectants against Pseudomonas aeruginosa, Hard Surface Carrier Test Method

Contact person

14-216

AOAC 6.2.06:2006 Official Method 964.02 Testing Disinfectants against Pseudomonas aeruginosa, Use-Dilution Method

Contact person

14-217

AOAC 6.3.02:2006 Official Method 955.17 Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes

Contact person

14-218

AOAC 6.3.05:2006 Official Method 966.04 Sporicidal Activity of Disinfectants Method I

Contact person

14-219

AOAC 6.3.06:2006 Official Method 965.12 Tuberculocidal Activity of Disinfectants

Contact person

14-223

14-296

ANSI/AAMI/ISO 11138-1:2006/(R)2010 Sterilization of health care products—Biological indicators—Part 1: General requirements

Withdrawn and replaced with newer version

14-224

14-297

ANSI/AAMI/ISO 11137-1:2006/(R)2010 Sterilization of health care products—Radiation—Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

Withdrawn and replaced with newer version

14-226

14-298

ANSI/AAMI/ISO 11137-3:2006/(R)2010 Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects

Withdrawn and replaced with newer version

14-234

14-299

ASTM F2097-10 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

Withdrawn and replaced with newer version

14-265

USP 32:2009 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests

Contact person

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 Assemblies and Similar Medical Devices

Contact person

14-270

USP 32:2009 Biological Indicator for Steam Sterilization—Self Contained

Contact person

14-271

USP 32: 2009 Biological Indicator for Dry-Heat Sterilization, Paper Carrier

Contact person

14-272

USP 32:2009 Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier

Contact person

14-273

USP 32:2009 Biological Indicator for Steam Sterilization, Paper Carrier

Contact person

14-278

USP 32:2009 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms

Contact person

14-280

AAMI/ANSI ST79:2006 and A1:2008, A2:2009 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities

Contact person

14-284

14-300

ASTM D4169-09 Standard Practice for Performance Testing of Shipping Containers and Systems

Withdrawn and replaced with newer version

14-285

AAMI/ANSI/ISO 14161:2009 Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of results

Contact person

N. Tissue Engineering

15-16

15-19

ASTM F2450-10 Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products

Withdrawn and replaced with newer version

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 the basic safety and essential performance of respiratory gas monitors

ISO 21647:2004 TECHNICAL CORRIGENDUM 1

B. Cardiology

3-80

Non-invasive sphygmomanometers—Part 1: Requirements and test methods for non-automated measurement type

ANSI/AAMI/ISO 81060-1:2007

3-81

Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type

ANSI/AAMI/ISO 81060-2:2009

3-82

Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for implantable pacemakers TECHNICAL CORRIGENDUM 1

IS0 5841 -3:2000 TECHNICAL CORRIGENDUM 1

C. Dental/ENT

4-189

Dentistry—Soft lining materials for removable dentures—Part 1: Materials for short-term use

ISO 10139-1:2005 TECHNICAL CORRIGENDUM 1 2006-03-01

D. General

5-56

Medical devices—Symbols to be used with medical device labels, labelling, and information to be supplied—Part 2: Symbol development, selection and validation

ISO 15223-2 First edition 2010-01-15

5-57

Human factors engineering—Design of medical devices

ANSI/AAMI HE75:2009

5-58

Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

IEC 60601-1-11 Edition 1.0 2010-04

5-59

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied—Part 1: General requirements

ISO 15223-1 First Edition 2007

5-60

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, Interpretation Sheet

IEC 60601-1-2 (2007) Third edition/I-SH 01

5-61

Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied—Part 1: General requirements

ANSI/AAMI/ISO 15223-1:2007

E. Materials

8-194

Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wire

ASTM F 2754/F 2754M—09

8-195

Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants

ASTM F 2633-07

F. Ophthalmic

10-61

Ophthalmic optics—Contact lenses—Part 1: Vocabulary, classification system and recommendations for labelling specifications AMENDMENT 1

ISO 18369-1 First edition 2006-08-05 AMENDMENT 1 2009-02-15

G. Orthopedic

11-224

Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model

ASTM F 2706—08

H. Radiology

12-212

Medical electrical equipment—Characteristics of digital X-ray imaging devices—Part 1: Determination of the detective quantum efficiency

IEC 62220-1 First Edition 2003-10

12-213

Medical electrical equipment—Characteristics of digital X-ray imaging devices—Part 1-2: Determination of the detective quantum efficiency—Detectors used in mammography

IEC 62220-1-2 First Edition 2007-06

12-214

Medical electrical equipment—Characteristics of digital X-ray imaging devices—Part 1-3: Determination of the detective quantum efficiency—Detectors used in dynamic imaging

IEC 62220-1-3 Edition 1.0 2008-06

12-215

Medical electrical equipment—Exposure index of digital X-ray imaging systems—Part 1: Definitions and requirements for general radiography

IEC 62494-1 Edition 1.0 2008-08

12-216

Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods

IEC 62563-1 Edition 1.0 2009-12

I. Sterility

14-289

Cleanrooms and associated controlled environments—Biocontamination control—Part 2: Evaluation and interpretation of biocontamination data

ISO 14698-2:2003 TECHNICAL CORRIGENDUM 1

J. Tissue Engineering

15-20

Standard Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue-Engineered Medical Products

ASTM F 2027-08

15-21

Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products

ASTM F 2150-07

15-22

Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions

ASTM F 2791-00

15-23

Standard Guide for Quantitating Cell Viability within Biomaterial Scaffolds

ASTM F 2739-08

15-24

Standard Guide for Pre-clinical

in vivo

Evaluation in Critical Size Segmental Bone Defects

ASTM F 2721-09

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

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