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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2004-N-0451] (formerly Docket No. 2004N-0226)
 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 
                    ( print 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**
Old 
                             Recognition No.
Replacement 
                             Recognition No.
Title of Standard1
ChangeA. Anesthesia1-61
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 versionB. Biocompatibility2-96

ASTM F 1903-98 (Reapproved 2003) Standard Practice for Testing For Biological Responses to Particles in vitro
Type of standard and Contact person2-98
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 version2-100

ASTM E1372-95 (2003) Standard Test Method for Conducting a 90-Day Oral Toxicity Study in Rats
Withdrawn2-115

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 person2-117

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 person2-118

ANSI/AAMI/ISO 10993-11:2006 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
Contact person2-119

ASTM F 813-07 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
Title, Type of standard and Contact person2-135

ANSI/AAMI/ISO 10993-12:2007 Biological evaluation of medical devices—Part 12: Sample preparation and reference materials
Title and Contact person( print page 61150)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 version2-148
2-158
USP 33-NF28 2010 Biological Tests <87> Biological Reactivity Test, In Vitro—Elution Test
Withdrawn and replaced with newer version2-149
2-159
USP 33-NF28 2010 Biological Tests <88> Biological Reactivity Tests, In Vivo, Procedure—Preparation of Sample
Withdrawn and replaced with newer version2-150
2-160
USP 33-NF28 2010 Biological Tests <88> Biological Reactivity Tests, In Vivo, Classification of Plastics—Intracutaneous Test
Withdrawn and replaced with newer version2-151
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 versionC. Cardiology3-74
3-79
ASTM F 2079—09 Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
Withdrawn and replaced with newer version3-75

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 recognitionD. Dental/ENT4-86

ANSI/ADA Specification No. 38 2000 (Reaffirmed 2010) Metal-Ceramic Dental Restorative Systems
Reaffirmation4-91

ANSI/ADA Specification No. 80 2001 (Reaffirmed 2007) Dental Materials—Determination of Color Stability Test Procedure
Reaffirmation4-107
4-188
ISO 9917-2 Second edition 2010-04-15 Dentistry—Water-based cements—Part 2: Resin-modified cements
Withdrawn and replaced with newer version4-117

ANSI/ADA Specification No. 12 2002 (Reaffirmed 2007) Denture Base Polymers
Reaffirmation4-119

ANSI/ADA Specification No. 82 1998 (Reaffirmed 2009)—Dental Reversible/Irreversible Hydrocolloid Impression Material Systems
Reaffirmation4-139

ANSI/ADA Specification No. 48-Visible Light Curing Units: 2004, Reaffirmed 2009
Reaffirmation4-160

ANSI/ASA S3.1-1999 (Reaffirmed 2003) (Reaffirmed 2008) Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms
Reaffirmation4-164

ANSI/ASA S3.7-1997 (Reaffirmed 2003) (Reaffirmed 2008) Methods for Coupler Calibration of Earphones
Reaffirmation4-166

ANSI/ASA S3.20-1995 (Reaffirmed 2003) (Reaffirmed 2008) Bioacoustical Terminology
Reaffirmation4-167

ANSI/ASA S3.21-2004 (Reaffirmed 2009) Methods for Manual Pure-Tone Threshold Audiometry
Reaffirmation4-169
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 versionE. General5-31

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
Withdrawn5-32

CEN EN 980:1996+A1:1999+A2:2001 Graphical Symbols for Use in the Labelling of Medical Devices
Withdrawn( print page 61151)5-38
5-62
ANSI/ASQ Z1.4-2008 Sampling Procedures and Tables for Inspection by Attributes
Withdrawn and replaced with newer versionF. General Hospital/General Plastic Surgery6-62
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 version6-64
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 version6-70

ASTM E825-98 (Reapproved 2009) Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature
Reaffirmation6-110

ASTM F 1441-03 (Reapproved 2009) Standard Specification for Soft-Tissue Expander Devices
Reaffirmation6-112

ANSI/AAMI PB70:2003/(R)2009 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
Reaffirmation6-123

ASTM E667-98 (Reapproved 2009) Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers
Reaffirmation6-124

ASTM E1104-98 (Reapproved 2009) Standard Specification for Clinical Thermometer Probe Covers and Sheaths
Reaffirmation6-125

ASTM E1965-98 (Reapproved 2009) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
Reaffirmation6-127
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 version6-173
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 versionG. IVD7-49
7-210
CLSI H26-A2 Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard-Second Edition
Withdrawn and replaced with newer version7-82
7-211
CLSI C34-A3 Sweat Testing: Sample Collection and Quantitative Chloride Analysis; Approved Guideline-Third Edition
Withdrawn and replaced with newer version7-96
7-212
CLSI EP18-A2 Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline-Second Edition
Withdrawn and replaced with newer version7-100

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
Title7-141
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 version7-181
7-214
CLSI M35-A2 Abbreviated Identification of Bacteria and Yeast; Approved Guideline-Second Edition
Withdrawn, see 7-1977-186
7-215
CLSI M44-A2 Method for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Approved Guideline-Second Edition
Withdrawn and Replaced with newer version7-199
7-216
CLSI M100-S20 Performance Standards for Antimicrobial Susceptibility Testing; Twentieth Informational Supplement
Withdrawn and Replaced with newer version7-208
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 versionH. Materials( print page 61152)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 version8-71
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 version8-85
8-193
ASTM F 1854—09 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
Withdraw and replaced with newer version8-88

ASTM F2024-00 Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
Type of standard and Contact person8-130

ASTM F 620—06 Standard Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants
Type of standard8-131

ASTM F 799—06 Standard Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
Type of standard8-137

ASTM F 75—07, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
Type of standard8-138

ASTM F 745—07 Standard Specification for 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications
Type of standard8-156

ASTM F 139—08 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
Type of standard8-183

ASTM F 560—08 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
Type of standardI. Neurology17-2

ASTM F1542-94 (2000) Standard Specification for the Requirements and Disclosure of Self-Closing Aneurysm Clips
Withdrawn17-6
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 versionJ. OB-GYN/Gastroenterology9-23

ASTM F1518-00 Standard Practice for Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes Used in the Examination of the Hollow Viscera
WithdrawnK. Ophthalmic10-12
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 version10-30

ANSI Z80.7 (2002) Ophthalmics—Intraocular Lenses
Withdrawn10-34

ANSI Z80.20 (2004) Ophthalmics—Contact lenses- Standard Terminology, Tolerances, Measurements and Physicochemical Properties
Withdrawn10-44
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 versionL. Orthopedics11-171

ASTM F 1814—97a (Reapproved 2009) Standard Guide for Evaluating Modular Hip and Knee Joint Components
Reaffirmation( print page 61153)11-179
11-220
ASTM F 2068—09 Standard Specification for Femoral Prostheses—Metallic Implants
Withdrawn and replaced with newer version11-180

ASTM F 366—04 (Reapproved 2009) Standard Specification for Fixation Pins and Wires
Reaffirmation11-181
11-221
ASTM F 1717—09 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
Withdrawn and replaced with newer version11-188
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 version11-189
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 version11-197

ASTM F 983—86 (Reapproved 2009) Standard Practice for Permanent Marking of Orthopaedic Implant Components
Reaffirmation11-199

ASTM F 565—04 (Reapproved 2009) 
                            e
                             Standard Practice for Care and Handling of Orthopedic Implants and Instruments
Reaffirmation11-203

ASTM F 1541—02 (Reapproved 2007) 
                            e
                             Standard Specification and Test Methods for External Skeletal Fixation Devices
Title, Type of standard and Relevant guidance11-210

ASTM F 543—07
                            e
                             Standard Specification and Test Methods for Metallic Medical Bone Screws
Title, Type of standard and Relevant guidance11-214

ASTM F 382—99 (Reapproved 2008) 
                            e
                             Standard Specification and Test Method for Metallic Bone Plates
Title and Type of standardM. Sterility14-54
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 version14-55

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 person14-63
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 version14-77
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 version14-88
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 version14-116
14-292
ANSI/AAMI ST72:2002/(R)2010 Bacterial Endotoxins—Test methodologies, routine monitoring, and alternatives to batch testing
Withdrawn and replaced with newer version14-118
14-293
ANSI/AAMI ST50:2004/(R)2010 Dry heat (heated air) sterilizers
Withdrawn and replaced with newer version14-152
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 version14-164
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 version14-181

AAMI/ANSI ST58: 2005 Chemical sterilization and high-level disinfection in health care facilities
Contact person( print page 61154)14-197

ASTM F1608-00 (Reapproved 2009) Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
Reaffirmation14-211

AOAC 6.2.01:2006 Official Method 955.14 Testing Disinfectants against Salmonella choleraesuis, Use-Dilution Method
Contact person14-212

AOAC 6.2.02:2006 Official Method 991.47 Testing Disinfectants against Salmonella choleraesuis, Hard Surface Carrier Test Method
Contact person14-213

AOAC 6.2.03:2006 Official Method 991.48 Testing Disinfectant against Staphylococcus aureus, Hard Surface Carrier Test Method
Contact person14-214

AOAC 6.2.04:2006 Official Method 955.15 Testing Disinfectants Against Staphylococcus aureus, Use-Dilution Method
Contact person14-215

AOAC 6.2.05:2006 Official Method 991.49 Testing Disinfectants against Pseudomonas aeruginosa, Hard Surface Carrier Test Method
Contact person14-216

AOAC 6.2.06:2006 Official Method 964.02 Testing Disinfectants against Pseudomonas aeruginosa, Use-Dilution Method
Contact person14-217

AOAC 6.3.02:2006 Official Method 955.17 Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes
Contact person14-218

AOAC 6.3.05:2006 Official Method 966.04 Sporicidal Activity of Disinfectants Method I
Contact person14-219

AOAC 6.3.06:2006 Official Method 965.12 Tuberculocidal Activity of Disinfectants
Contact person14-223
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 version14-224
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 version14-226
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 version14-234
14-299
ASTM F2097-10 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
Withdrawn and replaced with newer version14-265

USP 32:2009 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
Contact person14-266

USP 32:2009 <71> Sterility Tests
Contact person14-267

USP 32:2009 <85> Bacterial Endotoxins Test
Contact person14-268

USP 32:2009 <151> Pyrogen Test
Contact person14-269

USP 32:2009 <161> Transfusion and Infusion Assemblies and Similar Medical Devices
Contact person14-270

USP 32:2009 Biological Indicator for Steam Sterilization—Self Contained
Contact person14-271

USP 32: 2009 Biological Indicator for Dry-Heat Sterilization, Paper Carrier
Contact person14-272

USP 32:2009 Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier
Contact person14-273

USP 32:2009 Biological Indicator for Steam Sterilization, Paper Carrier
Contact person14-278

USP 32:2009 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
Contact person14-280

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( print page 61155)14-284
14-300
ASTM D4169-09 Standard Practice for Performance Testing of Shipping Containers and Systems
Withdrawn and replaced with newer version14-285

AAMI/ANSI/ISO 14161:2009 Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of results
Contact personN. Tissue Engineering15-16
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 version1
                         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 Standard1
Reference No. & DateA. Anesthesia1-83
Medical electrical equipment—Particular requirements for the basic safety and essential performance of respiratory gas monitors
ISO 21647:2004 TECHNICAL CORRIGENDUM 1B. Cardiology3-80
Non-invasive sphygmomanometers—Part 1: Requirements and test methods for non-automated measurement type
ANSI/AAMI/ISO 81060-1:20073-81
Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type
ANSI/AAMI/ISO 81060-2:20093-82
Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for implantable pacemakers TECHNICAL CORRIGENDUM 1
IS0 5841 -3:2000 TECHNICAL CORRIGENDUM 1C. Dental/ENT4-189
Dentistry—Soft lining materials for removable dentures—Part 1: Materials for short-term use
ISO 10139-1:2005 TECHNICAL CORRIGENDUM 1 2006-03-01D. General5-56
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 2010-01-155-57
Human factors engineering—Design of medical devices
ANSI/AAMI HE75:20095-58
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 2010-045-59
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 20075-60
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 015-61
Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied—Part 1: General requirements
ANSI/AAMI/ISO 15223-1:2007E. Materials8-194
Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wire
ASTM F 2754/F 2754M—09( print page 61156)8-195
Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
ASTM F 2633-07F. Ophthalmic10-61
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 2009-02-15G. Orthopedic11-224
Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
ASTM F 2706—08H. Radiology12-212
Medical electrical equipment—Characteristics of digital X-ray imaging devices—Part 1: Determination of the detective quantum efficiency
IEC 62220-1 First Edition 2003-1012-213
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 2007-0612-214
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 2008-0612-215
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 2008-0812-216
Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
IEC 62563-1 Edition 1.0 2009-12I. Sterility14-289
Cleanrooms and associated controlled environments—Biocontamination control—Part 2: Evaluation and interpretation of biocontamination data
ISO 14698-2:2003 TECHNICAL CORRIGENDUM 1J. Tissue Engineering15-20
Standard Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue-Engineered Medical Products
ASTM F 2027-0815-21
Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
ASTM F 2150-0715-22
Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
ASTM F 2791-0015-23
Standard Guide for Quantitating Cell Viability within Biomaterial Scaffolds
ASTM F 2739-0815-24
Standard Guide for Pre-clinical 
                            *in vivo*
                             Evaluation in Critical Size Segmental Bone Defects
ASTM F 2721-091
                         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 
                    ( print 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