Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 029

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451]

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 029

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: 029” (Recognition List Number: 029), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

DATES:

Submit written or electronic comments concerning this document at any time. See section VII of this document for the effective date of the recognition of standards announced in this document.

ADDRESSES:

Submit written requests for single copies of “Modifications to the List of Recognized Standards, Recognition List Number: 029” 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. 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: 029 modifications and other standards related information.

FOR FURTHER INFORMATION CONTACT:

Scott A. Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3628, Silver Spring, MD 20993, 301-796-6574.

I. Background

Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C 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 Publication of Standard Recognition Lists

February 25, 1998 (63 FR 9561).

October 16, 1998 (63 FR 55617).

July 12, 1999 (64 FR 37546).

November 15, 2000 (65 FR 69022).

May 7, 2001 (66 FR 23032).

January 14, 2002 (67 FR 1774).

October 2, 2002 (67 FR 61893).

April 28, 2003 (68 FR 22391).

March 8, 2004 (69 FR 10712).

June 18, 2004 (69 FR 34176).

October 4, 2004 (69 FR 59240).

May 27, 2005 (70 FR 30756).

November 8, 2005 (70 FR 67713).

March 31, 2006 (71 FR 16313).

June 23, 2006 (71 FR 36121).

November 3, 2006 (71 FR 64718).

May 21, 2007 (72 FR 28500).

September 12, 2007 (72 FR 52142).

December 19, 2007 (72 FR 71924).

September 9, 2008 (73 FR 52358).

March, 18, 2009 (74 FR 11586).

September 8, 2009 (74 FR 46203).

May 5, 2010 (75 FR 24711).

June 10, 2010 (75 FR 32943).

October 4, 2010 (75 FR 61148).

March 14, 2011 (76 FR 13631).

August 2, 2011 (76 FR 46300).

March 16, 2012 (77 FR 15765).

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: 029

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: 029” 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. Biocompatibility

2-115

2-189

ASTM F895-11 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity

Withdrawn and replaced with newer version.

2-164

2-190

ANSI/AAMI/ISO 10993-13:2010 Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices

Withdrawn and replaced with newer version.

2-165

ANSI/AAMI/ISO 10993-14:2001/(R)2011 Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramics

Reaffirmation.

B. Cardiovascular

3-37

1-87

IEC 60601-2-23(1999-12) Medical electrical equipment—Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment

Transferred to Anesthesia.

3-44

ANSI/AAMI BP22:1994/(R)2011 Blood pressure transducers

Reaffirmation.

3-55

ASTM F1830-97 (Reapproved 2005) Standard Practice for Selection of Blood for in vitro Evaluation of Blood Pumps

Extent of recognition.

3-56

ASTM F1841-97 (Reapproved 2005) Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps

Extent of recognition.

3-62

3-102

IEC 60601-2-31 Edition 2.1 2011-09 Medical electrical equipment—Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

Withdrawn and replaced with newer version.

C. General

5-28

IEC 60601-1-2, (Second Edition, 2001), Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests

Withdrawn.

5-30

ANSI/AAMI/IEC 60601-1-2:2001, Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests

Withdrawn.

5-40

ISO 14971 Second edition 2007-03-01, Medical devices—Application of risk management to medical devices

Extent of recognition.

5-52

5-71

ANSI/AAMI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text), Medical electrical equipment—Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)

Withdrawn and replaced with new version.

5-56

ISO 15223-2 First edition 2010-01-15, Medical devices—Symbols to be used with medical devices labels, labeling, and information to be supplied—Part 2: Symbol development, selection and validation

Contact person.

5-59

5-72

ISO/FDIS 15223-1 2012 Medical devices—Symbols to be used with medical device labels, labeling and information to be supplied—Part 1: General requirements

Withdrawn and replaced with new version.

5-61

ANSI/AAMI/ISO 15223-1:2007, Medical devices—Symbols to be used with medical device labels, labeling, and information to be supplied—Part 1: General requirements

Withdrawn.

D. General Hospital/General Plastic Surgery

6-110

ASTM F 882-84 (Reapproved 2002), Standard Performance and Safety Specification for Cryosurgical Medical Instruments

Withdrawn.

6-114

6-274

ISO 11608-1 Second edition 2012-04-01 Needle-based injection systems for medical use—Requirements and test methods—Part 1: Needle-based injection systems

Withdrawn and replaced with newer version.

6-115

6-275

ISO 11608-2 Second edition 2012-04-01 Needle-based injection systems for medical use—Requirements and test methods—Part 2: Needles

Withdrawn and replaced with newer version.

6-117

ASTM F2172-02 (Reapproved 2011), Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers

Contact person.

6-118

ASTM F2196-02, Standard Specification for Circulating Liquid and Forced Air Patient Temperature Management Devices

Withdrawn. See 6-238.

6-119

ANSI/AAMI BF7:1989/(R)2011 Blood transfusion microfilters

Reaffirmation.

6-132

ISO 11810-1 First edition 2005-02-15, Lasers and laser-related equipment—Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers—Part 1: Primary ignition and penetration

Contact person.

6-172

6-276

ISO 8536-1 Fourth edition 2011-09-01 Infusion equipment for medical use—Part 1: Infusion glass bottles

Withdrawn and replaced with newer version.

6-175

ASTM D5151-06 (Reapproved 2011) Standard Test Method for Detection of Holes in Medical Gloves

Reaffirmation.

6-178

ASTM D6124-06 (Reapproved 2011) Standard Test Method for Residual Powder on Medical Gloves

Reaffirmation and Contact person.

6-183

ASTM D5250-06 (Reapproved 2011) Standard Specification for Poly(vinyl chloride) Gloves for Medical Application

Reaffirmation and contact person.

6-202

ISO 11810-2:2007, Lasers and laser-related equipment—Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers—Part 2: Secondary ignition

Title and contact person.

6-236

IEC 80601-2-59 Edition 1.0 2008-10 Medical electrical equipment—Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening

Title and contact person.

6-237

IEC 80601-2-59 (First edition—2008) Medical electrical equipment—Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening CORRIGENDUM1

Title and contact person.

6-238

IEC 80601-2-35 Edition 2.0 2009-10, Medical electrical equipment—Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

Contact person.

6-241

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

Contact person.

6-242

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

Contact person.

6-245

ISO 8536-4 Fifth edition 2010-10-01, Infusion equipment for medical use—Part 4: Infusion sets for single use, gravity feed

Contact person.

6-273

ISO 23908 First edition 2011-06-11, Sharps injury protection—Requirements and test methods—Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

Contact person.

E. In Vitro Diagnostics

7-54

CLSI D12-A2, Immunoprecipitin Analyses: Procedures for Evaluating the Performance of Materials—Second Edition; Approved Guideline

Withdrawn.

7-76

NCCLS M15-A, Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline

Contact person and type of standard.

7-146

CLSI M6-A2, Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved Standard—Second Edition

Contact person and title.

7-148

CLSI M28-A2, Procedures for the Recovery and Identification of Parasites From the Intestinal Tract; Approved Guideline—Second Edition

Contact person and title.

7-157

7-228

CLSI M11-A8, Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition

Withdrawn and replaced with newer version.

7-171

CLSI M38-A2, Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi; Approved Standard—Second Edition

Contact person and title.

7-179

CLSI M27-S3, Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Third Informational Supplement

Contact person and title.

7-184

CLSI M40-A, Quality Control of Microbiological Transport Systems; Approved Standard

Contact person and title.

7-195

7-229

CLSI M02-A11, Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—Eleventh Edition

Withdrawn and replaced with newer version.

7-196

7-230

CLSI M07-A9, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard—Ninth Edition

Withdrawn and replaced with newer version.

7-197

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

Contact person and title.

7-198

CLSI M23-A3, Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters; Approved Guideline—Third Edition

Contact person and title.

7-200

CLSI M48-A, Laboratory Detection and Identification of Mycobacteria; Approved Guideline

Contact person and title.

7-215

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

Contact person.

7-216

7-231

CLSI M100-S22, Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Second Informational Supplement

Withdrawn and replaced with newer version.

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

Contact person.

7-218

CLSI M45-A2, Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline—Second Edition

Contact person.

F. Materials

8-108

8-216

ASTM F1295-11 Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)

Withdrawn and replaced with newer version.

8-111

ASTM F1160-05 (Reapproved 2011) Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings

Reaffirmation.

8-112

ASTM F1044-05 (Reapproved 2011) Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings

Reaffirmation.

8-113

ASTM F1147-05 (Reapproved 2011) Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings

Reaffirmation.

8-127

ISO 5834-2:2006, Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 2: Moulded forms

Withdrawn. See 8-208.

8-128

ASTM F2213-06 (Reapproved 2011) Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment

Reaffirmation and relevant guidance.

8-130

8-217

ASTM F620-11 Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition

Withdrawn and replaced with newer version.

8-131

8-218

ASTM F799-11 Standard Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)

Withdrawn and replaced with newer version.

8-164

8-219

ASTM F136-11 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

Withdrawn and replaced with newer version.

8-174

8-220

ASTM F629-11 Standard Practice for Radiography of Cast Metallic Surgical Implants

Withdrawn and replaced with newer version.

8-180

8-221

ASTM F2066-11 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)

Withdrawn and replaced with newer version.

8-182

8-222

ASTM F1537-11 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)

Withdrawn and replaced with newer version.

8-186

8-223

ASTM F2759-11 Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices

Withdrawn and replaced with newer version.

8-210

8-227

ASTM F2182-11a Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging

Withdrawn and replaced with newer version.

G. Orthopedics

11-175

ASTM F1582-98 (Reapproved 2011) Standard Terminology Relating to Spinal Implants

Reaffirmation.

11-185

ASTM F2267-04 (Reapproved 2011) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

Reaffirmation.

11-186

11-235

ASTM F2077-11 Test Methods For Intervertebral Body Fusion Devices

Withdrawn and replaced with newer version.

11-195

ASTM F1612-95 (2005), Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components with Torsion

Withdrawn. See 11-225.

11-203

ASTM F1541-02 (Reapproved 2011) Standard Specification and Test Methods for External Skeletal Fixation Devices

Reaffirmation and contact person.

11-220

ASTM F2068-09, Standard Specification for Femoral Prostheses—Metallic Implants

Extent of recognition and CFR citations.

11-230

11-236

ASTM F1717-11a Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

Withdrawn and replaced with newer version.

H. Physical Medicine

16-172

ANSI/RESNA WC/Volume 1—1998, Section 5: Determination of Overall Dimensions, Mass, and Turning Space—Wheelchair

Duplicate. See 16-188.

16-186

16-189

ASME A18.1-2011 (Revision of ASME A18.1-2008) Safety Standard for Platform Lifts and Stairway Chairlifts

Withdrawn and replaced with newer version.

I. Radiology

12-102

ANSI/IESNA RP-27.2-00 Recommended Practice for Photobiological Safety for Lamps & Lamp Systems—Measurement Techniques

CFR citation and product codes, devices affected, processes impacted, and contact person.

12-153

ANSI/IESNA RP-27.1-05 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems—General Requirements

CFR citation and product codes, devices affected, processes impacted, and contact person.

12-179

ANSI/IESNA RP-27.3-07 Recommended Practice for Photobiological Safety for Lamps—Risk Group Classification and Labeling

Extent of recognition, CFR citation and product codes, devices affected, processes impacted, type of standard, contact person, and relevant guidance.

J. Software/Informatics

13-8

IEC 62304 First edition 2006-05 Medical device software—Software life cycle processes

Extent of recognition.

K. Sterility

14-55

14-358

ANSI/AAMI/ISO 14160:2011 Sterilization of health care products—Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives—Requirements for characterization, development, validation and routine control of a sterilization process for medical devices

Withdrawn and replaced with newer version.

14-123

14-359

ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)

Withdrawn and replaced with newer version.

14-227

ANSI/AAMI/ISO 11737-1:2006 (R) 2011, Sterilization of health care products—Microbiological methods—Part 1: Determination of the population of microorganisms on product

Reaffirmation and contact person.

14-229

ASTM F1980-07 (Reapproved 2011) Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

Reaffirmation.

14-264

AAMI/ANSI ST8:2008, Hospital steam sterilizers

Contact person.

14-277

ISO TS 17665-2:2009, Sterilization of health care products—Moist heat—Part 2: Guidance on the application of ISO 17665-1

Extent of recognition and contact person.

14-292

14-360

ANSI/AAMI ST72:2011 Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing

Withdrawn and replaced with newer version.

14-311

AAMI/ANSI ST55:2010, Table-top steam sterilizers

Contact person.

1

All standard titles in this table conform to the style requirements of the respective organizations.

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: 029.

Table 3—New Entries to the List of Recognized Standards

Recognition No.

Title of standard

1

Reference No. and date

A. Anesthesia

1-86

Respiratory tract humidifiers for medical use—Particular requirements for respiratory humidification systems

ISO 8185 Third edition 2007-07-01.

1-87

Medical electrical equipment—Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment

60601-2-23 Edition 3.0 2011-02.

1-88

Medical electrical equipment—Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

ISO 80601-2-12 First edition 2011-04-15.

1-89

Medical electrical equipment—Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

ISO 80601-2-12:2011 TECHNICAL CORRIGENDUM 1.

B. Cardiovascular

3-101

Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

ANSI/AAMI/IEC 60601-2-27:2011.

3-103

Cardiovascular implants—Endovascular devices—Part 3: Vena cava filters

ISO 25539-3 First edition 2011-12-01.

3-104

Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices

ASTM F2914-12.

C. General Hospital/General Plastic Surgery

6-277

Prefilled syringes—Part 4: Glass barrels for injectables

ISO 11040-4 Second edition 2007-02-01.

6-278

Prefilled syringes—Part 5: Plunger stoppers for injectables

ISO 11040-5 Third edition 2012-01-15.

6-279

Medical electrical equipment—Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators CORRIGENDUM 1

IEC 60601-2-19 (Second edition—2009).

6-280

Medical electrical equipment—Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators CORRIGENDUM 1

IEC 60601-2-20 (Second edition—2009).

6-281

Medical electrical equipment—Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use CORRIGENDUM 1

IEC 80601-2-35 (Second edition—2009).

D. Materials

8-224

Standard Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants

ASTM F2102—06

€

1

.

8-225

Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air

ASTM F2003—02 (Reapproved 2008).

8-226

Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application

ASTM F603—12.

E. OB-GYN/Gastroenterology

9-75

Optics and Optical instruments—Medical endoscopes and endoscopic accessories—Part 3: Determination of field of view and direction of view of endoscopes with optics

ISO 8600-3 First edition 1997-07-01.

9-76

Water for haemodialysis and related therapies

ISO 13959 Second edition 2009-04-15.

9-77

Guidance for the preparation and quality management of fluids for haemodialysis and related therapies

ISO 23500 First edition 2011-05-15.

9-78

Quality of dialysis fluid for haemodialysis and related therapies

ISO 11663 First edition 2009-04-15.

F. Ophthalmic

10-73

American National Standard for Ophthalmics—Instruments—General-Purpose Clinical Visual Acuity Charts

ANSI Z80.21-2010.

10-74

Ophthalmic instruments—Fundus cameras

ISO 10940 Second edition 2009-08-01.

G. Orthopedic

11-237

Implants for surgery—Partial and total hip joint prostheses—Part 6: Determination of endurance properties of head and neck region of stemmed femoral components

ISO 7206-6 First edition 1992-03-l5.

11-238

Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials

ASTM F 2033-12.

11-239

Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads

ASTM F2345-03 (Reapproved 2008).

11-240

Standard Specification and Test Method for Metallic Bone Plates

ASTM F382-99 (Reapproved 2008).

11-241

Standard Specification and Test Methods for Metallic Medical Bone Screws

ASTM F543-07

€

1

.

11-242

Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments

ASTM F1839-08

€

2

.

11-243

Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs

ASTM F2346-05 (Reapproved 2011).

H. Radiology

12-249

Photobiological safety of lamps and lamp systems

IEC 62471 First edition 2006-07.

I. Software/Informatics

13-31

Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard

CLSI AUTO12-A.

13-32

Medical device software—Software life cycle processes

ANSI/AAMI/IEC 62304:2006.

J. Sterility

14-361

Sterilization of health care products—Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives—Requirements for characterization, development, validation and routine control of a sterilization process for medical devices

ISO 14160 Second edition 2011-07-01.

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 FD&C 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: 029” 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” 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 no longer necessary to send 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: 029. These modifications to the list of recognized standards are effective upon publication of this notice in the

Federal Register

.

Dated: August 14, 2012.

Leslie Kux,

Assistant Commissioner for Policy.

[FR Doc. 2012-20323 Filed 8-17-12; 8:45 am]

BILLING CODE 4160-01-P