Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 031

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451] (formerly 2004N-0226)

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 031

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: 031” (Recognition List Number: 031), 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 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: 031” 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 for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 031 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. 3632, Silver Spring, MD 20993, 301-796-6287.

SUPPLEMENTARY INFORMATION:

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

, can be accessed at

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.

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 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: 031

FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency will recognize for use in premarket submissions 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: 031” to identify these current modifications.

In table 1, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others, if applicable; (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, FDA lists modifications the Agency is making that involve the initial addition of standards not previously recognized by FDA.

Table 1—Modifications to the List of Recognized Standards

Old recognition No.

Replacement recognition No.

Title of standard

1

Change

A. Anesthesia

1-74

1-91

ISO 5360 Third edition 2012-01-15 Anaesthetic vaporizers—Agent-specific filling systems

Withdrawn and replaced with newer version.

1-35

1-93

ISO 5361 Second edition 2012-10-01 Anaesthetic and respiratory equipment—Tracheal tubes and connectors

Withdrawn and replaced with newer version.

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

Transition period extended.

1-88

ISO 80601-2-12 Medical electrical equipment—Part 2-12: Particular requirements for the safety of lung ventilators—Critical care ventilators

Transition period extended.

B. Biocompatibility

2-119

ASTM F813-07 (Reapproved 2012) Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

Reaffirmation.

2-122

ASTM F719-81 (Reapproved 2012) Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation

Reaffirmation.

2-123

ASTM F720-81 (Reapproved 2012) Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test

Reaffirmation.

2-124

ASTM F750-87 (Reapproved 2012) Standard Practice for Evaluating Materials Extracts by Systemic Injection in the Mouse

Reaffirmation.

2-125

2-197

ASTM F749-13 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit

Withdrawn and replaced with newer version.

2-135

2-198

ANSI/AAMI/ISO 10993-12:2012 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials

Withdrawn and replaced with newer version.

2-146

ASTM F2148-07 (Reapproved 2012) Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)

Reaffirmation.

2-152

ISO 10993-10:2002/Amd.1:2006(E) Biological evaluation of medical devices—Part 10: Tests for irritation and delayed-type hypersensitivity AMENDMENT 1

Withdrawn, see 2-174.

2-192

2-199

USP 36-NF31:2013 <87> Biological Reactivity Test, In Vitro—Direct Contact Test

Withdrawn and replaced with newer version.

2-193

2-200

USP 36-NF31:2013Biological Tests <87> Biological Reactivity Tests, In Vitro—Elution Test

Withdrawn and replaced with newer version.

2-194

2-201

USP 36-NF31:2013 Biological Tests <88> Biological Reactivity Tests, In Vivo Procedure Preparation of Sample

Withdrawn and replaced with newer version.

2-195

2-202

USP 36-NF31:2013 Biological Tests <88> Biological Reactivity Tests, In Vitro Classification of Plastics—Intracutaneous Test

Withdrawn and replaced with newer version.

2-196

2-203

USP 36-NF31:2013 Biological Tests <88> Biological Reactivity Tests, In Vivo Classification of Plastics—Systemic Injection Test

Withdrawn and replaced with newer version.

C. Cardiovascular

3-38

3-115

IEC 60601-2-34 Edition 3.0 2011-05 Medical Electrical Equipment—Part 2-34: Particular Requirements for the Basic Safety and Essential Performance of Invasive Blood Pressure Monitoring Equipment

Newer version with transition period.

3-55

ASTM F1830-97 (Reapproved 2013) Standard Practice for Selection of Blood for In Vitro Evaluation of Blood Pumps

Reaffirmation.

3-56

ASTM F1841-97 (Reapproved 2013) Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps

Reaffirmation.

3-66

ASTM F2081-06 (Reapproved 2013) Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

Reaffirmation.

3-79

ASTM F2079-09 (Reapproved 2013) Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents

Reaffirmation.

3-86

ASTM F2394-07 (Reapproved 2013) Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System

Reaffirmation.

3-87

ASTM F2477-07 (Reapproved 2013) Standard Test Methods for in vitro Pulsatile Durability

Reaffirmation.

3-81

3-117

ANSI/AAMI/ISO 81060-2 Second edition 2013-05-01, Non-Invasive Sphygmomanometers—Part 2: Clinical Validation of Automated Measurement Type

Withdrawn and replaced with newer version.

3-94

3-116

ISO 25539-2 Second edition 2012-12-01 Cardiovascular Implants—Endovascular Devices—Part 2: Vascular Stents Part 2: Vascular Stent

Withdrawn and replaced with newer version.

D. Dental/ENT

4-75

ISO 7785-1 Second edition 1997-08-01 Dental Handpieces—Part 1: High-Speed Air Turbine Handpieces

Withdrawn, see 4-206.

4-76

ISO 7785-2 Second edition 1995-08-0 Dental Handpieces—Part 2: Straight and Geared Angle Handpieces

Withdrawn, see 4-206.

4-83

ISO 11498 First edition 1997-02-15 Dental Handpieces: Dental Low-Voltage Electrical Motors

Withdrawn, see 4-206.

4-84

ISO 13294 First edition 1997-05-01 Dental Handpieces—Dental Air-Motors

Withdrawn, see 4-206.

4-90

ANSI S3.39:1987 (Reaffirmed by ANSI June 15, 2012) American National Standard Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance)

Reaffirmation.

4-119

ANSI/ADA Specification No. 82:1998/ISO 13716:1999 Reaffirmed by ANSI: January 2009 Dental Reversible/Irreversible Hydrocolloid Impression Material Systems

Reaffirmation.

4-123

4-203

ANSI/ASA S3.6-2010 (Revision of ANSI S3.6-2004) Specification for Audiometers

Withdrawn and replaced with newer version.

4-167

ANSI/ASA S3.21-2004 (R2009) Methods for Manual Pure-Tone Threshold Audiometry

Reaffirmation.

4-172

4-204

ANSI/ASA S3.42-2012/Part 2/IEC 60118-15:2012 American National Standard Testing Hearing Aids—Part 2: Methods for characterizing signal processing in hearing aids with a speech-like signal (a nationally adopted international standard)

Withdrawn and replaced with newer version.

4-187

IEC 60601-2-18 Edition 3.0 2009-08 Medical electrical equipment—Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

Transition period extended.

E. General

5-53

IEC 60601-1-2 Edition 3.0 2007-03 Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic compatibility—Requirements and tests

Transition period extended.

5-54

ANSI/AAMI/IEC 60601-1-2:2007/(R)2012 Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic compatibility—Requirements and tests

Reaffirmation and transition period extended.

5-55

5-76

IEC 60601-1-8 Edition 2.1 2012-11 Medical electrical equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral standard: General requirements, tests, and guidance for alarm systems in medical electrical equipment and medical electrical systems

Withdrawn and replaced with newer version. Transition period extended.

5-71

5-77

ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, 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.

5-74

5-77

ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, 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.

F. General Hospital/General Plastic Surgery

6-9

6-300

IEC 60601-2-21 Edition 2.0 2009-02 Medical electrical equipment—Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

Newer version with transition period.

6-29

6-298

IEC 60601-2-19 Edition 2.0 2009-02 Medical electrical equipment—Part 2-19: Particulars for the basic safety and essential performance of infant incubators

Newer version with transition period.

6-32

6-299

IEC 60601-2-20 Edition 2.0 2009-02 Medical electrical equipment—Part 2-20: Particular requirements for the basic safety and essential performance of infant radiant warmers

Newer version with transition period.

6-116

6-294

ISO 11608-3 Second edition 2012-10-01 Needle-based injection systems for medical use—Requirements and test methods—Part 3: Finished containers

Withdrawn and replaced with newer version.

6-119

6-295

ANSI/AAMI BF7:2012 Blood transfusion microfilters

Withdrawn and replaced with newer version.

6-147

ASTM D6978—05 (Reapproved 2013) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs

Reaffirmation.

6-174

ISO 11608-4 First edition 2006-03-15 Pen-injectors for medical use—Part 4: Requirements and test methods for electronic and electromechanical pen-injectors

Contact person.

6-179

ISO 21649 First edition 2006-06-01, Needle-free injectors for medical use—Requirements and test methods

Contact person.

6-112

6-296

ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities

Withdrawn and replaced with newer version.

6-214

ASTM D6355—07 (Reapproved 2012) Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves

Reaffirmation.

6-216

ISO 8536-7 Third edition 2009-01-15 Infusion equipment for medical use—Part 7: Caps made of aluminium-plastics combinations for infusion bottles

Contact person.

6-227

ANSI/AAMI/IEC 60601-2-21:2009, Medical electrical equipment—Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

Transition period extended.

6-228

IEC 60601-2-2 Edition 5.0 2009-02, Medical Electrical Equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

Transition period extended.

6-229

ANSI/AAMI/IEC 60601-2-2:2009, Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories

Transition period extended.

6-230

ANSI/AAMI/IEC 60601-2-19:2009, Medical Electrical Equipment—Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

Transition period extended.

6-231

ANSI/AAMI/IEC 60601-2-20:2009, Medical Electrical Equipment—Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

Transition period extended.

6-233

IEC 60601-2-52 Edition 1.0 2009-12 Medical electrical equipment—Part 2-52: Particular requirements for basic safety and essential performance of medical beds

Transition period extended.

6-234

IEC 60601-2-50 Edition 2.0 2009-03 Medical electrical equipment—Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

Contact person.

6-235

ANSI/AAMI/IEC 60601-2-50:2009 Medical Electrical Equipment—Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

Contact person.

6-239

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

Contact person.

6-240

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

Contact person.

6-241

6-297

ISO 1135-4 Fifth edition 2012-03-01 Transfusion equipment for medical use—Part 4: Transfusion sets for single use

Withdrawn and replaced with newer version.

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

Contact person.

6-275

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

Contact person.

6-276

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

Contact person.

G. In Vitro Diagnostics

7-3

CLSI/NCCLS GP10-A 1995, Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operating Characteristic (ROC) Plots; Approved Guideline

Withdrawn, see 7-234.

7-4

CLSI/NCCLS GP14-A 1996, Labeling of Home-Use In Vitro Testing Products; Approved Guideline

Withdrawn.

7-37

NCCLS I/LA6-A, Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Specimen Handling, and Use of Test Products in the Clinical Laboratory; Approved Guideline

Withdrawn.

7-41

NCCLS I/LA19-A, Primary Reference Preparations Used to Standardize Calibration of Immunochemical Assays for Serum Prostate Specific Antigen (PSA); Approved Guideline (1997)

Withdrawn.

7-154

CLSI MM02-A2, Immunoglobulin and T-Cell Receptor Gene Rearrangement Assays

Withdrawn.

7-171

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

Extent of recognition, process affected, and contact person.

7-178

CLSI M22-A3, Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third Edition

Extent of recognition, process affected, and contact person.

7-179

7-240

CLSI M27-S4, Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth Informational Supplement

Withdrawn and replaced with newer version.

7-200

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

Extent of recognition, type of standard, and process affected.

7-206

CLSI I/LA 20-A2 Analytical Performance Characteristics and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies and Defined Allergen Specificities; Approved Guideline—Second Edition

Relevant guidance.

7-215

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

Extent of recognition, process affected, and contact person.

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

Extent of recognition, process affected, and 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

Extent of recognition and process affected.

7-222

CLSI M24-A2, Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes; Approved Standards—Second Edition

Extent of recognition, process affected, contact person, and title and type of standard.

7-228

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

Extent of recognition, process affected, and contact person.

7-229

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

Extent of recognition, process affected, and contact person.

7-230

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

Extent of recognition, process affected, and contact person.

7-231

7-241

CLSI M100-S23, Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Third Informational Supplement

Withdrawn and replaced with newer version.

7-234

CLSI EP24-A2, Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline—Second Edition

Extent of recognition.

H. Materials

8-122

8-335

ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants

Withdrawn and replaced with newer version.

8-147

8-336

ASTM F562-13 Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)

Withdrawn and replaced with newer version.

8-153

ASTM F2119-07 (Reapproved 2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants

Reaffirmation.

8-154

8-337

ASTM F621-12 Standard Specification for Stainless Steel Forgings for Surgical Implants

Withdrawn and replaced with newer version.

8-156

8-338

ASTM F139-12 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)

Withdrawn and replaced with newer version.

8-158

ASTM F1713-08 (Reapproved 2013) Standard Specification for Wrought Titanium-13Niobium-13 Zirconium Alloy for Surgical Implant Applications (UNS R58130)

Reaffirmation.

8-166

8-339

ASTM F1091-12 Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)

Withdrawn and replaced with newer version.

8-203

8-340

ASTM F2026-12 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

Withdrawn and replaced with newer version.

8-219

8-341

ASTM F136-12a Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

Withdrawn and replaced with newer version.

8-222

8-342

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.

8-332

8-343

ASTM F899-12b Standard Specification for Wrought Stainless Steels for Surgical Instruments

Withdrawn and replaced with newer version.

I. OB-GYN/Gastroenterology

9-31

ANSI/AAMI ID54:1996/(R)2012 Enteral feeding set adapters and connectors

Reaffirmation.

9-60

IEC 60601-2-16 Edition 3.0 2008-04 Medical electrical equipment—Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration

Withdrawn, see 9-80.

9-61

IEC 60601-2-18 Edition 3.0 2009-08 Medical electrical equipment—Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

Transition period extended.

9-72

9-81

ANSI/AAMI/IEC 60601-2-16:2012 Medical electrical equipment—Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment

Newer version with transition period.

9-62

IEC 60601-2-2 Edition 5.0 2009-02 Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of frequency surgical equipment and high frequency surgical accessories

Transition period extended.

9-63

IEC 60601-2-16 (Third edition—2008), Medical electrical equipment—Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment CORRIGENDUM 1

Withdrawn, see 9-80.

9-64

ANSI/AAMI/IEC 60601-2-2:2009 Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories

Transition period extended.

9-80

IEC 60601-2-16 Edition 4.0 2012-03 Medical electrical equipment—Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

Transition period extended.

J. Ophthalmic

10-15

10-77

ISO 9394 Third edition 2012-10-01 Ophthalmic optics—Contact lenses and contact lens care products—Determination of biocompatibility by ocular study with rabbit eyes

Withdrawn and replaced with newer version.

10-36

10-78

ISO 11979-3 Third edition 2012-12-01 Ophthalmic implants—Intraocular lenses—Part 3: Mechanical properties and test methods

Withdrawn and replaced with newer version.

10-40

10-79

ISO 11979-1 Third edition 2012-09-15 Ophthalmic implants—Intraocular lenses—Part 1: Vocabulary

Withdrawn and replaced with newer version.

10-45

10-80

ISO 18369-2 Second edition 2012-12-01 Ophthalmic optics—Contact lenses—Part 2: Tolerances

Withdrawn and replaced with newer version.

10-56

ANSI Z80.12-2007 (R2012) American National Standard for Ophthalmics—Multifocal Intraocular Lenses

Reaffirmation.

10-57

ANSI Z80.13-2007 (R2012) American National Standard for Ophthalmics—Phakic Intraocular Lenses

Reaffirmation.

10-76

ISO 11979-8 Second edition 2006-07-01 AMENDMENT 1 2011-05-15 Ophthalmic implants—Intraocular lenses—Part 8: Fundamental requirements

Withdrawn.

K. Orthopedics

11-73

11-252

ISO 5838-1 Third edition 2013-03-01 Implants for surgery—Metallic skeletal pins and wires—Part 1: General requirements

Withdrawn and replaced with a newer version.

11-206

11-253

ASTM F1800-12 Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements

Withdrawn and replaced with a newer version.

11-208

11-254

ISO 14630 Fourth edition 2012-12-01 Non-active surgical implants—General requirements

Withdrawn and replaced with a newer version.

11-213

ASTM F1223-08 (Reapproved 2012) Standard Test Method for Determination of Total Knee Replacement Constraint

Reaffirmation.

11-215

ASTM F897-02 (Reapproved 2013) Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws

Reaffirmation.

11-242

ASTM F1839-08 (Reapproved 2012) Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments

Reaffirmation.

11-246

11-255

ASTM F1717-13 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

Withdrawn and replaced with a newer version.

L. Physical Medicine

16-24

16-190

ISO 7176-11 Second edition 2012-12-01 Wheelchairs—Part 11: Test dummies

Withdrawn and replaced with a newer version.

16-28

16-191

ISO 7176-16 Second edition 2012-12-01 Wheelchairs—Part 16: Resistance to ignition of postural support devices

Withdrawn and replaced with a newer version.

16-50

16-192

ISO 7176-3 Third edition 2012-12-15 Wheelchairs—Part 3: Determination of effectiveness of brakes

Withdrawn and replaced with a newer version.

M. Radiology

12-34

12-201

IEC 60601-2-54 Edition 1.0 2009-06 Medical electrical equipment—Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

Newer version with transition period.

12-54

12-254

IEC 60601-2-8 Edition 2.0 2010-11 Medical electrical equipment—Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV

Newer version with extended transition period.

12-127

12-201

IEC 60601-2-54 Edition 1.0 2009-06 Medical electrical equipment—Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

Newer version with transition period.

12-133

12-255

IEC 60601-2-11 Edition 3.0 2013-01 Medical electrical equipment—Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment

Newer version with transition period.

12-202

IEC 60601-2-43 Edition 2.0 2010-03 Medical electrical equipment—Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

Transition period extended.

12-203

12-256

IEC 60601-2-44 Edition 3.1 2012-09 Medical electrical equipment—Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography

Newer version with extended transition period.

12-204

IEC 60601-2-28 Edition 2.0 2010-03 Medical electrical equipment—Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

Transition period extended.

12-205

IEC 60601-2-5 Edition 3.0 2009-07 Medical electrical equipment—Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment

Transition period extended.

12-206

IEC 60601-2-1 Edition 3.0 2009-10 Medical electrical equipment—Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV

Transition period extended.

12-207

IEC 60601-2-33 Edition 3.0 2010-03 Medical electrical equipment—Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnostic

Transition period extended.

12-208

IEC 60601-2-22 Third Edition 2007-05 Medical electrical equipment—Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

Transition period extended.

12-209

IEC 60601-2-37 Edition 2.0 2007-08 Medical electrical equipment—Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

Transition period extended.

12-210

IEC 60601-1-3 Edition 2.0 2008-01 Medical electrical equipment—Part 1-3: General requirements for basic safety and essential performance—Collateral Standard: Radiation protection in diagnostic X-ray equipment

Transition period extended.

12-211

IEC 60601-2-29 Edition 3.0 2008-06 Medical electrical equipment Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators

Transition period extended.

12-224

IEC 60601-2-44 (Third edition -2009) Medical electrical equipment—Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography CORRIGENDUM 1

Withdrawn, see 12-256.

12-236

IEC 60601-2-45 Edition 3.0 2011-02 Medical electrical equipment—Part 2-45: Particular requirements for the safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices

Transition period extended.

12-250

IEC 60601-2-44 Edition 3.0 2012-08 Amendment 1 Medical electrical equipment—Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography

Withdrawn, see 12-256.

N. Sterility

14-64

14-378

ASTM F1929-12 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration

Withdrawn and replaced with newer version.

14-230

ASTM F2203-02 (Reapproved 2012) Standard Test Method for Linear Measurement Using Precision Steel Rule

Reaffirmation.

14-231

ASTM F2217-02 (Reapproved 2012) Standard Practice for Coating/Adhesive Weight Determination

Reaffirmation.

14-235

ASTM F1140 -07 (Reapproved 2012) Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages

Reaffirmation.

14-236

ASTM F2054-07 (Reapproved 2012) Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates

Reaffirmation.

14-244

14-379

ISO 14644-8 Second edition 2013-02-15 Cleanrooms and associated controlled environments—Part 8: Classification of air cleanliness by chemical concentration (ACC)

Withdrawn and replaced with newer version.

14-264

ANSI/AAMI ST8:2008 Hospital steam sterilizers

Contact person.

14-275

ANSI/AAMI ST41:2008/(R)2012 Ethylene oxide sterilization in health care facilities: Safety and effectiveness

Reaffirmation.

14-281

14-380

ASTM F17-12 Standard Terminology Relating to Flexible Barrier Packaging

Withdrawn and replaced with newer version.

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

Relevant guidance.

14-311

ANSI/AAMI ST55:2010 Table-top steam sterilizers

Contact person

14-312

14-394

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities

Withdrawn and replaced with newer version.

14-341

ASTM E2303-11

€1

Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities

Editorial change.

14-345

14-381

ISO/ASTM 51261 Second edition 2013-04-15 Practice for calibration of routine dosimetry systems for radiation processing

Withdrawn and replaced with newer version.

14-346

14-382

ISO/ASTM 51276 Third edition 2012-07-15 Practice for use of a polymethylmethacrylate dosimetry system

Withdrawn and replaced with newer version.

14-347

14-383

ISO/ASTM 51702 Third edition 2013-04-15 Practice for dosimetry in a gamma facility for radiation processing

Withdrawn and replaced with newer version.

14-349

ANSI/AAMI/ISO 13408-3:2006/(R)2012 Aseptic processing of health care products—Part 3: Lyophilization

Reaffirmation.

14-350

ANSI/AAMI/ISO 13408-4:2005/(R)2012 Aseptic processing of health care products—Part 4: Clean-in-place technologies

Reaffirmation.

14-351

ANSI/AAMI/ISO 13408-5:2006/(R)2012 Aseptic processing of health care products—Part 5: Sterilization in place

Reaffirmation.

O. Tissue Engineering

15-5

15-37

ASTM F2347—11 Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications

Withdrawn and replaced with newer version.

15-14

ASTM F2603 −06 (Reapproved 2012) Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds

Reaffirmation.

15-29

ASTM F2259 −10 (Reapproved 2012)

€1

Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (

1

H NMR) Spectroscopy

Reaffirmation.

15-32

ASTM F2260 −03 (Reapproved 2012)

€1

Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (

1

H NMR) Spectroscopy

Reaffirmation.

1

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

III. Listing of New Entries

In table 2, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 031.

Table 2—New Entries to the List of Recognized Standards

Recognition No.

Title of standard

1

Reference No. and Date

A. Anesthesia

1-90

Oxygen concentrators for medical use—Safety requirements

ISO 8359 Second edition 1996-12-15 Amendment 1 2012-07-01

1-92

Sleep apnoea breathing therapy—Part 2: Masks and application accessories

ISO 17510-2 Second edition 2007-10-01

B. Dental/ENT

4-205

Dentistry—Handpieces and motors

ISO 14457 First edition 2012-09-15

C. General

5-75

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 2012

D. In Vitro Diagnostics

7-242

Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline

CLSI C56-A

7-243

Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline

CLSI M51-A

E. Neurology

17-11

Medical electrical equipment—Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

IEC 60601-2-10 Edition 2.0 2012-06

F. Radiology

12-251

Medical electrical equipment—Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment

IEC 60601-2-63 Edition 1.0 2012-09

12-252

Medical electrical equipment—Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment

IEC 60601-2-65 Edition 1.0 2012-09

12-253

Medical electrical equipment—Medical electron accelerators—Functional performance characteristics

IEC 60976 Edition 2.0 2007-10

G. Software/Informatics

13-37

Laboratory Automation: Data Content for Specimen Identification; Approved Standard

NCCLS AUTO7-A

H. Sterility

14-384

Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals

ISO 10993-7:2008 TECHNICAL CORRIGENDUM 1 Published 2009-11-15

14-385

Aseptic processing of health care products—Part 1: General requirements

ANSI/AAMI/ISO 13408-1:2008/(R2011)

14-386

Aseptic processing of health care products—Part 1: General requirements

ISO 13408-1 Second edition 2008-06-15

14-387

Aseptic processing of health care products—Part 7: Alternate processes for medical devices and combination products

ANSI/AAMI/ISO 13408-7:2012

14-388

Aseptic processing of health care products—Part 7: Alternate processes for medical devices and combination products

ISO 13408-7 First edition 2012-08-01

14-389

Cleanrooms and associated controlled environments—Part 9: Classification of surface cleanliness by particle concentration

ISO 14644-9 First edition 2012-08-15

14-390

Cleanrooms and associated controlled environments—Part 10: Classification of surface cleanliness by chemical concentration

ISO 14644-10 First edition 2013-03-01

14-391

Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing

ISO/ASTM 51608 Second edition 2005-05-15

14-392

Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV

ISO/ASTM 51649 Second edition 2005-05-15

14-393

Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV

ISO/ASTM 51818 Second edition 2009-06-15

I. Tissue Engineering

15-38

Standard Guide for Characterization of Ceramic and Mineral Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant Applications

ATSM F2883—11

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 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 revisions to the list of

recognized consensus standards, as needed, in the

Federal Register

once a year, or more often, if necessary. Beginning with Recognition List Number: 033, FDA will no longer be announcing minor revisions to the list of recognized consensus standards such as technical contact person, relevant guidance, processes affected, CFR citations, and product codes.

V. Recommendation of Standards for Recognition by FDA

Any person may recommend consensus standards as candidates for recognition under 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. The Center for Devices and Radiological Health (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: 031” 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 only necessary to send one set of 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: 031. These modifications to the list of recognized standards are effective upon publication of this notice in the

Federal Register

.

Dated: July 31, 2013.

Leslie Kux,

Assistant Commissioner for Policy.

[FR Doc. 2013-19019 Filed 8-5-13; 8:45 am]

BILLING CODE 4160-01-P