Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 026

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: 026

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: 026” (Recognition List Number: 026), 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: 026” 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 e-mail:

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: 026 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, 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 as follows:

Table 1—Previous Publications 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).

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: 026

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: 026” to identify these current modifications.

In table 2 of this document, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others, (2) the correction of errors made by FDA in listing previously recognized standards, and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards.

In section III of this document, FDA lists modifications the Agency is making that involve the initial addition of standards not previously recognized by FDA.

Table 2—Modifications to the List of Recognized Standards

Old

recognition

No.

Replacement recognition

No.

Title of standard

1

Change

A. Anesthesia

1-56

CGA V-7.1 1997 (R2003) (2008) Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases—First Edition

Reaffirmation.

B. Biocompatibility

2-96

2-162

ASTM F1903-10 Standard Practice for Testing For Biological Responses to Particles In Vitro

Withdrawn and replaced with newer version.

2-117

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

Extent of recognition.

C. Cardiovascular

3-54

ANSI/AAMI/ISO 7198:1998/2001/(R)2010 Cardiovascular implants—Tubular vascular prostheses

Reaffirmation.

3-58

ANSI/AAMI/ISO 5840:2005/(R)2010 Cardiovascular implants—Cardiac valve prostheses

Reaffirmation.

3-66

ASTM F 2081-06 Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

Device affected, Processes impacted, Type of standard, CFR citation and product codes, and Contact person.

D. Dental/ENT

4-89

ADA Specification No. 53 Polymer-Based Crowns and Bridge Resins

Reaffirmation.

4-111

ADA Specification No. 13 Denture Cold-Curing Repair Resins: 1981 (Reaffirmed 2006)

Withdrawn.

4-112

ADA Specification No. 16 Dental Impression Paste—Zinc Oxide Eugenol Type

Withdrawn.

4-124

4-191

ANSI/ASA S3.22-2009 American National Standard Specification of Hearing Aid Characteristics

Withdrawn and replaced with newer version.

4-127

4-192

ADA Specification 58 Root Canal Files, Type H (Hedstrom) 2007

Withdrawn and replaced with newer version.

4-138

4-193

ADA Specification No. 15 Artificial Teeth for Dental Prostheses

Withdrawn and replaced with newer version.

4-148

4-194

ADA Specification No. 78 Dental Obturating Cones

Withdrawn and replaced with newer version.

4-158

ISO 10139-1:2005 Dentistry—Soft lining materials for removable dentures—Part 1: Materials for short-term use Technical Corrigendum 1:2006

Withdrawn duplicate.

See

4-189.

E. General Hospital/General Plastic Surgery

6-144

6-243

ASTM D5712-10 Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method

Withdrawn and replaced with a newer version.

6-145

ASTM D3578-05 Standard Specification for Rubber Examination Gloves

Reaffirmation.

6-149

ASTM D7160-05 (Reapproved 2010) Standard Practice for Determination of Expiration Dating for Medical Gloves

Reaffirmation.

6-150

ASTM D7161-05 (Reapproved 2010) Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions

Reaffirmation.

6-165

ASTM D6977-04 (Reapproved 2010) Standard Specification for Polychloroprene Examination Gloves for Medical Application

Reaffirmation.

6-167

6-244

ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application

Withdrawn and replaced with newer version.

6-169

ASTM D3772-01 (Reapproved 2010) Standard Specification for Natural Rubber Finger Cots

Reaffirmation.

6-201

6-245

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

Withdrawn and replaced with newer version.

6-218

6-246

USP 33-NF 28 2010 <11> Nonabsorbable Surgical Suture

Withdrawn and replaced with newer version.

6-220

6-247

USP 33-NF 28 2010 Absorbable Surgical Suture

Withdrawn and replaced with newer version.

6-221

6-248

USP 33-NF 28 2010 <881> Tensile Strength

Withdrawn and replaced with newer version.

6-222

6-249

USP 33-NF 28 2010 <861> Suture-Diameter

Withdrawn and replaced with newer version.

6-223

6-250

USP 33-NF 28 2010 <871> Sutures—Needle Attachment

Withdrawn and replaced with newer version.

6-224

6-251

USP 33 NF-28 2010 <11> Sterile Water for Irrigation

Withdrawn and replaced with newer version.

6-225

6-252

USP 33 NF-28 2010 <11> Heparin Lock Flush Solution

Withdrawn and replaced with newer version.

F. IVD

7-183

CLSI M38-A2 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi

Withdrawn duplicate.

See

7-171.

7-188

7-218

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

Withdrawn and replaced with newer version.

G. Materials

8-10

ASTM F603-00 Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant Application

Withdrawn.

8-88

8-195

ASTM F2024-10 Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings

Withdrawn and replaced with newer version.

8-101

ASTM F 2118—03 (Reapproved 2009) Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials

Reaffirmation.

8-103

ASTM F1801—97 (Reapproved 2009)

ε

1

Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials

Reaffirmation.

8-107

ASTM F746—04 (Reapproved 2009)

ε

1

Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials

Reaffirmation.

8-117

ASTM F86—04 (Reapproved 2009) Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants

Reaffirmation.

H. OB-GYN/Gastroenterology

9-47

AAMI RD16 Cardiovascular implants and artificial organs—Hemodialyzers, hemodiafilters

Withdrawn.

See

9-65.

9-48

AAMI RD17 Cardiovascular implants and artificial organs—Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofilters

Withdrawn.

See

9-66.

9-50

ANSI/AAMI RD52:2004/(R)2010 and ANSI/AAMI RD52:2004/A1:2007/(R)2010, A2:2007/(R)2010, A3:2009, & A4:2009 (Consolidated Text) Dialysate for haemodialysis

Reaffirmation.

9-51

9-65

ANSI/AAMI/ISO 8637:2010 Cardiovascular implants and extracorporeal systems—Hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators

Withdrawn and replaced with newer version.

9-52

9-66

ANSI/AAMI/ISO 8638:2010 Cardiovascular implants and extracorporeal systems—Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters

Withdrawn and replaced with newer version.

9-55

ANSI/AAMI RD62:2006 and ANSI/AAMI RD62:2006/A1:2009 Water treatment equipment for haemodialysis applications

Reaffirmation.

I. Orthopedics

11-168

ASTM F 1781-03 (Reapproved 2009) Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants

Reaffirmation.

11-183

ASTM F1875-98 (Reapproved 2009) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface

Reaffirmation.

J. Physical Medicine

16-30

16-167

ISO 7176-9: Third edition, 2009-11-15 Wheelchairs—Part 9: Climatic tests for electric wheelchairs

Withdrawn and replaced with newer version.

16-31

16-168

RESNA WC-1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1: Determination of static stability

Withdrawn and replaced with newer version.

16-32

16-169

RESNA WC-2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 2: Determination of dynamic stability of electrically powered wheelchairs

Withdrawn and replaced with newer version.

16-33

16-170

RESNA WC-2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 3: Determination of effectiveness of brakes

Withdrawn and replaced with newer version.

16-34

16-171

RESNA WC-2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 4: Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical distance range

Withdrawn and replaced with newer version.

16-35

16-172

RESNA WC-1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 5: Determination of dimensions, mass and maneuvering space

Withdrawn and replaced with newer version.

16-36

16-173

RESNA WC-2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 6: Determination of maximum speed, acceleration and deceleration of electrically powered wheelchairs

Withdrawn and replaced with newer version.

16-37

16-174

RESNA WC-1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 7: Method of Measurement of Seating and Wheel Dimensions

Withdrawn and replaced with newer version.

16-38

16-175

RESNA WC-1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and test methods for static, impact and fatigue strengths

Withdrawn and replaced with newer version.

16-39

16-176

RESNA WC-2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 9: Climatic tests for electrically powered wheelchairs

Withdrawn and replaced with newer version.

16-40

16-177

RESNA WC-2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 10: Determination of obstacle-climbing ability of electrically powered wheelchairs

Withdrawn and replaced with newer version.

16-41

16-178

RESNA WC-1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test dummies

Withdrawn and replaced with newer version.

16-42

16-179

RESNA WC-1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 13: Determination of coefficient of friction of test surfaces

Withdrawn and replaced with newer version.

16-43

16-180

RESNA WC-2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 14: Power and control systems for electrically powered wheelchairs—Requirements and test methods

Withdrawn and replaced with newer version.

16-44

16-181

RESNA WC-1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for information disclosure, documentation and labeling

Withdrawn and replaced with newer version.

16-45

16-182

RESNA WC-1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to ignition of upholstered parts—Requirements and test methods

Withdrawn and replaced with newer version.

16-46

16-183

RESNA WC-1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 20: Determination of the performance of stand-up type wheelchairs

Withdrawn and replaced with newer version.

16-47

16-184

RESNA WC-1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 22: Set-up procedures

Withdrawn and replaced with newer version.

16-48

ANSI/RESNA WC/Volume 1-1998, Section 93: Maximum Overall Dimensions

Withdrawn.

16-49

ANSI/RESNA WC/Volume 1-1998, Section 0: Nomenclature, Terms, and Definitions

Withdrawn.

16-160

16-185

RESNA WC-2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters

Withdrawn and replaced with newer version.

16-161

16-186

ASME A18.1-2008 (Revision of ASME A18.1-2005) Safety Standard for Platform Lifts and Stairway Chairlifts

Withdrawn and replaced with newer version.

K. Radiology

12-122

12-217

IEC 62083 Edition 2.0:2009-09 Medical electrical equipment—Requirements for the safety of radiotherapy treatment planning systems

Withdrawn and replaced with newer version.

12-36

IEC 60601-2-9 (1996-10) Medical electrical equipment—Part 2: Particular requirements for the safety of patient contact dosimeters used in radiotherapy with electrically connected radiation detectors—Ed. 2.0.

Withdrawn.

12-183

12-218

NEMA PS 3.1—3.18 (2009) Digital Imaging and Communications in Medicine (DICOM) Set

Withdrawn and replaced with newer version.

L. Software/Informatics

13-4

UL 1998 Standard for Safety Software in Programmable Components, Second Edition

Reaffirmation.

M. Sterility

14-265

14-301

USP 33:2010 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests

Withdrawn and replaced with newer version.

14-266

14-302

USP 33: 2010 <71> Sterility Tests

Withdrawn and replaced with newer version.

14-267

14-303

USP 33:2010 <85> Bacterial Endotoxins Test

Withdrawn and replaced with newer version.

14-268

14-304

USP 33:2010 <151> Pyrogen Test

Withdrawn and replaced with newer version.

14-269

14-305

USP 33:2010 <161> Transfusion and Infusion Assemblies and Similar Medical Devices

Withdrawn and replaced with newer version.

14-270

14-306

USP 33:2010 Biological Indicators for Steam Sterilization, Self-Contained

Withdrawn and replaced with newer version.

14-271

14-307

USP 33:2010 Biological Indicator for Dry-Heat Sterilization, Paper Carrier

Withdrawn and replaced with newer version.

14-272

14-308

USP 33:2010 Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier

Withdrawn and replaced with newer version.

14-273

14-309

USP 33:2010 Biological Indicator for Steam Sterilization, Paper Carrier

Withdrawn and replaced with newer version.

14-278

14-310

USP 33:2010 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms

Withdrawn and replaced with newer version.

1

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

III. Listing of New Entries

In table 3 of this document, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 026.

Table 3—New Entries to the List of Recognized Standards

Recognition No.

Title of standard

1

Reference No. and date

A. Anesthesia

1-84

Anaesthetic and respiratory equipment—Tracheostomy tubes—Part 3: Paediatric tracheostomy tubes TECHNICAL CORRIGENDUM 1

ISO 5366-3:2001 TECHNICAL CORRIGENDUM 1.

B. Biocompatibility

2-163

Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products

ANSI/AAMI/ISO 10993-9:2009.

2-164

Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices

ANSI/AAMI/ISO 10993-13:2010.

2-165

Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramics

ANSI/AAMI/ISO 10993-14:2001.

2-166

Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables

ANSI/AAMI/ISO 10993-16:2010.

2-167

Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials

ISO/TS 10993-19 First edition 2006-06-01.

2-168

Biological evaluation of medical devices— Part 9: Framework for identification and quantification of potential degradation products

ISO 10993-9 Second edition 2009-12-15.

2-169

Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices

ISO 10993-13 First edition 1998-11-15.

2-170

Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramics

ISO 10993-14 First edition 2001-11-15.

2-171

Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables

ISO 10993-16 Second edition 2010-02-15.

2-172

Biological evaluation of medical devices—Part 19: Physico-chemical, morphological, and topographical characterization of materials

ANSI/AAMI/ISO TIR10993-19:2006.

C. Cardiovascular

3-83

Implants for surgery—Active implantable medical devices—Part 5: Circulatory support devices

ANSI/AAMI/ISO 14708-5:2010.

3-84

Cardiovascular implants—Endovascular devices—Part 1: Endovascular prostheses Amendment 1: Test methods

ANSI/AAMI/ISO 25539-1:2003/A1:2005/(R)2009.

3-85

Cardiovascular implants—Endovascular devices—Part 2: Vascular stents

ANSI/AAMI/ISO 25539-2:2008.

3-86

Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System

ASTM F 2394-07.

3-87

Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents

ASTM F 2477-07.

3-88

Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading

ASTM F 2514-08.

3-89

Active implantable medical devices—Four-pole connector system for implantable cardiac rhythm management devices—Dimensional and test requirements

ISO 27186 First edition 2010-03-15.

3-90

Cardiovascular implants—Tubular vascular prostheses

ISO 7198 First edition 1998-08-01.

3-91

Cardiovascular implants—Cardiac valve prostheses

ISO 5840 Fourth edition 2005-03-01.

3-92

Implants for surgery—Active implantable medical devices—Part 5: Circulatory support devices

ISO 14708-5 First edition 2010-02-01.

3-93

Cardiovascular implants—Endovascular device—Part 1: Endovascular prostheses AMENDMENT 1: Test methods

ISO 25539-1 First edition 2001-11-13 AMENDMENT 1 2005-07-15.

3-94

Cardiovascular implants—Endovascular devices—Part 2: Vascular stents

ISO 25539-2 First edition 2008-09-01.

D. General

5-63

Small-bore connectors for liquids and gases in healthcare applications—Part 1: General requirements

ISO 80369-1 First edition 2010-12-15.

5-64

Small bore connectors for liquids and gases in healthcare applications—Part 1: General requirements

AAMI/ISO/FDS-1 80369-01 2010.

E. Materials

8-196

Implants for surgery—Metallic materials—Part 1: Wrought stainless steel TECHNICAL CORRIGENDUM 1

ISO 5832-1:2007 TECHNICAL CORRIGENDUM 1 2008-04-15.

8-197

Implants for surgery—Metallic materials—Part 12: Wrought cobalt-chromium-molybdenum alloy TECHNICAL CORRIGENDUM 1

ISO 5832-12:2007 TECHNICAL CORRIGENDUM 1 2008-09-15.

8-198

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

ASTM F 2102-06

ε

1

.

8-199

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

ASTM F 2633-07.

8-200

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

ASTM F 2003-02 (Reapproved 2008).

8-201

Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)

ASTM F 2214-02 (Reapproved 2008).

8-202

Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants

ASTM F 2183-02 (Reapproved 2008).

F. Nanotechnology

18-1

Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS)

ASTM E 2490-09.

G. Ophthalmic

10-62

Ophthalmics—Ophthalmic Instruments—Tonometers

ANSI Z80.10-2009.

10-63

Ophthalmic implants—Intraocular lenses—Guidance on assessment of the need for clinical investigation of intraocular lens design modifications

ISO/TR 22979-2006.

H. Radiology

12-219

Medical electrical equipment—X-ray tube assemblies for medical diagnosis—Characteristics of focal spots CORRIGENDUM 1

IEC 60336 (Fourth edition—2005).

12-220

Safety of laser products—Part 1: Equipment classification and requirements CORRIGENDUM 1

IEC 60825-1 (Second edition—2007).

12-221

Evaluation and routine testing in medical imaging departments—Part 3-4: Acceptance tests—Imaging performance of dental X-ray equipment

IEC 61223-3-4 First edition 2000-03.

12-222

Evaluation and routine testing in medical imaging departments—Part 3-5: Acceptance tests—Imaging performance of computed tomography X-ray equipment

IEC 61223-3-5 First edition 2004-08.

12-223

Evaluation and routine testing in medical imaging departments—Part 3-5: Acceptance tests—Imaging performance of computed tomography X-ray equipment CORRIGENDUM 1

IEC 61223-3-5 (First edition 2004).

12-224

Medical electrical equipment—Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography CORRIGENDUM 1

IEC 60601-2-44 (Third edition—2009).

12-225

Computed Tomography Dose Check

NEMA XR 25 2010.

12-226

Evaluation and routine testing in medical imaging departments—Part 2-6: Constancy tests—Imaging performance of computed tomography X-ray equipment

IEC 61223-2-6 Second edition 2006-11.

I. Tissue Engineering

15-25

ASTM F2312—10 Standard Terminology Relating to Tissue Engineered Medical Products

ASTM F2312-10.

15-26

ASTM F2211—04 Standard Classification for Tissue Engineered Medical Products (TEMPs)

ASTM F2211-04.

1

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

IV. List of Recognized Standards

FDA maintains the Agency's current list of FDA recognized consensus standards in a searchable database that may be accessed directly at FDA's Internet site at

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.

FDA will incorporate the modifications and minor revisions described in this notice into the database and, upon publication in the

Federal Register

, this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the

Federal Register

once a year, or more often, if necessary.

V. Recommendation of Standards for Recognition by FDA

Any person may recommend consensus standards as candidates for recognition under the new provision of section 514 of the 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: 026” 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. 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: 026. These modifications to the list or recognized standards are effective upon publication of this notice in the

Federal Register.

Dated: March 8, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.

[FR Doc. 2011-5815 Filed 3-11-11; 8:45 am]

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