Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 034

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: 034

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: 034” (Recognition List Number: 034), 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: 034” 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: 034 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.

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: 034

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: 034” to identify these current modifications.

In table 1 of this document, 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 of this document, 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

1-15

ISO 5361-4:1987, Tracheal tubes—Part 4: Cole type

Withdrawn. See 1-93.

1-18

1-94

ISO 8359 Second edition 1996-12-15, Oxygen concentrators for medical use—Safety requirements [Including: AMENDMENT 1 2012-07-01]

Withdrawn and replaced with newer version including amendment.

1-36

1-95

ISO 5366-3 Second edition 2001-08-15, Anaesthetic and respiratory equipment—Tracheostomy tubes—Part 3: Pediatric tracheostomy tubes [Including: TECHNICAL CORRIGENDUM 1 Published 2003-01-15]

Withdrawn and replaced with newer version including technical corrigendum.

1-44

ISO 5366-1 Fourth edition 2000-12-15, Anaesthetic and respiratory equipment—Tracheostomy tubes—Part 1: Tubes and connectors for use in adults

Extent of recognition.

1-46

ISO 5367 Fourth edition 2000-06-01 Breathing tubes intended for use with anaesthetic apparatus and ventilators

Extent of recognition.

1-47

AS 4259-1995 Ancillary devices for expired air resuscitation

Extent of recognition.

1-56

1-97

CGA V-7.1:2011 Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases

Withdrawn and replaced with newer version.

1-57

ASTM F1101-90 (Reapproved 2003)

ε1

, Standard Specification for Ventilators Intended for Use During Anesthesia

Extent of recognition.

1-58

ASTM G175-03 (Reapproved 2011), Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications

Extent of recognition.

1-65

ISO 21647:2004 Medical electrical equipment—Particular requirements for the basic safety and essential performance of respiratory gas monitors

Withdrawn. See 1-96.

1-69

ASTM F1464-93 (Reapproved 2005) Standard Specification for Oxygen Concentrators for Domiciliary Use

Extent of recognition.

1-70

ASTM F1246-91 (Reapproved 2005) Standard Specification for Electrically Powered Home Care Ventilators, Part 1—Positive-Pressure Ventilators and Ventilator Circuits

Extent of recognition.

1-78

ASME PVHO-1-2007 Safety Standard for Pressure Vessels for Human Occupancy

Extent of recognition.

1-81

CGA V-5:2008 (Reaffirmed 2013), Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications)

Reaffirmation.

1-83

ISO 21647:2004 TECHNICAL CORRIGENDUM 1, Medical electrical equipment—Particular requirements for the basic safety and essential performance of respiratory gas monitors

Withdrawn. See 1-96.

1-84

ISO 5366-3:2001 Anaesthetic and Respiratory Equipment—Tracheostomy Tubes—Part 3: Pediatric Tracheostomy Tubes TECHNICAL CORRIGENDUM 1

Withdrawn. See 1-95.

1-86

ISO 8185 Third edition 2007-07-01 Corrected versions 2008-06-15 Respiratory tract humidifiers for medical use—Particular requirements for respiratory humidification systems

Extent of recognition.

1-88

1-98

ISO 80601-2-12 First edition 2011-04-15 Medical electrical equipment—Part 2-12: Particular requirements for the safety of lung ventilators—Critical care ventilators [Including: TECHNICAL CORRIGENDUM 1 Published 2011-10-15]

Withdrawn and replaced with newer version including technical corrigendum.

1-89

ISO 80601-2-12 TECHNICAL CORRIGENDUM 1 Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

Withdrawn. See 1-98.

1-90

ISO 8359 Second edition 1996-12-15 AMENDMENT 1 2012-07-01 Oxygen concentrators for medical use—Safety requirements

Withdrawn. See 1-94.

1-92

ISO 17510-2 Second Edition 2007-10-01, Sleep apnoea breathing therapy—Part 2: Masks and application accessories

Extent of recognition.

1-93

ISO 5361

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

Extent of recognition.

B. Biocompatibility

2-123

2-204

ASTM F720-13 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test

Withdrawn and replaced with newer version.

2-182

2-205

ISO 14155 Second edition 2011-02-01 Clinical investigations of medical devices for human subjects—Good clinical practices [Including TECHNICAL CORRIGENDUM 1:2011]

Withdrawn and replaced with newer version including technical corrigendum.

2-183

ISO 14155:2011 and TECHNICAL CORRIGENDUM 1 Published 2011-07-15 Clinical investigation of medical devices for human subjects—Good clinical practice

Withdrawn. See 2-205.

2-93

ASTM F763-04 (Reapproved 2010), Standard Practice for Short-Term Screening of Implant Materials

Extent of recognition.

2-94

ASTM F981-04 (Reapproved 2010) Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone

Extent of recognition.

2-114

ASTM F1877-05 (Reapproved 2010) Standard Practice for Characterization of Particles

Extent of recognition.

2-118

ANSI/AAMI/ISO 10993-11:2006/(R) 2010 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity

Extent of recognition.

2-120

ANSI/AAMI/ISO 10993-6:2007/(R) 2010 Biological evaluation of medical devices—Part 06: Tests for local effects after implantation

Extent of recognition.

2-126

ASTM F748-06 (Reapproved 2010) Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

Extent of recognition.

2-133

ASTM F1408-97 (Reapproved 2008) Standard Practice for Subcutaneous Screening Test for Implant Materials

Extent of recognition.

2-134

ASTM F2065-00 (Reapproved 2010) Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials

Extent of recognition.

2-136

ASTM E1262-88 (Reapproved 2008) Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay

Extent of recognition.

2-137

ASTM E1263-97 (Reapproved 2008) Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes

Withdrawn.

2-138

ASTM E1280-97 (Reapproved 2008) Standard Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell Mutagenicity

Withdrawn.

2-139

ASTM E1397-91 (Reapproved 2008) Standard Practice for the In Vitro Rat Hepatocyte DNA Repair Assay

Withdrawn.

2-140

ASTM E1398-91 (Reapproved 2008) Standard Practice for the In Vivo Rat Hepatocyte DNA Repair Assay

Withdrawn.

2-141

ASTM F1984-99 (Reapproved 2008) Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials

Extent of recognition.

2-142

ASTM F1983-99 (Reapproved 2008) Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Application

Extent of recognition.

2-143

ASTM F1904-98 (Reapproved 2008) Standard Practice for Testing the Biological Responses to Particles in vivo

Extent of recognition.

2-144

ASTMF619-03 (Reapproved 2008) Standard Practice for Extraction of Medical Plastics

Extent of recognition.

2-145

ASTM F1439-03 (Reapproved 2008) Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials

Extent of recognition.

2-153

ANSI/AAMI/ISO 10993-5:2009, Biological evaluation of medical devices—Part 5: Tests for In Vitro cytotoxicity

Extent of recognition.

2-154

ASTM F756-08 Standard Practice for Assessment of Hemolytic Properties of Materials

Extent of recognition.

2-155

ASTM F2147-01 (Reapproved 2010) Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens

Extent of recognition.

2-156

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

Extent of recognition.

2-162

ASTM F1903-10 Standard Practice for Testing for Biological Responses to Particles in vitro

Extent of recognition.

2-163

ANSI/AAMI/ISO 10993-9:2009 Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products

Extent of recognition.

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

Extent of recognition.

2-167

ISO/TS 10993-19 First edition 2006-06-01 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological, and topographical characterization of materials

Extent of recognition.

2-168

ISO 10993-9 Second edition 2009-12-15 Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products

Extent of recognition.

2-169

ISO 10993-13 Second edition 2010-06-15 Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices

Extent of recognition.

2-170

ISO 10993-14 First edition 2001-11-15 Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramics

Extent of recognition.

2-171

ISO 10993-16 Second edition 2010-02-15 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables

Extent of recognition.

2-172

ANSI/AAMI/ISO TIR 10993-19:2006 Biological evaluation of medical devices—Part 19: Physicochemical, morphological, and topographical characterization of materials

Extent of recognition.

2-173

ANSI/AAMI/ISO 10993-10:2010 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization

Extent of recognition.

2-174

ISO 10993-10:2010 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization

Extent of recognition.

2-175

ISO 10993-3 Second edition 2003-10-15 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

Extent of recognition.

2-176

ISO 10993-11 Second edition 2006-08-15 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity

Extent of recognition.

2-177

ISO 10993-06 Second edition 2007-04-15 Biological evaluation of medical devices—Part 6: Tests for local effects after implantation

Extent of recognition.

2-179

ISO 10993-1 Fourth edition 2009-10-15 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process

Extent of recognition.

2-181

ANSI/AAMI/ISO 14155:2011, Clinical investigation of medical devices for human subjects—Good clinical practice

Extent of recognition.

2-189

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

Extent of recognition.

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

Extent of recognition.

2-191

ISO 10993-12 Fourth edition 2012-07-01, Biological evaluation of medical devices—Part 12: Sample preparation and reference materials

Extent of recognition.

C. Cardiovascular

3-41

ANSI/AAMI EC11:1991/(R)2007 Diagnostic electrocardiographic devices

Withdrawn. See 3-106.

3-52

ANSI/AAMIEC12:2000/(R)2010 Disposable ECG electrodes

Extent of recognition.

3-54

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

Extent of recognition.

3-58

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

Extent of recognition.

3-63

ISO 11318 Second edition 2002-08-01 Cardiac Defibrillators—Connector assembly DF-1 for implantable defibrillators—Dimensions and test requirements

Extent of recognition.

3-72

ANSI/AAMI EC53:1995/(R) 2008 ECG cables and leadwires

Extent of recognition.

3-73

3-118

ANSI/AAMI EC57:2012 Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms

Withdrawn and replaced with newer version.

3-75

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

Withdrawn. See 3-80, 3-122 and 3-123.

3-76

ASTM F2129-08 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices

Extent of recognition.

3-78

ANSI/AAMI/IEC 80601-2-30:2009 Medical electrical equipment—Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers

Extent of recognition.

3-80

ANSI/AAMI/ISO 81060-1:2007/(R) 2013 Non-invasive sphygmomanometers—Part 1: Requirements and test methods for non-automated measurement type

Reaffirmation.

3-83

ANSI/AAMI/ISO 14708-5:2010 Implants for surgery—Active implantable medical devices—Part 5: Circulatory support devices

Extent of recognition.

3-85

3-120

ANSI/AAMI/ISO 25539-2:2012 Cardiovascular implants—Endovascular devices—Part 2: Vascular stents

Withdrawn and replaced with newer version.

3-88

ASTM F2514-08 Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial

Extent of recognition.

3-90

ISO 7198 First edition 1998-08-01 Cardiovascular implants—Tubular vascular prostheses

Extent of recognition.

3-93

ISO 25539-1:2003 First edition 2001-11-13 AMENDMENT 1 2005-07-15 Cardiovascular implants—Endovascular devices—Part 1: Endovascular prostheses Amendment 1: Test methods

Withdrawn. See 3-121.

3-97

3-122

ISO 81060-2 Second edition 2013-05-01 Non-invasive sphygmomanometers—Part 2: Clinical validation of automated measurement type

Withdrawn and replace with newer version.

3-98

ISO 81060-2:2009 TECHNICAL CORRIGENDUM Published 2011-02-15 Non-invasive sphygmomanometers—Part 2: Clinical validation of automated measurement type

Withdrawn. See 3-122.

3-100

ANSI/AAMI/IEC 60601-2-27:2011 Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

Withdrawn. See 3-101.

3-107

3-123

IEC 80601-2-30 Edition 1.1 2013-07 Medical electrical equipment—Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

Withdrawn and replaced with newer version.

3-108

IEC 80601-2-30 (First edition 2009) Medical electrical equipment—Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers CORRIGENDUM 1

Withdrawn. See 3-123.

3-113

3-124

ISO 7199 Second edition 2009-04-15 Cardiovascular implants and artificial organs—Blood-gas exchangers (oxygenators) [Including: AMENDMENT 1 (2012)]

Withdrawn and replaced with newer version including amendment.

3-114

3-119

ISO 5841-3 Third edition 2013-40-15 Implants for surgery—Cardiac pacemakers—Part 3: Low-profile connectors (IS-1) for implantable pacemakers

Withdrawn and replace with newer version.

D. Dental/ENT

4-50

ADA Specification No.18:1992 Alginate Impression Materials

Extent of recognition.

4-62

ISO 1563 Second edition 1990-09-01 Dental alginate impression material

Withdrawn.

4-63

ISO 1564 Second edition 1995-11-01 Dental aqueous impression materials based on agar

Withdrawn.

4-86

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

Extent of recognition.

4-89

ANSI/ADA Specification No. 53: 1999 (Reaffirmed 2008) Polymer-Based Crowns and Bridge Materials

Extent of recognition.

4-91

ANSI/ADA Specification No. 80/ISO 7491:2000 (Reaffirmed 2013) Dental Materials—Determination of Color Stability

Reaffirmation and extent of recognition.

4-92

ANSI/ADA Specification No. 88:2000 (Reaffirmed 2010) Dental Brazing Alloys

Reaffirmation and extent of recognition.

4-96

ANSI/ADA Specification No. 30:2000 (Reaffirmed 2012) Dental Zinc Oxide-Eugenol and Zinc Oxide Non-Eugenol Cements

Reaffirmation and extent of recognition.

4-97

ANSI/ADA Specification No. 57: (Reaffirmed 2012) Endodontic Sealing Materials

Extent of recognition.

4-105

ANSI/ADA Specification No. 75:1997 (Reapproved 2003) Resilient Lining Materials for Removable Dentures—Part 1: Short-Term Materials

Extent of recognition.

4-109

ISO 13716 First edition 1999-05-01 Dentistry—reversible-irreversible hydrocolloid impression material system

Withdrawn.

4-126

ISO 10477 Second edition 2004-10-01 Dentistry—Polymer-based crown and bridge materials

Extent of recognition.

4-130

ADA Specification No. 17:1983 (Reaffirmed 2006) Denture Base Temporary Relining Resins

Extent of recognition.

4-134

4-207

ISO 7494-1 Second edition 2011-08-15 Dentistry—Dental units—Part 1: General requirements and test methods

Withdrawn and replaced with newer version.

4-135

4-213

ISO 10139-1 Second edition 2005-02-15 Dentistry—Soft lining materials for removable dentures—Part 1: Materials for short-term use [Including: TECHNICAL CORRIGENDUM 1 (2006)]

Withdrawn and replaced with newer version including technical corrigendum.

4-137

ISO 6877 Second edition 2006-04-01 Dentistry—Root-canal obturating points

Extent of recognition.

4-139

ANSI/ADA Specification No. 48 (Reaffirmed 2009) Visible Light Curing Units

Reaffirmation and extent of recognition.

4-143

4-208

ANSI/ADA Specification No. 96:2012 Dental-Water-Based Cements

Withdrawn and replaced with newer version.

4-144

4-209

ISO 24234 First edition 2004-10-15 Dentistry—Mercury and alloys for dental amalgam [Including: AMENDMENT 1 (2011)]

Withdrawn and replaced with newer version including amendment.

4-146

ISO 22674 First edition 2006-11-15 Dentistry—Metallic materials for fixed and removable restorations and appliances

Extent of recognition.

4-149

ANSI/ADA Specification No. 39/ISO 6874:2005 (Reaffirmed 2011) Pit and Fissure Sealants

Reaffirmation and extent of recognition.

4-150

ANSI/ADA Specification No. 19:2004/ISO 4823:2000 Dental—Elastometric Impression Materials

Extent of recognition.

4-151

ISO 22112 First edition 2005-11-01 Dentistry—Artificial teeth for dental prostheses

Extent of recognition.

4-153

ISO 9917-1 Second edition 2007-10-01 Dentistry—Water-based cements—Part 1: Powder/liquid acid-base cements

Extent of recognition.

4-154

4-210

ISO 4823 Third edition 2000-12-15 Dentistry—Elastometric impression materials [Including: AMENDMENT 1 (2000) TECHNICAL CORRIGENDUM 1(2004)]

Withdrawn and replaced with newer version including amendment and technical corrigendum.

4-155

ISO 4823: Technical Corrigendum 1 Published 2004-07-15—Dentistry—Elastometric impression materials—Third Edition

Withdrawn. See 4-210.

4-156

ISO 4823 Third edition 2000-12-15 Amendment 1 2007-07-01 Dentistry—Elastometric impression materials—Third Edition

Withdrawn. See 4-210.

4-157

ISO 3107 Third edition 2004-10-01 Dentistry—Zinc oxide/Eugenol and zinc oxide/non-eugenol cements—Third edition

Withdrawn. See 4-198.

4-159

4-211

ANSI/IEEE C63.19:2007 American National Standard Methods of Measurement of Compatibility between Wireless Communications Devices and Hearing Aids

Withdrawn and replaced with newer version.

4-170

4-212

ANSI/ASA S3.36-2012 American National Standard Specification for a Manikin for Simulated in situ Airborne Acoustic Measurements

Withdrawn and replaced with newer version.

4-178

ISO 6872 Third edition 2008-09-01 Dentistry—Ceramic materials

Extent of recognition.

4-179

ISO 7405 Second edition 2008-12-15 Dentistry—Evaluation of biocompatibility of medical devices used in dentistry

Extent of recognition.

4-180

ISO 9168 Third edition 2009-07-15 Dentistry—Hose connectors for air driven dental handpieces

Extent of recognition.

4-181

ISO 4049 Fourth edition 2009-10-01 Dentistry—Polymer-based restorative materials

Extent of recognition.

4-182

ISO 10139-2 Second edition 2009-08-01 Dentistry—Soft lining materials for removable dentures—Part 2: Materials for long-term use

Extent of recognition.

4-188

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

Extent of recognition.

4-189

ISO 10139-1:2005 TECHNICAL CORRIGENDUM 1 2006-03-01 Dentistry—Soft lining materials for removable dentures—Part 1: Materials for short-term use

Withdrawn. See 4-213.

4-195

ISO 14801 Second edition 2007-11-15 Dentistry—Implants-Dynamic fatigue test for endosseous dental implants

Extent of recognition.

4-196

ANSI/ADA Specification No.69:2010/ISO 6872:2008 Dental Ceramic

Extent of recognition.

4-198

ISO 3107 Fourth edition 2011-03-01 Dentistry—Zinc oxide/eugenol and zinc oxide/non-eugenol cements

Extent of recognition.

4-199

ISO 6876 Third edition 2012-06-01 Dentistry—Root Canal Sealing Materials

Extent of recognition.

4-200

ISO 24234 First edition 2004-10-15 Dentistry—Mercury and alloys for dental amalgam AMENDMENT 1

Withdrawn. See 4-209.

4-201

ISO 9693-2012 Dentistry—Compatibility testing—Metal-ceramic systems

Extent of recognition.

4-205

ISO 14457 First edition 2012-09-15 Dentistry—Handpieces and motors

Withdrawn. See 4-206.

E. General

5-22

ISO 2768-1 First edition 1989-11-15 General tolerances—Part 1: Tolerances for linear and angular dimensions without individual tolerance indications

Extent of recognition.

5-23

ISO 2768-2 First edition 1989-11-15 General Tolerances—Part 2: Geometrical tolerances for features without individual tolerance indications

Extent of recognition.

5-36

ISO/TR 16142 Second edition 2006-01-15 Medical devices—Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices

Extent of recognition.

5-37

5-81

ISO 2859-1 Second edition 1999-11-15 Sampling procedures for inspection by attributes—Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection [Including: TECHNICAL CORRIGENDUM 1 (2001)]

Withdrawn and replaced with newer version including technical corrigendum.

5-43

ANSI/ESD S20.20-2007 For the Development of an Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices)

Extent of recognition.

5-45

5-79

ASTM D7386-12 Standard Practice for Performance Testing of Packages for Single Parcel Delivery Systems

Withdrawn and replaced with new version.

5-46

ISO 2859-1:1999/Cor 1:2001 Sampling procedures for inspection by attributes—Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection

Withdrawn. See 5-81.

5-47

ISO 10012 First edition 2003-01-15 Measurement management systems—Requirements for measurement processes and measuring equipment

Extent of recognition.

5-50

IEC 62366 Edition 1.0 2007-10 Medical devices—Application of usability engineering to medical devices

Extent of recognition.

5-51

5-80

ASTM D-4332-13 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing

Withdrawn and replaced with new version.

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

Relevant guidance.

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 relevant guidance.

5-57

ANSI/AAMI HE75:2009 Human factors engineering—Design of medical devices

Extent of recognition.

5-58

5-82

IEC 60601-1-11 Edition 1.0:2010 Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment [Including: TECHNICAL CORRIGENDUM 1 (2011)]

Withdrawn and replaced with newer version including technical corrigendum.

5-62

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

Extent of recognition.

5-66

IEC 60601-1-10 Edition 1.0: 2007-11 Medical electrical equipment—Part 1-10: General requirements for basic safety and essential performance—Collateral Standard: Requirements for the development of physiologic closed-loop controllers

Extent of recognition.

5-67

ANSI/AAMI/IEC 62366:2007/(R)2013 Medical devices—Application of usability engineering to medical devices

Reaffirmation and extent of recognition.

5-69

IEC 60601-1-11 (First edition 2010) April 2011 Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment CORRIGENDUM 1

Withdrawn. See 5-82.

F. General Hospital/General Plastic Surgery

6-13

ISO 595-1 First edition 1986-12-15 Reusable all-glass or metal-and-glass syringes for medical use—Part 1: Dimensions

Withdrawn.

6-14

ISO 595-2 First edition 1987-12-15 Reusable all-glass or metal-and-glass syringes for medical use—Part 2: Design, performance requirements and tests

Withdrawn.

6-117

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

Extent of recognition.

6-142

ANSI/AAMI II36:2004 Medical electrical equipment—Part 2: Particular requirements for safety of baby incubators

Withdrawn. See 6-230.

6-143

ANSI/AAMI II51:2004 Medical electrical equipment—Part 2: Particular requirements for safety of transport incubators

Withdrawn. See 6-231.

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

Withdrawn.

6-161

6-301

ISO 10555-1 Second edition 2013-06-15 Corrected version 2013-07-01 Intravascular catheters—Sterile and single-use catheters—Part 1: General requirements

Withdrawn and replaced with newer version.

6-163

ISO 9626 First edition 1991-09-01 AMENDMENT 1 2001-06-01 Stainless steel needle tubing for the manufacture of medical devices

Withdrawn. See 6-302.

6-164

6-303

ISO 10555-5 Second edition 2013-06-15 Intravascular catheters—Sterile and single-use catheters—Part 5: Over-needle peripheral catheters

Withdrawn and replaced with newer version.

6-170

6-304

ISO 7886-1 First edition 1993-10-01 Sterile hypodermic syringes for single use—Part 1: Syringes for manual use [Including: TECHNICAL CORRIGENDUM 1 Published 1995-11-01]

Withdrawn and replaced with newer version including technical corrigendum.

6-171

6-305

ISO 10555-3 Second edition 2013-06-15 Intravascular catheters—Sterile and single-use catheters—Part 3: Central venous catheters

Withdrawn and replaced with newer version.

6-176

ASTM D7103-06 (Reapproved 2013) Standard Guide for Assessment of Medical Gloves

Extent of recognition.

6-187

6-306

ASTM F1671/F1671M-13 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System

Withdrawn and replaced with newer version.

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

Withdrawn. See 6-321.

6-236

6-307

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 [Including: CORRIGENDUM 1 (April 2009)]

Withdrawn and replaced with newer version including technical corrigendum.

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 CORRIGENDUM 1

Withdrawn. See 6-307.

6-238

6-308

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 [Including: CORRIGENDUM 1 (March 2012)]

Withdrawn and replaced with newer version including technical corrigendum.

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. See 6-318.

6-253

ISO 10535 Second edition 2006-12-15 Hoists for the transfer of disabled persons—Requirements and test methods

Extent of recognition.

6-264

ISO 10555-1 First edition 1995-06-15 AMENDMENT 1 1999-07-15 Sterile, single-use intravascular catheters—Part 1: General requirements

Withdrawn. See 6-301.

6-265

ISO 10555-1 First edition 1995-06-5 AMENDMENT 2 2004-05-15 Sterile, single-use intravascular catheters—Part 1: General requirements

Withdrawn. See 6-301.

6-266

ISO 10555-5 First edition 1996-06-15 AMENDMENT 1 Sterile, single-use intravascular catheters—Part 5: Over-needle peripheral catheters

Withdrawn. See 6-303.

6-267

ISO 10555-5 1996 TECHNICAL CORRIGENDUM 1 Published 2002-06-15 Sterile, single-use intravascular catheters—Part 5: Over-needle peripheral catheters

Withdrawn. See 6-303.

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

Extent of recognition.

6-279

IEC 60601-2-19 (Second Edition 2009) Medical electrical equipment—Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators CORRIGENDUM 1

Withdrawn. See 6-319.

6-280

IEC 60601-2-20 (Second edition 2009) Medical electrical equipment—Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators CORRIGENDUM 1

Withdrawn. See 6-320.

6-281

IEC 80601-2-35 (Second edition 2009) 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

Withdrawn. See 6-308.

6-283

6-309

USP 36-NF31:2013 Sodium Chloride Irrigation

Withdrawn and replaced with newer version.

6-284

6-310

USP 36-NF31:2013 Sodium Chloride Injection

Withdrawn and replaced with newer version.

6-285

6-311

USP 36-NF31:2013 Nonabsorbable Surgical Suture

Withdrawn and replaced with newer version.

6-286

3-312

USP 36-NF31:2013 <881> Tensile Strength

Withdrawn and replaced with newer version.

6-287

6-313

USP 36-NF31:2013 <861> Sutures—Diameter

Withdrawn and replaced with newer version.

6-288

6-314

USP 36-NF 31:2013 <871> Sutures—Needle Attachment

Withdrawn and replaced with newer version.

6-289

6-315

USP 36-NF31:2013 Sterile Water for Irrigation

Withdrawn and replaced with newer version.

6-290

6-316

USP 36-NF31:2013 Heparin Lock Flush Solution

Withdrawn and replaced with newer version.

6-291

6-317

USP 36-NF31:2013 Absorbable Surgical Suture

Withdrawn and replaced with newer version.

6-292

ISO 7886-1:1993 TECHNICAL CORRIGENDUM 1 Published 1995-11-01 Sterile hypodermic syringes for single-use—Part 1: Syringes for manual use

Withdrawn. See 6-304.

6-298

6-319

IEC 60601-2-19 Edition 2.0 2009-02 Medical electrical equipment—Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators [Including: CORRIGENDUM 1 (2012)]

Withdrawn and replaced with newer version including technical corrigendum.

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 transport incubators

Withdrawn. See 6-320.

G. In Vitro Diagnostics

7-100

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

Withdrawn.

7-137

7-244

CLSI NBS01-A6 Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard—Sixth Edition

Withdrawn and replaced with newer version.

7-239

CLSI EP32-R (Formerly X05-R) Metrological Traceability and Its Implementation; A Report

Designation number.

7-226

CLSI QMS01-A4 (Formerly GP26-A4) Quality Management System: A Model for Laboratory Services; Approved Guideline—Fourth Edition

Designation number.

7-224

CLSI EP28-A3c (Formerly C28-A3c) Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third Edition

Designation number.

7-223

CLSI QSM06-A3 (Formerly GP22-A3) Quality Management System: Continual Improvement; Approved Guideline—Third Edition

Designation number.

7-92

7-245

CLSI EP09-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third Edition

Withdrawn and replaced with newer version.

7-210

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

Extent of recognition.

7-152

CLSI EP12-A2 User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline—Second Edition

Extent of recognition.

7-174

CLSI EP21-A Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline

Extent of recognition.

7-178

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

Extent of recognition.

7-193

CLSI EP06-A Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline

Extent of recognition.

7-220

CLSI H59-A Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline

Extent of recognition.

H. Materials

8-67

8-344

ISO 7153-1 Second edition 1991-04-01 Surgical instruments—Metallic materials—Part 1: Stainless steel [Including: AMENDMENT 1(1999)]

Withdrawn and replaced with newer version including amendment.

8-138

ASTM F745-07 Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications

Withdrawn.

8-139

8-345

ASTM F1314-13 Standard Specification for Wrought Nitrogen Strengthened 22 Chromium-13 Nickel-5 Manganese-2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)

Withdrawn and replaced with newer version.

8-140

8-346

ASTM F1813-13 Standard Specification for Wrought Titanium-12 Molybdenum-6 Zirconium-2 Iron Alloy for Surgical Implant (UNS R58120)

Withdrawn and replaced with newer version.

8-141

8-347

ASTM F2146-13 Standard Specification for Wrought Titanium-3 Aluminum-2.5 Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)

Withdrawn and replaced with newer version.

8-169

8-348

ASTM F138-13 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybendum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

Withdrawn and replaced with newer version.

8-176

8-349

ASTM F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

Withdrawn and replaced with newer version.

8-149

8-350

ISO 5832-1 Fourth edition 2007-06-15 Implants for surgery—Metallic materials—Part 1: Wrought stainless steel [Including: TECHNICAL CORRIGENDUM 1(2008)]

Withdrawn and replaced with newer version including technical corrigendum.

8-196

ISO 5832-1: 2007 Implants for surgery—Metallic materials—Part 1: Wrought stainless steel TECHNICAL CORRIGENDUM 1

Withdrawn. See 8-350.

8-151

8-351

ISO 5832-12 Second edition 2007-05-01 Implants for surgery—Metallic materials—Part 12: Wrought cobalt-chromium-molybdenum alloy [Including: TECHNICAL CORRIGENDUM 1 2008]

Withdrawn and replaced with newer version including technical corrigendum.

8-197

ISO 5832-12:2007 TECHNICAL CORRIGENDUM 1 2008-09-05, Implants for surgery—Metallic materials—Part 12: Wrought cobalt-chromium-molybdenum alloy TECHNICAL CORRIGENDUM 1

Withdrawn. See 8-351.

8-211

8-352

ISO 5834-1 Third edition 2005-06-01 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 1: Powder form [Including: TECHNICAL CORRIGENDUM 1 2007]

Withdrawn and replaced with newer version including technical corrigendum.

8-212

ISO 5834-1:2005 Technical Corrigendum 1 Published 2007-05-01 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 1: Powder form TECHNICAL CORRIGENDUM 1

Withdrawn. See 8-352.

8-228

8-353

ASTM F86-13 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants

Withdrawn and replaced with newer version.

8-175

8-354

ASTM F1377-13 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)

Withdrawn and replaced with newer version.

8-163

8-355

ASTM F1586/F 1586M-13

ε1

Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)

Withdrawn and replaced with newer version.

8-129

8-356

ASTM F67-13 Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)

Withdrawn and replaced with newer version.

8-208

8-357

ASTM F648-13 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

Withdrawn and replaced with newer version.

8-103

ASTM F1801-97 (Reapproved 2009)

ε1

Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials

Extent of recognition.

8-107

ASTM F746-04 (Reapproved 2009)

ε1

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

Extent of recognition.

8-111

ASTM F1160-05 (Reapproved 2011)

ε1

Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings

Extent of recognition.

8-112

ASTM F1044-05 (Reapproved 2011)

ε1

Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings

Extent of recognition.

8-113

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

Extent of recognition.

8-114

ASTM F2255 (Reapproved 2010) Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension Loading

Extent of recognition.

8-115

ASTM F2256-05 (Reapproved 2010) Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading

Extent of recognition.

8-116

ASTM F2258-05 (Reapproved 2010) Standard Test Method for Strength Properties of Tissue Adhesives in Tension

Extent of recognition.

8-121

ASTM F2005-05 (Reapproved 2010) Standard Terminology for Nickel-Titanium Shape Memory Alloys

Extent of recognition.

8-123

ISO 5832-5 Third edition 2005-10-15 Implants for surgery—Metallic materials—Part 5: Wrought cobalt-chromium-tungsten-nickel alloy

Extent of recognition.

8-124

ASTM F2052-06

ε

Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment

Extent of recognition.

8-125

ASTM F2004-05 (Reapproved 2010) Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis

Extent of recognition.

8-126

8-370

ASTM F561-13 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids

Withdrawn and replaced with newer version.

8-128

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

Extent of recognition.

8-132

ASTM F1088-04a (Reapproved 2010) Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation

Extent of recognition.

8-134

ASTM F2082-06 Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery

Extent of recognition.

8-135

ASTM F2392-04 (Reapproved 2010) Standard Test Method for Burst Strength of Surgical Sealants

Extent of recognition.

8-136

ASTM F2458-05 (Reapproved 2010) Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants

Extent of recognition.

8-150

ISO 5832-9 Second edition 2007-06-15 Implants for surgery—Metallic materials—Part 9: Wrought high nitrogen stainless steel

Extent of recognition.

8-157

ISO 9583 First edition 1993-10-15 Implants for surgery—Non-destructive testing—Liquid penetrant inspection of metallic surgical implants

Extent of recognition.

8-159

ISO 9584 First edition 1993-10-15 Implants for surgery—Non-destructive testing—Radiographic examination of cast metallic surgical implants

Extent of recognition.

8-165

ASTM F1058-08

ε1

Standard Specification for Wrought 40 Cobalt-20 Chromium-16 Iron-15 Nickel-7 Molybdenum Alloy Wire and Strip for Surgical Implant Applications (UNS R30003 and UNS R30008)

Extent of recognition.

8-167

ASTM F1350-08 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)

Extent of recognition.

8-168

ASTM F1472-08

ε1

Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium Alloy for Surgical Implant Applications (UNS R56400)

Extent of recognition.

8-170

ASTM F961-08 Standard Specification for 35 Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)

Extent of recognition.

8-171

ASTM F1609-08 Standard Specification for Calcium Phosphate Coatings for Implantable Materials

Extent of recognition.

8-173

ASTM F601-03 (Reapproved 2008) Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants

Extent of recognition.

8-177

ASTM F2129-08 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices

Extent of recognition.

8-179

ASTM F754-08 Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders

Extent of recognition.

8-183

ASTM F560-08 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)

Extent of recognition.

8-184

ASTM F2516-07

ε2

Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials

Extent of recognition.

8-185

ASTM F451-08 Standard Specification for Acrylic Bone Cement

Extent of recognition.

8-187

ISO 13779-1 Second edition 2008-10-01 Implants for surgery—Hydroxyapatite—Part 1: Ceramic hydroxyapatite

Extent of recognition.

8-188

ISO 13779-2 Second edition 2008-10-01 Implants for surgery—Hydroxyapatite—Part 2: Coatings of hydroxyapatite

Extent of recognition.

8-189

ASTM F 1108-04 (Reapproved 2009) Standard Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants (UNS R56406)

Extent of recognition.

8-190

ASTM F 90-09 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)

Extent of recognition.

8-192

ASTM F1854-09 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants

Extent of recognition.

8-193

ASTM F2754/F 2754M-09 Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wire

Extent of recognition.

8-194

ISO 6474-1 First edition 2010-02-15 Implants for surgery—Ceramic materials—Part 1: Ceramic materials based on high purity alumina

Extent of recognition.

8-195

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

Extent of recognition.

8-199

ASTM F2633-07 Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants

Extent of recognition.

8-204

ASTM F2118-10 Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials

Extent of recognition.

8-205

ASTM F1635-11 Standard Test Method for In Vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants

Extent of recognition.

8-206

ASTM F688-10 Standard Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)

Extent of recognition.

8-207

ASTM F1926/F1926M-10 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and Coatings

Extent of recognition.

8-213

ISO 5834-3 First edition 2005-07-15 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 3: Accelerated ageing methods

Extent of recognition.

8-214

ISO 5834-4 First edition 2005-05-01 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 4: Oxidation index measurement method

Extent of recognition.

8-215

ISO 5834-5 First edition 2005-06-01 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 5: Morphology assessment method

Extent of recognition.

8-216

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

Extent of recognition.

8-217

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

Extent of recognition.

8-218

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

Extent of recognition.

8-220

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

Extent of recognition.

8-221

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

Extent of recognition.

8-224

ASTM F2102-06

ε1

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

Extent of recognition.

8-225

ASTM F2003-02 (Reapproved 2008) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air

Extent of recognition.

8-226

ASTM F603-12 Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application

Extent of recognition.

8-229

ASTM F75-12 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)

Extent of recognition.

8-330

ASTM F1978-12 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser

Extent of recognition.

8-331

ASTM F1580-12 Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants

Extent of recognition.

8-333

ASTM F2393-12 Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications

Extent of recognition.

8-334

ASTM F2459-12 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis

Extent of recognition.

I. Nanotechnology

18-1

ASTM E2490-09 Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS)

Extent of recognition.

18-2

ASTM E2535-07 (Reapproved 2013) Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings

Reaffirmation and extent of recognition.

J. Neurology

17-3

17-12

ISO 7197 Third edition 2006-06-01 Neurosurgical Implants—Sterile, single-use hydrocephalus shunts and components [Including TECHNICAL CORRIGENDUM 1 (2007)]

Withdrawn and replaced with newer version including technical corrigendum.

17-7

ISO 7197: 2006 Neurosurgical implants—Sterile, single-use hydrocephalus shunts and components TECHNICAL CORRIGENDUM 1

Withdrawn. See 17-12.

17-1

ANSI/AAMI NS28:1988/(R) 2010 Intracranial pressure monitoring devices

Extent of recognition.

17-4

ASTM F647-94 (Reapproved 2006) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application

Extent of recognition.

17-9

ASTM F2129-08 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices

Extent of recognition.

K. OB-GYN/Gastroenterology/Urology

9-34

9-82

ISO 4074 First edition 2002-02-15 Corrected version 2002-12-01 Natural latex rubber condoms—Requirements and test methods [Including TECHNICAL CORRIGENDUM 1 (2002), TECHNICAL CORRIGENDUM 2 (2002)]

Withdrawn and replaced with newer version including technical corrigendum.

9-57

ISO 4074:2002 TECHNICAL CORRIGENDUM 2, Natural latex rubber condoms—Requirements and test methods TECHNICAL CORRIGENDUM 2

Withdrawn. See 9-82.

9-75

9-84

ISO 8600-3 First edition 1997-07-01 Optics and Optical instruments—Medical endoscopes and endoscopic accessories—Part 3: Determination of field of view and direction of view of endoscopes with optics [Including AMENDMENT 1 (2003)]

Withdrawn and replaced with newer version including amendment.

9-36

9-90

ISO 8009 First edition 2004-10-01 Mechanical contraceptives—Reusable natural and silicone rubber contraceptive diaphragms—Requirements and tests [Including AMENDMENT 1(2012)]

Withdrawn and replaced with newer version including amendment.

9-37

9-83

ISO 8600-1 Third edition 2013-03-01 Endoscopes—Medical endoscopes and endotherapy devices—Part 1: General requirements

Withdrawn and replaced with newer version.

9-38

ISO 8600-3 First edition 1997-07-01 AMENDMENT 1, Optics and optical instruments—Medical endoscopes and endoscopic accessories Part 3: Determination of field of view and direction of view of endoscopes with optics

Withdrawn. See 9-84.

9-44

ASTM F623-99 (Reapproved 2006) Standard Performance Specification for Foley Catheter

Extent of recognition.

9-54

9-85

ASTM D6976-13 Standard Specification for Rubber Contraceptives—Vaginal Diaphragms

Withdrawn and replaced with a newer version.

9-56

ASTM D3492-08 Standard Specification for Rubber Contraceptives (Male Condoms)

Extent of recognition.

9-65

9-91

ANSI/AAMI/ISO 8637:2010 Cardiovascular implants and extracorporeal systems—Hemodialyzers, hemodiafilters, hemofilters, and hemoconcentrators [Including AMENDMENT 1 (2013)]

Withdrawn and replaced with newer version including amendment.

9-66

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

Extent of recognition.

9-67

ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms

Extent of recognition.

9-68

ISO 23409 First edition 2011-02-15 Male Condoms—Requirements and test methods for condoms made from synthetic materials

Extent of recognition.

9-73

ANSI/AAMI/ISO 13958:2009 Concentrates for hemodialysis and related therapies

Extent of recognition.

9-74

ISO 13958 Second edition 2009-04-15 Concentrates for haemodialysis and related therapies

Extent of recognition.

9-79

ISO 26722 First edition 2009-04-15 Water treatment equipment for haemodialysis applications and related therapies

Extent of recognition.

L. Ophthalmic

10-41

10-81

ISO 11979-7 Second edition 2006-05-01 Ophthalmic implants—Intraocular lenses—Part 7: Clinical investigations [Including Amendment 1:2012]

Withdrawn and replaced with newer version including amendment.

10-75

ISO 11979-7/Amendment 1:2012 Ophthalmic implants—Intraocular lenses—Part 7: Clinical investigations

Withdrawn. See 10-81.

10-42

10-82

ISO 11979-2 First edition 1999-12-15 Ophthalmic implants—Intraocular lenses—Part 2: Optical properties and test methods [Including TECHNICAL CORRIGENDUM 1 (2003)]

Withdrawn and replaced with newer version including technical corrigendum.

10-53

10-83

ISO 18369-1 First edition 2006-08-15 Ophthalmic optics—Contact lenses—Part 1: Vocabulary, classification system and recommendations for labeling specifications [Including AMENDMENT 1 2009]

Withdrawn and replaced with newer version including amendment.

10-61

ISO 18369-1:2006 Ophthalmic optics—Contact lenses Part 1: Vocabulary, classification system and recommendations for labeling specifications. ISO 18369-1 First edition 2006-08-05 AMENDMENT 1 2009-02-15

Withdrawn. See 10-83.

10-58

10-84

ANSI Z80.11-2012 American National Standard for Ophthalmics—Laser Systems for Corneal Reshaping

Withdrawn and replaced with newer version.

10-59

10-85

ISO 11980 Third edition 2012-11-15 Corrected version 2013-12-01 Ophthalmic optics—Contact lenses and contact lens care products—Guidance for clinical investigations

Withdrawn and replaced with newer version.

10-71

10-86

ISO 14729 First edition 2001-04-15 Ophthalmic optics—Contact lens care products—Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses [Including: AMENDMENT 1 2010]

Withdrawn and replaced with newer version including amendment.

10-43

ISO 11979-8 Second edition 2006-07-01 Ophthalmic implants—Intraocular lenses—Part 8: Fundamental requirements

Extent of recognition.

10-54

ISO 18369-4 First edition 2006-08-15 Ophthalmic optics—contact lenses—Part 4: Physicochemical properties of contact lens materials

Extent of recognition.

10-55

ISO 11979-6 Second edition 2007-07-15 Ophthalmic implants—Intraocular lenses—Part 6: Shelf-life and transport stability

Extent of recognition.

10-56

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

Reaffirmation and extent of recognition.

10-57

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

Reaffirmation and extent of recognition.

10-60

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

Extent of recognition.

10-62

ANSI Z80.10-2009 Ophthalmic Instruments—Tonometers

Extent of recognition.

10-64

10-89

ANSI Z80.7-2013 Ophthalmics—Intraocular Lenses

Withdrawn and replaced with newer version.

10-68

ISO 13212 Second edition 2011-05-15 Ophthalmic optics—Contact lens care products—Guidelines for determination of shelf-life

Extent of recognition.

10-69

ANSI Z80.18-2010 American National Standard for Ophthalmics—Contact Lens Care Products—Vocabulary, Performance Specifications and Test Methodology

Extent of recognition.

10-74

ISO 10940 Second edition 2009-08-01 Ophthalmic instruments—Fundus Cameras

Extent of recognition.

M. Orthopedic

11-190

11-256

ISO 14243-3 First edition 2004-09-15 Implants for surgery—Wear of total knee-joint prostheses—Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test [Including: TECHNICAL CORRIGENDUM 1(2006)]

Withdrawn and replaced with newer version including technical corrigendum.

11-218

ISO 14243-3:2004 TECHNICAL CORRIGENDUM 1 Implants for surgery—Wear of total knee-joint prostheses—Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test

Withdrawn. See 11-256.

11-210

11-257

ASTM F543-13 Standard Specification and Test Methods for Metallic Medical Bone Screws

Withdrawn and replaced with a newer version.

11-212

ASTM F1440-92 (Reapproved 2008) Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion

Withdrawn.

11-241

ASTM F543-07 Standard Specification and Test Methods for Metallic Medical Bone Screws

Withdrawn duplicate.

See 11-257.

11-244

11-258

ASTM F2083-12 Standard Specification for Knee Replacement Prosthesis

Withdrawn and replaced with a newer version.

11-74

ISO 5838-2 First edition 1991-01-15 Implants for surgery—Skeletal pins and wires—Part 2: Steinmann skeletal pins—Dimensions

Extent of recognition.

11-75

ISO 5838-3 First edition 1993-09-15 Implants for surgery—Skeletal pins and wires—Part 3: Kirschner skeletal wires

Extent of recognition.

11-80

ISO 8828 First edition 1988-10-15 Implants for surgery—Guidance on care and handling of orthopaedic implants

Extent of recognition.

11-83

ISO 13402 First edition 1995-08-01 Surgical and dental hand instruments—Determination of resistance against autoclaving, corrosion and thermal exposure

Extent of recognition.

11-168

ASTM F1781-03 (Reapproved 2009) Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants

Extent of recognition.

11-171

ASTM F1814-97a (Reapproved 2009) Standard Guide for Evaluating Modular Hip and Knee Joint Components

Extent of recognition.

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

Extent of recognition.

11-184

ISO 8827 First edition 1988-10-15 Implants for surgery—Staples with parallel legs for orthopaedic use—General requirements

Extent of recognition.

11-185

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

Extent of recognition.

11-191

ISO 14879-1 First edition 2000-06-01 Implants for surgery—Total knee-joint prostheses—Part 1: Determination of endurance properties of knee tibial trays

Extent of recognition.

11-196

ASTM F1672-95 (Reapproved 2011) Standard Specification for Resurfacing Patellar Prosthesis

Extent of recognition.

11-197

ASTM F983-86 (Reapproved 2013) Standard Practice for Permanent Marking of Orthopaedic Implant Components

Reaffirmation and extent of recognition.

11-199

ASTM F565-04 (Reapproved 2013) Standard Practice for Care and Handling of Orthopedic Implants and Instruments

Reaffirmation and extent of recognition.

11-203

ASTM F1541-02 (Reapproved 2011)

1

Standard Specification and Test Methods for External Skeletal Fixation Devices

Extent of recognition.

11-207

ASTM F2193-02 (Reapproved 2007) Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System

Extent of recognition.

11-211

ASTM F1798-97 (Reapproved 2008) Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants

Extent of recognition.

11-214

ASTM F382-99 (Reapproved 2008)

1

Standard Specification and Test Method for Metallic Bone Plates

Extent of recognition.

11-216

ASTM F1264-03 (Reapproved 2012) Standard Specification and Test Methods for Intramedullary Fixation Devices

Extent of recognition.

11-220

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

Extent of recognition.

11-222

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

Extent of recognition.

11-223

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

Extent of recognition.

11-224

ASTM F2706-08 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model

Extent of recognition.

11-225

ISO 7206-4 Third edition 2010-06-15 Implants for surgery—Partial and total hip-joint prostheses—Part 4: Determination of endurance properties and performance of stemmed femoral components

Extent of recognition.

11-226

ASTM F1089-10 Standard Test Method for Corrosion of Surgical Instruments

Extent of recognition.

11-227

ASTM F366-10 Standard Specification for Fixation Pins and Wires

Extent of recognition.

11-228

ASTM F564-10 Standard Specification and Test Methods for Metallic Bone Staples

Extent of recognition

11-231

ISO 7207-2 Second edition 2011-07-01 Implants for surgery—Components for partial and total knee joint prostheses—Part 2: Articulating surfaces made of metal, ceramic and plastics materials

Extent of recognition.

11-232

ISO 7207-1 Third edition 2007-02-01 Implants for surgery—Components for partial and total knee joint prostheses—Part 1: Classification, definitions and designation of dimensions

Extent of recognition.

11-234

ASTM F732-00 (Reapproved 2011) Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses

Extent of recognition.

11-235

ASTM F2077-11 Test Methods for Intervertebral Body Fusion Devices

Extent of recognition.

11-237

ISO 7206-6 First edition 1992-03-15 Implants for surgery—Partial and total hip joint prostheses—Part 6: Determination of endurance properties of head and neck region of stemmed femoral components

Extent of recognition.

11-238

ASTM F2033-12 Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials

Extent of recognition.

11-239

ASTM F 2345-03 (Reapproved 2013) Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads

Extent of recognition. Reaffirmation.

11-240

ASTM F382-99 (Reapproved 2008)

1

Standard Specification and Test Method for Metallic Bone Plates

Extent of recognition.

11-243

ASTM F2346-05 (Reapproved 2011) Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs

Extent of recognition.

11-245

ASTM F384-12 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices

Extent of recognition.

11-247

ASTM F2789-10 Standard Guide for Mechanical and Functional Characterization of Nucleus Devices

Extent of recognition.

11-248

ISO 14242-1 Second edition 2012-01-15 Implants for surgery—Wear of total hip-joint prostheses—Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test

Extent of recognition.

11-249

ISO 14242-2 First edition 2000-09-15 Implants for surgery—Wear of total hip-joint prostheses—Part 2: Methods of measurement

Extent of recognition.

11-250

ISO 14242-3 First edition 2009-03-15 Implants for surgery—Wear of total hip-joint prostheses—Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test

Extent of recognition.

N. Physical Medicine

16-25

ISO 7176-13 First edition 1989-08-01 Wheelchairs—Part 13: Determination of coefficient of friction of test surfaces

Extent of recognition.

16-27

ISO 7176-15 First edition 1996-11-15 Wheelchairs—Part 15: Requirements for information disclosure, documentation and labeling

Extent of recognition.

16-29

ISO 7176-6 Second edition 2001-10-01 Wheelchairs—Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs

Extent of recognition.

16-158

ISO 7176-1 Second edition 1999-10-01 Wheelchairs—Part 1: Determination of static stability

Extent of recognition.

16-159

ISO 7176-2 Second edition 2001-06-15 Wheelchairs—Part 2: Determination of dynamic stability of electric wheelchairs

Extent of recognition.

16-162

ISO 7176-4 Third edition 2008-10-01 Wheelchairs—Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range

Extent of recognition.

16-163

ISO 7176-5 Second edition 2008-06-01 Wheelchairs—Part 5: Determination of overall dimensions, mass and manoeuvring space

Extent of recognition.

16-164

ISO 7176-10 Second edition 2008-11-01 Wheelchairs—Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs

Extent of recognition.

16-165

ISO 7176-14 Second edition 2008-02-15 Wheelchairs—Part 14: Power and control systems for electrically powered wheelchairs and scooters—Requirements and test methods

Extent of recognition.

16-166

ISO 7176-21 Second edition 2009-04-01 Wheelchairs—Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers

Extent of recognition.

16-167

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

Extent of recognition.

16-168

ANSI/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

Extent of recognition.

16-169

ANSI/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

Extent of recognition.

16-170

ANSI/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

Extent of recognition.

16-171

ANSI/RESNA WC-2:2009 Section 4: Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical distance range

Extent of recognition.

16-172

ANSI/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

Extent of recognition.

16-173

ANSI/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

Extent of recognition.

16-174

ANSI/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

Extent of recognition.

16-175

ANSI/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

Extent of recognition.

16-176

ANSI/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

Extent of recognition.

16-177

ANSI/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

Extent of recognition.

16-178

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

Extent of recognition.

16-179

ANSI/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

Extent of recognition.

16-180

ANSI/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

Extent of recognition.

16-181

ANSI/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

Extent of recognition.

16-182

ANSI/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

Extent of recognition.

16-183

ANSI/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

Extent of recognition

16-184

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

Extent of recognition.

16-185

ANSI/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

Extent of recognition.

16-187

ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 26: Vocabulary

Extent of recognition.

O. Radiology

12-53

12-257

ISO 2919 Third edition 2012-02-15 Radiological protection—Sealed radioactive sources—General requirements and classification

Withdrawn and replaced with newer version.

12-59

IEC 61168 First edition 1993-12 Radiotherapy simulators—Functional performance characteristics

Extent of recognition.

12-66

AIUM MUS, Medical Ultrasound Safety

Extent of recognition.

12-139

AIUM AOMS-2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment

Extent of recognition.

12-140

AIUM RTD2-2004 Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Revision 2

Withdrawn. See 12-209 and 12-258.

12-145

12-259

IEC 61674 Edition 2.0 2012-11 Medical electrical equipment—Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging

Withdrawn and replaced with newer version.

12-149

12-260

IEC 60336 Fourth edition 2005-04 Medical electrical equipment—X-ray tube assemblies for medical diagnosis—Characteristics of focal spots [Including: Technical Corrigendum 1 (2006)]

Withdrawn and replaced with newer version including technical corrigendum.

12-150

ISO/IEC 10918-1:1994 TECHNICAL CORRIGENDUM 1:2005 Information technology—Digital compression and coding of continuous-tone still image—Part 1: Requirements and guidelines

Withdrawn. See 12-261.

12-156

ISO 11670:2003 TECHNICAL CORRIGENDUM 1:2004 Lasers and laser-related equipment—Test methods for laser beam parameters—Beam positional stability

Withdrawn. See 12-262.

12-157

ISO 13694:2000 TECHNICAL CORRIGENDUM 1:2005 Optics and optical instruments—Lasers and laser-related equipment—Test methods for laser beam power (energy) density distribution

Withdrawn. See 12-263.

12-159

12-264

NEMA MS 11-2010 Determination of Gradient-Induced Electric Fields In Diagnostic Magnetic Resonance Imaging

Withdrawn and replaced with newer version.

12-167

12-265

NEMA NU 2-2012 Performance Measurements of Positron Emission Tomographs (PETs)

Withdrawn and replaced with newer version.

12-179

ANSI/IESNA RP-27.3-2007, Recommended Practice for Photobiological Safety for Lamps—Risk Group Classification and Labeling

Extent of recognition.

12-180

12-266

IEC 61689 Edition 3.0 2013-02 Ultrasonic-Physiotherapy systems—Field specifications and methods of measurement in the frequency range 0. 5 MHz to 5 MHz

Withdrawn and replaced with newer version.

12-190

12-267

IEC 61217 Edition 2.0 2011-12 Radiotherapy equipment—Coordinates, movements and scales

Withdrawn and replaced with newer version.

12-194

ANSI/HPS N43.6-2007, Sealed Radioactive Sources—Classification

Extent of recognition.

12-207

12-271

IEC 60601-2-33 Edition 3.1 2013-04 Medical electrical equipment—Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

Withdrawn and replaced with newer version.

12-208

12-268

IEC 60601-2-22 Edition 3.1 2012-10 Medical electrical equipment—Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

Withdrawn and replaced with newer version.

12-210

12-269

IEC 60601-1-3 Edition 2.1 2013-04 Medical electrical equipment—Part 1-3: General requirements for basic safety and essential performance—Collateral Standard: Radiation protection in diagnostic X-ray equipment

Withdrawn and replaced with newer version.

12-219

IEC 60336 (2005) Medical electrical equipment—X-ray tube assemblies for medical diagnosis—Characteristics of focal spots

Withdrawn. See 12-260.

12-222

12-270

IEC 61223-3-5 First edition 2004-08 Evaluation and routine testing in medical imaging departments—Part 3-5: Acceptance tests—Imaging performance of computed tomography X-ray equipment [Including: TECHNICAL CORRIGENDUM 1 (2006)]

Withdrawn and replaced with newer version including technical corrigendum.

12-223

IEC 61223-3-5 (First edition 2004) Evaluation and routine testing in medical imaging departments—Part 3-5: Acceptance tests—Imaging performance of computed tomography X-ray equipment CORRIGENDUM 1

Withdrawn. See 12-270.

12-227

IEC 61391-1 First edition 2006-07 Ultrasonics—Pulse-echo scanners—Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response

Extent of recognition.

12-228

IEC 61391-2 Edition 1.0 2010-01 Ultrasonics—Pulse-echo scanners—Part 2: Measurement of maximum depth of penetration and local dynamic range

Extent of recognition.

12-233

12-262

ISO 11670 Second edition 2003-04-01 Lasers and laser-related equipment—Test methods for laser beam parameters—Beam positional stability [Including: TECHNICAL CORRIGENDUM 1 (2004)]

Withdrawn and replaced with newer version including technical corrigendum.

12-237

12-258

IEC 62359 Edition 2.0 2010-10 Ultrasonics—Field characterization—Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields [Including TECHNICAL CORRIGENDUM 1 (2011)]

Withdrawn and replaced with newer version including technical corrigendum.

12-243

12-263

ISO 13694 First edition 2000-04-01 Optics and optical instruments—Lasers and laser-related equipment—Test methods for laser beam power [energy] density distribution [Including: TECHNICAL CORRIGENDUM 1 (2005)]

Withdrawn and replaced with newer version including technical corrigendum.

12-244

IEC 62359 (Second edition 2010) March 2011 Ultrasonics—Field characterization—Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields CORRIGENDUM 1

Withdrawn. See 12-258.

12-247

ISO 11990-1 First edition 2011-08-01, Lasers and laser-related equipment—Determination of laser resistance of tracheal tubes—Part 1: Tracheal tube shaft

Extent of recognition.

P. Software/Informatics

13-4

ANSI/UL 1998 Standards for Safety Software in Programmable Components, Second Edition. [This Standard contains revisions through and including October 28, 2008.]

Extent of recognition.

Q. Sterility

14-143

14-395

ISO 14698-2 First edition 2003-09-15 Cleanrooms and associated controlled environments—Biocontamination control—Part 2: Evaluation and interpretation of biocontamination data. [Including: TECHNICAL CORRIGENDUM 1 Published 2004-11-01]

Withdrawn and replaced with newer version including technical corrigendum.

14-193

ANSI/AAMI/ISO 11607-1:2006/(R)2010 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems

Extent of recognition and relevant guidance.

14-194

ANSI/AAMI/ISO 11607-2:2006/(R)2010 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes

Extent of recognition and relevant guidance.

14-195

ANSI/AAMI/ISO 11140-1:2005(R)2010 Sterilization of health care products—Chemical indicators—Part 1: General requirements

Extent of recognition.

14-201

14-396

ANSI/AAMI ST77:2013 Containment devices for reusable medical device sterilization

Withdrawn and replaced with newer version.

14-214

14-397

AOAC 6.2.04:2013 Official Method 955.15 Testing Disinfectants Against Staphylococcus aureus, Use-Dilution Method

Withdrawn and replaced with newer version.

14-218

14-398

AOAC 6.3.05:2013 Official Method 966.04 Sporicidal Activity of Disinfectants Method I

Withdrawn and replaced with newer version.

14-219

14-399

AOAC 6.3.06:2012 Official Method 965.12 Tuberculocidal Activity of Disinfectants

Withdrawn and replaced with newer version.

14-230

14-400

ASTM F2203-13 Standard Test Method for Linear Measurement Using Precision Steel Rule

Withdrawn and replaced with newer version.

14-231

14-401

ASTM F2217/F2217M-13 Standard Practice for Coating/Adhesive Weight Determination

Withdrawn and replaced with newer version.

14-235

14-402

ASTM F1140/F1140M-13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages

Withdrawn and replaced with newer version.

14-236

14-403

ASTM F2054/F2054M-13 Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates

Withdrawn and replaced with newer version.

14-241

14-424

ISO 13408-6 First edition 2005-06-15 Aseptic processing of health care products—Part 6: Isolator systems [Including AMENDMENT 1 (2013)]

Withdrawn and replaced with newer version including amendment.

14-258

14-404

ASTM F2250-13 Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials

Withdrawn and replaced with newer version.

14-260

14-405

ASTM F2252/F2252M-13

ε1

Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape

Withdrawn and replaced with newer version.

14-264

14-406

ANSI/AAMI ST8:2013 Hospital steam sterilizers

Withdrawn and replaced with newer version.

14-274

ANSI/AAMI/ISO 15882:2008 Sterilization of health care products—Chemical indicators—Guidance for selection, use, and interpretation of results

Extent of recognition and relevant guidance.

14-285

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

Extent of recognition.

14-289

ISO 14698-2:2003 TECHNICAL CORRIGENDUM Cleanrooms and associated controlled environments—Biocontamination control—Part 2: Evaluation and interpretation of biocontamination data

Withdrawn. See 14-395.

14-296

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

Relevant guidance.

14-300

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

Extent of recognition.

14-326

14-407

ISO 11737-1 Second edition 2006-04-01, Sterilization of medical devices—Microbiological methods—Part 1: Determination of a population of microorganisms on products [Including: TECHNICAL CORRIGENDUM 1 Published 2007-05-15]

Withdrawn and replaced with newer version including technical corrigendum.

14-328

14-428

ISO 11137-1 First edition 2006-04-15 Sterilization of health care products—Radiation—Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including AMENDMENT 1 (2013)]

Withdrawn and replaced with newer version including amendment.

14-334

ISO 15882 Second edition 2008-09-01 Sterilization of health care products—Chemical indicators—Guidance for selection, use and interpretation of results

Extent of recognition, title.

14-335

14-408

ISO 10993-7 Second edition 2008-10-15 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals [Including: TECHNICAL CORRIGENDUM 1 Published 2009-11-15]

Withdrawn and replaced with newer version including technical corrigendum.

14-336

ISO 14161 Second edition 2009-09-15 Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of results

Extent of recognition.

14-338

ISO 11138-1 Second edition 2006-07-01, Sterilization of health care products—Biological indicators—Part 1: General requirements

Relevant guidance.

14-352

14-425

ANSI/AAMI/ISO 13408-6:2005 Aseptic processing of health care products—Part 6: Isolator systems [Including AMENDMENT 1 (2013)]

Withdrawn and replaced with newer version including amendment.

14-353

ISO 11140-1 Second edition 2005-07-15 Sterilization of health care products—Chemical indicators—Part 1: General requirements

Extent of recognition.

14-355

ISO 11607-1 First edition 2006-04-15 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems

Extent of recognition and relevant guidance.

14-356

ISO 11607-2 First edition 2006-04-15 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes

Extent of recognition.

14-357

ISO 11737-1:2006 TECHNICAL CORRIGENDUM 1 Published 2007-05-15 Sterilization of medical devices—Microbiological methods—Part 1: Determination of a population of microorganisms on products

Withdrawn. See 14-407.

14-360

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

Relevant guidance.

14-362

14-412

AOAC 6.2.01:2013 Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method

Withdrawn and replaced with newer version.

14-363

14-413

AOAC 6.2.06:2013 Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method

Withdrawn and replaced with newer version.

14-365

14-409

ISO 11137-2 Third edition 2013-06-01 Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose

Withdrawn and replaced with newer version.

14-366

14-414

USP 36-NF31:2013 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests

Withdrawn and replaced with newer version.

14-367

14-415

USP 36-NF31:2013 <71> Sterility Tests

Withdrawn and replaced with newer version.

14-368

14-416

USP 36-NF31:2013 <85> Bacterial Endotoxins Test

Withdrawn and replaced with newer version.

14-369

14-417

USP 36-NF31:2013 <151> Pyrogen Test (USP Rabbit Test)

Withdrawn and replaced with newer version.

14-370

14-418

USP 36-NF31:2013 <161> Transfusion and Infusion Assemblies and Similar Medical Devices

Withdrawn and replaced with newer version.

14-371

14-419

USP 36-NF31:2013 Biological Indicator for Steam Sterilization, Self-Contained

Withdrawn and replaced with newer version.

14-372

14-420

USP 36-NF31:2013 Biological Indicator for Dry-Heat Sterilization, Paper Carrier

Withdrawn and replaced with newer version.

14-373

14-421

USP 36-NF31:2013 Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier

Withdrawn and replaced with newer version.

14-374

14-422

USP 36-NF31:2013 Biological Indicator for Steam Sterilization, Paper Carrier

Withdrawn and replaced with newer version.

14-375

14-423

USP 36-NF31:2013 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms

Withdrawn and replaced with newer version.

14-380

14-410

ASTM F17-13 Standard Terminology Relating to Flexible Barrier Packaging

Withdrawn and replaced with newer version.

14-384

ISO 10993-7:2008 TECHNICAL CORRIGENDUM 1, Published 2009-11-15 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals

Withdrawn. See 14-408.

14-385

14-426

ANSI/AAMI/ISO 13408-1:2008 (R2011) Aseptic processing of health care products—Part 1: General requirements [Including AMENDMENT 1 (2013)]

Withdrawn and replaced with newer version including amendment.

14-386

14-427

ISO 13408-1 Second edition 2008-06-15 Aseptic processing of health care products—Part 1: General requirements [Including AMENDMENT 1 (2013)]

Withdrawn and replaced with newer version including amendment.

14-393

14-411

ISO/ASTM 51818 Third edition 2013-06-01 Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV

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 2 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: 034.

Table 2.—New Entries to the List of Recognized Standards

Recognition No.

Title of standard

1

Reference No. and date

A. Anesthesia

1-96

Medical electrical equipment—Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

ISO 80601-2-55 First edition 2011-12-15.

B. Cardiovascular

3-121

Cardiovascular implants—Endovascular devices—Part 1: Endovascular prostheses [Including: Amendment 1 (2005)]

ISO 25539-1 First edition 2003-03-01.

C. General

5-83

MEDICAL ELECTRICAL EQUIPMENT—Part 1-11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2010, MOD)

ANSI/AAMI HA60601-1-1:2011.

5-84

Design of training and instructional materials for medical devices used in non-clinical environments

AAMI TIR49:2013.

5-85

Medical electrical equipment—Part 1-6: General requirements for basic safety and essential performance—Collateral standard: Usability

IEC 60601-1-6 Edition 3.0 2010-01.

5-86

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

IEC 60601-1-8 Edition 2.0 2006-10.

D. General Hospital/General Plastic Surgery

6-302

Stainless steel needle tubing for the manufacture of medical devices [Including: AMENDMENT 1 2001-06-01]

ISO 9626 First edition 1991-09-01.

6-318

Infusion equipment for medical use—Part 4: Infusion sets for single use, gravity feed [Including: AMENDMENT 1 2013-03-01]

ISO 8536-4 Fifth edition 2010-10-01.

6-320

Medical electrical equipment—Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators [Including: CORRIGENDUM 1 (February 2012) and CORRIGENDUM 2 (February 2013)]

IEC 60601-2-20 Edition 2.0 2009-02.

6-321

Medical electrical equipment—Part 2-52: Particular requirements for basic safety and essential performance of medical beds [Including: CORRIGENDUM 1 (September 2010)]

IEC 60601-2-52 Edition 1.0 2009-12.

6-322

Intravascular catheters—Sterile and single-use catheters—Part 4: Balloon dilatation catheters

ISO 10555-4 Second edition 2013-06-15.

E. Material

8-358

Standard Specification for Polyoxymethylene (Acetal) for Medical Applications

ASTM F1855-00 (Reapproved 2011).

8-359

Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials

ASTM F2038-00 (Reapproved 2011).

8-360

Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Cross-Linking and Fabrication

ASTM F2042-00 (Reapproved 2011).

8-361

Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants

ASTM F755-99 (Reapproved 2011).

8-362

Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications

ASTM F2989-13.

8-363

Standard Test Method for Tensile Properties of Plastics

ASTM D638-10.

8-364

Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement

ASTM D792-08.

8-365

Standard Test Method for Density of Plastics by the Density-Gradient Technique

ASTM D1505-10.

8-366

Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials—Part 2: Preparation of test specimens and determination of properties

ISO 11542-2 First edition 1998-11-15.

8-367

Standard Test Method for Measurement of Fatigue Crack Growth Rates

ASTM E647-13

ε1

.

8-368

Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry

ASTM F2625-10.

8-369

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

ASTM F2003-02 (Reapproved 2008).

F. OB-GYN/Gastroenterology/Urology

9-86

Rubber condoms for clinical trials—Measurement of physical properties Including [AMENDMENT 1 2011-02-15)]

ISO 16037 First Edition 2002-05-15.

9-87

Female condoms—Requirements and test methods

ISO 25841 First Edition 2011-07-15.

9-88

Prophylactic dams—Requirements and test methods

ISO 29942 First Edition 2011-07-01.

9-89

Cardiovascular implants and extracorporeal blood circuit for haemodialysers, haemodiafilters, and haemofilters

ISO 8638 Third edition 2010-07-01.

9-92

Cardiovascular implants and extracorporeal systems—Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators Including [AMENDMENT 1 2013-04-01)]

ISO 8637 Third edition 2010-07-01.

G. Ophthalmics

10-87

Standard Test Method for Tensile Properties of Thin Plastic Sheeting

ASTM D882-12.

10-88

Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials

ASTM D790-10.

H. Orthopedics

11-259

Standard Specification For Total Elbow Prostheses

ASTM F2887-12.

11-260

Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty

ASTM F2943-13.

11-261

Standard Specification for Shoulder Prostheses

ASTM F1378-12

11-262

Standard Specification for Acetabular Prostheses

ASTM F2091-01 (Reapproved 2012).

11-263

Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation

ASTM F2028-08 (Reapproved 2012)

1

.

11-264

Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices

ASTM F1820-13.

11-265

Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis

ASTM F2580-13.

11-266

Standard Specification for Total Ankle Replacement Prosthesis

ASTM F2665-09.

11-267

Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses

ASTM F2009-00 (Reapproved 2011).

11-268

Standard Test Method for Static Evaluation of Glenoid Locking Mechanism in Shear

ASTM F1829-98 (Reapproved 2009).

11-269

Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses

ASTM F2423-11.

11-270

Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants

ASTM F2502-11.

11-271

Standard Specification for Metallic Implantable Strands and Cables

ASTM F2180-02 (Reapproved 2011).

11-272

Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices

ASTM F1714-96 (Reapproved 2013).

11-273

Implants for surgery—Wear of total intervertebral spinal disc prostheses—Part 1 Loading and displacement parameters for wear testing and corresponding environmental conditions for test

ISO 18192-1 Second edition 2011-03-01.

11-274

Implants for surgery—Wear of total intervertebral spinal disc prostheses—Part 2: Nucleus replacements

ISO 18192-2 First edition 2010-06-15.

11-275

Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy

ASTM F2381-10.

I. Radiology

12-261

Information technology—Digital compression and coding of continuous-tone still images: Requirements and guidelines [Including: TECHNICAL CORRIGENDUM 1 (2005)]

ISO/IEC 10918-1 First edition 1994-02-15.

J. Software/Informatics

13-63

Application of risk management for IT-networks incorporating medical devices—Part 2-4: Application guidance—General implementation guidance for healthcare delivery organizations

IEC/TR 80001-2-4 Edition 1.0 2012-11.

13-64

Application of risk management for IT-networks incorporating medical devices—Part 2-4: General implementation guidance for healthcare delivery organizations

ANSI/AAMI/IEC TIR80001-2-4:2012.

K. Sterility

14-429

Practice for use of a radiochromic film dosimetry system

ISO/ASTM 51275 Third edition 2013-06-01.

14-430

Practice for use of an alanine-EPR dosimetry system

ISO/ASTM 51607 Third edition 2013-06-01.

14-431

Guide for estimating uncertainties in dosimetry for radiation processing

ISO/ASTM 51707 Second edition 2005-05-15.

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 033, FDA no longer announces 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) The title of the standard, (2) any reference number and date, (3) the 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: 034” 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: 034. These modifications to the list of recognized standards are effective upon publication of this notice in the

Federal Register

.

Dated: January 23, 2014.

Leslie Kux,

Assistant Commissioner for Policy.

[FR Doc. 2014-01847 Filed 1-29-14; 8:45 am]

BILLING CODE 4160-01-P