Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 020

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 020

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: 020” (Recognition List Number: 020), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

DATES:

Effective September 9, 2008. Submit written or electronic comments concerning this document at any time.

ADDRESSES:

Submit written requests for single copies of “Modifications to the List of Recognized Standards, Recognition List Number: 020” to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health (CDRH) (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your requests, or fax your request to 240-276-3151. 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 to

standards@cdrh.fda.gov

. This document may also be accessed on FDA's Internet site at

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm

. See section VI of this document for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 020 modifications and other standards related information.

FOR FURTHER INFORMATION CONTACT:

Carol L. Herman, Center for Devices and Radiological Health (HFZ-84), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 240-276-8714.

SUPPLEMENTARY INFORMATION:

I. Background

Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements.

In a notice published in the

Federal Register

of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled “Recognition and Use of Consensus Standards.” The document described how FDA would implement its standard recognition program and provided the initial list of recognized standards.

Modifications to the initial list of recognized standards, as published in

the

Federal Register

, are identified in table 1 of this document.

Table 1.—Previous Publications of Standard Recognition Lists

October 16, 1998

(63 FR 55617)

October 4, 2004

(69 FR 59240)

July 12, 1999

(64 FR 37546)

May 27, 2005

(70 FR 30756)

November 15, 2000

(65 FR 69022)

November 8, 2005

(70 FR 67713)

May 7, 2001

(66 FR 23032)

March 31, 2006

(71 FR 16313)

January 14, 2002

(67 FR 1774)

June 23, 2006

(71 FR 36121)

October 2, 2002

(67 FR 61893)

November 3, 2006

(71 FR 64718)

April 28, 2003

(68 FR 22391)

May 21, 2007

(72 FR 28500)

March 8, 2004

(69 FR 10712)

September 12, 2007

(72 FR 52142)

June 18, 2004

(69 FR 34176)

December 19, 2007

(72 FR 71924)

These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The agency maintains “hypertext markup language (HTML)” and “portable document format (PDF)” versions of the list of “FDA Recognized Consensus Standards.” Both versions are publicly accessible at the agency's Internet site. See section VI of this document for electronic access information. Interested persons should review the supplementary information sheet for the standard to understand fully the extent to which FDA recognizes the standard.

II. Modifications to the List of Recognized Standards, Recognition List Number: 020

FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the agency will recognize for use in satisfying premarket reviews and other requirements for devices. In addition to these changes, FDA has also established a new internal numbering system that assigns unique identification recognition numbers. FDA believes this new numbering system will facilitate the use of FDA Form 3654, “Standards Data Report for 510(k)s,” which was implemented in November 2007. 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: 020” to identify these current modifications.

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

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

Table 2.—Modifications to the List of Recognized Standards

Old Recognition No.

Replacement

Recognition No.

Standard

Change

A. Anesthesia

1-11

IEC 60601-3-1:1996-08 Medical Electrical Equipment Part 3-1: Essential Performance Requirements for Transcutaneous Oxygen and Carbon Dioxide Partial Pressure Monitoring Equipment

Withdrawn

1-46

ISO 5367:2000 Breathing Tubes Intended for Use With Anaesthetic Apparatus and Ventilators

Relevant guidance and Extent of recognition

1-51

ASTM F1101-90(1997) Standard Specification for Ventilators Intended for Use During Anesthesia

Withdrawn

1-62

ISO 5356-1:2004 Anaesthetic and Respiratory Equipment—Conical Connectors: Part 1: Cones and Sockets

Relevant guidance

1-66

ISO 9919:2005: Medical Electrical Equipment—Particular Requirements for the Basic Safety and Essential Performance of Pulse Oximeter Equipment for Medical Use

Relevant guidance

1-68

CGA V-5:2005 Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications)

Relevant guidance

1-72

ISO 10651-5:2006 Lung Ventilators for Medical Use—Particular Requirements for Basic Safety and Essential Performance—Part 5: Gas-powered Emergency Resuscitators

Relevant guidance, Code of Federal Regulations (CFR) Citation and Product Codes

1-73

ISO 10651-4:2002 Lung Ventilators—Part 4: Particular Requirements for Operator Powered Resuscitators

Relevant guidance

B. Biocompatibility

2-21

2-118

ANSI/AAMI/ISO 10993-11: 2006 Biological Evaluation of Medical Devices—Part 11: Tests for System Toxicity

Withdrawn and replaced with newer version

2-56

2-119

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

Withdrawn and replaced with newer version

2-63

2-120

ANSI/AAMI/ISO 10993-6: 2007 Biological Evaluation of Medical Devices—Part 6: Tests for Local Effects After Implantation

Withdrawn and replaced with newer version

2-66

2-121

ASTM F2148-07e1 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)

Withdrawn and replaced with newer version

2-68

2-122

ASTM F719-81 (2007) e1 Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation

Withdrawn and replaced with newer version

2-69

2-123

ASTM F720-81 (2007) e1 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test

Withdrawn and replaced with newer version

2-70

2-124

ASTM F750-87 (2007) e1 Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse

Withdrawn and replaced with newer version

2-89

2-125

ASTM F749-98 (2007) e1 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit

Withdrawn and replaced with newer version

2-92

2-126

ASTM F748-06 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

Withdrawn and replaced with newer version

2-95

ASTM F1984-99(2003) Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials

Relevant guidance

2-109

2-128

USP 31-NF26 Biological Test <87> 2008 Biological Reactivity Test, In Vitro—Direct Contact Test

Withdrawn and replaced with newer version

2-110

2-129

USP 31-NF26 Biological Test <88> 2008 Biological Reactivity Test, In Vitro—Elution Test

Withdrawn and replaced with newer version

2-111

2-130

USP 31-NF26 Biological Test <88> 2008 Biological Reactivity Test, In Vitro, Procedure—Preparation of Sample

Withdrawn and replaced with newer version

2-112

2-131

USP 31-NF26 Biological Test <88> 2008 Biological Reactivity Test, In Vitro, Classification of Plastics—Intracutaneous Test

Withdrawn and replaced with newer version

2-113

2-132

USP 31-NF26Biological Test <88> 2008 Biological Reactivity Test, In Vivo—Classification of Plastics—Systemic Injection Test

Withdrawn and replaced with newer version

C. Cardiovascular/Neurology

3-2

ANSI/AAMI EC53:1995/(R)2001—ECG Cables and Leadwires

Reaffirmation

3-3

ANSI/AAMI NS28:1988/(R)2006—Intracranial Pressure Monitoring Devices

Reaffirmation

3-16

3-60

IEC 60601-2-10: Amendment 1: 2001-09, Medical Electrical Equipment—Part 2-10: Particular Requirements for the Safety of Nerve and Muscle Stimulators

Withdrawn and replaced with newer version

3-18

3-61

IEC 60601-2-27: 2005-08, Second Edition, Medical Electrical Equipment—Part 2-27: Particular Requirements for the Safety, Including Essential Performance, of Electrocardiographic Monitoring Equipment

Withdrawn and replaced with newer version

3-20

3-62

IEC 60601-2-31: 2008-03, Edition 2.0, Medical Electrical Equipment—Part 2-31: Particular Requirements for the Basic Safety and Essential Performance of External Cardiac Pacemakers with Internal Power Source

Withdrawn and replaced with newer version

3-25

3-63

ISO 11318:2002, Second Edition, Cardiac Defibrillators—Connector Assembly DF-1 for Implantable Defibrillators—Dimensions and Test Requirements

Withdrawn and replaced with newer version

3-40

ANSI/AAMI SP9:1994, Non-automated Sphygmomanometers

Withdrawn

3-41

ANSI/AAMI EC11:1991/(R)2007—Diagnostic Electrocardiographic Devices

Reaffirmation

3-42

ANSI/AAMI EC13:2002/(R)2007—Cardiac Monitors, Heart Rate Meters, and Alarms

Reaffirmation

3-43

3-65

ANSI/AAMI EC38:2007—Medical Electrical Equipment—Part 2-47: Particular Requirements for the Safety, Including Essential Performance, of Ambulatory Electrocardiographic Systems

Withdrawn and replaced with newer version

3-44

ANSI/AAMI BP22:1994/(R)2006, Blood Pressure Transducers

Reaffirmation

3-45

ANSI/AAMI EC57:1998/(R)2003, Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms

Reaffirmation

3-47

3-66

ASTM F2081-06, Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

Withdrawn and replaced with newer version

3-52

ANSI/AAMI EC12:2000/(R)2005, Disposable ECG Electrodes

Reaffirmation

3-57

3-67

ASTM F2129-06, Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices

Withdrawn and replaced with newer version

D. Dental/Ear, Nose, and Throat

4-43

ANSI/ADA Specification No. 5-Dental Casting Alloys:1997

Type of standard, and Relevant guidance

4-50

ANSI/ADA Specification No. 18-Alginate Impression Materials:1992

Title and Relevant guidance

4-52

4-147

ANSI/ADA Specification No. 27-Resin-Based Filling Materials: 2005

Withdrawn and replaced with newer year

4-62

ISO 1563:1990 Dental Alginate Impression Material

Relevant guidance and Extent of recognition

4-63

ISO 1564:1995 Dental Aqueous Impression Materials Based on Agar

Relevant guidance

4-65

4-151

ISO 3336:1993, Dentistry—Synthetic Polymer Teeth

Withdrawn and replaced with newer version

4-66

ISO 4049:1988, Dentistry—Resin-Based Filling Materials

Withdrawn—newer version previously recognized

4-67

ISO 6871-1:1994, Dental Base Metal Casting Alloys Part 1: Cobalt-based Alloys—TECHNICAL CORRIGENDUM 1:1998

Withdrawn—newer version previously recognized

4-68

ISO 6871-2:1994, Dental Base Metal Casting Alloys Part 2: Nickel-Based Alloys

Withdrawn—newer version previously recognized

4-69

ISO 6872:1995/Amendment 1:1997 Dental Ceramic

Date of standard and Extent of recognition

4-73

ISO 7405:1997 Dentistry—Preclinical Evaluation of Biocompatibility of Medical Devices Used in Dentistry—Test Methods for Dental Materials

Extent of recognition and Contact person

4-75

ISO 7785-1:1997 Dental Handpieces—Part 1: High-Speed Air Turbine Handpieces

Relevant guidance and Extent of recognition

4-76

ISO 7785-2:1995 Dental Handpieces—Part 2: Straight and Geared Angle Handpieces

Relevant guidance and Extent of recognition

4-78

ISO 9168:1991 Dental Handpieces—Hose Connectors

Relevant guidance and Extent of recognition

4-83

ISO 11498:1997 Dental Handpieces—Dental Low-Voltage Electrical Motors

Relevant guidance and Extent of recognition

4-84

ISO 13294:1997 Dental Handpieces—Dental Air-Motors

Relevant guidance and Extent of recognition

4-88

4-148

ANSI/ADA Specification No. 78-Endodontic Obturating Cones: 2005

Withdrawn and replaced with newer version

4-89

ANSI/ADA Specification No. 53-Polymer-Based Crowns and Bridge Resins: 1999 (Reaffirmed 2005)

Reaffirmation and Relevant guidance

4-90

ANSI/ASA S3.39:1987 (R2007), Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance)

Reaffirmation and Type of standard

4-91

ANSI/ADA Specification No. 80-Dental Materials—Determination of Color Stability: 2001

Relevant guidance

4-92

ANSI/ADA Specification No. 88-Dental Brazing Alloys: 2000 (Reaffirmed 2006)

Reaffirmation and Relevant guidance

4-93

4-159

IEEE ANSI C63.19:2007 Methods of Measurement of Compatibility Between Wireless Communications Devices and Hearing Aids

Withdrawn and replaced with newer version

4-94

ANSI/ADA Specification No. 14—Dental Base Metal Casting Alloys: 1982 (Reaffirmed 1998)

Reaffirmation, Date of standard, Type of standard, Offices, Relevant guidance

4-95

ANSI/ADA Specification No.17:1999, Dental Base Temporary Relining Resin

Withdrawn—newer version previously recognized

4-96

ANSI/ADA Specification No. 30—Dental Zinc Oxide—Eugenol and Zinc Oxide—Non-Eugenol Cements: 2000 (Reaffirmed 2005)

Reaffirmation and Relevant guidance

4-97

ANSI/ADA Specification No. 57—Endodontic Sealing Material: 2000 (Reaffirmed 2006)

Reaffirmation, Offices and Type of standard

4-98

ANSI/ADA Specification No. 96:2000, Dental-Water-Based Cements

Withdrawn—newer version previously recognized

4-99

ISO 4049: 2000 Dentistry—Polymer-based Filling, Restorative and Luting Materials

Relevant guidance, Type of standard and Extent of recognition

4-100

4-133

ISO 6876:2001, Dental Root Canal Sealing Materials

Withdrawn (duplicate)

4-101

ISO 8891:1998, Dental Casting Alloys With Noble Metal Content of At Least 25% but Less Than 75%

Withdrawn—newer version previously recognized

4-102

4-152

ISO 9693:1999, Metal-Ceramic Dental Restorative Systems

Withdrawn and replaced with newer version

4-104

4-149

ANSI/ADA Specification No. 39—Pit and Fissure Sealants: 2006

Withdrawn and replaced with newer version

4-105

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

Type of standard and Relevant guidance

4-107

ISO 9917-2:1998 Dental Water-Based Cements—Part 2: Light-Activated Cements

Devices affected, Type of standard, Relevant guidance and Extent of recognition

4-109

ISO 13716:1999 Dentistry—Reversible-Irreversible Hydrocolloid Impression Material Systems

Type of standard, Relevant guidance, Extent of recognition and Code of Federal Regulations (CFR) citation

4-110

ANSI/ADA Specification No. 11—Agar Impression Materials: 1997

Type of standard and Relevant guidance

4-111

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

Reaffirmation, Date of standard, Type of standard and Relevant guidance

4-112

ANSI/ADA Specification No. 16—Dental Impression Paste—Zinc Oxide-Eugenol Type: 1961 (Reaffirmed 1999)

Reaffirmation, Date of standard, Type of standard and Relevant guidance

4-113

ANSI/ADA Specification No. 20—Dental Duplicating Material: 1972 (Reaffirmed 1995)

Reaffirmation, Date of standard, Type of standard and Relevant guidance

4-115

4-153

ISO 9917-1:2007 Dentistry—Water-Based Cements—Part 1: Powder/Liquid Acid-Base Cements

Withdrawn and replaced with a newer year

4-117

ANSI/ADA Specification No. 12—Denture Base Polymers: 2002

Type of standard

4-119

ANSI/ADA Specification No. 82—Dental Reversible/Irreversible Hydrocolloid Impression Material Systems: 1998 (Reaffirmed 2003)

Reaffirmation, Date of standard, Type of standard and Relevant guidance

4-120

ISO 10139-2:1999 Dentistry—Soft Lining Materials for Removable Dentures—Part 2: Materials for Long-Term Use

Type of standard, Relevant guidance and Extent of recognition

4-121

ISO 7494-2:2003 Dentistry—Dental Units—Part 2: Water and Air Supply

Type of standard and Extent of recognition

4-125

ISO 1562:2004, Dentistry—Casting Gold Alloys

Withdrawn—newer version previously recognized

4-126

ISO 10477:2004 Dentistry—Polymer-Based Crown and Bridge Materials

Extent of recognition and Relevant guidance

4-127

ANSI/ADA Specification No. 58—Root Canal Files, Type H (Hedstrom): 2004

Type of standard and Extent of recognition

4-128

ISO 4823:2000,, Dentistry—Elastomeric Impression Materials and Technical Corrigendum 1:2004

Withdrawn

4-129

4-150

ANSI/ADA Specification No. 19—Dental Elastomeric Impression Material: 2004

Withdrawn and replaced with newer version

4-130

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

Reaffirmation, Processes impacted, Extent of recognition, CFR citations and Relevant guidance

4-131

ISO 3107: 2004 Dentistry—Zinc Oxide/Eugenol and Zinc Oxide/Non-eugenol Cements Technical Corrigendum 1:2006-Third Edition

Processes impacted and Relevant guidance

4-132

ISO 6874:2005 Dentistry—Polymer-Based Pit and Fissure Sealants

Extent of recognition and Relevant guidance

4-133

ISO 6876:2001 Dental Root Canal Sealing Materials

Processes impacted and Extent of recognition

4-134

ISO 7494-1:2004 Dentistry—Dental Units—Part 1: General Requirements and Test Methods

Extent of recognition

4-135

ISO 10139-1:2005 Dentistry—Soft Lining Materials for Removable Dentures—Part 1: Materials for Short-term Use

Relevant guidance and Extent of recognition

4-136

ASTM F2504-05 Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices

Relevant guidance

4-137

ISO 6877:2006 Dentistry—Root-Canal Obturating Points

Extent of recognition

4-139

ANSI/ADA Specification No. 48—Visible Light Curing Units: 2004

Relevant guidance

4-140

ISO 6871-2:1994/Amd 1:2005, Dental Base Metal Casting Alloys—Part 2: Nickel-Based Alloys

Withdrawn—newer version previously recognized

4-141

ISO 6871-1:1994, Dental Base Metal Casting Alloys—Part 1: Cobalt-Based Alloys

Withdrawn—newer version previously recognized

4-142

ISO 6871-1:1994/Amd 1:2005, Dental Base Metal Casting Alloys—Part 1: Cobalt-Based Alloys

Withdrawn—newer version previously recognized

4-143

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

Reaffirmation, Type of standard and Relevant guidance

4-145

ISO 22803:2004 Dentistry—Membrane Materials for Guided Tissue Regeneration in Oral and Maxillofacial Surgery—Contents of a Technical File

Relevant guidance and Devices affected

4-146

ISO 22674:2006 Dentistry—Metallic Materials for Fixed and Removable Restorations and Appliances

Devices affected and Processes impacted

E. General

5-7

12-185

IEC 60601-1-3(1994-07) Medical Electrical Equipment—Part 1: General Requirements for Safety; General Requirements for Radiation Protection in Diagnostic X-Ray Equipment

Transferred

5-8

5-41

IEC 60601-1-4:2000 Medical Electrical Equipment—Part 1-4: General Requirements for Safety—Collateral Standard: Programmable Electrical Medical Systems, Edition 1.1

Withdrawn and replaced with newer version

5-16

5-42

ASTM D903-98(2004) Standard Test Methods for Peel or Stripping Strength of Adhesive Bonds

Withdrawn and replaced with newer version

5-19

ASTM E876/1995 Standard Practice for Use of Statistics in the Evaluation of Spectrometric Data

Withdrawn

5-25

5-43

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

Withdrawn and replaced with newer version

5-28

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

Extent of recognition

5-30

AAMI/ANSI/IEC 60601-1-2 Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests (AAMI/ANSI/IEC 60601-1-2:2001 is the U.S. version of IEC 60601-1-2:2001 with identical requirements for electromagnetic compatibility (EMC) of medical electrical equipment.)

Type of standard and Extent of recognition

5-33

5-44

IEC 60601-1-8:2006 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, Second Edition

Withdrawn and replaced with newer version

5-34

IEC 60601-1-2 Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004))

Extent of recognition

5-35

AAMI/ANSI/IEC 60601-1-2 Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral standard: Electromagnetic Compatibility—Requirements and Tests (Edition 2:2001 with Amendment 1:2004) (AAMI/ANSI/IEC 60601-1-2:2001 with Amendment 1:2004 is the U.S. version of IEC 60601-1-2:2001 with Amendment 1:2004, with identical requirements for electromagnetic compatibility (EMC) of medical electrical equipment)

Type of standard and Extent of recognition

5-36

ANSI/AAMI/ISO TIR 16142:2006: Technical Information Report: Medical Devices—Guidance on the Selection of Standards in Support of Recognized Essential Principles of Safety and Performance of Medical Devices, Second Edition

CFR Citations, Product codes and Relevant guidance

F. General Hospital/General Plastic Surgery

6-16

ISO 7886-1:1993 Sterile Hypodermic Syringes for Single Use—Part 1: Syringes for Manual Use

Withdrawn

6-117

ASTM F2172-02: Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers

Relevant guidance

6-118

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

Relevant guidance, Contact person

6-131

6-203

ASTM D6499-07 Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products

Withdrawn and replaced with newer version

6-160

6-204

ISO 8537:2007 Sterile Single-Use Syringes, With or Without Needle, for Insulin

Withdrawn and replaced with newer version

6-166

6-215

ASTM F2132-01(2008) Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps

Withdrawn and replaced with newer version

6-167

ASTM D6319-00a(2005) Standard Specification for Nitrile Examination Gloves for Medical Application

Relevant guidance

6-188

6-205

USP 31:2008 Nonabsorbable Surgical Suture

Withdrawn and replaced with newer version

6-189

6-206

USP 31<11>2008 Sterile Sodium Chloride for Irrigation

Withdrawn and replaced with newer version

6-190

6-207

USP 31:2008 Absorbable Surgical Suture

Withdrawn and replaced with newer version

6-191

6-208

USP 31<881>:2008 Tensile Strength

Withdrawn and replaced with newer version

6-192

6-209

USP 31<861>:2008 Sutures—Diameter

Withdrawn and replaced with newer version

6-193

6-210

USP 31<871>:2008 Sutures Needle Attachment

Withdrawn and replaced with newer version

6-194

6-211

USP 31<11>: 2008 Sterile Water for Irrigation

Withdrawn and replaced with newer version

6-195

6-212

USP 31<11>: 2008 Heparin Lock Flush Solution

Withdrawn and replaced with newer version

6-196

6-213

USP 31<11>: 2008 Sodium Chloride Injection

Withdrawn and replaced with newer version

6-198

ASTM F2100-07 Standard Specification for Performance of Materials Used in Medical Face Masks

Relevant guidance

6-201

ISO 8536-4:2007 Infusion Equipment for Medical Use—Part 4: Infusion Sets for Single Use, Gravity Feed

Relevant guidance

G. In Vitro Diagnostic

7-6

7-131

CLSI ILA18-A2 Specifications for Immunological Testing for Infectious Diseases

Withdrawn and replaced with newer version

7-11

7-132

CLSI MM03-A2 Molecular Diagnostic Methods for Infectious Diseases

Withdrawn and replaced with newer version

7-12

CLSI/NCCLS C12-A Definitions of Quantities and Conventions Related to Blood pH and Gas Analysis; Approved Standard (1994)

Withdrawn

7-13

CLSI/NCCLS C21-A Performance Characteristics for Devices Measuring PO2 and PCO2 in Blood Samples; Approved Standard (1992)

Withdrawn

7-15

CLSI/NCCLS C25-A Fractional Oxyhemoglobin, Oxygen Content and Saturation, and Related Quantities in Blood: Terminology, Measurement, and Reporting; Approved Guideline (1997)

Withdrawn

7-16

CLSI/NCCLS C27-A Blood Gas Preanalytical Considerations: Specimen Collection, Calibration, and Controls; Approved Guideline (1993)

Withdrawn

7-18

7-133

CLSI C30-A2, Point-of Care Blood Glucose Testing in Acute and Chronic Care Facilities

Withdrawn and replaced with newer version

7-21

CLSI C42-A, Erythrocyte Protoporphyrin Testing; Approved Guideline (1996)

Contact person

7-22

7-134

CLSI GP20-A2 Fine-Needle Aspiration Biopsy (FNAB) Techniques

Withdrawn and replaced with newer versions

7-25

NCCLS H8-A2 Detection of Abnormal Hemoglobin Using Cellulose Acetate Electrophoresis—Second Edition; Approved Standard (1994)

Withdrawn

7-26

NCCLS H9-A Chromatographic (Microcolumn) Determination of Hemoglobin A2; Approved Standard (1989)

Withdrawn

7-27

NCCLS H10-A2 Solubility Test to Confirm the Presence of Sickling Hemoglobins—Second Edition; Approved Standard (1995)

Withdrawn

7-29

NCCLS H14-A2 Devices for Collection of Skin Puncture Blood Specimens—Second Edition; Approved Guideline (1990)

Withdrawn

7-34

7-135

CLSI H44-A2 Methods for Reticulocyte Counting (Flow Cytometry and Supravital Dyes)

Withdrawn and replaced with newer version

7-35

CLSI H47-A One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline (1996)

Contact person

7-36

7-136

CLSI ILA02-A2 Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens

Withdrawn and replaced with newer version

7-37

CLSI ILA06-A Detection and Quantitation of Rubella IgG Antibody

Contact person

7-38

CLSI/NCCLS I/LA10-A Choriogonadotropin Testing: Nomenclature, Reference Preparations, Assay Performance, and Clinical Application; Approved Guideline (1996)

Withdrawn

7-39

CLSI/NCCLS I/LA17-A Assessing the Quality of Systems for Alpha-Fetoprotein (AFP) Assays Used in Prenatal Screening and Diagnosis of Neural Tube Defects; Approved Guideline (1997)

Withdrawn

7-40

NCCLS I/LA18-A Specifications for Immunological Testing for Infectious Diseases; Approved Guideline (1994)

Withdrawn

7-41

CLSI ILA19-A Primary Reference Preparations Used to Standardize Calibration of Immunochemical Assays for Serum Prostate Specific Antigen (PSA); Approved Guideline (1997)

Contact person

7-42

CLSI ILA20-A Evaluation Methods and Analytical Performance Characteristics of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies of Defined Allergen Specificities; Approved Guideline (1997)

Contact person

7-43

7-137

CLSI LA04-A5 Blood Collection on Filter Paper for Newborn Screening Programs

Withdrawn and replaced with newer version

7-46

7-138

CLSI M27-A2, Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts

Withdrawn and replaced with newer version

7-49

CLSI H26-A Performance Goals for the Internal Quality Control of Multichannel Hematology Analyzers; Approved Standard

Contact person

7-50

NCCLS D11-A2 Glossary and Guidance for Immunodiagnostic Procedures, Reagents, and Reference Materials—Second Edition, Approved Guideline

Withdrawn

7-51

7-139

CLSI GP27-A2 Using Proficiency Testing to Improve the Clinical Laboratory

Withdrawn and replaced with newer version

7-52

CLSI / NCCLS NRSCL 8-A Terminology and Definitions for use in NCCLS Documents; Approved Standard

Withdrawn

7-53

7-140

CLSI GP22-A2 Continuous Quality Improvement

Withdrawn and replaced with newer version

7-55

7-141

CLSI H18-A3 Procedures for the Handling and Processing of Blood Specimens

Withdrawn and replaced with newer version

7-58

7-142

CLSI H11-A4 Procedures for the Collection of Arterial Blood Specimens

Withdrawn and replaced with newer version

7-59

13-9

CLSI / NCCLS AUTO2-A Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard

Transferred

7-60

13-10

NCCLS AUTO1-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard

Transferred

7-61

13-11

NCCLS AUTO3-A Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard

Transferred

7-62

13-12

NCCLS AUTO4-A Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard

Transferred

7-63

13-13

NCCLS AUTO5-A Laboratory Automation: Electromechanical Interfaces; Approved Standard

Transferred

7-64

13-14

NCCLS POCT1-A Point-of-Care Connectivity; Approved Standard

Transferred

7-67

7-143

CLSI EP14-A2 Evaluation of Matrix Effects

Withdrawn and replaced with newer version

7-68

13-15

NCCLS GP19-A2 Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline—Second Edition

Transferred

7-70

7-144

CLSI H4-A5 Procedures and Devices for the Collection of Diagnostic Blood Specimens by Skin Puncture

Withdrawn and replaced with newer version

7-72

7-145

CLSI H42-A2 Enumeration of Immunologically Defined Cell Populations by Flow Cytometry

Withdrawn and replaced with newer version

7-74

7-146

NCCLS M6-A2 Protocols for Evaluating Dehydrated Mueller-Hinton Agar

Withdrawn and replaced with newer version

7-77

7-147

CLSI M22-A3 Quality Control for Commercially Prepared Microbiological Culture Media

Withdrawn and replaced with newer version

7-79

7-148

CLSI M28-A2 Procedures for the Recovery and Identification of Parasites From the Intestinal Tract

Withdrawn and replaced with newer version

7-80

CLSI MM01-A2 Molecular Diagnostic Methods for Genetic Diseases

Withdrawn

7-83

NCCLS C46-A Blood Gas and pH Analysis and Related Measurements; Approved Guideline

Withdrawn

7-85

7-149

CLSI C24-A3 Statistical Quality Control for Quantitative Measurement Procedures

Withdrawn and replaced with newer version

7-90

7-150

CLSI H43-A2 Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells

Withdrawn and replaced with newer version

7-93

NCCLS EP10-A2, Preliminary Evaluation of Quantitative Clinical Laboratory Methods; Approved Guideline

Withdrawn

7-94

7-152

CLSI EP12-A2 User Protocol for Evaluation of Qualitative Test Performance

Withdrawn and replaced with newer version

7-95

7-153

CLSI EP15-A2 User Verification of Performance for Precision and Trueness

Withdrawn and replaced with newer version

7-98

7-154

CLSI MM02-A2 Immunoglobin and T-Cell Receptor Gene Rearrangement Assays

Withdrawn and replaced with newer version

7-99

CLSI MM5-A Nucleic Acid Amplification Assays for Molecular Hematopathology

Contact person

7-103

7-155

CLSI H03-A6 Procedures for the Collection of Diagnostic Blood Specimens by Venipunture

Withdrawn and replaced with newer version

7-106

7-156

CLSI M02-A9 Performance Standards for Antimicrobial Disk Susceptibility Tests

Withdrawn and replaced with newer version

7-107

7-157

CLSI M11-A7 Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria

Withdrawn and replaced with newer version

7-108

7-158

CLSI M7-A7 Methods for Antimicrobial Susceptibility Tests of Anaerobic Bacteria

Withdrawn and replaced with newer version

7-109

CLSI AUTO7-A Laboratory Automation: Data Content for Specimen Identification; Approved Standard

Withdrawn

7-111

7-159

CLSI H21-A5 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays

Withdrawn and replaced with newer version

7-114

13-16

CLSI LIS01-A Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems

Transferred

7-115

13-17

CLSI LIS02-A2 Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition

Transferred

7-116

13-18

CLSI LIS03-A Standard Guide for Selection of a Clinical Laboratory Information Management System

Transferred

7-117

13-19

CLSI LIS04-A Standard Guide for Documentation of Clinical Laboratory Computer Systems

Transferred

7-118

13-20

CLSI LIS05-A, Standard Specification for Transferring Clinical Observations Between Independent Computer Systems

Transferred

7-119

13-21

CLSI LIS06-A Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems

Transferred

7-120

13-22

CLSI LIS07-A Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory

Transferred

7-121

13-23

CLSI LIS08-A Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems

Transferred

7-122

13-24

CLSI LIS09-A Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures

Transferred

7-125

CLSI/NCCLS M28-A2 Volume 25, No. 16 Procedures for the Recovery and Identification of Parasites From the Intestinal Tract; Approved Guideline

Withdrawn

H. Materials

8-32

ASTM F1586-02: Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675)

Contact person

8-44

ASTM F0136-02a: Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

Contact person

8-46

8-154

ASTM F0621-08: Standard Specification for Stainless Steel Forgings for Surgical Implants

Withdrawn and replaced with newer year version

8-50

ASTM F1091-02: Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605)

Contact person

8-52

ASTM F1350-02: Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)

Contact person

8-53

ASTM F1472-02a: Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS R56400)

Contact person

8-54

8-155

ASTM F1580-07 Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants

Withdrawn and replaced with newer year version

8-57

ISO 5832-2:1999, Implants for Surgery—Metallic Materials—Part 2: Unalloyed Titanium

Contact person

8-58

ISO 5832-3:1996, Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy

Contact person

8-59

ISO 5832-4:1996, Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy

Contact person

8-61

ISO 5832-6:1997, Implants for Surgery—Metallic Materials—Part 6: Wrought Cobalt-Nickel-Chromium-Molybdenum Alloy

Contact person

8-63

ISO 5832-11:1994, Implants for Surgery—Metallic Materials—Part 11: Wrought Titanium 6-Aluminium 7-Niobium Alloy

Contact person

8-76

ASTM F138-03: Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

Contact person

8-77

8-156

ASTM F0139-08, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)

Withdrawn and replaced with newer year version

8-79

ASTM F0961-03, Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants [UNS R30035]

Contact person

8-81

ASTM F1609-03 Standard Specification for Calcium Phosphate Coatings for Implantable Materials

Contact person

11-81

8-157

ISO 9583:1993 Implants for Surgery—Non-Destructive Testing—Liquid Penetrant Inspection of Metallic Surgical Implants

Transferred

8-82

8-158

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

Withdrawn and replaced with newer year version

11-82

8-159

ISO 9584:1993 Implants for Surgery—Non-Destructive Testing—Radiographic Examination of Cast Metallic Surgical Implants

Transferred

8-86

ASTM F1926-03 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Coatings

Relevant guidance

8-88

ASTM F2024-00 Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings

Relevant guidance

8-98

8-162

ASTM F451-99a(2007)e1 Standard Specification for Acrylic Bone Cement

Withdrawn and replaced with newer year version

8-104

ASTM F1108-04 Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)

Contact person

8-108

ASTM F1295-05 Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700)

Contact person

8-110

ASTM F1377-04 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)

Contact person

8-112

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

Relevant guidance

8-113

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

Relevant guidance

8-119

ASTM F688-05 Standard Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)

Contact person

8-120

8-160

ASTM F0560-07 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)

Withdrawn and replaced with newer year version

8-123

ISO 5832-5:2005 Implants for Surgery—Metallic Materials—Part 5: Wrought Cobalt-Chromium-Tungsten-Nickel Alloy

Contact person

8-127

ISO 5834-2:2006 Implants for Surgery—Ultra-high-molecular-weight polyethylene—Part 2: Moulded Forms

Relevant guidance

8-129

ASTM F67-06 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)

Contact person

8-130

ASTM F620-06 Standard Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants

Contact person

8-131

ASTM F799-06 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)

Contact person

8-132

ASTM F1088-04ae1 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation

Contact person

8-137

ASTM F0075-07 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)

Contact person

8-138

ASTM F0745-07 Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications

Contact person

8-139

ASTM F1314-07 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)

Contact person

8-142

ASTM F1978-00(2007)e2 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser

Relevant guidance

8-144

ASTM F0754-00 Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Polymer Fabricated in Sheet, Tube and Rod Shapes

Contact person

8-145

ASTM F0090-07 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)

Contact person

8-147

ASTM F0562-07 Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)

Contact person

8-149

ISO 5832-1:2007 Implants for Surgery—Metallic Materials—Part 1: Wrought Stainless Steel

Contact person

8-150

ISO 5832-9:2007 Implants for Surgery—Metallic Materials—Part 9: Wrought High Nitrogen Stainless Steel

Contact person

8-151

ISO 5832-12:2007 Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy

Contact person

8-152

ASTM F1537-07 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)

Contact person

I. OB-GYN/Gastroenterology

9-4

IEC 60601-2-16 (1998) Medical Electrical Equipment—Part 2-16: Particular Requirements for the Safety of Haemodialysis, Haemodiafiltration and Haemofiltration Equipment

Relevant guidance and Contact person

9-6

IEC 60601-2-36 (1997) Medical Electrical Equipment—Part 2-36: Particular Requirements for the Safety of Equipment for Extracorporeally Induced Lithotripsy

Title, Relevant guidance, CFR Citation, and Product Codes

9-7

IEC 61846 (1998) Ultrasonics—Pressure Pulse Lithotripters—Characteristics of Fields

Relevant guidance, CFR Citation, and Product Codes

9-21

ISO 8600-4:1997 Optics and Optical Instruments—Medical Endoscopes and Certain Accessories—Part 4: Determination of Maximum Width of Insertion Portion

Relevant guidance

9-23

ASTM F1518-00 Standard Practice for Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes Used in the Examination of the Hollow Viscera

Relevant guidance, CDRH Office and Division associated with recognized standard

9-25

AAMI / ANSI HF18:2001 Electrosurgical Devices

Withdrawn

9-28

9-47

ANSI/AAMI RD16:2007 Cardiovascular Implants and Artificial Organs—Hemodialyzers, Hemodiafilters, Hemofilters, and Hemoconcentrators

Withdrawn and replaced with newer version

9-29

9-48

AAMI / ANSI RD17 :2007 Cardiovascular Implants and artificial organs—Extracorporeal Blood Circuit for Hemodialyzers, Hemodiafilters, and Hemofilters

Withdrawn and replaced with newer version

9-32

ASTM D3492-03 Standard Specification for Rubber Contraceptives (Male Condoms)

Relevant guidance

9-34

ISO 4074:2002/Cor.1:2003(E) Natural Latex Rubber Condoms—Requirements and Test Methods, Technical Corrigendum 1

Relevant guidance

9-37

ISO 8600-1:2005 Optics and Photonics—Medical Endoscopes and Endotherapy Devices—Part 1: General Requirements ISO 8600-1:2005

Relevant guidance

9-38

ISO 8600-3:1997 Amendment 1 2003, Optics and Optical Instruments—Medical Endoscopes and Endoscopic Accessories Part 3: Determination of Field of View and Direction of View of Endoscopes with Optics

Relevant guidance

9-39

ISO 8600-5:2005 Optics and Photonics—Medical Endoscopes and Endotherapy Devices—Part 5: Determination of Optical Resolution of Rigid Endoscopes with Optics

Relevant guidance

9-40

ISO 8600-6:2005 Optics and Photonics—Medical Endoscopes and Endotherapy Devices—Part 6: Vocabulary

Relevant guidance

9-41

ASTM D6324-05 Standard Test Methods for Male Condoms Made from Synthetic Materials

Relevant guidance

9-42

IEC 60601-2-18 (1996) Amendment 1 2000 Medical electrical equipment—Part 2: Particular Requirements for the Safety of Endoscopic Equipment

Relevant guidance

9-43

ISO 16038:2005 Rubber Condoms—Guidance on the Use of ISO 4074 in the Quality Management of Natural Rubber Latex Condoms

Relevant guidance

J. Ophthalmic

10-21

ISO 11979-2:1999 Ophthalmic Implants—Intraocular Lenses—Part 2: Optical Properties and Test Methods

Withdrawn

10-23

ISO 11981:1999 Ophthalmic Optics—Contact Lenses and Contact Lens Care Products—Determination of Physical Compatibility of Contact Lens Care Products With Contact Lenses

Withdrawn

10-42

ISO 11979-2:1999/Corrigendum1:2003 Ophthalmic Implants—Intraocular Lenses—Part 2: Optical Properties and Test Methods

Extent of recognition and Process impacted

10-44

ISO 11981:1999/Corrigendum1:2005 Ophthalmic Optics—Contact Lenses and Contact Lens Car Products—Determination of Physical Compatibility of Contact Lens Care Products with Contact Lenses

Relevant guidance and Process impacted

K. Orthopedic

11-73

ISO 5838-1:1995 Implants for Surgery—Skeletal Pins and Wires—Part 1: Material and Mechanical Requirements

Type of standard and Contact person

11-74

ISO 5838-2:1991 Implants for Surgery—Skeletal Pins and Wires—Part 2: Steinmann Skeletal Pins—Dimensions

Type of standard and Contact person

11-75

ISO 5838-3:1993 Implants for Surgery—Skeletal Pins and Wires—Part 3: Kirschner Skeletal Wires

Type of standard and Contact person

11-79

ISO 7206-8:1995 Implants for Surgery—Partial and Total Hip Joint Prostheses—Part 8: Endurance Performance of Stemmed Femoral Components with Application of Torsion

Type of standard, CFR Citation, Product codes and Relevant guidance

11-80

ISO 8828:1988 Implants for Surgery—Guidance on Care and Handling of Orthopaedic Implants

Contact person Processes Impacted

11-81

8-157

ISO 9583:1993 Implants for Surgery—Non-Destructive Testing—Liquid Penetrant Inspection of Metallic Surgical Implants

Transferred

11-82

8-159

ISO 9584:1993 Implants for Surgery—Non-Destructive Testing—Radiographic Examination of Cast Metallic Surgical Implants

Transferred

11-155

ISO 7207-2:1998 Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 2: Articulating Surfaces Made of Metal, Ceramic and Plastics Materials

Type of standard and Relevant guidance

11-164

11-203

ASTM F1541-02(2007) Standard Specification and Test Methods for External Skeletal Fixation Devices

Withdrawn and replaced with newer version

11-166

11-204

ASTM F0897-02(2007) Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws

Withdrawn and replaced with newer version

11-168

ASTM F1781-03 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants

Type of standard

11-171

ASTM F1814-97a(2003) Standard Guide for Evaluating Modular Hip and Knee Joint Components

Type of standard and Relevant guidance

11-172

ASTM F1798-97(2003) Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants

Type of standard and Relevant guidance

11-175

ASTM F1582-98(2003) Standard Terminology Relating to Spinal Implants

Type of standard, CFR Citation, Product codes and Relevant guidance

11-177

11-205

ASTM F1264-03(2007) Standard Specification and Test Methods for Intramedullary Fixation Devices

Withdrawn and replaced with newer version

11-178

ASTM F1440-92(2002) Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion

Processes impacted, Type of standard, CFR Citation, Product codes and Relevant guidance

11-179

ASTM F2068-03 Standard Specification for Femoral Prostheses—Metallic Implants

Processes impacted, Type of standard, CFR Citation, Product codes and Relevant guidance

11-180

ASTM F0366-04 Standard Specification for Fixation Pins and Wires

Type of standard and Contact person

11-181

ASTM F1717-04 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

Type of standard and Relevant guidance

11-182

11-206

ASTM F1800-07 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements

Withdrawn and replaced with newer version

11-183

ASTM F1875-98(2004) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface

Type of standard, CFR Citations, Product codes and Relevant guidance

11-184

ISO 8827:1988 Implants for surgery—Staples with Parallel Legs for Orthopaedic Use—General Requirements

Type of standard and Contact person

11-185

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

CFR Citations, Product codes and Relevant guidance

11-186

ASTM F2077-03 Test Methods for Intervertebral Body Fusion Devices

Type of standard, CFR Citations, Product codes and Relevant guidance

11-187

11-207

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

Withdrawn and replaced with newer version

11-188

ISO 14243-1:2002 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

Type of standard, CFR Citations and Product codes

11-189

ISO 14243-2:2000 Implants for Surgery—Wear of Total Knee-Joint Prostheses—Part 2: Methods of Measurement

Type of standard, Extent of recognition, CFR Citations and Product codes

11-190

ISO 14243-3:2004 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

Type of standard, CFR Citations and Product codes

11-191

ISO 14879-1:2000 Implants for Surgery—Total Knee-Joint Prostheses—Part 1: Determination of Endurance Properties of Knee Tibial Trays

Type of standard

11-192

ASTM F1223-05 Standard Test Method for Determination of Total Knee Replacement Constraint

Type of standard CFR Citations and Product codes

11-194

11-208

ISO 14630:2008 Non-Active Surgical Implants—General Requirements—3d Edition

Withdrawn and replaced with newer version

11-195

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

Type of standard, CFR Citations, Product codes and Relevant guidance

11-196

ASTM F1672-95(2005) Standard Specification for Resurfacing Patellar Prosthesis

Type of standard and Relevant guidance

11-197

ASTM F0983-86(2005) Standard Practice for Permanent Marking of Orthopaedic Implant Components

Contact person and Processes impacted

11-198

ASTM F0382-99(2003)e1 Standard Specification and Test Method for Metallic Bone Plates

Type of standard and Contact person

11-199

ASTM F0565-04 Standard Practice for Care and Handling of Orthopedic Implants and Instruments

Contact person and Processes impacted

11-200

11-209

ASTM F2083-07 Standard Specification for Total Knee Prosthesis

Withdrawn and replaced with newer version

11-201

ASTM F0564-02(2006) Standard Specification and Test Methods for Metallic Bone Staples

Contact person

11-202

11-210

ASTM F0543-07 Standard Specification and Test Methods for Metallic Medical Bone Screws

Withdrawn and replaced with newer version

L. Physical Medicine

16-19

ISO 7176-4:1997 Wheelchairs—Part 4: Energy Consumption of Electric Wheelchairs and Scooters for Determination of Theoretical Distance Range

Contact person and Type of standard

16-20

ISO 7176-5:1986 Wheelchairs—Part 5: Determination of Overall Dimensions, Mass and Turning Space

Contact person and Type of standard

16-23

ISO 7176-10:1988 Wheelchairs—Part 10: Determination of Obstacle-Climbing Ability of Electric Wheelchairs

Contact person and Type of standard

16-24

ISO 7176-11:1992 Wheelchairs—Part 11: Test Dummies

Contact person and Type of standard

16-25

ISO 7176-13:1989 Wheelchairs—Part 13: Determination of Coefficient of Friction of Test Surfaces

Contact person and Type of standard

16-26

ISO 7176-14:1997 Wheelchairs—Part 14: Power and Control Systems for Electric Wheelchairs—Requirements and Test Methods

Contact person and Type of standard

16-27

ISO 7176-15:1996 Wheelchairs—Part 15: Requirements for Information Disclosure, Documentation and Labeling

Contact person and Type of standard

16-28

ISO 7176-16: 1997 Wheelchairs—Part 16: Resistance to Ignition of Upholstered Parts—Requirements and Test Methods

Contact person and Type of standard

16-29

ISO 7176-6:2001 Wheelchairs—Part 6: Determination of Maximum Speed, Acceleration and Deceleration of Electric Wheelchairs

Contact person and Type of standard

16-30

ISO 7176-9:2001 Wheelchairs—Part 9: Climatic Tests for Electric Wheelchairs

Contact person and Type of standard

16-31

ANSI/RESNA WC/Volume 1-1998 Section 1: Determination of Static Stability

Contact person and Type of standard

16-32

ANSI/RESNA WC/Volume 2-1998 Section 2: Determination of Dynamic Stability of Electric Wheelchairs

Contact person and Type of standard

16-33

ANSI/RESNA WC/Volume 2-1998 Section 3: Test Methods and Requirements for the Effectiveness of Brakes

Contact person and Type of standard

16-34

ANSI/RESNA WC/Volume 2-1998 Section 4: Determination of Energy Consumption of Electric Wheelchairs

Contact person and Type of standard

16-35

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

Contact person and Type of standard

16-36

ANSI/RESNA WC/Volume 2-1998 Section 6: Determination of Maximum Speed, Acceleration, and Retardation of Electric Wheelchairs

Contact person and Type of standard

16-37

ANSI/RESNA WC/Volume 1-1998 Section 7: Wheelchairs - Determination of Seating and Wheel Dimensions

Contact person and Type of standard

16-38

ANSI/RESNA WC/Volume 1-1998 Section 8: Wheelchairs—Static, Impact and Fatigue Strength Tests

Contact person and Type of standard

16-39

ANSI/RESNA WC/Volume 2 - 1998 Section 9: Climatic Tests for Electric Wheelchairs

Contact person and Type of standard

16-40

ANSI/RESNA WC/Volume 2 - 1998 Section 10: Determination of the Obstacle-Climbing Ability of Electric Wheelchairs

Contact person and Type of standard

16-41

ANSI/RESNA WC/Volume 1 - 1998 Section 11: Wheelchairs—Test Dummies

Contact person and Type of standard

16-42

ANSI/RESNA WC/Volume 1 - 1998 Section 13: Determination of Coefficient of Friction of Test Surfaces

Contact person and Type of standard

16-43

ANSI/RESNA WC/Volume 2 - 1998 Section 14: Wheelchairs—Testing of Power and Control Systems for Electric Wheelchairs

Contact person and Type of standard

16-44

ANSI/RESNA WC/Volume 1 - 1998 Section 15: Wheelchairs—Requirements for Information Disclosures, Documentation and Labeling

Contact person and Type of standard

16-45

ANSI/RESNA WC/Volume 1 - 1998 Section 16: Wheelchairs—Determination of Flammability

Title change, Contact person and Type of standard

16-46

ANSI/RESNA WC/Volume 1 - 1998 Section 20: Wheelchairs—Determination of the Performance of Stand-Up Wheelchairs

Contact person and Type of standard

16-47

ANSI/RESNA WC/Volume 1 - 1998 Section 22: Wheelchairs—Set Up Procedures

Contact person and Type of standard

16-48

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

Contact person and Type of standard

16-49

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

Contact person and Type of standard

16-50

ISO 7176-3:2003 Wheelchairs—Part 3: Determination of Effectiveness of Brakes

Contact person and Type of standard

16-158

ISO 7176-1:1999 Wheelchairs—Part 1: Determination of Static Stability

Contact person and Type of standard

16-159

ISO 7176-2:2001 Wheelchairs—Part 2: Determination of Dynamic Stability of Electric Wheelchairs

Contact person and Type of standard

M. Radiology

12-17

NEMA MS 8-1993 (2000), Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems

Relevant guidance and Contact person

12-61

12-177

UL 122 (2007): Standard for Photographic Equipment—Ed. 5.0

Withdrawn and replaced with newer version

12-64

12-178

IEC 60601-2-45 Ed. 2.0, (2006) Medical Electrical Equipment—Part 2-45: Particular Requirements for the Safety of Mammographic X-ray Equipment and Mammographic Stereotactic Devices

Withdrawn and replaced with newer version

12-69

NEMA MS 6-1991 (R2000) Characterization of Special Purpose Coils for Diagnostic Magnetic Resonance Images

Relevant guidance, Contact person and CFR Citations

12-95

NEMA MS 2-2003 Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images

Relevant guidance and Contact person

12-96

NEMA MS 3-2003 Determination of Image Uniformity in Diagnostic Magnetic Resonance Images

Relevant guidance and Contact person

12-97

NEMA MS-1-2001 Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging

Relevant guidance, Contact person and CFR Citations

12-103

12-179

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

Withdrawn and replaced with newer version

12-120

IEC 60601-2-44 (2002-11): Medical Electrical Equipment—Part 2-44: Particular Requirements for the Safety of X-ray Equipment for Computed Tomography—Ed. 2.1

Relevant guidance and CFR Citations

12-123

12-180

IEC 61689:2007 Ultrasonics—Physiotherapy Systems—Field Specifications and Methods of Measurement in the Frequency Range 0,5 MHz to 5 MHz Ed. 2.0

Withdrawn and replaced with newer version

12-125

NEMA MS 5-2003 Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging

Relevant guidance and Contact person

12-129

12-181

NU 1-2007 Performance Measurements of Gamma Cameras

Withdrawn and replaced with newer version

12-131

12-184

IEC 61217 2002 Consolidated Ed. 1.1, 2007 Amendment 2 Ed. 1.0 Radiotherapy Equipment—Coordinates, Movements, and Scales

Withdrawn and replaced with newer version

12-150

IEC / ISO 10918-1:1994 Technical Corrigendum 1:2005 Information Technology—Digital Compression and Coding of Continuous-Tone Still Images—Part 1: Requirements

Relevant guidance, Contact person, CFR Citations, Product code, and Devices affected

12-151

NEMA MS 4 (2006) Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices

Relevant guidance, Contact person and CFR Citations

12-158

NEMA MS 10-2006 Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging

Relevant guidance, Contact person and CFR Citations

12-159

NEMA MS 11-2006 Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging

Relevant guidance, Contact person and CFR Citations

12-160

NEMA MS 12-2006 Quantification and Mapping of Geometric Distortion for Special Applications

Relevant guidance, Contact person and CFR Citations

12-161

IEC 60601-2-33 (2006), Medical Electrical Equipment—Part 2-33: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis

Relevant guidance and Contact person

12-164

12-182

IEC 60601-2-37:2007 Medical Electrical Equipment—Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment

Withdrawn and replaced with newer version

12-165

NEMA XR 22-2006 “Quality Control Manual” Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-Field Digital Mammography

Relevant guidance

12-166

NEMA XR 23-2006 “Quality Control Manual” Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-Field Digital Mammography

Relevant guidance

12-168

IEC 60825-1 Ed. 2.0 (2007) Safety of Laser Products—Part 1: Equipment Classification, and Requirements

Contact person and Processes impacted

12-169

IEC 60601-2-22 Ed. 3.0 (2007) Medical Electrical Equipment—Part 2-22: Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment

Contact person, Processes impacted and Title

12-170

12-183

NEMA PS 3.1 - 3.18 (2008) Digital Imaging and Communications in Medicine (DICOM) Set

Withdrawn and replaced with newer versions

5-7

12-185

IEC 60601-1-3 2008 Edition 2.0 Medical Electrical Equipment—Part 1-3:General Requirements for Basic Safety and Essential Performance—Collateral Standard: Radiation Protection in Diagnostic X-ray Equipment

Transferred

N. Software/Informatics

13-4

ANSI/UL 1998, Software in Programmable Components

CFR Citations, Product codes, Relevant guidance and Extent of recognition

13-5

IEEE 1074:1997, Standard for Developing Software Life Cycle Processes

Withdrawn

13-8

IEC 62304 Ed. 1.0, Medical Device Software—Software Life Cycle Processes

CFR Citations, Product codes, Relevant guidance, and Extent of recognition

7-59

13-9

CLSI AUTO2-A2 Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard

Transferred

7-60

13-10

CLSI AUTO1-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard

Transferred

7-61

13-11

CLSI AUTO3-A Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard

Transferred

7-62

13-12

CLSI AUTO4-A Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard

Transferred

7-63

13-13

CLSI AUTO5-A Laboratory Automation: Electromechanical Interfaces; Approved Standard

Transferred

7-64

13-14

CLSI POCT1-A2 Point-of-Care Connectivity; Approved Standard

Transferred

7-68

13-15

CLSI GP19-A2 Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline—Second Edition

Transferred

7-114

13-16

CLSI LIS01-A Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems

Transferred

7-115

13-17

CLSI LIS02-A2 Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition

Transferred

7-116

13-18

CLSI LIS03-A Standard Guide for Selection of a Clinical Laboratory Information Management System

Transferred

7-117

13-19

CLSI LIS04-A Standard Guide for Documentation of Clinical Laboratory Computer Systems

Transferred

7-118

13-20

CLSI LIS05-A Standard Specification for Transferring Clinical Observations Between Independent Computer Systems

Transferred

7-119

13-21

CLSI LIS06-A Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems

Transferred

7-120

13-22

CLSI LIS07-A Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory

Transferred

7-121

13-23

CLSI LIS08-A Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems

Transferred

7-122

13-24

CLSI LIS09-A Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures

Transferred

O. Sterility

14-24

AAMI/ANSI/ISO 11134:1993 Sterilization of Health Care Products—Requirements for Validation and Routine Control-Industrial Moist Heat Sterilization

Withdrawn

14-53

AAMI/ANSI ST66:1996 Sterilization of Health Care Products—Chemical Indicators—Part 2: Indicators for Air Removal Test Sheets and Packs

Withdrawn

14-54

AAMI/ANSI/ISO 11737-2:1998 Sterilization of Medical Devices—Microbiological Methods—Part 2: Tests of Sterility Performed in the Validation of a Sterilization Process

CFR Citations, Product codes and Devices affected

14-55

AAMI/ANSI/ISO 14160:1998 Sterilization of Single-Use Medical Devices Incorporating Materials of Animal Origin—Validation and Routine Control of Sterilization by Liquid Chemical Sterilants

Relevant guidance

14-60

ASTM F1327:1998 Standard Terminology Relating to Barrier Materials for Medical Packaging

Withdrawn

14-63

ASTM F1886: 1998 (2004) Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection

CFR Citations and Product codes

14-64

ASTM F1929:1998 (2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration

CFR Citations and Product codes

14-70

AAMI/ANSI/ISO 14161:2000 Sterilization of Health Care Products—Biological Indicators—Guidance for the Selection, Use and Interpretation of Results, 2ed.

CFR Citations, Product codes and Devices affected

14-76

AAMI/ANSI/ISO 10993-7:1995 (R) 2001 Biological Evaluation of Medical Devices—Part 7: Ethylene Oxide Sterilization Residuals

CFR Citations, Product codes and Contact person

14-88

AAMI/ANSI/ISO 14937:2000 Sterilization of Health Care Products—General Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices

CFR Citations and Product codes

14-90

14-256

ASTM F2095-07 Standard Test Methods for Pressure Decay Leak Test for Nonporous Flexible Packages With and Without Restraining Plates

Withdrawn and replaced with newer version

14-116

AAMI ST72:2002 Bacterial endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing

CFR Citations, Product codes, Type of standard, Guidance and Extent of recognition

14-120

ASTM D3078:2002 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission

CFR Citations, Product codes and Type of standard

14-123

ASTM F2096-04 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)

CFR Citations, Product codes, CDRH Office and Division associated with recognized standard

14-135

AAMI/ANSI ST63:2002 Sterilization of Health Care Products—Requirements for the Development, Validation and Routine Control of an Industrial Sterilization Process for Medical Devices—Dry Heat

CFR Citations, Product codes and Type of standard

14-136

AAMI/ANSI ST67:2003 Sterilization of Health Care Products—Requirements for Products Labeled 'Sterile' 1st Edition

CFR Citations, Product codes and Guidance

14-138

ISO 13408-2:2003 Aseptic Processing of Health Care Products—Part 2: Filtration

CFR Citations, Product codes, Type of standard and Guidance

14-139

ISO 14644-1:1999 Cleanrooms and Associated Controlled Environments—Part 1: Classification of Air Cleanliness

CFR Citations, Product codes and Type of standard

14-140

ISO 14644-2:2000 Cleanrooms and Associated Controlled Environments—Part 2: Specification for Testing and Monitoring to Prove Continued Compliance With ISO 14644-1

CFR Citations, Product codes and Type of standard

14-141

ISO 14644-4:2001 Cleanrooms and Associated Controlled Environments—Part 4: Design, Construction and Startup

CFR Citations, Product codes and Type of standard

14-142

ISO 14698-1:2003 Cleanrooms and Associated Controlled Environments—Biocontamination Control—Part 1: General Principles and Methods

CFR Citations, Product codes and Type of standard

14-143

ISO 14698-2:2003 Cleanrooms and Associated Controlled Environments—Biocontamination Control—Part 2: Evaluation and Interpretation of Biocontamination Data

CFR Citations, Product codes and Type of standard

14-148

ASTM F2250-03 Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials

CFR Citations, Product codes and Type of standard

14-149

ASTM F2251-03e1 Standard Test Method for Thickness Measurement of Flexible Packaging Material

CFR Citations, Product codes and Type of standard

14-150

ASTM F2252-03 Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape

CFR Citations, Product codes and Type of standard

14-164

AAMI/ANSI ST81:2004 Sterilization of Medical Devices—Information to be Provided by the Manufacturer for the Processing of Resterilizable Devices

CFR Citations, Product codes, and Devices affected

14-165

ISO 14644-5:2004 Cleanrooms and Associated Controlled Environments—Part 5: Operations

CFR Citations, Product codes and Type of standard

14-166

ISO 14644-7:2004 Cleanrooms and Associated Controlled Environments—Part 7: Separative Devices (Clean Air Hoods, Gloveboxes, Isolators and Mini-Environments)

CFR Citations, Product codes and Type of standard

14-168

14-245

ASTM F2338-07 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method

Withdrawn and replaced with newer version

14-169

ASTM F2391-05 Standard Test Method for Measuring Package and Seal Integrity Using Helium as Tracer Gas

CFR Citations, Product codes and Type of standard

14-170

ASTM F2475-05 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials

CFR Citations, Product codes and Type of standard

14-191

ISO 13408-4:2005 Aseptic Processing of Health care Products—Part 4: Clean-in-Place Technologies

CFR Citations, Product codes, Type of standard and Relevant guidance

14-193

AAMI/ANSI/ISO 11607-1:2006 Packaging for terminally Sterilized Medical Devices—Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems, 3d ed.

CFR Citations, Product codes, Devices affected and Relevant guidance

14-194

AAMI/ANSI/ISO 11607-2:2006 Packaging for Terminally Sterilized Medical Devices—Part 2: Validation Requirements for Forming, Sealing and Assembly Processes, 1st ed.

CFR Citations, Product codes, Devices affected and Relevant guidance

14-197

ASTM F1608:00(2004) Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)

CFR Citations and Product codes

14-199

ASTM D4169-05 Standard Practice for Performance Testing of Shipping Containers and Systems

Related CFR Citations and Product codes

14-202

14-246

USP 31:2008 Biological Indicator for Dry-Heat Sterilization, Paper Carrier

Withdrawn and replaced with newer version

14-203

14-247

USP 31:2008 Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier.

Withdrawn and replaced with newer version

14-204

14-248

USP 31:2008 Biological Indicator for Steam Sterilization, Paper Carrier

Withdrawn and replaced with newer version

14-205

14-249

USP 31:2008 <61> Microbial Limits Test

Withdrawn and replaced with newer version

14-206

14-250

USP 31:2008 <71> Microbiological Tests, Sterility Tests

Withdrawn and replaced with newer version

14-207

14-251

USP 31:2008 <85> Biological Tests and Assays, Bacterial Endotoxin Test (LAL)

Withdrawn and replaced with newer version

14-208

14-252

USP 31:2008 <151> Pyrogen Test (USP Rabbit Test)

Withdrawn and replaced with newer version

14-209

14-253

USP 31:2008 <161> Transfusion and Infusion Assemblies and Similar Medical Devices

Withdrawn and replaced with newer version

14-210

14-254

USP 31:2008 Biological Indicator for Steam Sterilization—Self Contained

Withdrawn and replaced with newer version

14-220

AAMI/ANSI ST79:2006 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities

Type of Standard

14-221

AAMI/ANSI/ISO TIR 11139:2006 Sterilization of Health Care Products—Vocabulary

CFR Citations, Product codes, Title, Devices affected, and Type of standard

14-222

AAMI/ANSI/ISO 18472:2006 Sterilization of Health Care Products—Biological and Chemical Indicators—Test Equipment

Type of standard

14-223

ANSI/AAMI/ISO 11138-1:2006 Sterilization of Health Care Products—Biological Indicators—Part 1: General Requirements

Type of standard, Guidance and Extent of recognition

14-224

AAMI/ANSI/ISO 11137-1:2006 Sterilization of Health Care Products—Radiation—Part 1: Requirements for Development, Validation, and Routine Control of a Sterilization Process for Medical Devices

CFR Citations, Product codes, and Type of standard

14-225

AAMI/ANSI/ISO 11137-2:2006 Sterilization of Health Care Products—Radiation—Part 2: Establishing the Sterilization Dose

CFR Citations, Product codes and Type of standard

14-226

AAMI/ANSI/ISO 11137-3:2006 Sterilization of Health Care Products—Radiation—Part 3: Guidance on Dosimetric Aspects

CFR Citations, Product codes and Type of standard

14-227

AAMI/ANSI/ISO 11737-1:2006 Sterilization of Medical Devices-Microbiological Methods-Part 1: Determination of the Population of Microorganisms on Products, 2d, ed.

CFR Citations, Product codes, Devices affected, CDRH Office and Division associated with recognized standard

14-228

ANSI/AAMI/ISO 11135-1:2007 Sterilization of Health Care Products—Ethylene Oxide—Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices

CFR Citations, Product codes, Devices affected, and Type of standard

14-229

ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

CFR Citations and Product codes

14-230

ASTM F2203-02(2007) Standard Test Method for Linear Measurement Using Precision Steel Rule

CFR Citations, Product codes and Type of standard

14-231

ASTM F2217-02(2007) Standard Practice for Coating/Adhesive Weight Determination

CFR Citations, Product codes and Type of standard

14-232

ASTM F2227-02(2007) Standard Test Method for Non-Destructive Detection of Leaks in Non-Sealed and Empty Medical Packaging Trays by CO2 Tracer Gas Method

CFR Citations, Product codes and Type of standard

14-233

ASTM F2228-02(2007) Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method

CFR Citations, Product codes and Type of standard

14-234

ASTM F2097-07 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

CFR Citations, Product codes and Type of standard

14-235

ASTM F1140-07 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages

CFR Citations, Product codes and Type of standard

14-236

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

CFR Citations, Product codes and Type of standard

14-237

ASTM F88-07 Standard Test Method for Seal Strength of Flexible Barrier Materials

CFR Citations, Product codes and Type of standard

14-239

ISO 13408-3:2006 Aseptic Processing of Health Care Products—Part 3: Lyophilization

CFR Citations and Product codes

14-240

ISO 13408-5:2006 Aseptic Processing of Health Care Products—Part 5: Sterilization-in-Place

CFR Citations and Product codes

14-241

ISO 13408-6:2005 Aseptic Processing of Health Care Products—Part 6: Isolator Systems

CFR Citations and Product codes

14-242

ISO 14644-3:2005 Cleanrooms and Associated Controlled Environments—Part 3: Test Methods

CFR Citations and Product codes

14-243

ISO 14644-6:2007 Cleanrooms and Associated Controlled Environments—Part 6: Vocabulary

CFR Citations and Product codes

14-244

ISO 14644-8:2006 Cleanrooms and Associated Controlled Environments—Part 8: Classification of Airborne Molecular Contamination

CFR Citations and Product codes

P. Tissue Engineering

15-12

ASTM F2103-01(2007)e1 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications

CFR Citations and Product codes, Relevant guidance, Type of standard and CDRH Office and Division associated with recognized standard

15-5

ASTM F2347-03, Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications

CFR Citations and Product codes, Relevant guidance, Type of standard and CDRH Office and Division associated with recognized standard

15-6

ASTM F2450-04, Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical Products

CFR Citations and Product codes, Relevant guidance, Type of standard and CDRH Office and Division associated with recognized standard

15-7

ASTM F2315-03, Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels

CFR Citations and Product codes, Relevant guidance, Type of standard and CDRH Office and Division associated with recognized standard

15-8

ASTM F2064-00(2006), Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for use in Biomedical and Tissue-Engineered Medical Products Application

CFR Citations and Product codes, Relevant guidance, Type of standard and CDRH Office and Division associated with recognized standard

15-9

ASTM F2311-06, Standard Guide for Classification of Therapeutic Skin Substitutes

CFR Citations and Product codes, Relevant guidance, Type of standard and CDRH Office and Division associated with recognized standard

15-10

ASTM F2451-05, Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage

CFR Citations and Product codes, Relevant guidance, Type of standard and CDRH Office and Division associated with recognized standard

15-11

ASTM F2212-02(2007)e1, Standard Guide for Characterization of Type I Collagen as a Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products

CFR Citations and Product codes, Relevant guidance, Type of standard and CDRH Office and Division associated with recognized standard

III. Listing of New Entries

In table 3 of this document, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 020.

Table 3.—New Entries to the List of Recognized Standards

Recognition No.

Title of Standard

Reference No. and Date

A. Biocompatibility

2-127

Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Delayed-Type Hypersensitivity—Amendment 1

ANSI/AAMI BE 78:2002/A1:2006

B. Cardiovascular/Neurology

3-70

Manual, Electronic or Automated Sphygmomanometers

ANSI/AAMI SP10:2002/A1:2003—Amendment 1 to ANSI/AAMI SP10:2002

3-71

Manual, Electronic and Automated Sphygmomanometers

ANSI/AAMI SP10:2002/A2:2006—Amendment 2 to ANSI/AAMI SP10:2002

C. Dental/ Ear, Nose, and Throat

4-151

Dentistry—Artificial Teeth for Dental Prostheses

ISO 22112:2005

4-152

Metal-Ceramic Dental Restorative Systems

ISO 9693:1999/Amendment 1:2005

4-154

Dentistry—Elastometric Impression Materials-Third Edition

ISO 4823:2000

4-155

Dentistry—Elastomeric Impression Materials Technical Corrigendum 1-Third Edition

ISO 4823:2000 Technical Corrigendum 1:2004

4-156

Dentistry—Elastomeric Impression Materials Amendment 1-Third Edition

ISO 4823:2000 Amendment 1:2007

4-157

Dentistry—Zinc Oxide/Eugenol and Zinc Oxide/Non-eugenol Cements-Third Edition

ISO 3107: 2004

4-158

Dentistry—Soft Lining Materials for Removable Dentures—Part 1: Materials for Short-Term Use Technical Corrigendum 1

ISO 10139-1:2005 Technical Corrigendum 1:2006

D. General Hospital/ General Plastic Surgery

6-214

Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves

ASTM D6355-07

E. In Vitro Diagnostic

7-160

Abbreviated Identification of Bacteria and Yeast; Approved Guideline

CLSI M35-A,

7-161

Laboratory Detection and Identification of Mycobacteria; Proposed Guideline.

CLSI M48-P

7-162

Point-of-Care Monitoring of Anticoagulant Therapy; Approved Guideline

CLSI H49-A

7-163

Body Fluid Analysis for Cellular Composition

CLSI H56-A

7-164

Microwave Device Use in the Histology Laboratory; Approved Guideline

CLSI GP28-A

7-165

Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard-Second Edition

CLSI H20-A2

7-166

Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline—Second Edition

CLSI GP20-A2

7-167

Nongynecologic Cytologic Specimens: Collection and Cytopreparatory Techniques; Approved Guideline

CLSI GP23-A

7-168

Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi; Approved Standard

CLSI M38-A

F. Materials

8-161

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

ASTM F2516-07

G. OB-GYN/Gastroenterology

9-46

Medical Electrical Equipment—Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment

ANSI/AAMI 60601-2-2:2006

9-49

Concentrates for Hemodialysis

AAMI / ANSI RD61:2006

9-50

Dialysate for Hemodialysis

ANSI/AAMI RD52:2004

9-51

Cardiovascular Implants and Artificial Organs—Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators

ISO 8637:2004

9-52

Cardiovascular Implants and Artificial Organs—Extracorporeal Blood Circuit for Haemodialysers, Haemodiafilters and Haemofilters

ISO 8638:2004

9-53

Standard Practice for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes

ASTM F1992-99(2007)

9-54

Standard Specification for Rubber Contraceptives—Vaginal Diaphragms

ASTM D6976-08

H. Ophthalmic

10-56

Ophthalmics Multifocal Intraocular Lenses

ANSI Z80.12-2007

10-57

Phakic Intraocular Lenses

ANSI Z80.13-2007

I. Physical Medicine

16-161

Safety Standard for Platform Lifts and Stairway Chairlifts

ASME A18.1-2005

J. Sterility

14-255

Standard Terminology Relating to Flexible Barrier Packaging

ASTM F17-07a

IV. List of Recognized Standards

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

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

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

Federal Register

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

Federal Register

once a year, or more often, if necessary.

V. Recommendation of Standards for Recognition by FDA

Any person may recommend consensus standards as candidates for recognition under the new provision of section 514 of the act by submitting such recommendations, with reasons for the recommendation, to the contact person (see

FOR FURTHER INFORMATION CONTACT

). To be properly considered such recommendations should contain, at a minimum, the following information: (1) Title of the standard, (2) any reference number and date, (3) name and address of the national or international standards development organization, (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply, and (5) a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity.

VI. Electronic Access

Persons interested in obtaining a copy of “Guidance on the Recognition and Use of Consensus Standards” by using the Internet. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts,

Federal Register

reprints, information on premarket submissions [including lists of approved applications and manufacturers' addresses], small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at

http://www.fda.gov/cdrh

. A search capability for all CDRH guidance documents is available at

http://www.fda.gov/cdrh/guidance.html

. Guidance documents are also available at

http://www.regulations.gov

.

This

Federal Register

document on modifications in FDA's recognition of consensus standards is available at

http://www.fda.gov/cdrh/fedregin.html

.

VII. Submission of Comments and Effective Date

Interested persons may submit to the contact person (see

FOR FURTHER INFORMATION CONTACT

) written or electronic comments regarding this document. Two copies of any mailed comments are to be submitted, except that individuals may submit one paper copy. 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: 020. These modifications to the list or recognized standards are effective upon publication of this notice in the

Federal Register

.

Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at

http://www.regulations.gov

.

Dated: August 27, 2008.

Daniel G. Schultz,

Director, Center for Devices and Radiological Health.

[FR Doc. E8-20939 Filed 9-8-08; 8:45 am]

BILLING CODE 4160-01-S