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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2004-N-0451] (formerly FDA-2004-N-0226)
 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 
                    ( print page 52359)
                    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
ChangeA. Anesthesia1-11

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
Withdrawn1-46

ISO 5367:2000 Breathing Tubes Intended for Use With Anaesthetic Apparatus and Ventilators
Relevant guidance and Extent of recognition1-51

ASTM F1101-90(1997) Standard Specification for Ventilators Intended for Use During Anesthesia
Withdrawn1-62

ISO 5356-1:2004 Anaesthetic and Respiratory Equipment—Conical Connectors: Part 1: Cones and Sockets
Relevant guidance1-66

ISO 9919:2005: Medical Electrical Equipment—Particular Requirements for the Basic Safety and Essential Performance of Pulse Oximeter Equipment for Medical Use
Relevant guidance1-68

CGA V-5:2005 Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications)
Relevant guidance1-72

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 Codes1-73

ISO 10651-4:2002 Lung Ventilators—Part 4: Particular Requirements for Operator Powered Resuscitators
Relevant guidanceB. Biocompatibility2-21
2-118
ANSI/AAMI/ISO 10993-11: 2006 Biological Evaluation of Medical Devices—Part 11: Tests for System Toxicity
Withdrawn and replaced with newer version2-56
2-119
ASTM F813-07 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
Withdrawn and replaced with newer version( print page 52360)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 version2-66
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 version2-68
2-122
ASTM F719-81 (2007) e1 Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation
Withdrawn and replaced with newer version2-69
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 version2-70
2-124
ASTM F750-87 (2007) e1 Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse
Withdrawn and replaced with newer version2-89
2-125
ASTM F749-98 (2007) e1 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
Withdrawn and replaced with newer version2-92
2-126
ASTM F748-06 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
Withdrawn and replaced with newer version2-95

ASTM F1984-99(2003) Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
Relevant guidance2-109
2-128
USP 31-NF26 Biological Test <87> 2008 Biological Reactivity Test, In Vitro—Direct Contact Test
Withdrawn and replaced with newer version2-110
2-129
USP 31-NF26 Biological Test <88> 2008 Biological Reactivity Test, In Vitro—Elution Test
Withdrawn and replaced with newer version2-111
2-130
USP 31-NF26 Biological Test <88> 2008 Biological Reactivity Test, In Vitro, Procedure—Preparation of Sample
Withdrawn and replaced with newer version2-112
2-131
USP 31-NF26 Biological Test <88> 2008 Biological Reactivity Test, In Vitro, Classification of Plastics—Intracutaneous Test
Withdrawn and replaced with newer version2-113
2-132
USP 31-NF26Biological Test <88> 2008 Biological Reactivity Test, In Vivo—Classification of Plastics—Systemic Injection Test
Withdrawn and replaced with newer versionC. Cardiovascular/Neurology3-2

ANSI/AAMI EC53:1995/(R)2001—ECG Cables and Leadwires
Reaffirmation3-3

ANSI/AAMI NS28:1988/(R)2006—Intracranial Pressure Monitoring Devices
Reaffirmation3-16
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 version3-18
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 version3-20
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 version3-25
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( print page 52361)3-40

ANSI/AAMI SP9:1994, Non-automated Sphygmomanometers
Withdrawn3-41

ANSI/AAMI EC11:1991/(R)2007—Diagnostic Electrocardiographic Devices
Reaffirmation3-42

ANSI/AAMI EC13:2002/(R)2007—Cardiac Monitors, Heart Rate Meters, and Alarms
Reaffirmation3-43
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 version3-44

ANSI/AAMI BP22:1994/(R)2006, Blood Pressure Transducers
Reaffirmation3-45

ANSI/AAMI EC57:1998/(R)2003, Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms
Reaffirmation3-47
3-66
ASTM F2081-06, Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
Withdrawn and replaced with newer version3-52

ANSI/AAMI EC12:2000/(R)2005, Disposable ECG Electrodes
Reaffirmation3-57
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 versionD. Dental/Ear, Nose, and Throat4-43

ANSI/ADA Specification No. 5-Dental Casting Alloys:1997
Type of standard, and Relevant guidance4-50

ANSI/ADA Specification No. 18-Alginate Impression Materials:1992
Title and Relevant guidance4-52
4-147
ANSI/ADA Specification No. 27-Resin-Based Filling Materials: 2005
Withdrawn and replaced with newer year4-62

ISO 1563:1990 Dental Alginate Impression Material
Relevant guidance and Extent of recognition4-63

ISO 1564:1995 Dental Aqueous Impression Materials Based on Agar
Relevant guidance4-65
4-151
ISO 3336:1993, Dentistry—Synthetic Polymer Teeth
Withdrawn and replaced with newer version4-66

ISO 4049:1988, Dentistry—Resin-Based Filling Materials
Withdrawn—newer version previously recognized4-67

ISO 6871-1:1994, Dental Base Metal Casting Alloys Part 1: Cobalt-based Alloys—TECHNICAL CORRIGENDUM 1:1998
Withdrawn—newer version previously recognized4-68

ISO 6871-2:1994, Dental Base Metal Casting Alloys Part 2: Nickel-Based Alloys
Withdrawn—newer version previously recognized4-69

ISO 6872:1995/Amendment 1:1997 Dental Ceramic
Date of standard and Extent of recognition4-73

ISO 7405:1997 Dentistry—Preclinical Evaluation of Biocompatibility of Medical Devices Used in Dentistry—Test Methods for Dental Materials
Extent of recognition and Contact person4-75

ISO 7785-1:1997 Dental Handpieces—Part 1: High-Speed Air Turbine Handpieces
Relevant guidance and Extent of recognition( print page 52362)4-76

ISO 7785-2:1995 Dental Handpieces—Part 2: Straight and Geared Angle Handpieces
Relevant guidance and Extent of recognition4-78

ISO 9168:1991 Dental Handpieces—Hose Connectors
Relevant guidance and Extent of recognition4-83

ISO 11498:1997 Dental Handpieces—Dental Low-Voltage Electrical Motors
Relevant guidance and Extent of recognition4-84

ISO 13294:1997 Dental Handpieces—Dental Air-Motors
Relevant guidance and Extent of recognition4-88
4-148
ANSI/ADA Specification No. 78-Endodontic Obturating Cones: 2005
Withdrawn and replaced with newer version4-89

ANSI/ADA Specification No. 53-Polymer-Based Crowns and Bridge Resins: 1999 (Reaffirmed 2005)
Reaffirmation and Relevant guidance4-90

ANSI/ASA S3.39:1987 (R2007), Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance)
Reaffirmation and Type of standard4-91

ANSI/ADA Specification No. 80-Dental Materials—Determination of Color Stability: 2001
Relevant guidance4-92

ANSI/ADA Specification No. 88-Dental Brazing Alloys: 2000 (Reaffirmed 2006)
Reaffirmation and Relevant guidance4-93
4-159
IEEE ANSI C63.19:2007 Methods of Measurement of Compatibility Between Wireless Communications Devices and Hearing Aids
Withdrawn and replaced with newer version4-94

ANSI/ADA Specification No. 14—Dental Base Metal Casting Alloys: 1982 (Reaffirmed 1998)
Reaffirmation, Date of standard, Type of standard, Offices, Relevant guidance4-95

ANSI/ADA Specification No.17:1999, Dental Base Temporary Relining Resin
Withdrawn—newer version previously recognized4-96

ANSI/ADA Specification No. 30—Dental Zinc Oxide—Eugenol and Zinc Oxide—Non-Eugenol Cements: 2000 (Reaffirmed 2005)
Reaffirmation and Relevant guidance4-97

ANSI/ADA Specification No. 57—Endodontic Sealing Material: 2000 (Reaffirmed 2006)
Reaffirmation, Offices and Type of standard4-98

ANSI/ADA Specification No. 96:2000, Dental-Water-Based Cements
Withdrawn—newer version previously recognized4-99

ISO 4049: 2000 Dentistry—Polymer-based Filling, Restorative and Luting Materials
Relevant guidance, Type of standard and Extent of recognition4-100
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 recognized4-102
4-152
ISO 9693:1999, Metal-Ceramic Dental Restorative Systems
Withdrawn and replaced with newer version4-104
4-149
ANSI/ADA Specification No. 39—Pit and Fissure Sealants: 2006
Withdrawn and replaced with newer version4-105

ANSI/ADA Specification No. 75—Resilient Lining Materials for Removable Dentures—Part 1: Short-Term Materials: 1997 (Reaffirmed 2003)
Type of standard and Relevant guidance4-107

ISO 9917-2:1998 Dental Water-Based Cements—Part 2: Light-Activated Cements
Devices affected, Type of standard, Relevant guidance and Extent of recognition( print page 52363)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) citation4-110

ANSI/ADA Specification No. 11—Agar Impression Materials: 1997
Type of standard and Relevant guidance4-111

ANSI/ADA Specification No. 13—Denture Cold-Curing Repair Resins: 1981 (Reaffirmed 2006)
Reaffirmation, Date of standard, Type of standard and Relevant guidance4-112

ANSI/ADA Specification No. 16—Dental Impression Paste—Zinc Oxide-Eugenol Type: 1961 (Reaffirmed 1999)
Reaffirmation, Date of standard, Type of standard and Relevant guidance4-113

ANSI/ADA Specification No. 20—Dental Duplicating Material: 1972 (Reaffirmed 1995)
Reaffirmation, Date of standard, Type of standard and Relevant guidance4-115
4-153
ISO 9917-1:2007 Dentistry—Water-Based Cements—Part 1: Powder/Liquid Acid-Base Cements
Withdrawn and replaced with a newer year4-117

ANSI/ADA Specification No. 12—Denture Base Polymers: 2002
Type of standard4-119

ANSI/ADA Specification No. 82—Dental Reversible/Irreversible Hydrocolloid Impression Material Systems: 1998 (Reaffirmed 2003)
Reaffirmation, Date of standard, Type of standard and Relevant guidance4-120

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 recognition4-121

ISO 7494-2:2003 Dentistry—Dental Units—Part 2: Water and Air Supply
Type of standard and Extent of recognition4-125

ISO 1562:2004, Dentistry—Casting Gold Alloys
Withdrawn—newer version previously recognized4-126

ISO 10477:2004 Dentistry—Polymer-Based Crown and Bridge Materials
Extent of recognition and Relevant guidance4-127

ANSI/ADA Specification No. 58—Root Canal Files, Type H (Hedstrom): 2004
Type of standard and Extent of recognition4-128

ISO 4823:2000,, Dentistry—Elastomeric Impression Materials and Technical Corrigendum 1:2004
Withdrawn4-129
4-150
ANSI/ADA Specification No. 19—Dental Elastomeric Impression Material: 2004
Withdrawn and replaced with newer version4-130

ANSI/ADA Specification No. 17—Denture Base Temporary Relining Resins: 1983 (Reaffirmed 2006)
Reaffirmation, Processes impacted, Extent of recognition, CFR citations and Relevant guidance4-131

ISO 3107: 2004 Dentistry—Zinc Oxide/Eugenol and Zinc Oxide/Non-eugenol Cements Technical Corrigendum 1:2006-Third Edition
Processes impacted and Relevant guidance4-132

ISO 6874:2005 Dentistry—Polymer-Based Pit and Fissure Sealants
Extent of recognition and Relevant guidance4-133

ISO 6876:2001 Dental Root Canal Sealing Materials
Processes impacted and Extent of recognition4-134

ISO 7494-1:2004 Dentistry—Dental Units—Part 1: General Requirements and Test Methods
Extent of recognition4-135

ISO 10139-1:2005 Dentistry—Soft Lining Materials for Removable Dentures—Part 1: Materials for Short-term Use
Relevant guidance and Extent of recognition( print page 52364)4-136

ASTM F2504-05 Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices
Relevant guidance4-137

ISO 6877:2006 Dentistry—Root-Canal Obturating Points
Extent of recognition4-139

ANSI/ADA Specification No. 48—Visible Light Curing Units: 2004
Relevant guidance4-140

ISO 6871-2:1994/Amd 1:2005, Dental Base Metal Casting Alloys—Part 2: Nickel-Based Alloys
Withdrawn—newer version previously recognized4-141

ISO 6871-1:1994, Dental Base Metal Casting Alloys—Part 1: Cobalt-Based Alloys
Withdrawn—newer version previously recognized4-142

ISO 6871-1:1994/Amd 1:2005, Dental Base Metal Casting Alloys—Part 1: Cobalt-Based Alloys
Withdrawn—newer version previously recognized4-143

ANSI/ADA Specification No.96, Dental-Water-Based Cements
Reaffirmation, Type of standard and Relevant guidance4-145

ISO 22803:2004 Dentistry—Membrane Materials for Guided Tissue Regeneration in Oral and Maxillofacial Surgery—Contents of a Technical File
Relevant guidance and Devices affected4-146

ISO 22674:2006 Dentistry—Metallic Materials for Fixed and Removable Restorations and Appliances
Devices affected and Processes impactedE. General5-7
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
Transferred5-8
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 version5-16
5-42
ASTM D903-98(2004) Standard Test Methods for Peel or Stripping Strength of Adhesive Bonds
Withdrawn and replaced with newer version5-19

ASTM E876/1995 Standard Practice for Use of Statistics in the Evaluation of Spectrometric Data
Withdrawn5-25
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 version5-28

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 recognition5-30

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 recognition5-33
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( print page 52365)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 recognition5-35

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 recognition5-36

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 guidanceF. General Hospital/General Plastic Surgery6-16

ISO 7886-1:1993 Sterile Hypodermic Syringes for Single Use—Part 1: Syringes for Manual Use
Withdrawn6-117

ASTM F2172-02: Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers
Relevant guidance6-118

ASTM F2196-02 Standard Specification for Circulating Liquid and Forced Air Patient Temperature Management Devices
Relevant guidance, Contact person6-131
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 version6-160
6-204
ISO 8537:2007 Sterile Single-Use Syringes, With or Without Needle, for Insulin
Withdrawn and replaced with newer version6-166
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 version6-167

ASTM D6319-00a(2005) Standard Specification for Nitrile Examination Gloves for Medical Application
Relevant guidance6-188
6-205
USP 31:2008 Nonabsorbable Surgical Suture
Withdrawn and replaced with newer version6-189
6-206
USP 31<11>2008 Sterile Sodium Chloride for Irrigation
Withdrawn and replaced with newer version6-190
6-207
USP 31:2008 Absorbable Surgical Suture
Withdrawn and replaced with newer version6-191
6-208
USP 31<881>:2008 Tensile Strength
Withdrawn and replaced with newer version6-192
6-209
USP 31<861>:2008 Sutures—Diameter
Withdrawn and replaced with newer version6-193
6-210
USP 31<871>:2008 Sutures Needle Attachment
Withdrawn and replaced with newer version6-194
6-211
USP 31<11>: 2008 Sterile Water for Irrigation
Withdrawn and replaced with newer version6-195
6-212
USP 31<11>: 2008 Heparin Lock Flush Solution
Withdrawn and replaced with newer version( print page 52366)6-196
6-213
USP 31<11>: 2008 Sodium Chloride Injection
Withdrawn and replaced with newer version6-198

ASTM F2100-07 Standard Specification for Performance of Materials Used in Medical Face Masks
Relevant guidance6-201

ISO 8536-4:2007 Infusion Equipment for Medical Use—Part 4: Infusion Sets for Single Use, Gravity Feed
Relevant guidanceG. In Vitro Diagnostic7-6
7-131
CLSI ILA18-A2 Specifications for Immunological Testing for Infectious Diseases
Withdrawn and replaced with newer version7-11
7-132
CLSI MM03-A2 Molecular Diagnostic Methods for Infectious Diseases
Withdrawn and replaced with newer version7-12

CLSI/NCCLS C12-A Definitions of Quantities and Conventions Related to Blood pH and Gas Analysis; Approved Standard (1994)
Withdrawn7-13

CLSI/NCCLS C21-A Performance Characteristics for Devices Measuring PO2 and PCO2 in Blood Samples; Approved Standard (1992)
Withdrawn7-15

CLSI/NCCLS C25-A Fractional Oxyhemoglobin, Oxygen Content and Saturation, and Related Quantities in Blood: Terminology, Measurement, and Reporting; Approved Guideline (1997)
Withdrawn7-16

CLSI/NCCLS C27-A Blood Gas Preanalytical Considerations: Specimen Collection, Calibration, and Controls; Approved Guideline (1993)
Withdrawn7-18
7-133
CLSI C30-A2, Point-of Care Blood Glucose Testing in Acute and Chronic Care Facilities
Withdrawn and replaced with newer version7-21

CLSI C42-A, Erythrocyte Protoporphyrin Testing; Approved Guideline (1996)
Contact person7-22
7-134
CLSI GP20-A2 Fine-Needle Aspiration Biopsy (FNAB) Techniques
Withdrawn and replaced with newer versions7-25

NCCLS H8-A2 Detection of Abnormal Hemoglobin Using Cellulose Acetate Electrophoresis—Second Edition; Approved Standard (1994)
Withdrawn7-26

NCCLS H9-A Chromatographic (Microcolumn) Determination of Hemoglobin A2; Approved Standard (1989)
Withdrawn7-27

NCCLS H10-A2 Solubility Test to Confirm the Presence of Sickling Hemoglobins—Second Edition; Approved Standard (1995)
Withdrawn7-29

NCCLS H14-A2 Devices for Collection of Skin Puncture Blood Specimens—Second Edition; Approved Guideline (1990)
Withdrawn7-34
7-135
CLSI H44-A2 Methods for Reticulocyte Counting (Flow Cytometry and Supravital Dyes)
Withdrawn and replaced with newer version7-35

CLSI H47-A One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline (1996)
Contact person7-36
7-136
CLSI ILA02-A2 Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens
Withdrawn and replaced with newer version7-37

CLSI ILA06-A Detection and Quantitation of Rubella IgG Antibody
Contact person( print page 52367)7-38

CLSI/NCCLS I/LA10-A Choriogonadotropin Testing: Nomenclature, Reference Preparations, Assay Performance, and Clinical Application; Approved Guideline (1996)
Withdrawn7-39

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)
Withdrawn7-40

NCCLS I/LA18-A Specifications for Immunological Testing for Infectious Diseases; Approved Guideline (1994)
Withdrawn7-41

CLSI ILA19-A Primary Reference Preparations Used to Standardize Calibration of Immunochemical Assays for Serum Prostate Specific Antigen (PSA); Approved Guideline (1997)
Contact person7-42

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 person7-43
7-137
CLSI LA04-A5 Blood Collection on Filter Paper for Newborn Screening Programs
Withdrawn and replaced with newer version7-46
7-138
CLSI M27-A2, Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
Withdrawn and replaced with newer version7-49

CLSI H26-A Performance Goals for the Internal Quality Control of Multichannel Hematology Analyzers; Approved Standard
Contact person7-50

NCCLS D11-A2 Glossary and Guidance for Immunodiagnostic Procedures, Reagents, and Reference Materials—Second Edition, Approved Guideline
Withdrawn7-51
7-139
CLSI GP27-A2 Using Proficiency Testing to Improve the Clinical Laboratory
Withdrawn and replaced with newer version7-52

CLSI / NCCLS NRSCL 8-A Terminology and Definitions for use in NCCLS Documents; Approved Standard
Withdrawn7-53
7-140
CLSI GP22-A2 Continuous Quality Improvement
Withdrawn and replaced with newer version7-55
7-141
CLSI H18-A3 Procedures for the Handling and Processing of Blood Specimens
Withdrawn and replaced with newer version7-58
7-142
CLSI H11-A4 Procedures for the Collection of Arterial Blood Specimens
Withdrawn and replaced with newer version7-59
13-9
CLSI / NCCLS AUTO2-A Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard
Transferred7-60
13-10
NCCLS AUTO1-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard
Transferred7-61
13-11
NCCLS AUTO3-A Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard
Transferred7-62
13-12
NCCLS AUTO4-A Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard
Transferred7-63
13-13
NCCLS AUTO5-A Laboratory Automation: Electromechanical Interfaces; Approved Standard
Transferred7-64
13-14
NCCLS POCT1-A Point-of-Care Connectivity; Approved Standard
Transferred( print page 52368)7-67
7-143
CLSI EP14-A2 Evaluation of Matrix Effects
Withdrawn and replaced with newer version7-68
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
Transferred7-70
7-144
CLSI H4-A5 Procedures and Devices for the Collection of Diagnostic Blood Specimens by Skin Puncture
Withdrawn and replaced with newer version7-72
7-145
CLSI H42-A2 Enumeration of Immunologically Defined Cell Populations by Flow Cytometry
Withdrawn and replaced with newer version7-74
7-146
NCCLS M6-A2 Protocols for Evaluating Dehydrated Mueller-Hinton Agar
Withdrawn and replaced with newer version7-77
7-147
CLSI M22-A3 Quality Control for Commercially Prepared Microbiological Culture Media
Withdrawn and replaced with newer version7-79
7-148
CLSI M28-A2 Procedures for the Recovery and Identification of Parasites From the Intestinal Tract
Withdrawn and replaced with newer version7-80

CLSI MM01-A2 Molecular Diagnostic Methods for Genetic Diseases
Withdrawn7-83

NCCLS C46-A Blood Gas and pH Analysis and Related Measurements; Approved Guideline
Withdrawn7-85
7-149
CLSI C24-A3 Statistical Quality Control for Quantitative Measurement Procedures
Withdrawn and replaced with newer version7-90
7-150
CLSI H43-A2 Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells
Withdrawn and replaced with newer version7-93

NCCLS EP10-A2, Preliminary Evaluation of Quantitative Clinical Laboratory Methods; Approved Guideline
Withdrawn7-94
7-152
CLSI EP12-A2 User Protocol for Evaluation of Qualitative Test Performance
Withdrawn and replaced with newer version7-95
7-153
CLSI EP15-A2 User Verification of Performance for Precision and Trueness
Withdrawn and replaced with newer version7-98
7-154
CLSI MM02-A2 Immunoglobin and T-Cell Receptor Gene Rearrangement Assays
Withdrawn and replaced with newer version7-99

CLSI MM5-A Nucleic Acid Amplification Assays for Molecular Hematopathology
Contact person7-103
7-155
CLSI H03-A6 Procedures for the Collection of Diagnostic Blood Specimens by Venipunture
Withdrawn and replaced with newer version7-106
7-156
CLSI M02-A9 Performance Standards for Antimicrobial Disk Susceptibility Tests
Withdrawn and replaced with newer version7-107
7-157
CLSI M11-A7 Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria
Withdrawn and replaced with newer version7-108
7-158
CLSI M7-A7 Methods for Antimicrobial Susceptibility Tests of Anaerobic Bacteria
Withdrawn and replaced with newer version7-109

CLSI AUTO7-A Laboratory Automation: Data Content for Specimen Identification; Approved Standard
Withdrawn7-111
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( print page 52369)7-114
13-16
CLSI LIS01-A Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems
Transferred7-115
13-17
CLSI LIS02-A2 Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition
Transferred7-116
13-18
CLSI LIS03-A Standard Guide for Selection of a Clinical Laboratory Information Management System
Transferred7-117
13-19
CLSI LIS04-A Standard Guide for Documentation of Clinical Laboratory Computer Systems
Transferred7-118
13-20
CLSI LIS05-A, Standard Specification for Transferring Clinical Observations Between Independent Computer Systems
Transferred7-119
13-21
CLSI LIS06-A Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems
Transferred7-120
13-22
CLSI LIS07-A Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory
Transferred7-121
13-23
CLSI LIS08-A Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems
Transferred7-122
13-24
CLSI LIS09-A Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures
Transferred7-125

CLSI/NCCLS M28-A2 Volume 25, No. 16 Procedures for the Recovery and Identification of Parasites From the Intestinal Tract; Approved Guideline
WithdrawnH. Materials8-32

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 person8-44

ASTM F0136-02a: Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
Contact person8-46
8-154
ASTM F0621-08: Standard Specification for Stainless Steel Forgings for Surgical Implants
Withdrawn and replaced with newer year version8-50

ASTM F1091-02: Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605)
Contact person8-52

ASTM F1350-02: Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
Contact person8-53

ASTM F1472-02a: Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
Contact person8-54
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 version8-57

ISO 5832-2:1999, Implants for Surgery—Metallic Materials—Part 2: Unalloyed Titanium
Contact person8-58

ISO 5832-3:1996, Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy
Contact person( print page 52370)8-59

ISO 5832-4:1996, Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy
Contact person8-61

ISO 5832-6:1997, Implants for Surgery—Metallic Materials—Part 6: Wrought Cobalt-Nickel-Chromium-Molybdenum Alloy
Contact person8-63

ISO 5832-11:1994, Implants for Surgery—Metallic Materials—Part 11: Wrought Titanium 6-Aluminium 7-Niobium Alloy
Contact person8-76

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 person8-77
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 version8-79

ASTM F0961-03, Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants [UNS R30035]
Contact person8-81

ASTM F1609-03 Standard Specification for Calcium Phosphate Coatings for Implantable Materials
Contact person11-81
8-157
ISO 9583:1993 Implants for Surgery—Non-Destructive Testing—Liquid Penetrant Inspection of Metallic Surgical Implants
Transferred8-82
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 version11-82
8-159
ISO 9584:1993 Implants for Surgery—Non-Destructive Testing—Radiographic Examination of Cast Metallic Surgical Implants
Transferred8-86

ASTM F1926-03 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Coatings
Relevant guidance8-88

ASTM F2024-00 Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
Relevant guidance8-98
8-162
ASTM F451-99a(2007)e1 Standard Specification for Acrylic Bone Cement
Withdrawn and replaced with newer year version8-104

ASTM F1108-04 Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
Contact person8-108

ASTM F1295-05 Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700)
Contact person8-110

ASTM F1377-04 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
Contact person8-112

ASTM F1044-05 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
Relevant guidance8-113

ASTM F1147-05 Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings
Relevant guidance8-119

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( print page 52371)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 version8-123

ISO 5832-5:2005 Implants for Surgery—Metallic Materials—Part 5: Wrought Cobalt-Chromium-Tungsten-Nickel Alloy
Contact person8-127

ISO 5834-2:2006 Implants for Surgery—Ultra-high-molecular-weight polyethylene—Part 2: Moulded Forms
Relevant guidance8-129

ASTM F67-06 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
Contact person8-130

ASTM F620-06 Standard Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants
Contact person8-131

ASTM F799-06 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
Contact person8-132

ASTM F1088-04ae1 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
Contact person8-137

ASTM F0075-07 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
Contact person8-138

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 person8-139

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 person8-142

ASTM F1978-00(2007)e2 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
Relevant guidance8-144

ASTM F0754-00 Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Polymer Fabricated in Sheet, Tube and Rod Shapes
Contact person8-145

ASTM F0090-07 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)
Contact person8-147

ASTM F0562-07 Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
Contact person8-149

ISO 5832-1:2007 Implants for Surgery—Metallic Materials—Part 1: Wrought Stainless Steel
Contact person8-150

ISO 5832-9:2007 Implants for Surgery—Metallic Materials—Part 9: Wrought High Nitrogen Stainless Steel
Contact person8-151

ISO 5832-12:2007 Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy
Contact person8-152

ASTM F1537-07 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
Contact personI. OB-GYN/Gastroenterology( print page 52372)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 person9-6

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 Codes9-7

IEC 61846 (1998) Ultrasonics—Pressure Pulse Lithotripters—Characteristics of Fields
Relevant guidance, CFR Citation, and Product Codes9-21

ISO 8600-4:1997 Optics and Optical Instruments—Medical Endoscopes and Certain Accessories—Part 4: Determination of Maximum Width of Insertion Portion
Relevant guidance9-23

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 standard9-25

AAMI / ANSI HF18:2001 Electrosurgical Devices
Withdrawn9-28
9-47
ANSI/AAMI RD16:2007 Cardiovascular Implants and Artificial Organs—Hemodialyzers, Hemodiafilters, Hemofilters, and Hemoconcentrators
Withdrawn and replaced with newer version9-29
9-48
AAMI / ANSI RD17 :2007 Cardiovascular Implants and artificial organs—Extracorporeal Blood Circuit for Hemodialyzers, Hemodiafilters, and Hemofilters
Withdrawn and replaced with newer version9-32

ASTM D3492-03 Standard Specification for Rubber Contraceptives (Male Condoms)
Relevant guidance9-34

ISO 4074:2002/Cor.1:2003(E) Natural Latex Rubber Condoms—Requirements and Test Methods, Technical Corrigendum 1
Relevant guidance9-37

ISO 8600-1:2005 Optics and Photonics—Medical Endoscopes and Endotherapy Devices—Part 1: General Requirements ISO 8600-1:2005
Relevant guidance9-38

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 guidance9-39

ISO 8600-5:2005 Optics and Photonics—Medical Endoscopes and Endotherapy Devices—Part 5: Determination of Optical Resolution of Rigid Endoscopes with Optics
Relevant guidance9-40

ISO 8600-6:2005 Optics and Photonics—Medical Endoscopes and Endotherapy Devices—Part 6: Vocabulary
Relevant guidance9-41

ASTM D6324-05 Standard Test Methods for Male Condoms Made from Synthetic Materials
Relevant guidance9-42

IEC 60601-2-18 (1996) Amendment 1 2000 Medical electrical equipment—Part 2: Particular Requirements for the Safety of Endoscopic Equipment
Relevant guidance9-43

ISO 16038:2005 Rubber Condoms—Guidance on the Use of ISO 4074 in the Quality Management of Natural Rubber Latex Condoms
Relevant guidanceJ. Ophthalmic10-21

ISO 11979-2:1999 Ophthalmic Implants—Intraocular Lenses—Part 2: Optical Properties and Test Methods
Withdrawn( print page 52373)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
Withdrawn10-42

ISO 11979-2:1999/Corrigendum1:2003 Ophthalmic Implants—Intraocular Lenses—Part 2: Optical Properties and Test Methods
Extent of recognition and Process impacted10-44

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 impactedK. Orthopedic11-73

ISO 5838-1:1995 Implants for Surgery—Skeletal Pins and Wires—Part 1: Material and Mechanical Requirements
Type of standard and Contact person11-74

ISO 5838-2:1991 Implants for Surgery—Skeletal Pins and Wires—Part 2: Steinmann Skeletal Pins—Dimensions
Type of standard and Contact person11-75

ISO 5838-3:1993 Implants for Surgery—Skeletal Pins and Wires—Part 3: Kirschner Skeletal Wires
Type of standard and Contact person11-79

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 guidance11-80

ISO 8828:1988 Implants for Surgery—Guidance on Care and Handling of Orthopaedic Implants
Contact person Processes Impacted11-81
8-157
ISO 9583:1993 Implants for Surgery—Non-Destructive Testing—Liquid Penetrant Inspection of Metallic Surgical Implants
Transferred11-82
8-159
ISO 9584:1993 Implants for Surgery—Non-Destructive Testing—Radiographic Examination of Cast Metallic Surgical Implants
Transferred11-155

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 guidance11-164
11-203
ASTM F1541-02(2007) Standard Specification and Test Methods for External Skeletal Fixation Devices
Withdrawn and replaced with newer version11-166
11-204
ASTM F0897-02(2007) Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
Withdrawn and replaced with newer version11-168

ASTM F1781-03 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
Type of standard11-171

ASTM F1814-97a(2003) Standard Guide for Evaluating Modular Hip and Knee Joint Components
Type of standard and Relevant guidance11-172

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 guidance11-175

ASTM F1582-98(2003) Standard Terminology Relating to Spinal Implants
Type of standard, CFR Citation, Product codes and Relevant guidance11-177
11-205
ASTM F1264-03(2007) Standard Specification and Test Methods for Intramedullary Fixation Devices
Withdrawn and replaced with newer version( print page 52374)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 guidance11-179

ASTM F2068-03 Standard Specification for Femoral Prostheses—Metallic Implants
Processes impacted, Type of standard, CFR Citation, Product codes and Relevant guidance11-180

ASTM F0366-04 Standard Specification for Fixation Pins and Wires
Type of standard and Contact person11-181

ASTM F1717-04 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
Type of standard and Relevant guidance11-182
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 version11-183

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 guidance11-184

ISO 8827:1988 Implants for surgery—Staples with Parallel Legs for Orthopaedic Use—General Requirements
Type of standard and Contact person11-185

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 guidance11-186

ASTM F2077-03 Test Methods for Intervertebral Body Fusion Devices
Type of standard, CFR Citations, Product codes and Relevant guidance11-187
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 version11-188

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 codes11-189

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 codes11-190

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 codes11-191

ISO 14879-1:2000 Implants for Surgery—Total Knee-Joint Prostheses—Part 1: Determination of Endurance Properties of Knee Tibial Trays
Type of standard11-192

ASTM F1223-05 Standard Test Method for Determination of Total Knee Replacement Constraint
Type of standard CFR Citations and Product codes11-194
11-208
ISO 14630:2008 Non-Active Surgical Implants—General Requirements—3d Edition
Withdrawn and replaced with newer version11-195

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 guidance11-196

ASTM F1672-95(2005) Standard Specification for Resurfacing Patellar Prosthesis
Type of standard and Relevant guidance( print page 52375)11-197

ASTM F0983-86(2005) Standard Practice for Permanent Marking of Orthopaedic Implant Components
Contact person and Processes impacted11-198

ASTM F0382-99(2003)e1 Standard Specification and Test Method for Metallic Bone Plates
Type of standard and Contact person11-199

ASTM F0565-04 Standard Practice for Care and Handling of Orthopedic Implants and Instruments
Contact person and Processes impacted11-200
11-209
ASTM F2083-07 Standard Specification for Total Knee Prosthesis
Withdrawn and replaced with newer version11-201

ASTM F0564-02(2006) Standard Specification and Test Methods for Metallic Bone Staples
Contact person11-202
11-210
ASTM F0543-07 Standard Specification and Test Methods for Metallic Medical Bone Screws
Withdrawn and replaced with newer versionL. Physical Medicine16-19

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 standard16-20

ISO 7176-5:1986 Wheelchairs—Part 5: Determination of Overall Dimensions, Mass and Turning Space
Contact person and Type of standard16-23

ISO 7176-10:1988 Wheelchairs—Part 10: Determination of Obstacle-Climbing Ability of Electric Wheelchairs
Contact person and Type of standard16-24

ISO 7176-11:1992 Wheelchairs—Part 11: Test Dummies
Contact person and Type of standard16-25

ISO 7176-13:1989 Wheelchairs—Part 13: Determination of Coefficient of Friction of Test Surfaces
Contact person and Type of standard16-26

ISO 7176-14:1997 Wheelchairs—Part 14: Power and Control Systems for Electric Wheelchairs—Requirements and Test Methods
Contact person and Type of standard16-27

ISO 7176-15:1996 Wheelchairs—Part 15: Requirements for Information Disclosure, Documentation and Labeling
Contact person and Type of standard16-28

ISO 7176-16: 1997 Wheelchairs—Part 16: Resistance to Ignition of Upholstered Parts—Requirements and Test Methods
Contact person and Type of standard16-29

ISO 7176-6:2001 Wheelchairs—Part 6: Determination of Maximum Speed, Acceleration and Deceleration of Electric Wheelchairs
Contact person and Type of standard16-30

ISO 7176-9:2001 Wheelchairs—Part 9: Climatic Tests for Electric Wheelchairs
Contact person and Type of standard16-31

ANSI/RESNA WC/Volume 1-1998 Section 1: Determination of Static Stability
Contact person and Type of standard16-32

ANSI/RESNA WC/Volume 2-1998 Section 2: Determination of Dynamic Stability of Electric Wheelchairs
Contact person and Type of standard16-33

ANSI/RESNA WC/Volume 2-1998 Section 3: Test Methods and Requirements for the Effectiveness of Brakes
Contact person and Type of standard16-34

ANSI/RESNA WC/Volume 2-1998 Section 4: Determination of Energy Consumption of Electric Wheelchairs
Contact person and Type of standard16-35

ANSI/RESNA WC/Volume 1-1998 Section 5: Determination of Overall Dimensions, Mass, and Turning Space—Wheelchair
Contact person and Type of standard( print page 52376)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 standard16-37

ANSI/RESNA WC/Volume 1-1998 Section 7: Wheelchairs - Determination of Seating and Wheel Dimensions
Contact person and Type of standard16-38

ANSI/RESNA WC/Volume 1-1998 Section 8: Wheelchairs—Static, Impact and Fatigue Strength Tests
Contact person and Type of standard16-39

ANSI/RESNA WC/Volume 2 - 1998 Section 9: Climatic Tests for Electric Wheelchairs
Contact person and Type of standard16-40

ANSI/RESNA WC/Volume 2 - 1998 Section 10: Determination of the Obstacle-Climbing Ability of Electric Wheelchairs
Contact person and Type of standard16-41

ANSI/RESNA WC/Volume 1 - 1998 Section 11: Wheelchairs—Test Dummies
Contact person and Type of standard16-42

ANSI/RESNA WC/Volume 1 - 1998 Section 13: Determination of Coefficient of Friction of Test Surfaces
Contact person and Type of standard16-43

ANSI/RESNA WC/Volume 2 - 1998 Section 14: Wheelchairs—Testing of Power and Control Systems for Electric Wheelchairs
Contact person and Type of standard16-44

ANSI/RESNA WC/Volume 1 - 1998 Section 15: Wheelchairs—Requirements for Information Disclosures, Documentation and Labeling
Contact person and Type of standard16-45

ANSI/RESNA WC/Volume 1 - 1998 Section 16: Wheelchairs—Determination of Flammability
Title change, Contact person and Type of standard16-46

ANSI/RESNA WC/Volume 1 - 1998 Section 20: Wheelchairs—Determination of the Performance of Stand-Up Wheelchairs
Contact person and Type of standard16-47

ANSI/RESNA WC/Volume 1 - 1998 Section 22: Wheelchairs—Set Up Procedures
Contact person and Type of standard16-48

ANSI/RESNA WC/Volume 1 - 1998 Section 93: Maximum Overall Dimensions
Contact person and Type of standard16-49

ANSI/RESNA WC/Volume 1 - 1998 Section 0: Nomenclature, Terms, and Definitions
Contact person and Type of standard16-50

ISO 7176-3:2003 Wheelchairs—Part 3: Determination of Effectiveness of Brakes
Contact person and Type of standard16-158

ISO 7176-1:1999 Wheelchairs—Part 1: Determination of Static Stability
Contact person and Type of standard16-159

ISO 7176-2:2001 Wheelchairs—Part 2: Determination of Dynamic Stability of Electric Wheelchairs
Contact person and Type of standardM. Radiology12-17

NEMA MS 8-1993 (2000), Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems
Relevant guidance and Contact person12-61
12-177
UL 122 (2007): Standard for Photographic Equipment—Ed. 5.0
Withdrawn and replaced with newer version12-64
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( print page 52377)12-69

NEMA MS 6-1991 (R2000) Characterization of Special Purpose Coils for Diagnostic Magnetic Resonance Images
Relevant guidance, Contact person and CFR Citations12-95

NEMA MS 2-2003 Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
Relevant guidance and Contact person12-96

NEMA MS 3-2003 Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
Relevant guidance and Contact person12-97

NEMA MS-1-2001 Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging
Relevant guidance, Contact person and CFR Citations12-103
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 version12-120

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 Citations12-123
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 version12-125

NEMA MS 5-2003 Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
Relevant guidance and Contact person12-129
12-181
NU 1-2007 Performance Measurements of Gamma Cameras
Withdrawn and replaced with newer version12-131
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 version12-150

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 affected12-151

NEMA MS 4 (2006) Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
Relevant guidance, Contact person and CFR Citations12-158

NEMA MS 10-2006 Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging
Relevant guidance, Contact person and CFR Citations12-159

NEMA MS 11-2006 Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging
Relevant guidance, Contact person and CFR Citations12-160

NEMA MS 12-2006 Quantification and Mapping of Geometric Distortion for Special Applications
Relevant guidance, Contact person and CFR Citations12-161

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 person12-164
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 version12-165

NEMA XR 22-2006 “Quality Control Manual” Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-Field Digital Mammography
Relevant guidance12-166

NEMA XR 23-2006 “Quality Control Manual” Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-Field Digital Mammography
Relevant guidance12-168

IEC 60825-1 Ed. 2.0 (2007) Safety of Laser Products—Part 1: Equipment Classification, and Requirements
Contact person and Processes impacted( print page 52378)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 Title12-170
12-183
NEMA PS 3.1 - 3.18 (2008) Digital Imaging and Communications in Medicine (DICOM) Set
Withdrawn and replaced with newer versions5-7
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
TransferredN. Software/Informatics13-4

ANSI/UL 1998, Software in Programmable Components
CFR Citations, Product codes, Relevant guidance and Extent of recognition13-5

IEEE 1074:1997, Standard for Developing Software Life Cycle Processes
Withdrawn13-8

IEC 62304 Ed. 1.0, Medical Device Software—Software Life Cycle Processes
CFR Citations, Product codes, Relevant guidance, and Extent of recognition7-59
13-9
CLSI AUTO2-A2 Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard
Transferred7-60
13-10
CLSI AUTO1-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard
Transferred7-61
13-11
CLSI AUTO3-A Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard
Transferred7-62
13-12
CLSI AUTO4-A Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard
Transferred7-63
13-13
CLSI AUTO5-A Laboratory Automation: Electromechanical Interfaces; Approved Standard
Transferred7-64
13-14
CLSI POCT1-A2 Point-of-Care Connectivity; Approved Standard
Transferred7-68
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
Transferred7-114
13-16
CLSI LIS01-A Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems
Transferred7-115
13-17
CLSI LIS02-A2 Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition
Transferred7-116
13-18
CLSI LIS03-A Standard Guide for Selection of a Clinical Laboratory Information Management System
Transferred7-117
13-19
CLSI LIS04-A Standard Guide for Documentation of Clinical Laboratory Computer Systems
Transferred7-118
13-20
CLSI LIS05-A Standard Specification for Transferring Clinical Observations Between Independent Computer Systems
Transferred7-119
13-21
CLSI LIS06-A Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems
Transferred( print page 52379)7-120
13-22
CLSI LIS07-A Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory
Transferred7-121
13-23
CLSI LIS08-A Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems
Transferred7-122
13-24
CLSI LIS09-A Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures
TransferredO. Sterility14-24

AAMI/ANSI/ISO 11134:1993 Sterilization of Health Care Products—Requirements for Validation and Routine Control-Industrial Moist Heat Sterilization
Withdrawn14-53

AAMI/ANSI ST66:1996 Sterilization of Health Care Products—Chemical Indicators—Part 2: Indicators for Air Removal Test Sheets and Packs
Withdrawn14-54

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 affected14-55

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 guidance14-60

ASTM F1327:1998 Standard Terminology Relating to Barrier Materials for Medical Packaging
Withdrawn14-63

ASTM F1886: 1998 (2004) Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
CFR Citations and Product codes14-64

ASTM F1929:1998 (2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
CFR Citations and Product codes14-70

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 affected14-76

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 person14-88

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 codes14-90
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 version14-116

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 recognition14-120

ASTM D3078:2002 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
CFR Citations, Product codes and Type of standard14-123

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( print page 52380)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 standard14-136

AAMI/ANSI ST67:2003 Sterilization of Health Care Products—Requirements for Products Labeled 'Sterile' 1st Edition
CFR Citations, Product codes and Guidance14-138

ISO 13408-2:2003 Aseptic Processing of Health Care Products—Part 2: Filtration
CFR Citations, Product codes, Type of standard and Guidance14-139

ISO 14644-1:1999 Cleanrooms and Associated Controlled Environments—Part 1: Classification of Air Cleanliness
CFR Citations, Product codes and Type of standard14-140

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 standard14-141

ISO 14644-4:2001 Cleanrooms and Associated Controlled Environments—Part 4: Design, Construction and Startup
CFR Citations, Product codes and Type of standard14-142

ISO 14698-1:2003 Cleanrooms and Associated Controlled Environments—Biocontamination Control—Part 1: General Principles and Methods
CFR Citations, Product codes and Type of standard14-143

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 standard14-148

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 standard14-149

ASTM F2251-03e1 Standard Test Method for Thickness Measurement of Flexible Packaging Material
CFR Citations, Product codes and Type of standard14-150

ASTM F2252-03 Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape
CFR Citations, Product codes and Type of standard14-164

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 affected14-165

ISO 14644-5:2004 Cleanrooms and Associated Controlled Environments—Part 5: Operations
CFR Citations, Product codes and Type of standard14-166

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 standard14-168
14-245
ASTM F2338-07 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
Withdrawn and replaced with newer version14-169

ASTM F2391-05 Standard Test Method for Measuring Package and Seal Integrity Using Helium as Tracer Gas
CFR Citations, Product codes and Type of standard14-170

ASTM F2475-05 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
CFR Citations, Product codes and Type of standard14-191

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 guidance14-193

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( print page 52381)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 guidance14-197

ASTM F1608:00(2004) Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
CFR Citations and Product codes14-199

ASTM D4169-05 Standard Practice for Performance Testing of Shipping Containers and Systems
Related CFR Citations and Product codes14-202
14-246
USP 31:2008 Biological Indicator for Dry-Heat Sterilization, Paper Carrier
Withdrawn and replaced with newer version14-203
14-247
USP 31:2008 Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier.
Withdrawn and replaced with newer version14-204
14-248
USP 31:2008 Biological Indicator for Steam Sterilization, Paper Carrier
Withdrawn and replaced with newer version14-205
14-249
USP 31:2008 <61> Microbial Limits Test
Withdrawn and replaced with newer version14-206
14-250
USP 31:2008 <71> Microbiological Tests, Sterility Tests
Withdrawn and replaced with newer version14-207
14-251
USP 31:2008 <85> Biological Tests and Assays, Bacterial Endotoxin Test (LAL)
Withdrawn and replaced with newer version14-208
14-252
USP 31:2008 <151> Pyrogen Test (USP Rabbit Test)
Withdrawn and replaced with newer version14-209
14-253
USP 31:2008 <161> Transfusion and Infusion Assemblies and Similar Medical Devices
Withdrawn and replaced with newer version14-210
14-254
USP 31:2008 Biological Indicator for Steam Sterilization—Self Contained
Withdrawn and replaced with newer version14-220

AAMI/ANSI ST79:2006 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities
Type of Standard14-221

AAMI/ANSI/ISO TIR 11139:2006 Sterilization of Health Care Products—Vocabulary
CFR Citations, Product codes, Title, Devices affected, and Type of standard14-222

AAMI/ANSI/ISO 18472:2006 Sterilization of Health Care Products—Biological and Chemical Indicators—Test Equipment
Type of standard14-223

ANSI/AAMI/ISO 11138-1:2006 Sterilization of Health Care Products—Biological Indicators—Part 1: General Requirements
Type of standard, Guidance and Extent of recognition14-224

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 standard14-225

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 standard14-226

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( print page 52382)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 standard14-228

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 standard14-229

ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
CFR Citations and Product codes14-230

ASTM F2203-02(2007) Standard Test Method for Linear Measurement Using Precision Steel Rule
CFR Citations, Product codes and Type of standard14-231

ASTM F2217-02(2007) Standard Practice for Coating/Adhesive Weight Determination
CFR Citations, Product codes and Type of standard14-232

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 standard14-233

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 standard14-234

ASTM F2097-07 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
CFR Citations, Product codes and Type of standard14-235

ASTM F1140-07 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
CFR Citations, Product codes and Type of standard14-236

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 standard14-237

ASTM F88-07 Standard Test Method for Seal Strength of Flexible Barrier Materials
CFR Citations, Product codes and Type of standard14-239

ISO 13408-3:2006 Aseptic Processing of Health Care Products—Part 3: Lyophilization
CFR Citations and Product codes14-240

ISO 13408-5:2006 Aseptic Processing of Health Care Products—Part 5: Sterilization-in-Place
CFR Citations and Product codes14-241

ISO 13408-6:2005 Aseptic Processing of Health Care Products—Part 6: Isolator Systems
CFR Citations and Product codes14-242

ISO 14644-3:2005 Cleanrooms and Associated Controlled Environments—Part 3: Test Methods
CFR Citations and Product codes14-243

ISO 14644-6:2007 Cleanrooms and Associated Controlled Environments—Part 6: Vocabulary
CFR Citations and Product codes14-244

ISO 14644-8:2006 Cleanrooms and Associated Controlled Environments—Part 8: Classification of Airborne Molecular Contamination
CFR Citations and Product codesP. Tissue Engineering15-12

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( print page 52383)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 standard15-6

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 standard15-7

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 standard15-8

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 standard15-9

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 standard15-10

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 standard15-11

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 DateA. Biocompatibility2-127
Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Delayed-Type Hypersensitivity—Amendment 1
ANSI/AAMI BE 78:2002/A1:2006B. Cardiovascular/Neurology3-70
Manual, Electronic or Automated Sphygmomanometers
ANSI/AAMI SP10:2002/A1:2003—Amendment 1 to ANSI/AAMI SP10:20023-71
Manual, Electronic and Automated Sphygmomanometers
ANSI/AAMI SP10:2002/A2:2006—Amendment 2 to ANSI/AAMI SP10:2002C. Dental/ Ear, Nose, and Throat4-151
Dentistry—Artificial Teeth for Dental Prostheses
ISO 22112:2005( print page 52384)4-152
Metal-Ceramic Dental Restorative Systems
ISO 9693:1999/Amendment 1:20054-154
Dentistry—Elastometric Impression Materials-Third Edition
ISO 4823:20004-155
Dentistry—Elastomeric Impression Materials Technical Corrigendum 1-Third Edition
ISO 4823:2000 Technical Corrigendum 1:20044-156
Dentistry—Elastomeric Impression Materials Amendment 1-Third Edition
ISO 4823:2000 Amendment 1:20074-157
Dentistry—Zinc Oxide/Eugenol and Zinc Oxide/Non-eugenol Cements-Third Edition
ISO 3107: 20044-158
Dentistry—Soft Lining Materials for Removable Dentures—Part 1: Materials for Short-Term Use Technical Corrigendum 1
ISO 10139-1:2005 Technical Corrigendum 1:2006D. General Hospital/ General Plastic Surgery6-214
Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves
ASTM D6355-07E. In Vitro Diagnostic7-160
Abbreviated Identification of Bacteria and Yeast; Approved Guideline
CLSI M35-A,7-161
Laboratory Detection and Identification of Mycobacteria; Proposed Guideline.
CLSI M48-P7-162
Point-of-Care Monitoring of Anticoagulant Therapy; Approved Guideline
CLSI H49-A7-163
Body Fluid Analysis for Cellular Composition
CLSI H56-A7-164
Microwave Device Use in the Histology Laboratory; Approved Guideline
CLSI GP28-A7-165
Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard-Second Edition
CLSI H20-A27-166
Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline—Second Edition
CLSI GP20-A27-167
Nongynecologic Cytologic Specimens: Collection and Cytopreparatory Techniques; Approved Guideline
CLSI GP23-A7-168
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi; Approved Standard
CLSI M38-AF. Materials8-161
Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials
ASTM F2516-07G. OB-GYN/Gastroenterology9-46
Medical Electrical Equipment—Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment
ANSI/AAMI 60601-2-2:20069-49
Concentrates for Hemodialysis
AAMI / ANSI RD61:20069-50
Dialysate for Hemodialysis
ANSI/AAMI RD52:20049-51
Cardiovascular Implants and Artificial Organs—Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators
ISO 8637:20049-52
Cardiovascular Implants and Artificial Organs—Extracorporeal Blood Circuit for Haemodialysers, Haemodiafilters and Haemofilters
ISO 8638:20049-53
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 D6976-08H. Ophthalmic10-56
Ophthalmics Multifocal Intraocular Lenses
ANSI Z80.12-2007( print page 52385)10-57
Phakic Intraocular Lenses
ANSI Z80.13-2007I. Physical Medicine16-161
Safety Standard for Platform Lifts and Stairway Chairlifts
ASME A18.1-2005J. Sterility14-255
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