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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2004-N-0451] (formerly Docket No. 2004N-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: 022” (Recognition List Number: 022), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
 DATES: Submit written or electronic comments concerning this document at any time. See section VII of this document for the effective date of the recognition of standards announced in this document.
 ADDRESSES: Submit written requests for single copies of “Modifications to the List of Recognized Standards, Recognition List Number: 022” to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. Send two self-addressed adhesive labels to assist that office in processing your requests, or fax your request to 301-847-8149. Submit written comments concerning this document, or recommendations for additional standards for recognition, to the contact person (see 
                        **FOR FURTHER INFORMATION CONTACT**
                        ). Submit electronic comments by e-mail: 
                        *standards@cdrh.fda.gov*. This document may also be accessed on FDA's Internet site at 
                        *http://www.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: 022 modifications and other standards related information.
 FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 3632, Silver Spring, MD 20993-0002, 301-796-6574.


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 of the act allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements. In a notice published in the 
                    **Federal Register**
                     of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled “Recognition and Use of Consensus Standards.” The notice described how FDA would implement its standard recognition program and provided the initial list of recognized standards. Modifications to the initial list of recognized standards, as published in the 
                    **Federal Register**
                    , are identified in table 1 of this document. **Table 1.—Federal Register Citation**
February 25, 1998 (63 FR 9561)
May 27, 2005 (70 FR 30756)October 16, 1998 (63 FR 55617)
November 8, 2005 (70 FR 67713)July 12, 1999 (64 FR 37546)
March 31, 2006 (71 FR 16313)November 15, 2000 (65 FR 69022)
June 23, 2006 (71 FR 36121)May 7, 2001 (66 FR 23032)
November 3, 2006 (71 FR 64718)January 14, 2002 (67 FR 1774)
May 21, 2007 (72 FR 28500)October 2, 2002 (67 FR 61893)
September 12, 2007 (72 FR 52142)April 28, 2003 (68 FR 22391)
December 19, 2007 (72 FR 71924)March 8, 2004 (69 FR 10712)
September 9, 2008 (73 FR 52358)June 18, 2004 (69 FR 34176)
March, 18, 2009 (74 FR 11586)October 4, 2004 (69 FR 59240)
 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: 022 FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the agency will recognize for use in satisfying premarket reviews and other requirements for devices. FDA will incorporate these modifications in the list of FDA Recognized Consensus Standards in the agency's searchable database. FDA will use the term “Recognition List Number: 022” 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.**
Old Recognition No.
Replacement Recognition No.
Standard
ChangeA. Anesthesia1-37
1-80
CGA C-9:2004 (Reaffirmed 2008) Standard Color Marking of Compressed Gas Containers for Medical Use
Withdrawn and replaced with newer version( print page 46205)1-68
1-81
CGA V-5:2008 Diameter-Index Safety System Noninterchangeable Low Pressure Connections for Medical Gas Applications
Withdrawn and replaced with newer version1-51

ASTM F1100-90 (1997) Standard Specification for Ventilators Intended for Use in Critical Care
Withdrawn1-59

ASTM F1456-01 Standard Specification for Minimum Performance and Safety Requirements for Capnometers
WithdrawnB. Biocompatibility2-64

ANSI/AAMI/ISO 10993-5:1999 Biological Evaluation of Medical Devices—Part 5: Tests for In Vitro Cytotoxicity
Contact person, Extent of recognition and Relevant guidance2-82

ASTM F2147-01 Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
Contact person and Extent of recognition2-83
2-136
ASTM E1262-88 (Reapproved 2008) Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
Withdrawn and replaced with newer version2-84
2-137
ASTM E1263-97 (Reapproved 2008) Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes
Withdrawn and replaced with newer version2-85
2-138
ASTM E1280-97 (Reapproved 2008) Standard Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell Mutagenicity
Withdrawn and replaced with newer version2-87

ISO 10993-10:2002 Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Delayed-type Hypersensitivity
Extent of recognition and Relevant guidance2-90
2-139
ASTM E1397-91 (Reapproved 2008) Standard Practice for In Vitro Rat Hepatocyte DNA Repair Assay
Withdrawn and replaced with newer version2-91
2-140
ASTM E1398-91 (Reapproved 2008) Standard Practice for In Vivo Rat Hepatocyte DNA Repair Assay
Withdrawn and replaced with newer version2-93

ASTM F763-04 Standard Practice for Short-Term Screening of Implant Materials
Extent of recognition and Contact person2-94

ASTM F981-04 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
Extent of recognition and Contact person2-95
2-141
ASTM F1984-99 (Reapproved 2008) Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
Withdrawn and replaced with newer version2-97
2-142
ASTM F1983-99 (Reapproved 2008) Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
Withdrawn and replaced with newer version2-98

ANSI/AAMI/ISO 10993-1:2003 Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing
Title, Extent of recognition, Relevant guidance and Contact person2-99
2-143
ASTM F1904-98 (Reapproved 2008) Standard Practice for Testing the Biological Responses to Particles in vivo
Withdrawn and replaced with newer version2-100

ASTM E1372-95 (Reapproved 2003) Standard Test Method for Conducting a 90-Day Oral Toxicity Study in Rats
Contact person2-106
2-144
ASTM F619-03 (Reapproved 2008) Standard Practice for Extraction of Medical Plastics
Withdrawn and replaced with newer version2-108

ASTM F1905-98(2003) Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity
Contact person and Extent of recognition2-114

ASTM F1877-05 Standard Practice for Characterization of Particles
Extent of recognition and Contact person( print page 46206)2-115

ASTM F895-84 (Reapproved 2006) Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
Extent of recognition, Relevant guidance and Contact person2-116
2-145
ASTM F1439-03 (Reapproved 2008) Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
Withdrawn and replaced with newer version2-118

ANSI/AAMI/ISO 10993-11:2006 Biological Evaluation of Medical Devices—Part 11: Tests for Systemic Toxicity
Extent of recognition, Relevant guidance and Contact person2-119

ASTM F813-07 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
Contact person2-121
2-146
ASTM F2148-07
                            €
                            1 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
Withdrawn and replaced with newer version2-122

ASTM F719-81 (Reapproved 2007)
                            €
                            1 Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation
Contact person and Relevant guidance2-124

ASTM F750-87 (Reapproved 2007)
                            €
                            1 Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse
Extent of recognition, Relevant guidance and Contact person2-125

ASTM F749-98 (Reapproved 2007)
                            €
                            1 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
Extent of recognition, Relevant guidance and Contact person2-126

ASTM F748-06 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
Extent of recognition, Relevant guidance and Contact person2-128
2-147
USP 32-NF26 Biological Tests <87> 2009 Biological Reactivity Test, In Vitro—Direct Contact Test
Withdrawn and replaced with newer version2-129
2-148
USP 32-NF26 Biological Tests <88> Biological Reactivity Test, In Vitro—Elution Test
Withdrawn and replaced with newer version2-130
2-149
USP 32-NF26 Biological Tests <88> Biological Reactivity Tests, In Vivo Procedure—Preparation of Sample
Withdrawn and replaced with newer version2-131
2-150
USP 32-NF26 Biological Tests <88> Biological Reactivity Test, In Vivo, Classification of Plastics—Intracutaneous Test
Withdrawn and replaced with newer version2-132
2-151
USP 32-NF26 Biological Tests <88> Biological Reactivity Tests, In Vivo, Classification of Plastics—Systemic Injection Test
Withdrawn and replaced with newer version2-133

ASTM F1408-97 (Reapproved 2008) Standard Practice for Subcutaneous Screening Test for Implant Materials
Contact person2-134

ASTM F2065-00 (2006) Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials
Contact person2-135

AAMI/ANSI/ISO 10993-12:2007 Biological Evaluation of Medical Devices—Part 12: Sample Preparation and Reference Materials
Extent of recognition, Relevant guidance and Contact personC. Dental/ENT4-69
4-178
ISO 6872:2008 Dentistry—Ceramic Materials
Withdrawn and replaced with newer version4-73
4-179
ISO 7405: 2008 Dentistry—Evaluation of Biocompatibility of Medical Devices Used in Dentistry
Withdrawn and replaced with newer version4-175

ANSI ASA S3.46-1997 (R 2007) Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids
ReaffirmationD. General( print page 46207)5-12
5-47
ISO 10012:2003 Measurement Management Systems—Requirements for Measurement Processes and Measuring Equipment
Withdrawn and replaced with newer version5-15
5-48
ANSI/ASQ Z1.9-2008 Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming
Withdrawn and replaced with newer version5-27

IEC 60601-1-1 Ed. 2.0 2000 Medical Electrical Equipment—Part 1-1: General Requirements for Safety—Collateral Standard: Safety requirements for Medical Electrical Systems
Title5-36

ISO/TR 16142:2006 Medical Devices—Guidance on the Selection of Standards in Support of Recognized Essential Principles of Safety and Performance of Medical Devices
Title5-41

IEC 60601-1-4 (2000) Consol. Ed. 1.1 Medical Electrical Equipment—Part 1-4: General Requirements for Safety—Collateral Standard: Programmable Electrical Medical Systems
Title5-44
5-49
IEC 60601-1-8, Ed. 1 Medical Electrical Equipment—Part 1-8: General Requirements for Safety—Collateral Standard: Alarm Systems—Requirements, Tests and Guidelines—General Requirements and Guidelines for Alarm Systems in Medical Equipment
Withdrawn and re-recognized previous versionE. General Hospital/General Plastic Surgery6-63
6-216
ISO 8536-7:2009 Infusion Equipment for Medical Use—Part 7: Caps Made of Aluminum-plastics Combinations for Infusion Bottles
Withdrawn and replaced with newer version6-112

ANSI/AAMI PB70:2003 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities
Contact person6-118

ASTM F2196-02 Standard Specification for Circulating Liquid and Forced Air Patient Temperature Management Devices
CFR citation and product code6-144

ASTM D5712—05
                            €
                            1 Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method
Title and Contact person6-145

ASTM D3578-05
                            €
                            1 Standard Specification for Rubber Examination Gloves
Title and Contact person6-147

ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
Contact person and Relevant guidance6-149

ASTM D7160-05 Standard Practice for Determination of Expiration Dating for Medical Gloves
Contact person6-150

ASTM D7161-05 Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions
Contact person6-165

ASTM D6977-04
                            €
                            1 Standard Specification for Polychloroprene Examination Gloves for Medical Application
Title and Contact person6-167

ASTM D6319-00a (Reapproved 2005)
                            €
                            1 Standard Specification for Nitrile Examination Gloves for Medical Application
Title and Contact person6-168

ASTM D3577-09
                            €
                            1 Standard Specification for Rubber Surgical Gloves
Withdrawn and replaced with newer version6-175

ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves
Contact person6-178

ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves
Contact person6-183

ASTM D5250-06
                            €
                            1 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
Title and Contact person6-186
6-217
ASTM F1670-08 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
Withdrawn and replaced with newer version( print page 46208)6-205
6-218
USP 32:2009 Nonabsorbable Surgical Suture
Withdrawn and replaced with newer version6-206
6-219
USP 32<11>:2009 Sterile Sodium Chloride for Irrigation
Withdrawn and replaced with newer version6-207
6-220
USP 32:2009 Absorbable Surgical Suture
Withdrawn and replaced with newer version6-208
6-221
USP 32<881>:2009 Tensile Strength
Withdrawn and replaced with newer version6-209
6-222
USP 32<861>:2009 Sutures—Diameter
Withdrawn and replaced with newer version6-210
6-223
USP 32<871>:2009 Sutures Needle Attachment
Withdrawn and replaced with newer version6-211
6-224
USP 32<11>:2009 Sterile Water for Irrigation
Withdrawn and replaced with newer version6-212
6-225
USP 32<11>:2009 Heparin Lock Flush Solution
Withdrawn and replaced with newer version6-213
6-226
USP 32<11>:2009 Sodium Chloride Injection
Withdrawn and replaced with newer versionF. In Vitro Diagnostics7-156
7-195
CLSI M02-A10, Performance Standards for Antimicrobial Disk Susceptibility Tests
Withdrawn and replaced with newer version7-158
7-196
CLSI M07-A8, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically
Withdrawn and replaced with newer version7-160
7-197
CLSI M35-A2, Abbreviated Identification of Bacteria and Yeast
Withdrawn and replaced with newer version7-78
7-198
CLSI M23-A3, Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters
Withdrawn and replaced with newer version7-177
7-199
CLSI M100-S19 Performance Standards for Antimicrobial Susceptibility Testing
Withdrawn and replaced with newer version7-161
7-200
CLSI M48-A, Laboratory Detection and Identification of Mycobacteria
Withdrawn and replaced with newer version7-102

NCCLS H1-A5, Tubes and Additives for Venous Blood Specimen Collection
Contact Person7-101

NCCLS H51-A, Assays of vonWillebrand Factor Antigen and Ristocetin Cofactor Activity
Contact Person7-165

CLSI H20-A2, Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods
Contact Person7-103
7-201
CLSI H3-A6, Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture
Withdrawn and replaced with newer version7-81
7-202
CLSI C28-A3 Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory
Withdrawn and replaced with newer version7-144
7-203
CLSI H04-A6, Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens
Withdrawn and replaced with newer versionG. Materials8-32
8-163
ASTM F1586-08 Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10Nickel-3Manganese-2.5Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675)
Withdrawn and replaced with newer version( print page 46209)8-44
8-164
ASTM F136-08
                            €
                            1 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
Withdrawn and replaced with newer version8-49
8-165
ASTM F1058-08 Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire and Strip for Surgical Implant Applications (UNS R30003 and UNS R30008)
Withdrawn and replaced with newer version8-50
8-166
ASTM F1091-08 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605)
Withdrawn and replaced with newer version8-52
8-167
ASTM F1350-08 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
Withdrawn and replaced with newer version8-53
8-168
ASTM F1472-08
                            €
                            1 Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
Withdrawn and replaced with newer version8-76
8-169
ASTM F138-08 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
Withdrawn and replaced with newer version8-79
8-170
ASTM F961-08 Standard Specification for 35Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
Withdrawn and replaced with newer version8-81
8-171
ASTM F1609-08 Standard Specification for Calcium Phosphate Coatings for Implantable Materials
Withdrawn and replaced with newer version8-86
8-172
ASTM F1926/F1926M-08 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and Coatings
Withdrawn and replaced with newer version8-94
8-173
ASTM F601-03 (Reapproved 2008) Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
Withdrawn and replaced with newer version8-95
8-174
ASTM F629-02 (Reapproved 2007)
                            €
                            1 Standard Practice for Radiography of Cast Metallic Surgical Implants
Withdrawn and replaced with newer version8-110
8-175
ASTM F1377-08 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
Withdrawn and replaced with newer version8-118
8-176
ASTM F2503-08 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
Withdrawn and replaced with newer version8-133
8-177
ASTM F2129-08 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
Withdrawn and replaced with newer version8-143
8-178
ASTM F648-07
                            €
                            1 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
Withdrawn and replaced with newer version8-144
8-179
ASTM F754-08 Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders
Withdrawn and replaced with newer version8-146
8-180
ASTM F2066-08 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
Withdrawn and replaced with newer version8-148
8-181
ASTM F899-09 Standard Specification for Wrought Stainless Steels for Surgical Instruments
Withdrawn and replaced with newer version8-152
8-182
ASTM F1537-08 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
Withdrawn and replaced with newer version8-160
8-183
ASTM F560-08 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
Withdrawn and replaced with newer version( print page 46210)8-161
8-184
ASTM F2516-07
                            €
                            2 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials
Withdrawn and replaced with newer version8-162
8-185
ASTM F451-08 Standard Specification for Acrylic Bone Cement
Withdrawn and replaced with newer versionH. OB-GYN/Gastroenterology9-34

ISO 4074:2002/Cor.1:2003(E):, Natural Latex Rubber Condoms—Requirements and Test Methods, Technical Corrigendum 1
Relevant guidance9-41
9-58
ASTM D6324-08 Standard Test Methods for Male Condoms Made from Polyurethane
Withdrawn and replaced with newer version9-43

ISO 16038:2005 Rubber condoms—Guidance on the Use of ISO 4074 in the Quality Management of Natural Rubber Latex Condoms
Relevant guidance9-56

ASTM D3492-08 Standard Specification for Rubber Contraceptives (Male Condoms)
Relevant guidance9-57

ISO 4074:2002/Cor.2:2008(E) Natural Latex Rubber Condoms—Requirements and Test Methods, Technical Corrigendum 2
Relevant guidanceI. Orthopedics11-172
11-211
ASTM F1798-97 (Reapproved 2008) Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
Withdrawn and replaced with newer version11-178
11-212
ASTM F1440-92 (Reapproved 2008) Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion
Withdrawn and replaced with newer version11-192
11-213
ASTM F1223-08 Standard Test Method for Determination of Total Knee Replacement Constraint
Withdrawn and replaced with newer version11-198
11-214
ASTM F0382-99 (Reapproved 2008) Standard Specification and Test Method for Metallic Bone Plates
Withdrawn and replaced with newer version11-204
11-215
ASTM F897-02 (Reapproved 2007) Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
Withdrawn and replaced with newer version11-205
11-216
ASTM F1264-03 (Reapproved 2007)
                            €
                            1 Standard Specification and Test Methods for Intramedullary Fixation Devices
Withdrawn and replaced with newer version11-209
11-217
ASTM F2083-08
                            €
                            1 Standard Specification for Total Knee Prosthesis
Withdrawn and replaced with newer versionJ. Radiology12-17
12-192
NEMA MS 8-2008 Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems
Withdrawn and replaced with new version12-48
12-193
AIUM AOL 2008 Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment Revision 1- A Standard for How Manufacturers Should Specify Acoustic Output Data
Withdrawn and replaced with newer version12-58
12-194
ANSI/HPS N43.6-2007 Sealed Radioactive Sources—Classification
Withdrawn and replaced with newer version12-69
12-195
NEMA MS 6-2008 Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
Withdrawn and replaced with newer version12-95
12-196
NEMA MS 2-2008 Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
Withdrawn and replaced with newer version12-100

NEMA UD 3-2004 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
Contact person( print page 46211)12-105

NEMA UD 2-2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Version 3
Contact person12-139

AIUM AOMS-2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
Title and Contact person12-140

AIUM RTD1-2004 Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Revision 1
Title and Contact person12-146

IEC 60601-2-17 (2004) Medical Electrical Equipment—Part 2-17: Particular Requirements for the Safety of Automatically-controlled Brachytherapy Afterloading Equipment
Title12-147

IEC 60601-2-5: (2000) Medical Electrical Equipment—Part 2-5: Particular Requirements for the Safety of Ultrasonic Physiotherapy Equipment Ed. 2.0
Title12-169
12-197
IEC 60601-2-22 (1995) Medical Electrical Equipment—Part 2-22: Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment—Edition 2.0
Withdrawn and re-recognized previous version12-178

IEC 60601-2-45 Ed. 2.0, (2001), Medical electrical equipment—Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices
Title12-182
12-198
IEC 60601-2-37 (2004), (2005) Amendment 2, Medical Electrical Equipment—Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
Withdrawn and re-recognized previous version12-185
12-199
IEC 60601-1-3: 1994 Medical Electrical Equipment—Part 1: General Requirements for Safety 3. Collateral Standard: General Requirements for Radiation Protection in Diagnostic X-ray Equipment—First Edition
Withdrawn and re-recognize previous version12-186
12-200
IEC 60601-2-29 (1999) Medical Electrical Equipment Part 2-29: Particular Requirements for the Safety of Radiotherapy Simulators—Second Edition
Withdrawn and re-recognized previous versionK. Software/Informatics13-16
13-29
CLSI LIS01-A2 Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems
Withdrawn and replaced with newer versionL. Sterility14-55

ANSI/AAMI/ISO 14160:1998/(R) 2008 Sterilization of Single-use Medical Devices Incorporating Materials of Animal Origin—Validation and Routine Control of Sterilization by Liquid Chemical Sterilants
Reaffirmation14-88

ANSI/AAMI/ 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.
Contact person14-116

ANSI/AAMI ST72:2002 Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing
Relevant guidance and Extent of recognition14-135

ANSI/AAMI 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
Relevant Guidance14-164

ANSI/AAMI ST81:2004 Sterilization of Medical Devices—Information to be Provided by the Manufacturer for the Processing of Resterilizable Medical Devices
Contact Person14-195

ANSI/AAMI/ISO 11140-1:2005 Sterilization of Health Care Products—Chemical Indicators—Part 1: General Requirements
Relevant Guidance, Extent of Recognition and Contact person( print page 46212)14-220
14-263
ANSI/AAMI ST79:2006/A1:2008 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities
Withdrawn and replaced with newer version14-223

ANSI/AAMI/ISO 11138-1:2006 Sterilization of Health Care Products—Biological Indicators—Part 1: General Requirements
Relevant Guidance14-224

ANSI/AAMI/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
Relevant Guidance14-225

ANSI/AAMI/ISO 11137-2:2006 Sterilization of Health Care Products—Radiation—Part 2: Establishing the Sterilization Dose
Relevant Guidance14-226

ANSI/AAMI/ISO 11137-3:2006 Sterilization of Health Care Products—Radiation—Part 3: Guidance on Dosimetric Aspects
Relevant Guidance14-228

ANSI/AAMI/ISO 11135-1:2007 Sterilization of Health Care Products—Ethylene oxide—Part 1: Requirements for Development, Validation, and Routine Control of a Sterilization Process for Medical Devices
Relevant Guidance14-261

ANSI/AAMI/ISO 17665-1:2006 Sterilization of Health Care Products—Moist Heat—Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices
Relevant Guidance14-119

ANSI/AAMI ST55:2003/(R)2008 Table-top Steam Sterilizers
Reaffirmation14-71
14-264
ANSI/AAMI ST8:2008 Hospital Steam Sterilizers
Withdrawn and replaced with newer version14-249
14-265
USP 32:2009 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
Withdrawn and replaced with newer version14-250
14-266
USP 32:2009 <71> Sterility Tests
Withdrawn and replaced with newer version14-251
14-267
USP 32:2009 <85> Bacterial Endotoxins Test
Withdrawn and replaced with newer version14-252
14-268
USP 32:2009 <151> Pyrogen Test (USP Rabbit Test)
Withdrawn and replaced with newer version14-253
14-269
USP 32:2009 <161> Transfusion and Infusion Assemblies and Similar Medical Devices
Withdrawn and replaced with newer version14-254
14-270
USP 32:2009 Biological Indicator for Steam Sterilization—Self Contained
Withdrawn and replaced with newer version14-246
14-271
USP 32:2009 Biological Indicator for Dry-Heat Sterilization, Paper Carrier
Withdrawn and replaced with newer version14-247
14-272
USP 32:2009 Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier
Withdrawn and replaced with newer version14-248
14-273
USP 32:2009 Biological Indicator for Steam Sterilization, Paper Carrier
Withdrawn and replaced with newer version14-238

ANSI/AAMI/ISO 11140-5:2007 Sterilization of Health Care Products—Chemical Indicators—Part 5: Class 2 Indicators for Bowie and Dick-type Air Removal Tests
Contact person and Relevant guidance14-171
14-274
ANSI/AAMI/ISO 15882:2008 Chemical Indicators—Guidance on the Selection, Use, and Interpretation of Results
Withdrawn and replaced with newer version14-49
14-275
ANSI/AAMI ST41:2008 Ethylene oxide Sterilization in Health Care Facilities: Safety and Effectiveness
Withdrawn and replaced with newer version14-136

ANSI/AAMI ST67:2003/(R) 2008 Sterilization of Health Care Products—Requirements for Products Labeled “STERILE”
Reaffirmation and Relevant guidance
 
 
 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: 022. **Table 3.**
Recognition No.
Title of Standard
Reference No. & DateA. Biocompatibility2-152
Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Delayed-type Hypersensitivity Amendment 1
ISO 10993 10:2002/Amd.1:2006(E)B. General5-46
Sampling Procedures for Inspection by Attributes—Part 1: Sampling Schemes Indexed by Acceptance Quality Limit (AQL) for Lot-by-lot Inspection
ISO 2859-1:1999/Cor 1:20015-50
Medical Devices—Application of Usability Engineering to Medical Devices
IEC 62366:2007C. In Vitro Diagnostics7-204
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
CLSI M27-A3D. Materials8-186
Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
ASTM F 2759—098-187
Implants for Surgery—Hydroxyapatite—Part 1: Ceramic Hydroxyapatite
ISO 13779-1:2008(E)8-188
Implants for Surgery—Hydroxyapatite—Part 2: Coatings of Hydroxyapatite
ISO 13779-2:2008(E)E. Neurology17-8
Implants for Surgery—Active Implantable Medical Devices Part 3: Implantable Neurostimulators (Neurology)
ISO 14708-3 2008-11-15F. OB-GYN/Gastroenterology9-59
Hemodialysis Systems
ANSI/AAMI RD5:2003/(R) 2008G. Orthopedics11-218
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
ISO 14243-3:2004 Technical Corrigendum 1H. Sterility14-276
Sterilization of Health Care Products—Moist Heat—Part 2: Guidance on the Application of ISO 17665-1
ISO/TS 17665-2:200914-277
Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
USP32:2009 <62>14-278
Biological Evaluation of Medical Devices—Part 7: Ethylene Oxide Sterilization Residuals
ANSI/AAMI/ISO 10993-7:2008I. Tissue Engineering15-14
Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
ASTM F2603-0615-15
Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy
ASTM F2259-03 (Reapproved 2008)
 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 document 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.
                    ( print page 46214) 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 You may obtain a copy of “Guidance on the Recognition and Use of Consensus Standards” by using the Internet. CDRH maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page includes the guidance as well as the current list of recognized standards and other standards related documents. After publication in the 
                    **Federal Register**
                    , this document announcing “Modification to the List of Recognized Standards, Recognition List Number: 022” will be available on the CDRH home page. You may access the CDRH home page at 
                    *http://www.fda.gov/​cdrh*. You may access “Guidance on the Recognition and Use of Consensus Standards,” and the searchable database for “FDA Recognized Consensus Standards” through the hyperlink at 
                    *http://www.fda.gov/​cdrh/​stdsprog.html*. 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: 022. These modifications to the list or recognized standards are effective upon publication of this document in the 
                    **Federal Register**
                    . Dated: August 26, 2009. Catherine M. Cook, Associate Director for Regulation and Policy.


[FR Doc. E9-21609 Filed 9-4-09; 8:45 am] BILLING CODE 4160-01-S