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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2004-N-0451]
 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: 021” (Recognition List Number: 021), 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: 021” to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health (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 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: 021 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 Place, Rockville, MD 20855, 240-276-8714.
                        ( print page 11587)


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 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. **Table 1—Federal Register Citation**
October 16, 1998 (63 FR 55617)
May 27, 2005 (70 FR 30756)July 12, 1999 (64 FR 37546)
November 8, 2005 (70 FR 67713)November 15, 2000 (65 FR 69022)
March 31, 2006 (71 FR 16313)May 7, 2001 (66 FR 23032)
June 23, 2006 (71 FR 36121)January 14, 2002 (67 FR 1774)
November 3, 2006 (71 FR 64718)October 2, 2002 (67 FR 61893)
May 21, 2007 (72 FR 28500)April 28, 2003 (68 FR 22391)
September 12, 2007 (72 FR 52142)March 8, 2004 (69 FR 10712)
December 19, 2007 (72 FR 71924)June 18, 2004 (69 FR 34176)
September 9, 2008 (73 FR 52358)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: 021 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: 021” 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. Anesthesia1-49

ASTM F 1981-99 Standard Specification for Suction Catheters for use in the Respiratory Tract
Withdrawn1-63
1-77
CGA V-1:2005 Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connection
Withdrawn and replaced with newer version1-64
1-78
ASME PVHO-1-2007 Safety Standard for Pressure Vessels for Human Occupancy
Withdrawn and replaced with newer version( print page 11588)1-71

ISO 10651-5:2006 Lung Ventilators for Medical Use—Particular requirements for Basic Safety and Essential Performance—Part 5: Gas-powered Emergency Resuscitators
Withdrawn duplicate1-74

ISO 5360:2006 Anaesthetic Vaporizers—Agent Specific Filling Systems
Contact person1-76
1-79
ISO 26825:2008 (E) Anaesthetic And Respiratory Equipment—User-Applied Labels For Syringes Containing Drugs Used During Anaesthesia—Colours, Design and Performance
Withdrawn and replaced with newer versionB. Biocompatibility2-71
2-133
ASTM F1408-97 (2008) Standard Practice for Subcutaneous Screening Test for Implant Materials
Withdrawn and replaced with newer version2-73
2-134
ASTM F2065-00(2006) Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials
Withdrawn and replaced with newer version2-87

AAMI/ANSI/ISO 10993-10:2002 Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Delayed-Type Hypersensitivity
Extent of Recognition, Relevant Guidance, and Contact Person2-88
2-135
AAMI/ANSI/ISO 10993-12:2007 Biological Evaluation of Medical Devices—Part 12: Sample Preparation and Reference Materials
Withdrawn and replaced with newer version2-127

ANSI/AAMI BE 78:2002/A1:2006 Biological Evaluation of Medical Devices—Part 10: Tests For Irritation and Delayed-Type Hypersensitivity—Amendment 1
WithdrawnC. Cardiovascular/Neurology3-67

ASTM F2129-06 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
Offices, Devices Affected, Relevant Guidance, CFR Citation and Product Codes, Contact PersonD. General Hospital/General Plastic Surgery6-29

IEC 60601-2-19 1996-10: Amendment 1—Medical Electrical Equipment Part 2: Particular Requirements for Safety of Baby Incubators
Relevant guidance6-32

IEC 60601-2-20 1996-10: Amendment 1—Medical Electrical Equipment Part 2: Particular Requirements for the Safety Of Transport Incubators
Relevant guidance6-62

ISO 8536-6:1995 Infusion Equipment for Medical Use—Part 6: Freeze Drying Closures for Infusion Bottles
Relevant guidance6-63

ISO 8536-7-1999: Infusion Equipment for Medical Use—Part 7: Caps Made of Aluminum-Plastics Combinations For Infusion Bottles
Relevant guidance6-64

ISO 8536-3-1999, Infusion Equipment for Medical Use—Part 3: Aluminum Caps for Infusion Bottles
Relevant guidance6-119

ANSI/AAMI BF7:1989/(R)2002/(R)2007 Blood Transfusion Micro-Filters
Reaffirmation 2007, Title, SDO, Date of standard, Relevant guidance6-122

ISO 8536-5-2004:, Infusion Equipment for Medical Use—Part 5: Burette Infusion Sets for Single Use, Gravity Feed
Relevant guidance6-127

ISO 1135-4-2004: Transfusion Equipment for Medical Use—Part 4: Transfusion Sets for Single Use
Relevant guidance6-142

ANSI/AAMI II36:2004 Medical Electrical Equipment—Part 2: Particular Requirements for Safety of Baby Incubators
Title, Relevant guidance6-143

ANSI/AAMI II51:2004, Medical Electrical Equipment—Part 2: Particular Requirements for Safety of Transport Incubators
Title, Relevant guidance( print page 11589)6-172

ISO 8536-1:2006 Infusion Equipment for Medical Use—Part 1: Infusion Glass Bottles
Relevant guidance6-173

ISO 8536-2:2001 Corrigendum 1:2003, Infusion Equipment for Medical Use—Part 2: Closures for Infusion Bottles
Relevant guidance6-182

IEC 60601-2-38 1996/Amendment 1:1999, Medical Electrical Equipment—Part 2-38: Particular Requirements for the Safety of Electrically Operated Hospital Beds
Relevant guidance6-201

ISO 8536-4:2007 Infusion Equipment for Medical Use—Part 4: Infusion Sets for Single Use, Gravity Feed
Relevant guidance6-215

ASTM F2132-01(2008)E1 Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps
TitleE. IVD7-138
7-169
CLSI M27-A3 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
Withdrawn and replaced with newer version7-54

CLSI D12-A2, Immunoprecipitin Analyses: Procedures for Evaluating the Performance of Materials—Second Edition; Approved Guideline
Title7-71

CLSI H15-A3, Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard—Third Edition
Contact person7-145

CLSI H42-A2, Enumeration of Immunologically Defined Cell Populations by Flow Cytometry.
Contact person7-73
7-170
CLSI ILA21-A2 Clinical Evaluation of Immunoassays
Withdrawn and replaced with newer version7-130

CLSI H20-A2, Reference Leucocyte Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard—Second Edition
Contact person7-164

CLSI GP 28-A Microwave Device Use in the Histology Laboratory; Approved Guideline
Contact person7-168
7-171
CLSI M38-A2 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi
Withdrawn and replaced with newer versionF. Neurology3-3
17-1
AAMI NS28:1988/(R) 2006 Intracranial Pressure Monitoring Devices
Transferred, Date of standard, Extent of recognition, Relevant guidance3-32
17-2
ASTM F1542-94(2000) Standard Specification for the Requirements and Disclosure of Self-Closing Aneurysm Clips
Transferred, Offices, Type of standard, Extent of recognition, Relevant guidance, Contact person3-33
17-3
ISO 7197:2006 Neurosurgical implants—Sterile, Single-use hydrocephalus Shunts and Components
Transferred—Withdrawn and replaced with newer version3-39
17-4
ASTM F647-94(2006) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
Transferred—Withdrawn and replaced with newer version3-60
17-5
IEC 60601-2-10 1987/Amendment 1 2001 Medical Electrical Equipment—Part 2-10: Particular Requirements for the Safety of Nerve and Muscle Stimulators
Transferred, Title change, Date of standard, Relevant guidance, Contact person3-67
17-6
ASTM F2129-06 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
Offices, Devices affected, Type of Standard, Product code, Relevant guidance, Contact personG. OB-GYN/Gastroenterology( print page 11590)9-30
9-55
ANSI/ AAMI RD62:2006 Water Treatment Equipment for Hemodialysis Applications
Withdrawn and replaced with newer version9-32
9-56
ASTM D3492-08 Standard Specification for Rubber Contraceptives (Male Condoms)
Withdrawn and replaced with newer version9-34

ISO 4074:2002/Cor.1:2003(E): Natural Latex Rubber Condoms—Requirements and Test Methods, Technical Corrigendum 1
Extent of recognition, Product codes, Relevant guidanceH. Radiology12-48

AIUM AOL, Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment: A Standard for How Manufacturers Should Specify Acoustic Output Data
Relevant guidance12-55
12-186
IEC 60601-2-29 (2008) Medical Electrical Equipment—Part 2-29: Particular Requirements for the Basic Safety and Essential Performance of Radiotherapy Simulators—Third Edition
Withdrawn and replaced with newer version12-66

AIUM MUS, Medical Ultrasound Safety
Relevant guidance12-96
12-187
NEMA MS 3-2008 Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
Withdrawn and replaced with newer version12-97
12-188
NEMA MS 1-2008 Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging
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
Relevant guidance12-105

NEMA UD 2-2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Version 3
Title, Relevant guidance12-139

AIUM AOMS-2005, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
Relevant guidance12-140

AIUM RTD1-2005, Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Revision 1
Relevant guidance12-161
12-189
IEC 60601-2-33 (2008) Medical Electrical Equipment—Part 2-33: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis Consolidated Edition 2.2
Withdrawn and replaced with a newer version12-182

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
Relevant guidance12-184
12-190
IEC 61217 (2008) Radiotherapy Equipment—Coordinates, Movements, and Scales Consolidated Edition 1.2
Withdrawn and replaced with newer versionI. Sterility14-120
14-257
ASTM D3078—02(2008) Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
Withdrawn and replaced with newer version14-148
14-258
ASTM F2250—03(2008) Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials
Withdrawn and replaced with newer version14-149
14-259
ASTM F2251—03(2008) Standard Test Method for Thickness Measurement of Flexible Packaging Material
Withdrawn and replaced with newer version14-150
14-260
ASTM F2252—03(2008) Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape
Withdrawn and replaced with newer versionJ. Tissue Engineering15-11
15-13
ASTM F2212-02(2008)e1, Standard Guide for Characterization of Type I Collagen as a Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products
Withdrawn and replaced with newer version
 
 
 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: 021. **Table 3**
Recognition No.
Title of Standard
Reference No. & DateA. Dental/ENT4-160
Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms
ANSI ASA S3.1-1999 (R 2003)4-161
Method for Measuring the Intelligibility of Speech Over Communication Systems
ANSI ASA S3.2-1989 (R 1999)4-162
Procedure for the Computation of Loudness of Steady Sounds
ANSI ASA S3.4-20074-163
Methods for Calculation of the Speech Intelligibility Index
ANSI ASA S3.5-1997 (R 2007)4-164
Method for Coupler Calibration of Earphones
ANSI ASA S3.7-1995 (R 2003)4-165
Mechanical Coupler for Measurement of Bone Vibrators
ANSI ASA S3.13-1987 (R 2007)4-166
Bioacoustical Terminology
ANSI ASA S3.20-1995 (R 2003)4-167
Methods for Manual Pure-Tone Threshold Audiometry
ANSI ASA S3.21-20044-168
Occluded Ear Simulator
ANSI ASA S3.25-1989 (R 2003)4-169
Method of Measurement of Performance Characteristics of Hearing Aids under Simulated Real-Ear Working Conditions
ANSI ASA S3.35-20044-170
Specification for a Manikin for Simulated 
                            *in situ*
                             Airborne Acoustic Measurements
ANSI ASA S3.36-1985 (R 2006)4-171
Preferred Earhook Nozzle Thread for Postauricular Hearing Aids
ANSI ASA S3.37-1987 (R 2007)4-172
Testing Hearing Aids with a Broad-Band Noise Signal
ANSI ASA S3.42-1992 (R 2007)4-173
Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment
ANSI ASA S3.44-1996 (R 2006)4-174
Procedures for Testing Basic Vestibular Function
ANSI ASA S3.45-19994-175
Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids
ANSI ASA S3.46-1997 (R 2002)4-176
Criteria for Evaluating Room Noise
ANSI ASA S12.2-1995 (R 1999)4-177
Rating Noise with Respect to Speech Interference
ANSI ASA S12.65-2006B. General5-45
Standard Practice for Performance Testing of Packages for Single Delivery Systems
ASTM D7386-08C. IVD7-172
Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory
C28-P37-173
Harmonization of Glycohemoglobin Measurements
C44-A7-174
Estimation of Total Analytical Error for Clinical Laboratory
EP21-A7-175
Apolipoprotein Immunoassays: Development and Recommended Performance Characteristics
ILA15-A7-176
Immunoassay Interference by Endogenous Antibodies
ILA30-A( print page 11592)7-177
Performance Standards for Antimicrobial Susceptibility Testing
M100-S187-178
Quality Control for Commercially Prepared Microbiological Culture Media
M22-A37-179
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
M27-S37-180
Western Blot Assay for Antibodies to Borrelia burgdorferi
M34-A7-181
Abbreviated Identification of Bacteria and Yeasts
M35-A7-182
Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii
M36-A7-183
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi
M38-A27-184
Quality Control of Microbiological Transport Systems
M40-A7-185
Viral Culture
M41-A7-186
Methods for Antifungal Disk Diffusion Susceptibility Testing
M44-A7-187
Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeast
M44-S27-188
Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria
M45-A7-189
Principles and Procedures for Blood Cultures
M47-A7-190
Quality Control for Commercial Microbial Identification Systems
M50-A7-191
Collection, Transport, Preparation, and Storage of Specimens
MM13-A7-192
Interpretive Criteria for Identification of Bacteria and Fungi by DNA Target Sequencing
MM18-A7-193
Evaluation of the Linearity of Quantitative Measurement
EP06-A7-194
Protocols for Determination of Limits of Detection and Limits of Quantitation
EP17-AD. Neurology17-7
Neurosurgical implants—Sterile, Single-use Hydrocephalus Shunts and Components
ISO 7197:2006/Technical Corrigendum1:2007E. OB-GYN/Gastroenterology9-57
Natural Latex Rubber Condoms—Requirements and Test Methods, Technical Corrigendum 2
ISO 4074:2002/Cor.2:2008(E)F. Ophthalmic10-58
Laser Systems for Corneal Reshaping
ANSI Z80.11-2007G. Radiology12-191
Ultrasonics—Field Characterization—Test Methods for the Determination of Thermal and Mechanical Indices Related to Medical Diagnostic Ultrasonic Fields
IEC 62359:2005H. Software/Informatic13-25
Managing and Validating Laboratory Information Systems; Approved Guideline
CLSI AUTO8-A13-26
Autoverification of Clinical Laboratory Test Results; Approved Guideline
CLSI AUTO10-A13-27
IT Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard
CLSI AUTO11-A13-28
Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard
CLSI AUTO9-AI. Sterility14-261
Sterilization of Health Care Products—Moist Heat—Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices
ANSI/AAMI/ISO 17665-1:2006
 
 
 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. 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: 021” 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: 021. These modifications to the list or recognized standards are effective upon publication of this document in the 
                    **Federal Register**
                    . Dated: March 10, 2009. Daniel G. Schultz, Director, Center for Devices and Radiological Health.


[FR Doc. E9-5858 Filed 3-17-09; 8:45 am] BILLING CODE 4160-01-S