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Notice

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 022

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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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.

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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.

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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.StandardChange
A. Anesthesia
1-371-80CGA C-9:2004 (Reaffirmed 2008) Standard Color Marking of Compressed Gas Containers for Medical UseWithdrawn and replaced with newer version
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1-681-81CGA V-5:2008 Diameter-Index Safety System Noninterchangeable Low Pressure Connections for Medical Gas ApplicationsWithdrawn and replaced with newer version
1-51ASTM F1100-90 (1997) Standard Specification for Ventilators Intended for Use in Critical CareWithdrawn
1-59ASTM F1456-01 Standard Specification for Minimum Performance and Safety Requirements for CapnometersWithdrawn
B. Biocompatibility
2-64ANSI/AAMI/ISO 10993-5:1999 Biological Evaluation of Medical Devices—Part 5: Tests for In Vitro CytotoxicityContact person, Extent of recognition and Relevant guidance
2-82ASTM F2147-01 Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact AllergensContact person and Extent of recognition
2-832-136ASTM E1262-88 (Reapproved 2008) Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation AssayWithdrawn and replaced with newer version
2-842-137ASTM E1263-97 (Reapproved 2008) Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow ErythrocytesWithdrawn and replaced with newer version
2-852-138ASTM E1280-97 (Reapproved 2008) Standard Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell MutagenicityWithdrawn and replaced with newer version
2-87ISO 10993-10:2002 Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Delayed-type HypersensitivityExtent of recognition and Relevant guidance
2-902-139ASTM E1397-91 (Reapproved 2008) Standard Practice for In Vitro Rat Hepatocyte DNA Repair AssayWithdrawn and replaced with newer version
2-912-140ASTM E1398-91 (Reapproved 2008) Standard Practice for In Vivo Rat Hepatocyte DNA Repair AssayWithdrawn and replaced with newer version
2-93ASTM F763-04 Standard Practice for Short-Term Screening of Implant MaterialsExtent of recognition and Contact person
2-94ASTM F981-04 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and BoneExtent of recognition and Contact person
2-952-141ASTM F1984-99 (Reapproved 2008) Standard Practice for Testing for Whole Complement Activation in Serum by Solid MaterialsWithdrawn and replaced with newer version
2-972-142ASTM F1983-99 (Reapproved 2008) Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant ApplicationsWithdrawn and replaced with newer version
2-98ANSI/AAMI/ISO 10993-1:2003 Biological Evaluation of Medical Devices—Part 1: Evaluation and TestingTitle, Extent of recognition, Relevant guidance and Contact person
2-992-143ASTM F1904-98 (Reapproved 2008) Standard Practice for Testing the Biological Responses to Particles in vivoWithdrawn and replaced with newer version
2-100ASTM E1372-95 (Reapproved 2003) Standard Test Method for Conducting a 90-Day Oral Toxicity Study in RatsContact person
2-1062-144ASTM F619-03 (Reapproved 2008) Standard Practice for Extraction of Medical PlasticsWithdrawn and replaced with newer version
2-108ASTM F1905-98(2003) Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause ImmunotoxicityContact person and Extent of recognition
2-114ASTM F1877-05 Standard Practice for Characterization of ParticlesExtent of recognition and Contact person
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2-115ASTM F895-84 (Reapproved 2006) Standard Test Method for Agar Diffusion Cell Culture Screening for CytotoxicityExtent of recognition, Relevant guidance and Contact person
2-1162-145ASTM F1439-03 (Reapproved 2008) Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant MaterialsWithdrawn and replaced with newer version
2-118ANSI/AAMI/ISO 10993-11:2006 Biological Evaluation of Medical Devices—Part 11: Tests for Systemic ToxicityExtent of recognition, Relevant guidance and Contact person
2-119ASTM F813-07 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical DevicesContact person
2-1212-146ASTM F2148-07€1 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)Withdrawn and replaced with newer version
2-122ASTM F719-81 (Reapproved 2007)€1 Standard Practice for Testing Biomaterials in Rabbits for Primary Skin IrritationContact person and Relevant guidance
2-124ASTM F750-87 (Reapproved 2007)€1 Standard Practice for Evaluating Material Extracts by Systemic Injection in the MouseExtent of recognition, Relevant guidance and Contact person
2-125ASTM F749-98 (Reapproved 2007)€1 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the RabbitExtent of recognition, Relevant guidance and Contact person
2-126ASTM F748-06 Standard Practice for Selecting Generic Biological Test Methods for Materials and DevicesExtent of recognition, Relevant guidance and Contact person
2-1282-147USP 32-NF26 Biological Tests <87> 2009 Biological Reactivity Test, In Vitro—Direct Contact TestWithdrawn and replaced with newer version
2-1292-148USP 32-NF26 Biological Tests <88> Biological Reactivity Test, In Vitro—Elution TestWithdrawn and replaced with newer version
2-1302-149USP 32-NF26 Biological Tests <88> Biological Reactivity Tests, In Vivo Procedure—Preparation of SampleWithdrawn and replaced with newer version
2-1312-150USP 32-NF26 Biological Tests <88> Biological Reactivity Test, In Vivo, Classification of Plastics—Intracutaneous TestWithdrawn and replaced with newer version
2-1322-151USP 32-NF26 Biological Tests <88> Biological Reactivity Tests, In Vivo, Classification of Plastics—Systemic Injection TestWithdrawn and replaced with newer version
2-133ASTM F1408-97 (Reapproved 2008) Standard Practice for Subcutaneous Screening Test for Implant MaterialsContact person
2-134ASTM F2065-00 (2006) Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid MaterialsContact person
2-135AAMI/ANSI/ISO 10993-12:2007 Biological Evaluation of Medical Devices—Part 12: Sample Preparation and Reference MaterialsExtent of recognition, Relevant guidance and Contact person
C. Dental/ENT
4-694-178ISO 6872:2008 Dentistry—Ceramic MaterialsWithdrawn and replaced with newer version
4-734-179ISO 7405: 2008 Dentistry—Evaluation of Biocompatibility of Medical Devices Used in DentistryWithdrawn and replaced with newer version
4-175ANSI ASA S3.46-1997 (R 2007) Methods of Measurement of Real-Ear Performance Characteristics of Hearing AidsReaffirmation
D. General
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5-125-47ISO 10012:2003 Measurement Management Systems—Requirements for Measurement Processes and Measuring EquipmentWithdrawn and replaced with newer version
5-155-48ANSI/ASQ Z1.9-2008 Sampling Procedures and Tables for Inspection by Variables for Percent NonconformingWithdrawn and replaced with newer version
5-27IEC 60601-1-1 Ed. 2.0 2000 Medical Electrical Equipment—Part 1-1: General Requirements for Safety—Collateral Standard: Safety requirements for Medical Electrical SystemsTitle
5-36ISO/TR 16142:2006 Medical Devices—Guidance on the Selection of Standards in Support of Recognized Essential Principles of Safety and Performance of Medical DevicesTitle
5-41IEC 60601-1-4 (2000) Consol. Ed. 1.1 Medical Electrical Equipment—Part 1-4: General Requirements for Safety—Collateral Standard: Programmable Electrical Medical SystemsTitle
5-445-49IEC 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 EquipmentWithdrawn and re-recognized previous version
E. General Hospital/General Plastic Surgery
6-636-216ISO 8536-7:2009 Infusion Equipment for Medical Use—Part 7: Caps Made of Aluminum-plastics Combinations for Infusion BottlesWithdrawn and replaced with newer version
6-112ANSI/AAMI PB70:2003 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care FacilitiesContact person
6-118ASTM F2196-02 Standard Specification for Circulating Liquid and Forced Air Patient Temperature Management DevicesCFR citation and product code
6-144ASTM D5712—05€1 Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry MethodTitle and Contact person
6-145ASTM D3578-05€1 Standard Specification for Rubber Examination GlovesTitle and Contact person
6-147ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy DrugsContact person and Relevant guidance
6-149ASTM D7160-05 Standard Practice for Determination of Expiration Dating for Medical GlovesContact person
6-150ASTM D7161-05 Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse ConditionsContact person
6-165ASTM D6977-04€1 Standard Specification for Polychloroprene Examination Gloves for Medical ApplicationTitle and Contact person
6-167ASTM D6319-00a (Reapproved 2005)€1 Standard Specification for Nitrile Examination Gloves for Medical ApplicationTitle and Contact person
6-168ASTM D3577-09€1 Standard Specification for Rubber Surgical GlovesWithdrawn and replaced with newer version
6-175ASTM D5151-06 Standard Test Method for Detection of Holes in Medical GlovesContact person
6-178ASTM D6124-06 Standard Test Method for Residual Powder on Medical GlovesContact person
6-183ASTM D5250-06€1 Standard Specification for Poly(vinyl chloride) Gloves for Medical ApplicationTitle and Contact person
6-1866-217ASTM F1670-08 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic BloodWithdrawn and replaced with newer version
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6-2056-218USP 32:2009 Nonabsorbable Surgical SutureWithdrawn and replaced with newer version
6-2066-219USP 32<11>:2009 Sterile Sodium Chloride for IrrigationWithdrawn and replaced with newer version
6-2076-220USP 32:2009 Absorbable Surgical SutureWithdrawn and replaced with newer version
6-2086-221USP 32<881>:2009 Tensile StrengthWithdrawn and replaced with newer version
6-2096-222USP 32<861>:2009 Sutures—DiameterWithdrawn and replaced with newer version
6-2106-223USP 32<871>:2009 Sutures Needle AttachmentWithdrawn and replaced with newer version
6-2116-224USP 32<11>:2009 Sterile Water for IrrigationWithdrawn and replaced with newer version
6-2126-225USP 32<11>:2009 Heparin Lock Flush SolutionWithdrawn and replaced with newer version
6-2136-226USP 32<11>:2009 Sodium Chloride InjectionWithdrawn and replaced with newer version
F. In Vitro Diagnostics
7-1567-195CLSI M02-A10, Performance Standards for Antimicrobial Disk Susceptibility TestsWithdrawn and replaced with newer version
7-1587-196CLSI M07-A8, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow AerobicallyWithdrawn and replaced with newer version
7-1607-197CLSI M35-A2, Abbreviated Identification of Bacteria and YeastWithdrawn and replaced with newer version
7-787-198CLSI M23-A3, Development of In Vitro Susceptibility Testing Criteria and Quality Control ParametersWithdrawn and replaced with newer version
7-1777-199CLSI M100-S19 Performance Standards for Antimicrobial Susceptibility TestingWithdrawn and replaced with newer version
7-1617-200CLSI M48-A, Laboratory Detection and Identification of MycobacteriaWithdrawn and replaced with newer version
7-102NCCLS H1-A5, Tubes and Additives for Venous Blood Specimen CollectionContact Person
7-101NCCLS H51-A, Assays of vonWillebrand Factor Antigen and Ristocetin Cofactor ActivityContact Person
7-165CLSI H20-A2, Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental MethodsContact Person
7-1037-201CLSI H3-A6, Procedures for the Collection of Diagnostic Blood Specimens by VenipunctureWithdrawn and replaced with newer version
7-817-202CLSI C28-A3 Defining, Establishing, and Verifying Reference Intervals in the Clinical LaboratoryWithdrawn and replaced with newer version
7-1447-203CLSI H04-A6, Procedures and Devices for the Collection of Diagnostic Capillary Blood SpecimensWithdrawn and replaced with newer version
G. Materials
8-328-163ASTM 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
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8-448-164ASTM 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 version
8-498-165ASTM 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 version
8-508-166ASTM F1091-08 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605)Withdrawn and replaced with newer version
8-528-167ASTM 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 version
8-538-168ASTM F1472-08€1 Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS R56400)Withdrawn and replaced with newer version
8-768-169ASTM 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 version
8-798-170ASTM F961-08 Standard Specification for 35Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)Withdrawn and replaced with newer version
8-818-171ASTM F1609-08 Standard Specification for Calcium Phosphate Coatings for Implantable MaterialsWithdrawn and replaced with newer version
8-868-172ASTM F1926/F1926M-08 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and CoatingsWithdrawn and replaced with newer version
8-948-173ASTM F601-03 (Reapproved 2008) Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical ImplantsWithdrawn and replaced with newer version
8-958-174ASTM F629-02 (Reapproved 2007)€1 Standard Practice for Radiography of Cast Metallic Surgical ImplantsWithdrawn and replaced with newer version
8-1108-175ASTM F1377-08 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)Withdrawn and replaced with newer version
8-1188-176ASTM F2503-08 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance EnvironmentWithdrawn and replaced with newer version
8-1338-177ASTM F2129-08 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant DevicesWithdrawn and replaced with newer version
8-1438-178ASTM F648-07€1 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical ImplantsWithdrawn and replaced with newer version
8-1448-179ASTM F754-08 Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding PowdersWithdrawn and replaced with newer version
8-1468-180ASTM F2066-08 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)Withdrawn and replaced with newer version
8-1488-181ASTM F899-09 Standard Specification for Wrought Stainless Steels for Surgical InstrumentsWithdrawn and replaced with newer version
8-1528-182ASTM 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 version
8-1608-183ASTM F560-08 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)Withdrawn and replaced with newer version
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8-1618-184ASTM F2516-07€2 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic MaterialsWithdrawn and replaced with newer version
8-1628-185ASTM F451-08 Standard Specification for Acrylic Bone CementWithdrawn and replaced with newer version
H. OB-GYN/Gastroenterology
9-34ISO 4074:2002/Cor.1:2003(E):, Natural Latex Rubber Condoms—Requirements and Test Methods, Technical Corrigendum 1Relevant guidance
9-419-58ASTM D6324-08 Standard Test Methods for Male Condoms Made from PolyurethaneWithdrawn and replaced with newer version
9-43ISO 16038:2005 Rubber condoms—Guidance on the Use of ISO 4074 in the Quality Management of Natural Rubber Latex CondomsRelevant guidance
9-56ASTM D3492-08 Standard Specification for Rubber Contraceptives (Male Condoms)Relevant guidance
9-57ISO 4074:2002/Cor.2:2008(E) Natural Latex Rubber Condoms—Requirements and Test Methods, Technical Corrigendum 2Relevant guidance
I. Orthopedics
11-17211-211ASTM F1798-97 (Reapproved 2008) Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis ImplantsWithdrawn and replaced with newer version
11-17811-212ASTM F1440-92 (Reapproved 2008) Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without TorsionWithdrawn and replaced with newer version
11-19211-213ASTM F1223-08 Standard Test Method for Determination of Total Knee Replacement ConstraintWithdrawn and replaced with newer version
11-19811-214ASTM F0382-99 (Reapproved 2008) Standard Specification and Test Method for Metallic Bone PlatesWithdrawn and replaced with newer version
11-20411-215ASTM F897-02 (Reapproved 2007) Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and ScrewsWithdrawn and replaced with newer version
11-20511-216ASTM F1264-03 (Reapproved 2007)€1 Standard Specification and Test Methods for Intramedullary Fixation DevicesWithdrawn and replaced with newer version
11-20911-217ASTM F2083-08€1 Standard Specification for Total Knee ProsthesisWithdrawn and replaced with newer version
J. Radiology
12-1712-192NEMA MS 8-2008 Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging SystemsWithdrawn and replaced with new version
12-4812-193AIUM AOL 2008 Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment Revision 1- A Standard for How Manufacturers Should Specify Acoustic Output DataWithdrawn and replaced with newer version
12-5812-194ANSI/HPS N43.6-2007 Sealed Radioactive Sources—ClassificationWithdrawn and replaced with newer version
12-6912-195NEMA MS 6-2008 Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR ImagingWithdrawn and replaced with newer version
12-9512-196NEMA MS 2-2008 Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance ImagesWithdrawn and replaced with newer version
12-100NEMA UD 3-2004 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound EquipmentContact person
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12-105NEMA UD 2-2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Version 3Contact person
12-139AIUM AOMS-2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound EquipmentTitle and Contact person
12-140AIUM RTD1-2004 Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Revision 1Title and Contact person
12-146IEC 60601-2-17 (2004) Medical Electrical Equipment—Part 2-17: Particular Requirements for the Safety of Automatically-controlled Brachytherapy Afterloading EquipmentTitle
12-147IEC 60601-2-5: (2000) Medical Electrical Equipment—Part 2-5: Particular Requirements for the Safety of Ultrasonic Physiotherapy Equipment Ed. 2.0Title
12-16912-197IEC 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 2.0Withdrawn and re-recognized previous version
12-178IEC 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 devicesTitle
12-18212-198IEC 60601-2-37 (2004), (2005) Amendment 2, Medical Electrical Equipment—Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring EquipmentWithdrawn and re-recognized previous version
12-18512-199IEC 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 EditionWithdrawn and re-recognize previous version
12-18612-200IEC 60601-2-29 (1999) Medical Electrical Equipment Part 2-29: Particular Requirements for the Safety of Radiotherapy Simulators—Second EditionWithdrawn and re-recognized previous version
K. Software/Informatics
13-1613-29CLSI LIS01-A2 Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer SystemsWithdrawn and replaced with newer version
L. Sterility
14-55ANSI/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 SterilantsReaffirmation
14-88ANSI/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 person
14-116ANSI/AAMI ST72:2002 Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch TestingRelevant guidance and Extent of recognition
14-135ANSI/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 HeatRelevant Guidance
14-164ANSI/AAMI ST81:2004 Sterilization of Medical Devices—Information to be Provided by the Manufacturer for the Processing of Resterilizable Medical DevicesContact Person
14-195ANSI/AAMI/ISO 11140-1:2005 Sterilization of Health Care Products—Chemical Indicators—Part 1: General RequirementsRelevant Guidance, Extent of Recognition and Contact person
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14-22014-263ANSI/AAMI ST79:2006/A1:2008 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care FacilitiesWithdrawn and replaced with newer version
14-223ANSI/AAMI/ISO 11138-1:2006 Sterilization of Health Care Products—Biological Indicators—Part 1: General RequirementsRelevant Guidance
14-224ANSI/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 DevicesRelevant Guidance
14-225ANSI/AAMI/ISO 11137-2:2006 Sterilization of Health Care Products—Radiation—Part 2: Establishing the Sterilization DoseRelevant Guidance
14-226ANSI/AAMI/ISO 11137-3:2006 Sterilization of Health Care Products—Radiation—Part 3: Guidance on Dosimetric AspectsRelevant Guidance
14-228ANSI/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 DevicesRelevant Guidance
14-261ANSI/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 DevicesRelevant Guidance
14-119ANSI/AAMI ST55:2003/(R)2008 Table-top Steam SterilizersReaffirmation
14-7114-264ANSI/AAMI ST8:2008 Hospital Steam SterilizersWithdrawn and replaced with newer version
14-24914-265USP 32:2009 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration TestsWithdrawn and replaced with newer version
14-25014-266USP 32:2009 <71> Sterility TestsWithdrawn and replaced with newer version
14-25114-267USP 32:2009 <85> Bacterial Endotoxins TestWithdrawn and replaced with newer version
14-25214-268USP 32:2009 <151> Pyrogen Test (USP Rabbit Test)Withdrawn and replaced with newer version
14-25314-269USP 32:2009 <161> Transfusion and Infusion Assemblies and Similar Medical DevicesWithdrawn and replaced with newer version
14-25414-270USP 32:2009 Biological Indicator for Steam Sterilization—Self ContainedWithdrawn and replaced with newer version
14-24614-271USP 32:2009 Biological Indicator for Dry-Heat Sterilization, Paper CarrierWithdrawn and replaced with newer version
14-24714-272USP 32:2009 Biological Indicator for Ethylene Oxide Sterilization, Paper CarrierWithdrawn and replaced with newer version
14-24814-273USP 32:2009 Biological Indicator for Steam Sterilization, Paper CarrierWithdrawn and replaced with newer version
14-238ANSI/AAMI/ISO 11140-5:2007 Sterilization of Health Care Products—Chemical Indicators—Part 5: Class 2 Indicators for Bowie and Dick-type Air Removal TestsContact person and Relevant guidance
14-17114-274ANSI/AAMI/ISO 15882:2008 Chemical Indicators—Guidance on the Selection, Use, and Interpretation of ResultsWithdrawn and replaced with newer version
14-4914-275ANSI/AAMI ST41:2008 Ethylene oxide Sterilization in Health Care Facilities: Safety and EffectivenessWithdrawn and replaced with newer version
14-136ANSI/AAMI ST67:2003/(R) 2008 Sterilization of Health Care Products—Requirements for Products Labeled “STERILE”Reaffirmation and Relevant guidance
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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 StandardReference No. & Date
A. Biocompatibility
2-152Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Delayed-type Hypersensitivity Amendment 1ISO 10993 10:2002/Amd.1:2006(E)
B. General
5-46Sampling Procedures for Inspection by Attributes—Part 1: Sampling Schemes Indexed by Acceptance Quality Limit (AQL) for Lot-by-lot InspectionISO 2859-1:1999/Cor 1:2001
5-50Medical Devices—Application of Usability Engineering to Medical DevicesIEC 62366:2007
C. In Vitro Diagnostics
7-204Reference Method for Broth Dilution Antifungal Susceptibility Testing of YeastsCLSI M27-A3
D. Materials
8-186Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal DevicesASTM F 2759—09
8-187Implants for Surgery—Hydroxyapatite—Part 1: Ceramic HydroxyapatiteISO 13779-1:2008(E)
8-188Implants for Surgery—Hydroxyapatite—Part 2: Coatings of HydroxyapatiteISO 13779-2:2008(E)
E. Neurology
17-8Implants for Surgery—Active Implantable Medical Devices Part 3: Implantable Neurostimulators (Neurology)ISO 14708-3 2008-11-15
F. OB-GYN/Gastroenterology
9-59Hemodialysis SystemsANSI/AAMI RD5:2003/(R) 2008
G. Orthopedics
11-218Implants 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 TestISO 14243-3:2004 Technical Corrigendum 1
H. Sterility
14-276Sterilization of Health Care Products—Moist Heat—Part 2: Guidance on the Application of ISO 17665-1ISO/TS 17665-2:2009
14-277Microbiological Examination of Nonsterile Products: Tests for Specified MicroorganismsUSP32:2009 <62>
14-278Biological Evaluation of Medical Devices—Part 7: Ethylene Oxide Sterilization ResidualsANSI/AAMI/ISO 10993-7:2008
I. Tissue Engineering
15-14Standard Guide for Interpreting Images of Polymeric Tissue ScaffoldsASTM F2603-06
15-15Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (1H NMR) SpectroscopyASTM 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.Start Printed 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.

Start Signature

Dated: August 26, 2009.

Catherine M. Cook,

Associate Director for Regulation and Policy.

End Signature End Supplemental Information

[FR Doc. E9-21609 Filed 9-4-09; 8:45 am]

BILLING CODE 4160-01-S