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Notice

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 030

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Start Preamble

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: 030” (Recognition List Number: 030), 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: 030” 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, Silver Spring, MD 20993. 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 email: standards@cdrh.fda.gov. This document may also be accessed on FDA's Internet site at http://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​Standards/​ucm123792.htm. 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: 030 modifications and other standards related information.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Scott A. Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring, MD 20993, 301-796-6287.

I. Background

Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C 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 of this document.

Table 1—Previous Publications of Standard Recognition Lists

February 25, 1998 (63 FR 9561)
October 16, 1998 (63 FR 55617)
July 12, 1999 (64 FR 37546)
November 15, 2000 (65 FR 69022)
May 7, 2001 (66 FR 23032)
January 14, 2002 (67 FR 1774)
October 2, 2002 (67 FR 61893)
April 28, 2003 (68 FR 22391)
March 8, 2004 (69 FR 10712)
June 18, 2004 (69 FR 34176)
October 4, 2004 (69 FR 59240)
May 27, 2005 (70 FR 30756)
November 8, 2005 (70 FR 67713)
March 31, 2006 (71 FR 16313)
June 23, 2006 (71 FR 36121)
November 3, 2006 (71 FR 64718).
May 21, 2007 (72 FR 28500).
September 12, 2007 (72 FR 52142).
December 19, 2007 (72 FR 71924).
September 9, 2008 (73 FR 52358).
March 18, 2009 (74 FR 11586).
September 8, 2009 (74 FR 46203).
May 5, 2010 (75 FR 24711).
June 10, 2010 (75 FR 32943).
October 4, 2010 (75 FR 61148).
March 14, 2011 (76 FR 13631).
August 2, 2011 (76 FR 46300).
March 16, 2012 (77 FR 15765).
August 20, 2012 (77 FR 50114).

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: 030

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: 030” 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 Start Printed Page 2999that involve the initial addition of standards not previously recognized by FDA.

Table 2—Modifications to the List of Recognized Standards

Old recognition No.Replacement recognition No.Title of standard 1Change
A. Biocompatibility
2-156AAMI/ANSI/ISO 10993-1:2009 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management processExtent of recognition.
2-1782-191ISO 10993-12 Fourth edition 2012-07-01 Biological evaluation of medical devices—Part 12: Sample preparation and reference materialsWithdrawn and replaced with newer version.
2-1842-192USP 35-NF30:2012<87> Biological Reactivity Test, In Vitro—Direct Contact TestWithdrawn and replaced with newer version.
2-1852-193USP 35-NF30:2012 Biological Tests <87> Biological Reactivity Test, In Vitro—Elution TestWithdrawn and replaced with newer version.
2-1862-194USP 35-NF30:2012 Biological Tests <88> Biological Reactivity Tests, In Vivo, Procedure Preparation of SampleWithdrawn and replaced with newer version.
2-1872-195USP 35-NF30:2012 Biological Tests <88> Biological Reactivity Test, In Vitro, Classification of Plastics—Intracutaneous TestWithdrawn and replaced with newer version.
2-1882-196USP 35-NF30:2012 Biological Tests <88> Biological Reactivity Tests, In Vivo, Classification of Plastics—Systemic Injection TestWithdrawn and replaced with newer version.
B. Cardiovascular
3-303-105IEC 60601-2-25 Edition 2.0 2011-10 Medical electrical equipment—Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographsWithdrawn and replaced with newer version.
3-61IEC 60601-2-27 Edition 3.0 2011-03 Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipmentWithdrawn, see 3-95.
3-101ANSI/AAMI/ISO 60601-2-27 Edition 3.0 2011-03 Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipmentWithdrawn, see 3-100.
3-59ISO 5841-3 Second edition 2000-10-15 Implants for surgery—Cardiac pacemakers—Part 3: Low-profile connectors [IS-1] for implantable pacemakersTitle, processes impacted, related CFR citation(s) and procode(s), and relevant guidance.
C. Dental/ENT
4-43ADA/ANSI Specification No. 5, Dental Casting Alloys: 1997Withdrawn, see 4-146.
4-874-196ANSI/ADA Specification No. 69, 2010 Dental CeramicWithdrawn and replaced with newer version.
4-94Specification No.14, Dental Base Metal Casting Alloys: 1982 (Reaffirmed 1998)Withdrawn, see 4-146.
4-96ANSI/ADA Specification No. 30, Reaffirmed by ANSI October 2010 Dental Zinc Oxide-Eugenol and Zinc Oxide Non-Eugenol CementsReaffirmation.
4-110ADA/ANSI ADA Specification No. 11, Agar Impression Materials: 1997Withdrawn.
4-113ADA/ANSI ADA Specification No. 20, Dental Duplicating Material; 1972 (Reaffirmed 1995)Withdrawn.
4-1314-198ISO 3107 Fourth edition 2011-03 Dentistry—Zinc oxide/Eugenol cements and zinc oxide/non-eugenol cementsWithdrawn and replaced with newer version.
4-1334-199ISO 6876 Third edition 2012-06-01 Dentistry—Root canal sealing materialsWithdrawn and replaced with newer version.
4-147ADA/ANSI Specification No. 27, Resin-Based Filling Materials: 2005Withdrawn.
4-1524-201ISO 9693 Second edition 1999-12-15 Metal-ceramic dental restorative systemsWithdrawn and replaced with newer version.
4-158ISO 10139-1:2005, Dentistry—Soft lining materials for removable dentures—Part 1: Materials for short-term use Technical Corrigendum 1:2006Withdrawn—Duplicate, see 4-189.
4-1924-202ANSI/ADA Specification No. 58, 2010 Root Canal Files, Type H (Hedstrom)Withdrawn and replaced with newer version.
D. General
5-56ISO 15223-2 First edition 2010-01-15 Medical devices—Symbols to be used with medical devices labels, labelling, and information to be supplied—Part 2: Symbol development, selection and validationWithdrawn.
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5-68AAMI/ANSI/ISO 15223-2, Medical devices—Symbols to be used with medical device labels, labellings, and information to be supplied—Part 2: Symbol development, selection and validationWithdrawn.
5-725-73ISO 15223-1 Second Edition 2012-07-01 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1: General requirementsWithdrawn and replaced with new version.
E. General Hospital/General Plastic Surgery
6-13ISO 595-1 First edition 1986-12-15 Reusable all-glass or metal-and-glass syringes for medical use—Part 1: DimensionsContact person and title.
6-14ISO 595-2 First edition 1987-12-15 Reusable all-glass or metal-and-glass syringes for medical use—Part 2: Design, performance requirements and testsContact person.
6-15ISO 7864 Third edition 1993-05-15 Sterile hypodermic needles for single useContact person.
6-107ASTM F 882-84 (Reapproved 2002) Standard Performance and Safety Specification for Cryosurgical Medical InstrumentsWithdrawn.
6-122ISO 8536-5 Second edition 2004-02-01 Infusion equipment for medical use—Part 5: Burette infusion sets for single use, gravity feedContact person.
6-148ISO 7886-3 First edition 2005-03-01 Sterile hypodermic syringes for single use—Part 3: Auto-disable syringes for fixed-dose immunizationContact person.
6-170ISO 7886-1 First edition 1993-10-01 Sterile hypodermic syringes for single use—Part 1: Syringes for manual useContact person and title.
6-2036-282ASTM D6499-12 Standard Test Method for The Immunological Measurement of Antigenic Protein in Natural Rubber and its ProductsWithdrawn and replaced with newer version.
6-204ISO 8537 Second edition 2007-10-01 Sterile single-use syringes, with or without needle, for insulinContact person.
6-2556-283USP 35-NF30:2012 Sodium Chloride IrrigationWithdrawn and replaced with newer version.
6-2566-284USP 35-NF30:2012 Sodium Chloride InjectionWithdrawn and replaced with newer version.
6-2576-285USP 35-NF30:2012 Nonabsorbable Surgical SutureWithdrawn and replaced with newer version.
6-2586-286USP 35-NF30:2012 <881> Tensile StrengthWithdrawn and replaced with newer version.
6-2596-287USP 35-NF30:2012 <861> Sutures-DiameterWithdrawn and replaced with newer version.
6-2606-288USP 35-NF30:2012 <871> Sutures-Needle AttachmentWithdrawn and replaced with newer version.
6-2616-289USP 35-NF30:2012 Sterile Water for IrrigationWithdrawn and replaced with newer version.
6-2626-290USP 35-NF30:2012 Heparin Lock Flush SolutionWithdrawn and replaced with newer version.
6-6236-291USP 35-NF30:2012 Absorbable Surgical SutureWithdrawn and replaced with newer version.
F. In Vitro Diagnostics
7-7  CLSI/NCCLS LA1-A2 1994 Assessing the Quality of Radioimmunoassay Systems—Second Edition; Approved GuidelineWithdrawn.
7-124CLSI/NCCLS I/LA24-A Fluorescence Calibration and Quantitative Measurement of Fluorescence Intensity; Approved GuidelineWithdrawn.
7-997-232CLSI MM05-A2 Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline—Second EditionWithdrawn and replaced with newer version.
7-1947-233CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second EditionWithdrawn and replaced with newer version.
G. Materials
8-1178-228ASTM F86-12 Standard Practice for Surface Preparation and Marking of Metallic Surgical ImplantsWithdrawn and replaced with a newer version.
8-124ASTM F2052-06e1 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance EnvironmentRelevant guidance.
Start Printed Page 3001
8-128ASTM F2213-06 (Reapproved 2011) Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance EnvironmentRelevant guidance.
8-153ASTM F2119-07 Standard Test Method for Evaluation of MR Image Artifacts from Passive ImplantsRelevant guidance.
8-176ASTM F2503-08 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance EnvironmentRelevant guidance.
8-227ASTM F2182-11a Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance ImagingRelevant guidance .
8-1378-229ASTM F75-12 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)Withdrawn and replaced with a newer version.
8-1428-330ASTM F1978-12 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber AbraserWithdrawn and replaced with a newer version.
8-1558-331ASTM F1580-12 Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical ImplantsWithdrawn and replaced with a newer version.
8-2098-332ASTM F899-12 Standard Specification for Wrought Stainless Steels for Surgical InstrumentsWithdrawn and replaced with a newer version.
H. OB-GYN/Gastroenterology
9-21IS0 8600-4 First edition 1997-07-01 Optics and optical instruments—Medical endoscopes and certain accessories—Part 4: Determination of maximum width of insertion portionContact person.
9-34ISO 4074 First edition 2002-02-15 Corrected version 2002-12-01 Natural latex rubber condoms—Requirements and test methodsContact person.
9-36ISO 8009 First edition 2004-10-01 Mechanical contraceptives—Reusable natural and silicone rubber contraceptive diaphragms—Requirements and testsContact person.
9-37ISO 8600-1 Second edition 2005-05-01 Optics and photonics—Medical endoscopes and endotherapy devices—Part 1: General requirementsContact person.
9-39ISO 8600-5 First edition 2005-03-15 Optics and photonics—Medical endoscopes and endotherapy devices—Part 5: Determination of optical resolution of rigid endoscopes with opticsContact person.
9-40ISO 8600-6 First edition 2005-03-15 Optics and photonics—Medical endoscopes and endotherapy devices—Part 6: VocabularyContact person.
9-43ISO 16038 First edition 2005-11-01 Rubber condoms—Guidance on the use of ISO 4074 in the quality management of natural rubber latex condomsContact person.
9-56ASTM D 3492-08 Standard Specification for Rubber Contraceptives (Male Condoms)Contact person.
9-61IEC 60601-2-18 Edition 3.0 2009-08 Medical electrical equipment—Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipmentContact person.
9-58ASTM D6324-08 Standard Test Methods for Male Condoms Made from PolyurethaneWithdrawn.
I. Ophthalmic
10-56ANSI Z80.12-2007 (R2012) American National Standard for Ophthalmics—Multifocal Intraocular LensesReaffirmation.
10-57ANSI Z80.13-2007 (R2012) American National Standard for Ophthalmics—Phakic Intraocular LensesReaffirmation.
J. Orthopedics
11-203ASTM F1541-02 (Reapproved 2011)  1 Standard Specification and Test Methods for External Skeletal Fixation DevicesTitle.
11-216ASTM F1264-03 (Reapproved 2012) Standard Specification and Test Methods for Intramedullary Fixation DevicesReaffirmation.
11-22911-244ASTM F2083-11 Standard Specification for Total Knee ProsthesisWithdrawn and replaced with newer version.
11-23311-245ASTM F384-12 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation DevicesWithdrawn and replaced with newer version.
Start Printed Page 3002
11-23611-246ASTM F1717-12 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy ModelWithdrawn and replaced with newer version.
K. Sterility
14-64ASTM F1929-98 (Reapproved 2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye PenetrationRelevant guidance.
14-169ASTM F2391-05 (Reapproved 2011) Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer GasRelevant guidance.
14-197ASTM F1608-00 (Reapproved 2009) Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)Relevant guidance.
14-21114-362AOAC 6.2.01:2012 Official Method 955.14 Testing Disinfectants against Salmonella enterica, Use-Dilution MethodWithdrawn and replaced with newer version.
14-212AOAC 6.2.02:2006 Official Method 991.47 Testing Disinfectants against Salmonella choleraesuis, Hard Surface Carrier Test MethodRelevant guidance.
14-213AOAC 6.2.03:2006 Official Method 991.48 Testing Disinfectants against Staphylococcus aureus, Hard Surface Carrier Test MethodRelevant guidance.
14-215AOAC 6.2.05:2006 Official Method 991.49 Testing Disinfectants against Pseudomonas aeruginosa, Hard Surface Carrier Test MethodRelevant guidance.
14-21614-363AOAC 6.2.06:2012 Official Method 964.02 Testing Disinfectants against Pseudomonas aeruginosa, Use-Dilution MethodWithdrawn and replaced with newer version.
14-217AOAC 6.3.02:2006 Official Method 955.17 Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytesRelevant guidance.
14-218AOAC 6.3.05:2006 Official Method 966.04 Sporicidal Activity of Disinfectants Method IRelevant guidance.
14-22514-364ANSI/AAMI/ISO 11137-2:2012 Sterilization of health care products—Radiation—Part 2: Establishing the sterilization doseWithdrawn and replaced with newer version.
14-229ASTM F1980-07 (Reapproved 2011) Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical DevicesRelevant guidance.
14-235ASTM F1140-07 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained PackagesRelevant guidance.
14-236ASTM F2054-07 Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining PlatesRelevant guidance.
14-238ANSI/AAMI/ISO 11140-5:2007/(R)2012 Sterilization of health care products—Chemical indicators—Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packsReaffirmation.
14-256ASTM F2095-07e1 Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining PlatesRelevant guidance and editorial change.
14-257ASTM D3078-02 (Reapproved 2008) € 1 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble EmissionRelevant guidance and editorial change.
14-278ANSI/AAMI/ISO 10993-7:2008(R)2012 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residualsReaffirmation.
14-282ASTM F2338-09 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay MethodRelevant guidance.
14-283ASTM F88/F88M-09 Standard Test Method for Seal Strength of Flexible Barrier MaterialsRelevant guidance.
14-288ASTM F1886/F1886M-09 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual InspectionRelevant guidance.
14-296ANSI/AAMI/ISO 11138-1:2006/(R)2010 Sterilization of health care products—Biological indicators—Part 1: General requirementsRelevant guidance, extent of recognition and title.
14-299ASTM F2097-10 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical ProductsRelevant guidance.
14-300ASTM D4169-09 Standard Practice for Performance Testing of Shipping Containers and SystemsRelevant guidance.
14-313ASTM F2475-11 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging MaterialsRelevant guidance.
14-31514-366USP 35-NF30:2012 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration TestsWithdrawn and replaced with newer version.
14-31614-367USP 35-NF30:2012 <71> Sterility TestsWithdrawn and replaced with newer version.
14-31714-368USP 35-NF30:2012 <85> Bacterial Endotoxins TestWithdrawn and replaced with newer version.
14-31814-369USP 35-NF30:2012 <151> Pyrogen Test (USP Rabbit Test)Withdrawn and replaced with newer version.
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14-31914-370USP 35-NF30:2012 <161> Transfusion and Infusion Assemblies and Similar Medical DevicesWithdrawn and replaced with newer version
14-32014-371USP 35-NF30:2012 Biological Indicator for Steam Sterilization, Self-ContainedWithdrawn and replaced with newer version.
14-32114-372USP 35-NF30:2012 Biological Indicator for Dry-Heat Sterilization, Paper CarrierWithdrawn and replaced with newer version.
14-32214-373USP 35-NF30:2012 Biological Indicator for Ethylene Oxide Sterilization, Paper CarrierWithdrawn and replaced with newer version.
14-32314-374USP 35-NF30:2012 Biological Indicator for Steam Sterilization, Paper CarrierWithdrawn and replaced with newer version.
14-32414-375USP 35-NF30:2012 <62> Microbiological Examination of Nonsterile Products: Tests for Specified MicroorganismsWithdrawn and replaced with newer version.
14-32914-365ISO 11137-2 Second edition 2012-03-15 Sterilization of health care products—Radiation—Part 2: Establishing the sterilization doseWithdrawn and replaced with newer version.
14-335ISO 10993-7 Second edition 2008-10-15 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residualsExtent of recognition and relevant guidance.
14-338ISO 11138-1 Second edition 2006-07-01 Sterilization of health care products—Biological indicators—Part 1: General requirementsRelevant guidance and extent of recognition.
14-345ISO/ASTM 51261 First edition 2002-03-15 Guide for selection and calibration of dosimetry systems for radiation processingRelevant guidance.
14-359ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)Relevant guidance.
14-360ANSI/AAMI ST72:2011 Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testingRelevant guidance.
1 All standard titles in this table conform to the style requirements of the respective organizations.

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: 030.

Table 3—New Entries to the List of Recognized Standards

Recognition No.Title of standard 1Reference No. and date
A. Cardiovascular
3-106Medical electrical equipment—Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographsANSI/AAMI/IEC 60601-2-25:2011.
3-107Medical electrical equipment—Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometersIEC 80601-2-30 Edition 1.0 2009-01.
3-108Medical electrical equipment—Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers CORRIGENDUM 1IEC 80601-2-30 (First edition—2009).
3-109Active implantable medical devices—Four-pole connector system for implantable cardiac rhythm management devices—Dimensional and test requirementsANSI/AAMI/ISO 27186:2010.
3-110Active implantable medical devices—Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillatorsAAMI TIR41:2011.
3-111Cardiovascular implants—Endovascular devices—Part 3: Vena cava filtersANSI/AAMI/ISO 25539-3: 2011.
3-112Cardiovascular implants and artificial organs—Blood-gas exchangers (oxygenators)ANSI/AAMI/ISO 7199: 2009.
3-113Cardiovascular implants and artificial organs—Blood-gas exchangers (oxygenators)ISO 7199 Second edition 2009-04-15.
B. Dental/ENT
4-200Dentistry—Mercury and alloys for dental amalgam AMENDMENT 1: Requirements for marking and manufacturer's instructions concerning mercuryISO 24234 First edition 2004-10-15 AMENDMENT 1 2011-08-15.
C. General
5-74Medical electrical equipment—Part 1: General requirements for basic safety and essential performance, Amendment 1ANSI/AAMI ES60601-1:2005/C1:2009/(R)2012.
D. General Hospital/General Plastic Surgery
6-292Sterile hypodermic syringes for single use—Part 1: Syringes for manual useISO 7886-1:1993 TECHNICAL CORRIGENDUM 1 Published 1995-11-01.
Start Printed Page 3004
6-293Sharps injury protection—Requirements and test methods—Sharps containersISO 23907 First edition 2012-09-01.
E. In Vitro Diagnostics
7-234Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline—Second EditionCLSI EP24-A2.
7-235Evaluation of Stability of In Vitro Diagnostic Reagents; Approved GuidelineCLSI EP25-A.
7-236Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved GuidelineCLSI M43-A.
7-237Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline—Third EditionCLSI MM01-A3.
7-238Quantitative Molecular Methods for Infectious Diseases; Approved Guideline—Second EditionCLSI MM06-A2.
7-239Metrological Traceability and Its Implementation; A ReportCLSI X5-R.
F. Materials
8-333Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant ApplicationsASTM F2393-12.
8-334Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric AnalysisASTM F2459-12.
G. OB-GYN/Gastroenterology
9-79Water treatment equipment for haemodialysis applications and related therapiesISO 26722 First edition 2009-04-15.
9-80Medical electrical equipment—Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipmentIEC 60601-2-16 Edition 4.0 2012-03.
9-81Mechanical contraceptives—Reusable natural and silicone rubber contraceptive diaphragms—Requirements and testsISO 8009 First edition 2004-10-01 ISO 8009: 2004/Amd. 1: 2012 (E) AMENDMENT 1 2012-02-15
H. Ophthalmic
10-75Ophthalmic implants—Intraocular lenses—Part 7: Clinical investigations AMENDMENT 1ISO 11979-7 Second edition 2006-05-01 AMENDMENT 1 2012-01-15.
10-76Ophthalmic implants—Intraocular lenses—Part 8: Fundamental requirements AMENDMENT 1ISO 11979-8 Second edition 2006-07-01 AMENDMENT 1 2011-05-15.
I. Orthopedic
11-247Standard Guide for Mechanical and Functional Characterization of Nucleus DevicesASTM F2789-10.
11-250Implants for surgery—Wear of total hip joint prostheses—Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for testISO 14242-3 First edition 2009-03-15.
11-249Implants for surgery—Wear of total hip joint prostheses—Part 2: Methods of measurementISO 14242-2 First edition 2000-09-15.
11-248Implants for surgery—Wear of total hip joint prostheses—Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for testISO 14242-1 Second edition 2012-01-15.
11-251Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical SystemsASTM F2554-10.
J. Radiology
12-250Medical electrical equipment—Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography CORRIGENDUM 1IEC 60601-2-44 (Third edition-2009).
12-251Medical electrical equipment—Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomographyIEC 60601-2-44 Edition 3.0 2012-08 Amendment 1.
K. Software/Informatics
13-33Validation of software for regulated processesAAMI TIR362007.
13-34Medical device software—Part 1: Guidance on the application of ISO 14971 to medical device softwareIEC/TR 80002-1 Edition 1.0 2009-09.
13-35Application of quality management system concepts to medical device data systemsANSI/AAMI SW87 2012.
13-36Guidance on the use of AGILE practices in the development of medical device softwareAAMI TIR45 2012.
Start Printed Page 3005
L. Sterility
14-376Sterilization of health care products—Moist heat—Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1ANSI/AAMI/ISO TIR 17665-2:2009.
14-377Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial BarrierASTM F2638-12.
1 All standard titles in this table conform to the style requirements of the respective organizations.

IV. List of Recognized Standards

FDA maintains the Agency's current list of FDA recognized consensus standards in a searchable database that may be accessed directly at FDA's Internet site at http://www.accessdata.fda.gov/​scripts/​cdrh/​cfdocs/​cfStandards/​search.cfm. FDA will incorporate the modifications and minor revisions described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often, if necessary.

V. Recommendation of Standards for Recognition by FDA

Any person may recommend consensus standards as candidates for recognition under section 514 of the FD&C 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. The Center for Devices and Radiological Health (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 notice announcing “Modification to the List of Recognized Standards, Recognition List Number: 030” will be available on the CDRH home page. You may access the CDRH home page at http://www.fda.gov/​MedicalDevices.

You may access “Guidance on the Recognition and Use of Consensus Standards,” and the searchable database for “FDA Recognized Consensus Standards” at http://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​Standards.

This Federal Register document on modifications in FDA's recognition of consensus standards is available at http://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​Standards/​ucm123792.htm.

VII. Submission of Comments and Effective Date

Interested persons may submit to the contact person (see FOR FURTHER INFORMATION CONTACT) either electronic or written comments regarding this document. It is only necessary to send one set of comments. 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: 030. These modifications to the list or recognized standards are effective upon publication of this notice in the Federal Register.

Start Signature

Dated: January 9, 2013.

Leslie Kux,

Assistant Commissioner for Policy.

End Signature End Further Info End Preamble

[FR Doc. 2013-00605 Filed 1-14-13; 8:45 am]

BILLING CODE 4160-01-P