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Notice

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 034

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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: 034” (Recognition List Number: 034), 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 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: 034” 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 for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 034 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, can be accessed at http://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​Standards/​ucm123792.htm.

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 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: 034

FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency will recognize for use in premarket submissions 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: 034” to identify these current modifications.

In table 1 of this document, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others, if applicable; (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 1—Modifications to the List of Recognized Standards

Old recognition No.Replacement recognition No.Title of standard 1Change
A. Anesthesia
1-15ISO 5361-4:1987, Tracheal tubes—Part 4: Cole typeWithdrawn. See 1-93.
1-181-94ISO 8359 Second edition 1996-12-15, Oxygen concentrators for medical use—Safety requirements [Including: AMENDMENT 1 2012-07-01]Withdrawn and replaced with newer version including amendment.
1-361-95ISO 5366-3 Second edition 2001-08-15, Anaesthetic and respiratory equipment—Tracheostomy tubes—Part 3: Pediatric tracheostomy tubes [Including: TECHNICAL CORRIGENDUM 1 Published 2003-01-15]Withdrawn and replaced with newer version including technical corrigendum.
1-44ISO 5366-1 Fourth edition 2000-12-15, Anaesthetic and respiratory equipment—Tracheostomy tubes—Part 1: Tubes and connectors for use in adultsExtent of recognition.
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1-46ISO 5367 Fourth edition 2000-06-01 Breathing tubes intended for use with anaesthetic apparatus and ventilatorsExtent of recognition.
1-47AS 4259-1995 Ancillary devices for expired air resuscitationExtent of recognition.
1-561-97CGA V-7.1:2011 Standard Method of Determining Cylinder Valve Outlet Connections for Medical GasesWithdrawn and replaced with newer version.
1-57ASTM F1101-90 (Reapproved 2003) ε1, Standard Specification for Ventilators Intended for Use During AnesthesiaExtent of recognition.
1-58ASTM G175-03 (Reapproved 2011), Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency ApplicationsExtent of recognition.
1-65ISO 21647:2004 Medical electrical equipment—Particular requirements for the basic safety and essential performance of respiratory gas monitorsWithdrawn. See 1-96.
1-69ASTM F1464-93 (Reapproved 2005) Standard Specification for Oxygen Concentrators for Domiciliary UseExtent of recognition.
1-70ASTM F1246-91 (Reapproved 2005) Standard Specification for Electrically Powered Home Care Ventilators, Part 1—Positive-Pressure Ventilators and Ventilator CircuitsExtent of recognition.
1-78ASME PVHO-1-2007 Safety Standard for Pressure Vessels for Human OccupancyExtent of recognition.
1-81CGA V-5:2008 (Reaffirmed 2013), Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications)Reaffirmation.
1-83ISO 21647:2004 TECHNICAL CORRIGENDUM 1, Medical electrical equipment—Particular requirements for the basic safety and essential performance of respiratory gas monitorsWithdrawn. See 1-96.
1-84ISO 5366-3:2001 Anaesthetic and Respiratory Equipment—Tracheostomy Tubes—Part 3: Pediatric Tracheostomy Tubes TECHNICAL CORRIGENDUM 1Withdrawn. See 1-95.
1-86ISO 8185 Third edition 2007-07-01 Corrected versions 2008-06-15 Respiratory tract humidifiers for medical use—Particular requirements for respiratory humidification systemsExtent of recognition.
1-881-98ISO 80601-2-12 First edition 2011-04-15 Medical electrical equipment—Part 2-12: Particular requirements for the safety of lung ventilators—Critical care ventilators [Including: TECHNICAL CORRIGENDUM 1 Published 2011-10-15]Withdrawn and replaced with newer version including technical corrigendum.
1-89ISO 80601-2-12 TECHNICAL CORRIGENDUM 1 Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilatorsWithdrawn. See 1-98.
1-90ISO 8359 Second edition 1996-12-15 AMENDMENT 1 2012-07-01 Oxygen concentrators for medical use—Safety requirementsWithdrawn. See 1-94.
1-92ISO 17510-2 Second Edition 2007-10-01, Sleep apnoea breathing therapy—Part 2: Masks and application accessoriesExtent of recognition.
1-93ISO 5361Second edition 2012-10-01 Anaesthetic and respiratory equipment—Tracheal tubes and connectorsExtent of recognition.
B. Biocompatibility
2-1232-204ASTM F720-13 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization TestWithdrawn and replaced with newer version.
2-1822-205ISO 14155 Second edition 2011-02-01 Clinical investigations of medical devices for human subjects—Good clinical practices [Including TECHNICAL CORRIGENDUM 1:2011]Withdrawn and replaced with newer version including technical corrigendum.
2-183ISO 14155:2011 and TECHNICAL CORRIGENDUM 1 Published 2011-07-15 Clinical investigation of medical devices for human subjects—Good clinical practiceWithdrawn. See 2-205.
2-93ASTM F763-04 (Reapproved 2010), Standard Practice for Short-Term Screening of Implant MaterialsExtent of recognition.
2-94ASTM F981-04 (Reapproved 2010) Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and BoneExtent of recognition.
2-114ASTM F1877-05 (Reapproved 2010) Standard Practice for Characterization of ParticlesExtent of recognition.
2-118ANSI/AAMI/ISO 10993-11:2006/(R) 2010 Biological evaluation of medical devices—Part 11: Tests for systemic toxicityExtent of recognition.
2-120ANSI/AAMI/ISO 10993-6:2007/(R) 2010 Biological evaluation of medical devices—Part 06: Tests for local effects after implantationExtent of recognition.
2-126ASTM F748-06 (Reapproved 2010) Standard Practice for Selecting Generic Biological Test Methods for Materials and DevicesExtent of recognition.
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2-133ASTM F1408-97 (Reapproved 2008) Standard Practice for Subcutaneous Screening Test for Implant MaterialsExtent of recognition.
2-134ASTM F2065-00 (Reapproved 2010) Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid MaterialsExtent of recognition.
2-136ASTM E1262-88 (Reapproved 2008) Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation AssayExtent of recognition.
2-137ASTM E1263-97 (Reapproved 2008) Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow ErythrocytesWithdrawn.
2-138ASTM E1280-97 (Reapproved 2008) Standard Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell MutagenicityWithdrawn.
2-139ASTM E1397-91 (Reapproved 2008) Standard Practice for the In Vitro Rat Hepatocyte DNA Repair AssayWithdrawn.
2-140ASTM E1398-91 (Reapproved 2008) Standard Practice for the In Vivo Rat Hepatocyte DNA Repair AssayWithdrawn.
2-141ASTM F1984-99 (Reapproved 2008) Standard Practice for Testing for Whole Complement Activation in Serum by Solid MaterialsExtent of recognition.
2-142ASTM F1983-99 (Reapproved 2008) Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant ApplicationExtent of recognition.
2-143ASTM F1904-98 (Reapproved 2008) Standard Practice for Testing the Biological Responses to Particles in vivoExtent of recognition.
2-144ASTMF619-03 (Reapproved 2008) Standard Practice for Extraction of Medical PlasticsExtent of recognition.
2-145ASTM F1439-03 (Reapproved 2008) Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant MaterialsExtent of recognition.
2-153ANSI/AAMI/ISO 10993-5:2009, Biological evaluation of medical devices—Part 5: Tests for In Vitro cytotoxicityExtent of recognition.
2-154ASTM F756-08 Standard Practice for Assessment of Hemolytic Properties of MaterialsExtent of recognition.
2-155ASTM F2147-01 (Reapproved 2010) Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact AllergensExtent of recognition.
2-156ANSI/AAMI/ISO 10993-1:2009 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk managementExtent of recognition.
2-162ASTM F1903-10 Standard Practice for Testing for Biological Responses to Particles in vitroExtent of recognition.
2-163ANSI/AAMI/ISO 10993-9:2009 Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation productsExtent of recognition.
2-165ANSI/AAMI/ISO 10993-14:2001/(R) 2011 Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramicsExtent of recognition.
2-167ISO/TS 10993-19 First edition 2006-06-01 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological, and topographical characterization of materialsExtent of recognition.
2-168ISO 10993-9 Second edition 2009-12-15 Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation productsExtent of recognition.
2-169ISO 10993-13 Second edition 2010-06-15 Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devicesExtent of recognition.
2-170ISO 10993-14 First edition 2001-11-15 Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramicsExtent of recognition.
2-171ISO 10993-16 Second edition 2010-02-15 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachablesExtent of recognition.
2-172ANSI/AAMI/ISO TIR 10993-19:2006 Biological evaluation of medical devices—Part 19: Physicochemical, morphological, and topographical characterization of materialsExtent of recognition.
2-173ANSI/AAMI/ISO 10993-10:2010 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitizationExtent of recognition.
2-174ISO 10993-10:2010 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitizationExtent of recognition.
2-175ISO 10993-3 Second edition 2003-10-15 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicityExtent of recognition.
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2-176ISO 10993-11 Second edition 2006-08-15 Biological evaluation of medical devices—Part 11: Tests for systemic toxicityExtent of recognition.
2-177ISO 10993-06 Second edition 2007-04-15 Biological evaluation of medical devices—Part 6: Tests for local effects after implantationExtent of recognition.
2-179ISO 10993-1 Fourth edition 2009-10-15 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management processExtent of recognition.
2-181ANSI/AAMI/ISO 14155:2011, Clinical investigation of medical devices for human subjects—Good clinical practiceExtent of recognition.
2-189ASTM F895-11, Standard Test Method for Agar Diffusion Cell Culture Screening for CytotoxicityExtent of recognition.
2-190ANSI/AAMI/ISO 10993-13:2010, Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devicesExtent of recognition.
2-191ISO 10993-12 Fourth edition 2012-07-01, Biological evaluation of medical devices—Part 12: Sample preparation and reference materialsExtent of recognition.
C. Cardiovascular
3-41ANSI/AAMI EC11:1991/(R)2007 Diagnostic electrocardiographic devicesWithdrawn. See 3-106.
3-52ANSI/AAMIEC12:2000/(R)2010 Disposable ECG electrodesExtent of recognition.
3-54ANSI/AAMI/ISO 7198:1998/2001/(R)2010 Cardiovascular implants—Tubular vascular prosthesesExtent of recognition.
3-58ANSI/AAMI/ISO 5840:2005/(R)2010 Cardiovascular implants—Cardiac valve prosthesesExtent of recognition.
3-63ISO 11318 Second edition 2002-08-01 Cardiac Defibrillators—Connector assembly DF-1 for implantable defibrillators—Dimensions and test requirementsExtent of recognition.
3-72ANSI/AAMI EC53:1995/(R) 2008 ECG cables and leadwiresExtent of recognition.
3-733-118ANSI/AAMI EC57:2012 Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithmsWithdrawn and replaced with newer version.
3-75ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003, Manual, electronic or automated sphygmomanometersWithdrawn. See 3-80, 3-122 and 3-123.
3-76ASTM F2129-08 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant DevicesExtent of recognition.
3-78ANSI/AAMI/IEC 80601-2-30:2009 Medical electrical equipment—Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometersExtent of recognition.
3-80ANSI/AAMI/ISO 81060-1:2007/(R) 2013 Non-invasive sphygmomanometers—Part 1: Requirements and test methods for non-automated measurement typeReaffirmation.
3-83ANSI/AAMI/ISO 14708-5:2010 Implants for surgery—Active implantable medical devices—Part 5: Circulatory support devicesExtent of recognition.
3-853-120ANSI/AAMI/ISO 25539-2:2012 Cardiovascular implants—Endovascular devices—Part 2: Vascular stentsWithdrawn and replaced with newer version.
3-88ASTM F2514-08 Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform RadialExtent of recognition.
3-90ISO 7198 First edition 1998-08-01 Cardiovascular implants—Tubular vascular prosthesesExtent of recognition.
3-93ISO 25539-1:2003 First edition 2001-11-13 AMENDMENT 1 2005-07-15 Cardiovascular implants—Endovascular devices—Part 1: Endovascular prostheses Amendment 1: Test methodsWithdrawn. See 3-121.
3-973-122ISO 81060-2 Second edition 2013-05-01 Non-invasive sphygmomanometers—Part 2: Clinical validation of automated measurement typeWithdrawn and replace with newer version.
3-98ISO 81060-2:2009 TECHNICAL CORRIGENDUM Published 2011-02-15 Non-invasive sphygmomanometers—Part 2: Clinical validation of automated measurement typeWithdrawn. See 3-122.
3-100ANSI/AAMI/IEC 60601-2-27:2011 Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipmentWithdrawn. See 3-101.
3-1073-123IEC 80601-2-30 Edition 1.1 2013-07 Medical electrical equipment—Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometersWithdrawn and replaced with newer version.
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3-108IEC 80601-2-30 (First edition 2009) Medical electrical equipment—Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers CORRIGENDUM 1Withdrawn. See 3-123.
3-1133-124ISO 7199 Second edition 2009-04-15 Cardiovascular implants and artificial organs—Blood-gas exchangers (oxygenators) [Including: AMENDMENT 1 (2012)]Withdrawn and replaced with newer version including amendment.
3-1143-119ISO 5841-3 Third edition 2013-40-15 Implants for surgery—Cardiac pacemakers—Part 3: Low-profile connectors (IS-1) for implantable pacemakersWithdrawn and replace with newer version.
D. Dental/ENT
4-50ADA Specification No.18:1992 Alginate Impression MaterialsExtent of recognition.
4-62ISO 1563 Second edition 1990-09-01 Dental alginate impression materialWithdrawn.
4-63ISO 1564 Second edition 1995-11-01 Dental aqueous impression materials based on agarWithdrawn.
4-86ANSI/ADA Specification No. 38 2000 (Reaffirmed 2010), Metal-Ceramic Dental Restorative SystemsExtent of recognition.
4-89ANSI/ADA Specification No. 53: 1999 (Reaffirmed 2008) Polymer-Based Crowns and Bridge MaterialsExtent of recognition.
4-91ANSI/ADA Specification No. 80/ISO 7491:2000 (Reaffirmed 2013) Dental Materials—Determination of Color StabilityReaffirmation and extent of recognition.
4-92ANSI/ADA Specification No. 88:2000 (Reaffirmed 2010) Dental Brazing AlloysReaffirmation and extent of recognition.
4-96ANSI/ADA Specification No. 30:2000 (Reaffirmed 2012) Dental Zinc Oxide-Eugenol and Zinc Oxide Non-Eugenol CementsReaffirmation and extent of recognition.
4-97ANSI/ADA Specification No. 57: (Reaffirmed 2012) Endodontic Sealing MaterialsExtent of recognition.
4-105ANSI/ADA Specification No. 75:1997 (Reapproved 2003) Resilient Lining Materials for Removable Dentures—Part 1: Short-Term MaterialsExtent of recognition.
4-109ISO 13716 First edition 1999-05-01 Dentistry—reversible-irreversible hydrocolloid impression material systemWithdrawn.
4-126ISO 10477 Second edition 2004-10-01 Dentistry—Polymer-based crown and bridge materialsExtent of recognition.
4-130ADA Specification No. 17:1983 (Reaffirmed 2006) Denture Base Temporary Relining ResinsExtent of recognition.
4-1344-207ISO 7494-1 Second edition 2011-08-15 Dentistry—Dental units—Part 1: General requirements and test methodsWithdrawn and replaced with newer version.
4-1354-213ISO 10139-1 Second edition 2005-02-15 Dentistry—Soft lining materials for removable dentures—Part 1: Materials for short-term use [Including: TECHNICAL CORRIGENDUM 1 (2006)]Withdrawn and replaced with newer version including technical corrigendum.
4-137ISO 6877 Second edition 2006-04-01 Dentistry—Root-canal obturating pointsExtent of recognition.
4-139ANSI/ADA Specification No. 48 (Reaffirmed 2009) Visible Light Curing UnitsReaffirmation and extent of recognition.
4-1434-208ANSI/ADA Specification No. 96:2012 Dental-Water-Based CementsWithdrawn and replaced with newer version.
4-1444-209ISO 24234 First edition 2004-10-15 Dentistry—Mercury and alloys for dental amalgam [Including: AMENDMENT 1 (2011)]Withdrawn and replaced with newer version including amendment.
4-146ISO 22674 First edition 2006-11-15 Dentistry—Metallic materials for fixed and removable restorations and appliancesExtent of recognition.
4-149ANSI/ADA Specification No. 39/ISO 6874:2005 (Reaffirmed 2011) Pit and Fissure SealantsReaffirmation and extent of recognition.
4-150ANSI/ADA Specification No. 19:2004/ISO 4823:2000 Dental—Elastometric Impression MaterialsExtent of recognition.
4-151ISO 22112 First edition 2005-11-01 Dentistry—Artificial teeth for dental prosthesesExtent of recognition.
4-153ISO 9917-1 Second edition 2007-10-01 Dentistry—Water-based cements—Part 1: Powder/liquid acid-base cementsExtent of recognition.
4-1544-210ISO 4823 Third edition 2000-12-15 Dentistry—Elastometric impression materials [Including: AMENDMENT 1 (2000) TECHNICAL CORRIGENDUM 1(2004)]Withdrawn and replaced with newer version including amendment and technical corrigendum.
4-155ISO 4823: Technical Corrigendum 1 Published 2004-07-15—Dentistry—Elastometric impression materials—Third EditionWithdrawn. See 4-210.
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4-156ISO 4823 Third edition 2000-12-15 Amendment 1 2007-07-01 Dentistry—Elastometric impression materials—Third EditionWithdrawn. See 4-210.
4-157ISO 3107 Third edition 2004-10-01 Dentistry—Zinc oxide/Eugenol and zinc oxide/non-eugenol cements—Third editionWithdrawn. See 4-198.
4-1594-211ANSI/IEEE C63.19:2007 American National Standard Methods of Measurement of Compatibility between Wireless Communications Devices and Hearing AidsWithdrawn and replaced with newer version.
4-1704-212ANSI/ASA S3.36-2012 American National Standard Specification for a Manikin for Simulated in situ Airborne Acoustic MeasurementsWithdrawn and replaced with newer version.
4-178ISO 6872 Third edition 2008-09-01 Dentistry—Ceramic materialsExtent of recognition.
4-179ISO 7405 Second edition 2008-12-15 Dentistry—Evaluation of biocompatibility of medical devices used in dentistryExtent of recognition.
4-180ISO 9168 Third edition 2009-07-15 Dentistry—Hose connectors for air driven dental handpiecesExtent of recognition.
4-181ISO 4049 Fourth edition 2009-10-01 Dentistry—Polymer-based restorative materialsExtent of recognition.
4-182ISO 10139-2 Second edition 2009-08-01 Dentistry—Soft lining materials for removable dentures—Part 2: Materials for long-term useExtent of recognition.
4-188ISO 9917-2 Second edition 2010-04-15 Dentistry—Water-based cements—Part 2: Resin-modified cementsExtent of recognition.
4-189ISO 10139-1:2005 TECHNICAL CORRIGENDUM 1 2006-03-01 Dentistry—Soft lining materials for removable dentures—Part 1: Materials for short-term useWithdrawn. See 4-213.
4-195ISO 14801 Second edition 2007-11-15 Dentistry—Implants-Dynamic fatigue test for endosseous dental implantsExtent of recognition.
4-196ANSI/ADA Specification No.69:2010/ISO 6872:2008 Dental CeramicExtent of recognition.
4-198ISO 3107 Fourth edition 2011-03-01 Dentistry—Zinc oxide/eugenol and zinc oxide/non-eugenol cementsExtent of recognition.
4-199ISO 6876 Third edition 2012-06-01 Dentistry—Root Canal Sealing MaterialsExtent of recognition.
4-200ISO 24234 First edition 2004-10-15 Dentistry—Mercury and alloys for dental amalgam AMENDMENT 1Withdrawn. See 4-209.
4-201ISO 9693-2012 Dentistry—Compatibility testing—Metal-ceramic systemsExtent of recognition.
4-205ISO 14457 First edition 2012-09-15 Dentistry—Handpieces and motorsWithdrawn. See 4-206.
E. General
5-22ISO 2768-1 First edition 1989-11-15 General tolerances—Part 1: Tolerances for linear and angular dimensions without individual tolerance indicationsExtent of recognition.
5-23ISO 2768-2 First edition 1989-11-15 General Tolerances—Part 2: Geometrical tolerances for features without individual tolerance indicationsExtent of recognition.
5-36ISO/TR 16142 Second edition 2006-01-15 Medical devices—Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devicesExtent of recognition.
5-375-81ISO 2859-1 Second edition 1999-11-15 Sampling procedures for inspection by attributes—Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection [Including: TECHNICAL CORRIGENDUM 1 (2001)]Withdrawn and replaced with newer version including technical corrigendum.
5-43ANSI/ESD S20.20-2007 For the Development of an Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices)Extent of recognition.
5-455-79ASTM D7386-12 Standard Practice for Performance Testing of Packages for Single Parcel Delivery SystemsWithdrawn and replaced with new version.
5-46ISO 2859-1:1999/Cor 1:2001 Sampling procedures for inspection by attributes—Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspectionWithdrawn. See 5-81.
5-47ISO 10012 First edition 2003-01-15 Measurement management systems—Requirements for measurement processes and measuring equipmentExtent of recognition.
5-50IEC 62366 Edition 1.0 2007-10 Medical devices—Application of usability engineering to medical devicesExtent of recognition.
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5-515-80ASTM D-4332-13 Standard Practice for Conditioning Containers, Packages, or Packaging Components for TestingWithdrawn and replaced with new version.
5-53IEC 60601-1-2 Edition 3.0 2007-03 Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic compatibility—Requirements and testsRelevant guidance.
5-54ANSI/AAMI/IEC 60601-1-2:2007/(R)2012 Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic compatibility—Requirements and testsReaffirmation and relevant guidance.
5-57ANSI/AAMI HE75:2009 Human factors engineering—Design of medical devicesExtent of recognition.
5-585-82IEC 60601-1-11 Edition 1.0:2010 Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment [Including: TECHNICAL CORRIGENDUM 1 (2011)]Withdrawn and replaced with newer version including technical corrigendum.
5-62ANSI/ASQ Z1.4-2008 Sampling Procedures and Tables for Inspection by AttributesExtent of recognition.
5-66IEC 60601-1-10 Edition 1.0: 2007-11 Medical electrical equipment—Part 1-10: General requirements for basic safety and essential performance—Collateral Standard: Requirements for the development of physiologic closed-loop controllersExtent of recognition.
5-67ANSI/AAMI/IEC 62366:2007/(R)2013 Medical devices—Application of usability engineering to medical devicesReaffirmation and extent of recognition.
5-69IEC 60601-1-11 (First edition 2010) April 2011 Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment CORRIGENDUM 1Withdrawn. See 5-82.
F. 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: DimensionsWithdrawn.
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 testsWithdrawn.
6-117ASTM F2172-02 (Reapproved 2011) Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid WarmersExtent of recognition.
6-142ANSI/AAMI II36:2004 Medical electrical equipment—Part 2: Particular requirements for safety of baby incubatorsWithdrawn. See 6-230.
6-143ANSI/AAMI II51:2004 Medical electrical equipment—Part 2: Particular requirements for safety of transport incubatorsWithdrawn. See 6-231.
6-150ASTM D7161-05 (Reapproved 2010) Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse ConditionsWithdrawn.
6-1616-301ISO 10555-1 Second edition 2013-06-15 Corrected version 2013-07-01 Intravascular catheters—Sterile and single-use catheters—Part 1: General requirementsWithdrawn and replaced with newer version.
6-163ISO 9626 First edition 1991-09-01 AMENDMENT 1 2001-06-01 Stainless steel needle tubing for the manufacture of medical devicesWithdrawn. See 6-302.
6-1646-303ISO 10555-5 Second edition 2013-06-15 Intravascular catheters—Sterile and single-use catheters—Part 5: Over-needle peripheral cathetersWithdrawn and replaced with newer version.
6-1706-304ISO 7886-1 First edition 1993-10-01 Sterile hypodermic syringes for single use—Part 1: Syringes for manual use [Including: TECHNICAL CORRIGENDUM 1 Published 1995-11-01]Withdrawn and replaced with newer version including technical corrigendum.
6-1716-305ISO 10555-3 Second edition 2013-06-15 Intravascular catheters—Sterile and single-use catheters—Part 3: Central venous cathetersWithdrawn and replaced with newer version.
6-176ASTM D7103-06 (Reapproved 2013) Standard Guide for Assessment of Medical GlovesExtent of recognition.
6-1876-306ASTM F1671/F1671M-13 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test SystemWithdrawn and replaced with newer version.
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6-233IEC 60601-2-52 Edition 1.0 2009-12 Medical electrical equipment—Part 2-52: Particular requirements for basic safety and essential performance of medical bedsWithdrawn. See 6-321.
6-2366-307IEC 80601-2-59 Edition 1.0 2008-10 Medical Electrical Equipment—Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening [Including: CORRIGENDUM 1 (April 2009)]Withdrawn and replaced with newer version including technical corrigendum.
6-237IEC 80601-2-59 (First edition 2008) Medical Electrical Equipment—Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening CORRIGENDUM 1Withdrawn. See 6-307.
6-2386-308IEC 80601-2-35 Edition 2.0 2009-10 Medical electrical equipment—Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use [Including: CORRIGENDUM 1 (March 2012)]Withdrawn and replaced with newer version including technical corrigendum.
6-245ISO 8536-4 Fifth edition 2010-10-01 Infusion equipment for medical use—Part 4: Infusion sets for single use, gravity feedWithdrawn. See 6-318.
6-253ISO 10535 Second edition 2006-12-15 Hoists for the transfer of disabled persons—Requirements and test methodsExtent of recognition.
6-264ISO 10555-1 First edition 1995-06-15 AMENDMENT 1 1999-07-15 Sterile, single-use intravascular catheters—Part 1: General requirementsWithdrawn. See 6-301.
6-265ISO 10555-1 First edition 1995-06-5 AMENDMENT 2 2004-05-15 Sterile, single-use intravascular catheters—Part 1: General requirementsWithdrawn. See 6-301.
6-266ISO 10555-5 First edition 1996-06-15 AMENDMENT 1 Sterile, single-use intravascular catheters—Part 5: Over-needle peripheral cathetersWithdrawn. See 6-303.
6-267ISO 10555-5 1996 TECHNICAL CORRIGENDUM 1 Published 2002-06-15 Sterile, single-use intravascular catheters—Part 5: Over-needle peripheral cathetersWithdrawn. See 6-303.
6-273ISO 23908 First edition 2011-06-11 Sharps injury protection—Requirements and test methods—Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood samplingExtent of recognition.
6-279IEC 60601-2-19 (Second Edition 2009) Medical electrical equipment—Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators CORRIGENDUM 1Withdrawn. See 6-319.
6-280IEC 60601-2-20 (Second edition 2009) Medical electrical equipment—Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators CORRIGENDUM 1Withdrawn. See 6-320.
6-281IEC 80601-2-35 (Second edition 2009) Medical electrical equipment—Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use CORRIGENDUM 1Withdrawn. See 6-308.
6-2836-309USP 36-NF31:2013 Sodium Chloride IrrigationWithdrawn and replaced with newer version.
6-2846-310USP 36-NF31:2013 Sodium Chloride InjectionWithdrawn and replaced with newer version.
6-2856-311USP 36-NF31:2013 Nonabsorbable Surgical SutureWithdrawn and replaced with newer version.
6-2863-312USP 36-NF31:2013 <881> Tensile StrengthWithdrawn and replaced with newer version.
6-2876-313USP 36-NF31:2013 <861> Sutures—DiameterWithdrawn and replaced with newer version.
6-2886-314USP 36-NF 31:2013 <871> Sutures—Needle AttachmentWithdrawn and replaced with newer version.
6-2896-315USP 36-NF31:2013 Sterile Water for IrrigationWithdrawn and replaced with newer version.
6-2906-316USP 36-NF31:2013 Heparin Lock Flush SolutionWithdrawn and replaced with newer version.
6-2916-317USP 36-NF31:2013 Absorbable Surgical SutureWithdrawn and replaced with newer version.
6-292ISO 7886-1:1993 TECHNICAL CORRIGENDUM 1 Published 1995-11-01 Sterile hypodermic syringes for single-use—Part 1: Syringes for manual useWithdrawn. See 6-304.
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6-2986-319IEC 60601-2-19 Edition 2.0 2009-02 Medical electrical equipment—Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators [Including: CORRIGENDUM 1 (2012)]Withdrawn and replaced with newer version including technical corrigendum.
6-299IEC 60601-2-20 Edition 2.0 2009-02 Medical electrical equipment—Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubatorsWithdrawn. See 6-320.
G. In Vitro Diagnostics
7-100ISO 15197 First edition 2003-05-01 In Vitro diagnostic test systems—Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitusWithdrawn.
7-1377-244CLSI NBS01-A6 Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard—Sixth EditionWithdrawn and replaced with newer version.
7-239CLSI EP32-R (Formerly X05-R) Metrological Traceability and Its Implementation; A ReportDesignation number.
7-226CLSI QMS01-A4 (Formerly GP26-A4) Quality Management System: A Model for Laboratory Services; Approved Guideline—Fourth EditionDesignation number.
7-224CLSI EP28-A3c (Formerly C28-A3c) Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third EditionDesignation number.
7-223CLSI QSM06-A3 (Formerly GP22-A3) Quality Management System: Continual Improvement; Approved Guideline—Third EditionDesignation number.
7-927-245CLSI EP09-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third EditionWithdrawn and replaced with newer version.
7-210CLSI H26-A2 Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard—Second EditionExtent of recognition.
7-152CLSI EP12-A2 User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline—Second EditionExtent of recognition.
7-174CLSI EP21-A Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved GuidelineExtent of recognition.
7-178CLSI M22-A3 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third EditionExtent of recognition.
7-193CLSI EP06-A Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved GuidelineExtent of recognition.
7-220CLSI H59-A Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved GuidelineExtent of recognition.
H. Materials
8-678-344ISO 7153-1 Second edition 1991-04-01 Surgical instruments—Metallic materials—Part 1: Stainless steel [Including: AMENDMENT 1(1999)]Withdrawn and replaced with newer version including amendment.
8-138ASTM F745-07 Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant ApplicationsWithdrawn.
8-1398-345ASTM F1314-13 Standard Specification for Wrought Nitrogen Strengthened 22 Chromium-13 Nickel-5 Manganese-2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)Withdrawn and replaced with newer version.
8-1408-346ASTM F1813-13 Standard Specification for Wrought Titanium-12 Molybdenum-6 Zirconium-2 Iron Alloy for Surgical Implant (UNS R58120)Withdrawn and replaced with newer version.
8-1418-347ASTM F2146-13 Standard Specification for Wrought Titanium-3 Aluminum-2.5 Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)Withdrawn and replaced with newer version.
8-1698-348ASTM F138-13 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybendum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)Withdrawn and replaced with newer version.
8-1768-349ASTM F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance EnvironmentWithdrawn and replaced with newer version.
8-1498-350ISO 5832-1 Fourth edition 2007-06-15 Implants for surgery—Metallic materials—Part 1: Wrought stainless steel [Including: TECHNICAL CORRIGENDUM 1(2008)]Withdrawn and replaced with newer version including technical corrigendum.
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8-196ISO 5832-1: 2007 Implants for surgery—Metallic materials—Part 1: Wrought stainless steel TECHNICAL CORRIGENDUM 1Withdrawn. See 8-350.
8-1518-351ISO 5832-12 Second edition 2007-05-01 Implants for surgery—Metallic materials—Part 12: Wrought cobalt-chromium-molybdenum alloy [Including: TECHNICAL CORRIGENDUM 1 2008]Withdrawn and replaced with newer version including technical corrigendum.
8-197ISO 5832-12:2007 TECHNICAL CORRIGENDUM 1 2008-09-05, Implants for surgery—Metallic materials—Part 12: Wrought cobalt-chromium-molybdenum alloy TECHNICAL CORRIGENDUM 1Withdrawn. See 8-351.
8-2118-352ISO 5834-1 Third edition 2005-06-01 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 1: Powder form [Including: TECHNICAL CORRIGENDUM 1 2007]Withdrawn and replaced with newer version including technical corrigendum.
8-212ISO 5834-1:2005 Technical Corrigendum 1 Published 2007-05-01 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 1: Powder form TECHNICAL CORRIGENDUM 1Withdrawn. See 8-352.
8-2288-353ASTM F86-13 Standard Practice for Surface Preparation and Marking of Metallic Surgical ImplantsWithdrawn and replaced with newer version.
8-1758-354ASTM F1377-13 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)Withdrawn and replaced with newer version.
8-1638-355ASTM F1586/F 1586M-13ε1 Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)Withdrawn and replaced with newer version.
8-1298-356ASTM F67-13 Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)Withdrawn and replaced with newer version.
8-2088-357ASTM F648-13 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical ImplantsWithdrawn and replaced with newer version.
8-103ASTM F1801-97 (Reapproved 2009) ε1 Standard Practice for Corrosion Fatigue Testing of Metallic Implant MaterialsExtent of recognition.
8-107ASTM F746-04 (Reapproved 2009) ε1 Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant MaterialsExtent of recognition.
8-111ASTM F1160-05 (Reapproved 2011) ε1Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic CoatingsExtent of recognition.
8-112ASTM F1044-05 (Reapproved 2011) ε1Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic CoatingsExtent of recognition.
8-113ASTM F1147-05 (Reapproved 2011) Standard Test Method for Tension Testing of Calcium Phosphate and Metal CoatingsExtent of recognition.
8-114ASTM F2255 (Reapproved 2010) Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension LoadingExtent of recognition.
8-115ASTM F2256-05 (Reapproved 2010) Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension LoadingExtent of recognition.
8-116ASTM F2258-05 (Reapproved 2010) Standard Test Method for Strength Properties of Tissue Adhesives in TensionExtent of recognition.
8-121ASTM F2005-05 (Reapproved 2010) Standard Terminology for Nickel-Titanium Shape Memory AlloysExtent of recognition.
8-123ISO 5832-5 Third edition 2005-10-15 Implants for surgery—Metallic materials—Part 5: Wrought cobalt-chromium-tungsten-nickel alloyExtent of recognition.
8-124ASTM F2052-06 ε Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance EnvironmentExtent of recognition.
8-125ASTM F2004-05 (Reapproved 2010) Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal AnalysisExtent of recognition.
8-1268-370ASTM F561-13 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and FluidsWithdrawn and replaced with newer version.
8-128ASTM F2213-06 (Reapproved 2011) Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance EnvironmentExtent of recognition.
8-132ASTM F1088-04a (Reapproved 2010) Standard Specification for Beta-Tricalcium Phosphate for Surgical ImplantationExtent of recognition.
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8-134ASTM F2082-06 Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free RecoveryExtent of recognition.
8-135ASTM F2392-04 (Reapproved 2010) Standard Test Method for Burst Strength of Surgical SealantsExtent of recognition.
8-136ASTM F2458-05 (Reapproved 2010) Standard Test Method for Wound Closure Strength of Tissue Adhesives and SealantsExtent of recognition.
8-150ISO 5832-9 Second edition 2007-06-15 Implants for surgery—Metallic materials—Part 9: Wrought high nitrogen stainless steelExtent of recognition.
8-157ISO 9583 First edition 1993-10-15 Implants for surgery—Non-destructive testing—Liquid penetrant inspection of metallic surgical implantsExtent of recognition.
8-159ISO 9584 First edition 1993-10-15 Implants for surgery—Non-destructive testing—Radiographic examination of cast metallic surgical implantsExtent of recognition.
8-165ASTM F1058-08ε1 Standard Specification for Wrought 40 Cobalt-20 Chromium-16 Iron-15 Nickel-7 Molybdenum Alloy Wire and Strip for Surgical Implant Applications (UNS R30003 and UNS R30008)Extent of recognition.
8-167ASTM F1350-08 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)Extent of recognition.
8-168ASTM F1472-08ε1 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium Alloy for Surgical Implant Applications (UNS R56400)Extent of recognition.
8-170ASTM F961-08 Standard Specification for 35 Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)Extent of recognition.
8-171ASTM F1609-08 Standard Specification for Calcium Phosphate Coatings for Implantable MaterialsExtent of recognition.
8-173ASTM F601-03 (Reapproved 2008) Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical ImplantsExtent of recognition.
8-177ASTM F2129-08 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant DevicesExtent of recognition.
8-179ASTM F754-08 Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding PowdersExtent of recognition.
8-183ASTM F560-08 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)Extent of recognition.
8-184ASTM F2516-07ε2 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic MaterialsExtent of recognition.
8-185ASTM F451-08 Standard Specification for Acrylic Bone CementExtent of recognition.
8-187ISO 13779-1 Second edition 2008-10-01 Implants for surgery—Hydroxyapatite—Part 1: Ceramic hydroxyapatiteExtent of recognition.
8-188ISO 13779-2 Second edition 2008-10-01 Implants for surgery—Hydroxyapatite—Part 2: Coatings of hydroxyapatiteExtent of recognition.
8-189ASTM F 1108-04 (Reapproved 2009) Standard Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants (UNS R56406)Extent of recognition.
8-190ASTM F 90-09 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)Extent of recognition.
8-192ASTM F1854-09 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical ImplantsExtent of recognition.
8-193ASTM F2754/F 2754M-09 Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled WireExtent of recognition.
8-194ISO 6474-1 First edition 2010-02-15 Implants for surgery—Ceramic materials—Part 1: Ceramic materials based on high purity aluminaExtent of recognition.
8-195ASTM F2024-10 Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite CoatingsExtent of recognition.
8-199ASTM F2633-07 Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical ImplantsExtent of recognition.
8-204ASTM F2118-10 Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement MaterialsExtent of recognition.
8-205ASTM F1635-11 Standard Test Method for In Vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical ImplantsExtent of recognition.
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8-206ASTM F688-10 Standard Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)Extent of recognition.
8-207ASTM F1926/F1926M-10 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and CoatingsExtent of recognition.
8-213ISO 5834-3 First edition 2005-07-15 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 3: Accelerated ageing methodsExtent of recognition.
8-214ISO 5834-4 First edition 2005-05-01 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 4: Oxidation index measurement methodExtent of recognition.
8-215ISO 5834-5 First edition 2005-06-01 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 5: Morphology assessment methodExtent of recognition.
8-216ASTM F1295-11 Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700)Extent of recognition.
8-217ASTM F620-11 Standard Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical ImplantsExtent of recognition.
8-218ASTM F799-11 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)Extent of recognition.
8-220ASTM F629-11 Standard Practice for Radiography of Cast Metallic Surgical ImplantsExtent of recognition.
8-221ASTM F2066-11 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)Extent of recognition.
8-224ASTM F2102-06ε1 Standard Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical ImplantsExtent of recognition.
8-225ASTM F2003-02 (Reapproved 2008) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in AirExtent of recognition.
8-226ASTM F603-12 Standard Specification for High-Purity Dense Aluminum Oxide for Medical ApplicationExtent of recognition.
8-229ASTM F75-12 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)Extent of recognition.
8-330ASTM F1978-12 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber AbraserExtent of recognition.
8-331ASTM F1580-12 Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical ImplantsExtent of recognition.
8-333ASTM F2393-12 Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant ApplicationsExtent of recognition.
8-334ASTM F2459-12 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric AnalysisExtent of recognition.
I. Nanotechnology
18-1ASTM E2490-09 Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS)Extent of recognition.
18-2ASTM E2535-07 (Reapproved 2013) Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational SettingsReaffirmation and extent of recognition.
J. Neurology
17-317-12ISO 7197 Third edition 2006-06-01 Neurosurgical Implants—Sterile, single-use hydrocephalus shunts and components [Including TECHNICAL CORRIGENDUM 1 (2007)]Withdrawn and replaced with newer version including technical corrigendum.
17-7ISO 7197: 2006 Neurosurgical implants—Sterile, single-use hydrocephalus shunts and components TECHNICAL CORRIGENDUM 1Withdrawn. See 17-12.
17-1ANSI/AAMI NS28:1988/(R) 2010 Intracranial pressure monitoring devicesExtent of recognition.
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17-4ASTM F647-94 (Reapproved 2006) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical ApplicationExtent of recognition.
17-9ASTM F2129-08 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant DevicesExtent of recognition.
K. OB-GYN/Gastroenterology/Urology
9-349-82ISO 4074 First edition 2002-02-15 Corrected version 2002-12-01 Natural latex rubber condoms—Requirements and test methods [Including TECHNICAL CORRIGENDUM 1 (2002), TECHNICAL CORRIGENDUM 2 (2002)]Withdrawn and replaced with newer version including technical corrigendum.
9-57ISO 4074:2002 TECHNICAL CORRIGENDUM 2, Natural latex rubber condoms—Requirements and test methods TECHNICAL CORRIGENDUM 2Withdrawn. See 9-82.
9-759-84ISO 8600-3 First edition 1997-07-01 Optics and Optical instruments—Medical endoscopes and endoscopic accessories—Part 3: Determination of field of view and direction of view of endoscopes with optics [Including AMENDMENT 1 (2003)]Withdrawn and replaced with newer version including amendment.
9-369-90ISO 8009 First edition 2004-10-01 Mechanical contraceptives—Reusable natural and silicone rubber contraceptive diaphragms—Requirements and tests [Including AMENDMENT 1(2012)]Withdrawn and replaced with newer version including amendment.
9-379-83ISO 8600-1 Third edition 2013-03-01 Endoscopes—Medical endoscopes and endotherapy devices—Part 1: General requirementsWithdrawn and replaced with newer version.
9-38ISO 8600-3 First edition 1997-07-01 AMENDMENT 1, Optics and optical instruments—Medical endoscopes and endoscopic accessories Part 3: Determination of field of view and direction of view of endoscopes with opticsWithdrawn. See 9-84.
9-44ASTM F623-99 (Reapproved 2006) Standard Performance Specification for Foley CatheterExtent of recognition.
9-549-85ASTM D6976-13 Standard Specification for Rubber Contraceptives—Vaginal DiaphragmsWithdrawn and replaced with a newer version.
9-56ASTM D3492-08 Standard Specification for Rubber Contraceptives (Male Condoms)Extent of recognition.
9-659-91ANSI/AAMI/ISO 8637:2010 Cardiovascular implants and extracorporeal systems—Hemodialyzers, hemodiafilters, hemofilters, and hemoconcentrators [Including AMENDMENT 1 (2013)]Withdrawn and replaced with newer version including amendment.
9-66ANSI/AAMI/ISO 8638:2010 Cardiovascular implants and Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofiltersExtent of recognition.
9-67ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex CondomsExtent of recognition.
9-68ISO 23409 First edition 2011-02-15 Male Condoms—Requirements and test methods for condoms made from synthetic materialsExtent of recognition.
9-73ANSI/AAMI/ISO 13958:2009 Concentrates for hemodialysis and related therapiesExtent of recognition.
9-74ISO 13958 Second edition 2009-04-15 Concentrates for haemodialysis and related therapiesExtent of recognition.
9-79ISO 26722 First edition 2009-04-15 Water treatment equipment for haemodialysis applications and related therapiesExtent of recognition.
L. Ophthalmic
10-4110-81ISO 11979-7 Second edition 2006-05-01 Ophthalmic implants—Intraocular lenses—Part 7: Clinical investigations [Including Amendment 1:2012]Withdrawn and replaced with newer version including amendment.
10-75ISO 11979-7/Amendment 1:2012 Ophthalmic implants—Intraocular lenses—Part 7: Clinical investigationsWithdrawn. See 10-81.
10-4210-82ISO 11979-2 First edition 1999-12-15 Ophthalmic implants—Intraocular lenses—Part 2: Optical properties and test methods [Including TECHNICAL CORRIGENDUM 1 (2003)]Withdrawn and replaced with newer version including technical corrigendum.
10-5310-83ISO 18369-1 First edition 2006-08-15 Ophthalmic optics—Contact lenses—Part 1: Vocabulary, classification system and recommendations for labeling specifications [Including AMENDMENT 1 2009]Withdrawn and replaced with newer version including amendment.
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10-61ISO 18369-1:2006 Ophthalmic optics—Contact lenses Part 1: Vocabulary, classification system and recommendations for labeling specifications. ISO 18369-1 First edition 2006-08-05 AMENDMENT 1 2009-02-15Withdrawn. See 10-83.
10-5810-84ANSI Z80.11-2012 American National Standard for Ophthalmics—Laser Systems for Corneal ReshapingWithdrawn and replaced with newer version.
10-5910-85ISO 11980 Third edition 2012-11-15 Corrected version 2013-12-01 Ophthalmic optics—Contact lenses and contact lens care products—Guidance for clinical investigationsWithdrawn and replaced with newer version.
10-7110-86ISO 14729 First edition 2001-04-15 Ophthalmic optics—Contact lens care products—Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses [Including: AMENDMENT 1 2010]Withdrawn and replaced with newer version including amendment.
10-43ISO 11979-8 Second edition 2006-07-01 Ophthalmic implants—Intraocular lenses—Part 8: Fundamental requirementsExtent of recognition.
10-54ISO 18369-4 First edition 2006-08-15 Ophthalmic optics—contact lenses—Part 4: Physicochemical properties of contact lens materialsExtent of recognition.
10-55ISO 11979-6 Second edition 2007-07-15 Ophthalmic implants—Intraocular lenses—Part 6: Shelf-life and transport stabilityExtent of recognition.
10-56ANSI Z80.12-2007 (R2012) American National Standard for Ophthalmics—Multifocal Intraocular LensesReaffirmation and extent of recognition.
10-57ANSI Z80.13-2007 (R2012) American National Standard for Ophthalmics—Phakic Intraocular LensesReaffirmation and extent of recognition.
10-60ISO 11981 Second edition 2009-07-01 Ophthalmic optics—Contact lenses and contact lens care products—Determination of physical compatibility of contact lens care products with contact lensesExtent of recognition.
10-62ANSI Z80.10-2009 Ophthalmic Instruments—TonometersExtent of recognition.
10-6410-89ANSI Z80.7-2013 Ophthalmics—Intraocular LensesWithdrawn and replaced with newer version.
10-68ISO 13212 Second edition 2011-05-15 Ophthalmic optics—Contact lens care products—Guidelines for determination of shelf-lifeExtent of recognition.
10-69ANSI Z80.18-2010 American National Standard for Ophthalmics—Contact Lens Care Products—Vocabulary, Performance Specifications and Test MethodologyExtent of recognition.
10-74ISO 10940 Second edition 2009-08-01 Ophthalmic instruments—Fundus CamerasExtent of recognition.
M. Orthopedic
11-19011-256ISO 14243-3 First edition 2004-09-15 Implants for surgery—Wear of total knee-joint prostheses—Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test [Including: TECHNICAL CORRIGENDUM 1(2006)]Withdrawn and replaced with newer version including technical corrigendum.
11-218ISO 14243-3:2004 TECHNICAL CORRIGENDUM 1 Implants for surgery—Wear of total knee-joint prostheses—Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for testWithdrawn. See 11-256.
11-21011-257ASTM F543-13 Standard Specification and Test Methods for Metallic Medical Bone ScrewsWithdrawn and replaced with a newer version.
11-212ASTM F1440-92 (Reapproved 2008) Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without TorsionWithdrawn.
11-241ASTM F543-07 Standard Specification and Test Methods for Metallic Medical Bone ScrewsWithdrawn duplicate. See 11-257.
11-24411-258ASTM F2083-12 Standard Specification for Knee Replacement ProsthesisWithdrawn and replaced with a newer version.
11-74ISO 5838-2 First edition 1991-01-15 Implants for surgery—Skeletal pins and wires—Part 2: Steinmann skeletal pins—DimensionsExtent of recognition.
11-75ISO 5838-3 First edition 1993-09-15 Implants for surgery—Skeletal pins and wires—Part 3: Kirschner skeletal wiresExtent of recognition.
11-80ISO 8828 First edition 1988-10-15 Implants for surgery—Guidance on care and handling of orthopaedic implantsExtent of recognition.
11-83ISO 13402 First edition 1995-08-01 Surgical and dental hand instruments—Determination of resistance against autoclaving, corrosion and thermal exposureExtent of recognition.
11-168ASTM F1781-03 (Reapproved 2009) Standard Specification for Elastomeric Flexible Hinge Finger Total Joint ImplantsExtent of recognition.
Start Printed Page 4927
11-171ASTM F1814-97a (Reapproved 2009) Standard Guide for Evaluating Modular Hip and Knee Joint ComponentsExtent of recognition.
11-183ASTM F1875-98 (Reapproved 2009) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper InterfaceExtent of recognition.
11-184ISO 8827 First edition 1988-10-15 Implants for surgery—Staples with parallel legs for orthopaedic use—General requirementsExtent of recognition.
11-185ASTM F2267-04 (Reapproved 2011) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial CompressionExtent of recognition.
11-191ISO 14879-1 First edition 2000-06-01 Implants for surgery—Total knee-joint prostheses—Part 1: Determination of endurance properties of knee tibial traysExtent of recognition.
11-196ASTM F1672-95 (Reapproved 2011) Standard Specification for Resurfacing Patellar ProsthesisExtent of recognition.
11-197ASTM F983-86 (Reapproved 2013) Standard Practice for Permanent Marking of Orthopaedic Implant ComponentsReaffirmation and extent of recognition.
11-199ASTM F565-04 (Reapproved 2013) Standard Practice for Care and Handling of Orthopedic Implants and InstrumentsReaffirmation and extent of recognition.
11-203ASTM F1541-02 (Reapproved 2011) 1 Standard Specification and Test Methods for External Skeletal Fixation DevicesExtent of recognition.
11-207ASTM F2193-02 (Reapproved 2007) Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal SystemExtent of recognition.
11-211ASTM F1798-97 (Reapproved 2008) Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis ImplantsExtent of recognition.
11-214ASTM F382-99 (Reapproved 2008) 1 Standard Specification and Test Method for Metallic Bone PlatesExtent of recognition.
11-216ASTM F1264-03 (Reapproved 2012) Standard Specification and Test Methods for Intramedullary Fixation DevicesExtent of recognition.
11-220ASTM F2068-09 Standard Specification for Femoral Prostheses—Metallic ImplantsExtent of recognition.
11-222ISO 14243-1 Second edition 2009-11-15 Implants for surgery—Wear of total knee-joint prostheses—Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for testExtent of recognition.
11-223ISO 14243-2 Second edition 2009-11-15 Implants for surgery—Wear of total knee-joint prostheses—Part 2: Methods of measurementExtent of recognition.
11-224ASTM F2706-08 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy ModelExtent of recognition.
11-225ISO 7206-4 Third edition 2010-06-15 Implants for surgery—Partial and total hip-joint prostheses—Part 4: Determination of endurance properties and performance of stemmed femoral componentsExtent of recognition.
11-226ASTM F1089-10 Standard Test Method for Corrosion of Surgical InstrumentsExtent of recognition.
11-227ASTM F366-10 Standard Specification for Fixation Pins and WiresExtent of recognition.
11-228ASTM F564-10 Standard Specification and Test Methods for Metallic Bone StaplesExtent of recognition
11-231ISO 7207-2 Second edition 2011-07-01 Implants for surgery—Components for partial and total knee joint prostheses—Part 2: Articulating surfaces made of metal, ceramic and plastics materialsExtent of recognition.
11-232ISO 7207-1 Third edition 2007-02-01 Implants for surgery—Components for partial and total knee joint prostheses—Part 1: Classification, definitions and designation of dimensionsExtent of recognition.
11-234ASTM F732-00 (Reapproved 2011) Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint ProsthesesExtent of recognition.
11-235ASTM F2077-11 Test Methods for Intervertebral Body Fusion DevicesExtent of recognition.
11-237ISO 7206-6 First edition 1992-03-15 Implants for surgery—Partial and total hip joint prostheses—Part 6: Determination of endurance properties of head and neck region of stemmed femoral componentsExtent of recognition.
11-238ASTM F2033-12 Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric MaterialsExtent of recognition.
Start Printed Page 4928
11-239ASTM F 2345-03 (Reapproved 2013) Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral HeadsExtent of recognition. Reaffirmation.
11-240ASTM F382-99 (Reapproved 2008) 1 Standard Specification and Test Method for Metallic Bone PlatesExtent of recognition.
11-243ASTM F2346-05 (Reapproved 2011) Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial DiscsExtent of recognition.
11-245ASTM F384-12 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation DevicesExtent of recognition.
11-247ASTM F2789-10 Standard Guide for Mechanical and Functional Characterization of Nucleus DevicesExtent of recognition.
11-248ISO 14242-1 Second edition 2012-01-15 Implants for surgery—Wear of total hip-joint prostheses—Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for testExtent of recognition.
11-249ISO 14242-2 First edition 2000-09-15 Implants for surgery—Wear of total hip-joint prostheses—Part 2: Methods of measurementExtent of recognition.
11-250ISO 14242-3 First edition 2009-03-15 Implants 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 testExtent of recognition.
N. Physical Medicine
16-25ISO 7176-13 First edition 1989-08-01 Wheelchairs—Part 13: Determination of coefficient of friction of test surfacesExtent of recognition.
16-27ISO 7176-15 First edition 1996-11-15 Wheelchairs—Part 15: Requirements for information disclosure, documentation and labelingExtent of recognition.
16-29ISO 7176-6 Second edition 2001-10-01 Wheelchairs—Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairsExtent of recognition.
16-158ISO 7176-1 Second edition 1999-10-01 Wheelchairs—Part 1: Determination of static stabilityExtent of recognition.
16-159ISO 7176-2 Second edition 2001-06-15 Wheelchairs—Part 2: Determination of dynamic stability of electric wheelchairsExtent of recognition.
16-162ISO 7176-4 Third edition 2008-10-01 Wheelchairs—Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance rangeExtent of recognition.
16-163ISO 7176-5 Second edition 2008-06-01 Wheelchairs—Part 5: Determination of overall dimensions, mass and manoeuvring spaceExtent of recognition.
16-164ISO 7176-10 Second edition 2008-11-01 Wheelchairs—Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairsExtent of recognition.
16-165ISO 7176-14 Second edition 2008-02-15 Wheelchairs—Part 14: Power and control systems for electrically powered wheelchairs and scooters—Requirements and test methodsExtent of recognition.
16-166ISO 7176-21 Second edition 2009-04-01 Wheelchairs—Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargersExtent of recognition.
16-167ISO 7176-9: Third edition 2009-11-15 Wheelchairs—Part 9: Climatic tests for electric wheelchairsExtent of recognition.
16-168ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1: Determination of static stabilityExtent of recognition.
16-169ANSI/RESNA WC-2:2009 American National Standard for Wheelchairs—Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 2: Determination of dynamic stability of electrically powered wheelchairsExtent of recognition.
16-170ANSI/RESNA WC-2:2009 American National Standard for Wheelchairs—Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 3: Determination of effectiveness of brakesExtent of recognition.
16-171ANSI/RESNA WC-2:2009 Section 4: Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical distance rangeExtent of recognition.
Start Printed Page 4929
16-172ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 5: Determination of dimensions, mass and maneuvering spaceExtent of recognition.
16-173ANSI/RESNA WC-2:2009 American National Standard for Wheelchairs—Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 6: Determination of maximum speed, acceleration and deceleration of electrically powered wheelchairsExtent of recognition.
16-174ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 7: Method of Measurement of Seating and Wheel DimensionsExtent of recognition.
16-175ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and test methods for static, impact and fatigue strengthsExtent of recognition.
16-176ANSI/RESNA WC-2:2009 American National Standard for Wheelchairs—Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 9: Climatic tests for electrically powered wheelchairsExtent of recognition.
16-177ANSI/RESNA WC-2:2009 American National Standard for Wheelchairs—Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 10: Determination of obstacle-climbing ability of electrically powered wheelchairsExtent of recognition.
16-178ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test dummiesExtent of recognition.
16-179ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 13: Determination of coefficient of friction of test surfacesExtent of recognition.
16-180ANSI/RESNA WC-2:2009 American National Standard for Wheelchairs—Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 14: Power and control systems for electrically powered wheelchairs—Requirements and test methodsExtent of recognition.
16-181ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for information disclosure, documentation and labelingExtent of recognition.
16-182ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to ignition of upholstered parts—Requirements and test methodsExtent of recognition.
16-183ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 20: Determination of the performance of stand-up type wheelchairsExtent of recognition
16-184ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 22: Set-up proceduresExtent of recognition.
16-185ANSI/RESNA WC-2:2009,American National Standard for Wheelchairs—Volume 2, Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scootersExtent of recognition.
16-187ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 26: VocabularyExtent of recognition.
O. Radiology
12-5312-257ISO 2919 Third edition 2012-02-15 Radiological protection—Sealed radioactive sources—General requirements and classificationWithdrawn and replaced with newer version.
12-59IEC 61168 First edition 1993-12 Radiotherapy simulators—Functional performance characteristicsExtent of recognition.
12-66AIUM MUS, Medical Ultrasound SafetyExtent of recognition.
Start Printed Page 4930
12-139AIUM AOMS-2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound EquipmentExtent of recognition.
12-140AIUM RTD2-2004 Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Revision 2Withdrawn. See 12-209 and 12-258.
12-14512-259IEC 61674 Edition 2.0 2012-11 Medical electrical equipment—Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imagingWithdrawn and replaced with newer version.
12-14912-260IEC 60336 Fourth edition 2005-04 Medical electrical equipment—X-ray tube assemblies for medical diagnosis—Characteristics of focal spots [Including: Technical Corrigendum 1 (2006)]Withdrawn and replaced with newer version including technical corrigendum.
12-150ISO/IEC 10918-1:1994 TECHNICAL CORRIGENDUM 1:2005 Information technology—Digital compression and coding of continuous-tone still image—Part 1: Requirements and guidelinesWithdrawn. See 12-261.
12-156ISO 11670:2003 TECHNICAL CORRIGENDUM 1:2004 Lasers and laser-related equipment—Test methods for laser beam parameters—Beam positional stabilityWithdrawn. See 12-262.
12-157ISO 13694:2000 TECHNICAL CORRIGENDUM 1:2005 Optics and optical instruments—Lasers and laser-related equipment—Test methods for laser beam power (energy) density distributionWithdrawn. See 12-263.
12-15912-264NEMA MS 11-2010 Determination of Gradient-Induced Electric Fields In Diagnostic Magnetic Resonance ImagingWithdrawn and replaced with newer version.
12-16712-265NEMA NU 2-2012 Performance Measurements of Positron Emission Tomographs (PETs)Withdrawn and replaced with newer version.
12-179ANSI/IESNA RP-27.3-2007, Recommended Practice for Photobiological Safety for Lamps—Risk Group Classification and LabelingExtent of recognition.
12-18012-266IEC 61689 Edition 3.0 2013-02 Ultrasonic-Physiotherapy systems—Field specifications and methods of measurement in the frequency range 0. 5 MHz to 5 MHzWithdrawn and replaced with newer version.
12-19012-267IEC 61217 Edition 2.0 2011-12 Radiotherapy equipment—Coordinates, movements and scalesWithdrawn and replaced with newer version.
12-194ANSI/HPS N43.6-2007, Sealed Radioactive Sources—ClassificationExtent of recognition.
12-20712-271IEC 60601-2-33 Edition 3.1 2013-04 Medical electrical equipment—Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosisWithdrawn and replaced with newer version.
12-20812-268IEC 60601-2-22 Edition 3.1 2012-10 Medical electrical equipment—Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipmentWithdrawn and replaced with newer version.
12-21012-269IEC 60601-1-3 Edition 2.1 2013-04 Medical electrical equipment—Part 1-3: General requirements for basic safety and essential performance—Collateral Standard: Radiation protection in diagnostic X-ray equipmentWithdrawn and replaced with newer version.
12-219IEC 60336 (2005) Medical electrical equipment—X-ray tube assemblies for medical diagnosis—Characteristics of focal spotsWithdrawn. See 12-260.
12-22212-270IEC 61223-3-5 First edition 2004-08 Evaluation and routine testing in medical imaging departments—Part 3-5: Acceptance tests—Imaging performance of computed tomography X-ray equipment [Including: TECHNICAL CORRIGENDUM 1 (2006)]Withdrawn and replaced with newer version including technical corrigendum.
12-223IEC 61223-3-5 (First edition 2004) Evaluation and routine testing in medical imaging departments—Part 3-5: Acceptance tests—Imaging performance of computed tomography X-ray equipment CORRIGENDUM 1Withdrawn. See 12-270.
12-227IEC 61391-1 First edition 2006-07 Ultrasonics—Pulse-echo scanners—Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function responseExtent of recognition.
12-228IEC 61391-2 Edition 1.0 2010-01 Ultrasonics—Pulse-echo scanners—Part 2: Measurement of maximum depth of penetration and local dynamic rangeExtent of recognition.
12-23312-262ISO 11670 Second edition 2003-04-01 Lasers and laser-related equipment—Test methods for laser beam parameters—Beam positional stability [Including: TECHNICAL CORRIGENDUM 1 (2004)]Withdrawn and replaced with newer version including technical corrigendum.
12-23712-258IEC 62359 Edition 2.0 2010-10 Ultrasonics—Field characterization—Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields [Including TECHNICAL CORRIGENDUM 1 (2011)]Withdrawn and replaced with newer version including technical corrigendum.
Start Printed Page 4931
12-24312-263ISO 13694 First edition 2000-04-01 Optics and optical instruments—Lasers and laser-related equipment—Test methods for laser beam power [energy] density distribution [Including: TECHNICAL CORRIGENDUM 1 (2005)]Withdrawn and replaced with newer version including technical corrigendum.
12-244IEC 62359 (Second edition 2010) March 2011 Ultrasonics—Field characterization—Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields CORRIGENDUM 1Withdrawn. See 12-258.
12-247ISO 11990-1 First edition 2011-08-01, Lasers and laser-related equipment—Determination of laser resistance of tracheal tubes—Part 1: Tracheal tube shaftExtent of recognition.
P. Software/Informatics
13-4ANSI/UL 1998 Standards for Safety Software in Programmable Components, Second Edition. [This Standard contains revisions through and including October 28, 2008.]Extent of recognition.
Q. Sterility
14-14314-395ISO 14698-2 First edition 2003-09-15 Cleanrooms and associated controlled environments—Biocontamination control—Part 2: Evaluation and interpretation of biocontamination data. [Including: TECHNICAL CORRIGENDUM 1 Published 2004-11-01]Withdrawn and replaced with newer version including technical corrigendum.
14-193ANSI/AAMI/ISO 11607-1:2006/(R)2010 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systemsExtent of recognition and relevant guidance.
14-194ANSI/AAMI/ISO 11607-2:2006/(R)2010 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processesExtent of recognition and relevant guidance.
14-195ANSI/AAMI/ISO 11140-1:2005(R)2010 Sterilization of health care products—Chemical indicators—Part 1: General requirementsExtent of recognition.
14-20114-396ANSI/AAMI ST77:2013 Containment devices for reusable medical device sterilizationWithdrawn and replaced with newer version.
14-21414-397AOAC 6.2.04:2013 Official Method 955.15 Testing Disinfectants Against Staphylococcus aureus, Use-Dilution MethodWithdrawn and replaced with newer version.
14-21814-398AOAC 6.3.05:2013 Official Method 966.04 Sporicidal Activity of Disinfectants Method IWithdrawn and replaced with newer version.
14-21914-399AOAC 6.3.06:2012 Official Method 965.12 Tuberculocidal Activity of DisinfectantsWithdrawn and replaced with newer version.
14-23014-400ASTM F2203-13 Standard Test Method for Linear Measurement Using Precision Steel RuleWithdrawn and replaced with newer version.
14-23114-401ASTM F2217/F2217M-13 Standard Practice for Coating/Adhesive Weight DeterminationWithdrawn and replaced with newer version.
14-23514-402ASTM F1140/F1140M-13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained PackagesWithdrawn and replaced with newer version.
14-23614-403ASTM F2054/F2054M-13 Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining PlatesWithdrawn and replaced with newer version.
14-24114-424ISO 13408-6 First edition 2005-06-15 Aseptic processing of health care products—Part 6: Isolator systems [Including AMENDMENT 1 (2013)]Withdrawn and replaced with newer version including amendment.
14-25814-404ASTM F2250-13 Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging MaterialsWithdrawn and replaced with newer version.
14-26014-405ASTM F2252/F2252M-13ε1 Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using TapeWithdrawn and replaced with newer version.
14-26414-406ANSI/AAMI ST8:2013 Hospital steam sterilizersWithdrawn and replaced with newer version.
14-274ANSI/AAMI/ISO 15882:2008 Sterilization of health care products—Chemical indicators—Guidance for selection, use, and interpretation of resultsExtent of recognition and relevant guidance.
14-285ANSI/AAMI/ISO 14161:2009 Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of resultsExtent of recognition.
14-289ISO 14698-2:2003 TECHNICAL CORRIGENDUM Cleanrooms and associated controlled environments—Biocontamination control—Part 2: Evaluation and interpretation of biocontamination dataWithdrawn. See 14-395.
Start Printed Page 4932
14-296ANSI/AAMI/ISO 11138-1:2006/(R)2010, Sterilization of health care products—Biological indicators—Part 1: General requirementsRelevant guidance.
14-300ASTM D4169-09 Standard Practice for Performance Testing of Shipping Containers and SystemsExtent of recognition.
14-32614-407ISO 11737-1 Second edition 2006-04-01, Sterilization of medical devices—Microbiological methods—Part 1: Determination of a population of microorganisms on products [Including: TECHNICAL CORRIGENDUM 1 Published 2007-05-15]Withdrawn and replaced with newer version including technical corrigendum.
14-32814-428ISO 11137-1 First edition 2006-04-15 Sterilization of health care products—Radiation—Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including AMENDMENT 1 (2013)]Withdrawn and replaced with newer version including amendment.
14-334ISO 15882 Second edition 2008-09-01 Sterilization of health care products—Chemical indicators—Guidance for selection, use and interpretation of resultsExtent of recognition, title.
14-33514-408ISO 10993-7 Second edition 2008-10-15 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals [Including: TECHNICAL CORRIGENDUM 1 Published 2009-11-15]Withdrawn and replaced with newer version including technical corrigendum.
14-336ISO 14161 Second edition 2009-09-15 Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of resultsExtent of recognition.
14-338ISO 11138-1 Second edition 2006-07-01, Sterilization of health care products—Biological indicators—Part 1: General requirementsRelevant guidance.
14-35214-425ANSI/AAMI/ISO 13408-6:2005 Aseptic processing of health care products—Part 6: Isolator systems [Including AMENDMENT 1 (2013)]Withdrawn and replaced with newer version including amendment.
14-353ISO 11140-1 Second edition 2005-07-15 Sterilization of health care products—Chemical indicators—Part 1: General requirementsExtent of recognition.
14-355ISO 11607-1 First edition 2006-04-15 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systemsExtent of recognition and relevant guidance.
14-356ISO 11607-2 First edition 2006-04-15 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processesExtent of recognition.
14-357ISO 11737-1:2006 TECHNICAL CORRIGENDUM 1 Published 2007-05-15 Sterilization of medical devices—Microbiological methods—Part 1: Determination of a population of microorganisms on productsWithdrawn. See 14-407.
14-360ANSI/AAMI ST72:2011, Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testingRelevant guidance.
14-36214-412AOAC 6.2.01:2013 Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution MethodWithdrawn and replaced with newer version.
14-36314-413AOAC 6.2.06:2013 Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution MethodWithdrawn and replaced with newer version.
14-36514-409ISO 11137-2 Third edition 2013-06-01 Sterilization of health care products—Radiation—Part 2: Establishing the sterilization doseWithdrawn and replaced with newer version.
14-36614-414USP 36-NF31:2013 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration TestsWithdrawn and replaced with newer version.
14-36714-415USP 36-NF31:2013 <71> Sterility TestsWithdrawn and replaced with newer version.
14-36814-416USP 36-NF31:2013 <85> Bacterial Endotoxins TestWithdrawn and replaced with newer version.
14-36914-417USP 36-NF31:2013 <151> Pyrogen Test (USP Rabbit Test)Withdrawn and replaced with newer version.
14-37014-418USP 36-NF31:2013 <161> Transfusion and Infusion Assemblies and Similar Medical DevicesWithdrawn and replaced with newer version.
14-37114-419USP 36-NF31:2013 Biological Indicator for Steam Sterilization, Self-ContainedWithdrawn and replaced with newer version.
14-37214-420USP 36-NF31:2013 Biological Indicator for Dry-Heat Sterilization, Paper CarrierWithdrawn and replaced with newer version.
14-37314-421USP 36-NF31:2013 Biological Indicator for Ethylene Oxide Sterilization, Paper CarrierWithdrawn and replaced with newer version.
14-37414-422USP 36-NF31:2013 Biological Indicator for Steam Sterilization, Paper CarrierWithdrawn and replaced with newer version.
14-37514-423USP 36-NF31:2013 <62> Microbiological Examination of Nonsterile Products: Tests for Specified MicroorganismsWithdrawn and replaced with newer version.
14-38014-410ASTM F17-13 Standard Terminology Relating to Flexible Barrier PackagingWithdrawn and replaced with newer version.
Start Printed Page 4933
14-384ISO 10993-7:2008 TECHNICAL CORRIGENDUM 1, Published 2009-11-15 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residualsWithdrawn. See 14-408.
14-38514-426ANSI/AAMI/ISO 13408-1:2008 (R2011) Aseptic processing of health care products—Part 1: General requirements [Including AMENDMENT 1 (2013)]Withdrawn and replaced with newer version including amendment.
14-38614-427ISO 13408-1 Second edition 2008-06-15 Aseptic processing of health care products—Part 1: General requirements [Including AMENDMENT 1 (2013)]Withdrawn and replaced with newer version including amendment.
14-39314-411ISO/ASTM 51818 Third edition 2013-06-01 Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keVWithdrawn and replaced with newer version.
1 All standard titles in this table conform to the style requirements of the respective organizations.

III. Listing of New Entries

In table 2 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: 034.

Table 2.—New Entries to the List of Recognized Standards

Recognition No.Title of standard 1Reference No. and date
A. Anesthesia
1-96Medical electrical equipment—Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitorsISO 80601-2-55 First edition 2011-12-15.
B. Cardiovascular
3-121Cardiovascular implants—Endovascular devices—Part 1: Endovascular prostheses [Including: Amendment 1 (2005)]ISO 25539-1 First edition 2003-03-01.
C. General
5-83MEDICAL ELECTRICAL EQUIPMENT—Part 1-11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2010, MOD)ANSI/AAMI HA60601-1-1:2011.
5-84Design of training and instructional materials for medical devices used in non-clinical environmentsAAMI TIR49:2013.
5-85Medical electrical equipment—Part 1-6: General requirements for basic safety and essential performance—Collateral standard: UsabilityIEC 60601-1-6 Edition 3.0 2010-01.
5-86Medical electrical equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systemsIEC 60601-1-8 Edition 2.0 2006-10.
D. General Hospital/General Plastic Surgery
6-302Stainless steel needle tubing for the manufacture of medical devices [Including: AMENDMENT 1 2001-06-01]ISO 9626 First edition 1991-09-01.
6-318Infusion equipment for medical use—Part 4: Infusion sets for single use, gravity feed [Including: AMENDMENT 1 2013-03-01]ISO 8536-4 Fifth edition 2010-10-01.
6-320Medical electrical equipment—Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators [Including: CORRIGENDUM 1 (February 2012) and CORRIGENDUM 2 (February 2013)]IEC 60601-2-20 Edition 2.0 2009-02.
6-321Medical electrical equipment—Part 2-52: Particular requirements for basic safety and essential performance of medical beds [Including: CORRIGENDUM 1 (September 2010)]IEC 60601-2-52 Edition 1.0 2009-12.
6-322Intravascular catheters—Sterile and single-use catheters—Part 4: Balloon dilatation cathetersISO 10555-4 Second edition 2013-06-15.
E. Material
8-358Standard Specification for Polyoxymethylene (Acetal) for Medical ApplicationsASTM F1855-00 (Reapproved 2011).
8-359Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured MaterialsASTM F2038-00 (Reapproved 2011).
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8-360Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Cross-Linking and FabricationASTM F2042-00 (Reapproved 2011).
8-361Standard Specification for Selection of Porous Polyethylene for Use in Surgical ImplantsASTM F755-99 (Reapproved 2011).
8-362Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant ApplicationsASTM F2989-13.
8-363Standard Test Method for Tensile Properties of PlasticsASTM D638-10.
8-364Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by DisplacementASTM D792-08.
8-365Standard Test Method for Density of Plastics by the Density-Gradient TechniqueASTM D1505-10.
8-366Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials—Part 2: Preparation of test specimens and determination of propertiesISO 11542-2 First edition 1998-11-15.
8-367Standard Test Method for Measurement of Fatigue Crack Growth RatesASTM E647-13ε1.
8-368Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning CalorimetryASTM F2625-10.
8-369Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in AirASTM F2003-02 (Reapproved 2008).
F. OB-GYN/Gastroenterology/Urology
9-86Rubber condoms for clinical trials—Measurement of physical properties Including [AMENDMENT 1 2011-02-15)]ISO 16037 First Edition 2002-05-15.
9-87Female condoms—Requirements and test methodsISO 25841 First Edition 2011-07-15.
9-88Prophylactic dams—Requirements and test methodsISO 29942 First Edition 2011-07-01.
9-89Cardiovascular implants and extracorporeal blood circuit for haemodialysers, haemodiafilters, and haemofiltersISO 8638 Third edition 2010-07-01.
9-92Cardiovascular implants and extracorporeal systems—Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators Including [AMENDMENT 1 2013-04-01)]ISO 8637 Third edition 2010-07-01.
G. Ophthalmics
10-87Standard Test Method for Tensile Properties of Thin Plastic SheetingASTM D882-12.
10-88Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating MaterialsASTM D790-10.
H. Orthopedics
11-259Standard Specification For Total Elbow ProsthesesASTM F2887-12.
11-260Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint ArthroplastyASTM F2943-13.
11-261Standard Specification for Shoulder ProsthesesASTM F1378-12
11-262Standard Specification for Acetabular ProsthesesASTM F2091-01 (Reapproved 2012).
11-263Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or DisassociationASTM F2028-08 (Reapproved 2012) 1.
11-264Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular DevicesASTM F1820-13.
11-265Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip ProsthesisASTM F2580-13.
11-266Standard Specification for Total Ankle Replacement ProsthesisASTM F2665-09.
11-267Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular ProsthesesASTM F2009-00 (Reapproved 2011).
11-268Standard Test Method for Static Evaluation of Glenoid Locking Mechanism in ShearASTM F1829-98 (Reapproved 2009).
11-269Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc ProsthesesASTM F2423-11.
11-270Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation ImplantsASTM F2502-11.
11-271Standard Specification for Metallic Implantable Strands and CablesASTM F2180-02 (Reapproved 2011).
11-272Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator DevicesASTM F1714-96 (Reapproved 2013).
11-273Implants for surgery—Wear of total intervertebral spinal disc prostheses—Part 1 Loading and displacement parameters for wear testing and corresponding environmental conditions for testISO 18192-1 Second edition 2011-03-01.
11-274Implants for surgery—Wear of total intervertebral spinal disc prostheses—Part 2: Nucleus replacementsISO 18192-2 First edition 2010-06-15.
11-275Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared SpectroscopyASTM F2381-10.
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I. Radiology
12-261Information technology—Digital compression and coding of continuous-tone still images: Requirements and guidelines [Including: TECHNICAL CORRIGENDUM 1 (2005)]ISO/IEC 10918-1 First edition 1994-02-15.
J. Software/Informatics
13-63Application of risk management for IT-networks incorporating medical devices—Part 2-4: Application guidance—General implementation guidance for healthcare delivery organizationsIEC/TR 80001-2-4 Edition 1.0 2012-11.
13-64Application of risk management for IT-networks incorporating medical devices—Part 2-4: General implementation guidance for healthcare delivery organizationsANSI/AAMI/IEC TIR80001-2-4:2012.
K. Sterility
14-429Practice for use of a radiochromic film dosimetry systemISO/ASTM 51275 Third edition 2013-06-01.
14-430Practice for use of an alanine-EPR dosimetry systemISO/ASTM 51607 Third edition 2013-06-01.
14-431Guide for estimating uncertainties in dosimetry for radiation processingISO/ASTM 51707 Second edition 2005-05-15.
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 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 revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often, if necessary. Beginning with recognition list 033, FDA no longer announces minor revisions to the list of recognized consensus standards such as technical contact person, relevant guidance, processes affected, CFR citations, and product codes.

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) The title of the standard, (2) any reference number and date, (3) the 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: 034” 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: 034. These modifications to the list of recognized standards are effective upon publication of this notice in the Federal Register.

Start Signature

Dated: January 23, 2014.

Leslie Kux,

Assistant Commissioner for Policy.

End Signature End Further Info End Preamble

[FR Doc. 2014-01847 Filed 1-29-14; 8:45 am]

BILLING CODE 4160-01-P