Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 034
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Notice.
Citation: "79 FR 4913"
Document Number: "Docket No.
"Notices"
SUMMARY:
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
FOR FURTHER INFORMATION CONTACT:
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
In a notice published in the
Modifications to the initial list of recognized standards, as published in the
These notices describe the addition, withdrawal, and revision of certain standards recognized by
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.
In table 1 of this document,
In section III of this document,
Table 1--Modifications to the List of Recognized Standards Old Replacement Title of standard *1 Change recognition recognition No. No. A. Anesthesia 1-15 ISO 5361-4:1987, Tracheal Withdrawn. See tubes--Part 4: Cole type 1-93. 1-18 1-94 ISO 8359 Second edition 1996- Withdrawn and 12-15, Oxygen concentrators for replaced with medical use--Safety newer version requirements [Including: including AMENDMENT 1 2012-07-01] amendment. 1-36 1-95 ISO 5366-3 Second edition 2001- Withdrawn and 08-15, Anaesthetic and replaced with respiratory equipment-- newer version Tracheostomy tubes--Part 3: including Pediatric tracheostomy tubes technical [Including: TECHNICAL corrigendum. CORRIGENDUM 1 Published 2003- 01-15] 1-44 ISO 5366-1 Fourth edition 2000- Extent of 12-15, Anaesthetic and recognition. respiratory equipment-- Tracheostomy tubes--Part 1: Tubes and connectors for use in adults 1-46 ISO 5367 Fourth edition 2000- Extent of 06-01 Breathing tubes intended recognition. for use with anaesthetic apparatus and ventilators 1-47 AS 4259-1995 Ancillary devices Extent of for expired air resuscitation recognition. 1-56 1-97 CGA V-7.1:2011 Standard Method Withdrawn and of Determining Cylinder Valve replaced with Outlet Connections for Medical newer version. Gases 1-57 ASTM F1101-90 (Reapproved 2003) Extent of &egr;1, Standard Specification recognition. for Ventilators Intended for Use During Anesthesia 1-58 ASTM G175-03 (Reapproved 2011), Extent of Standard Test Method for recognition. Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications 1-65 ISO 21647:2004 Medical Withdrawn. See electrical equipment-- 1-96. Particular requirements for the basic safety and essential performance of respiratory gas monitors 1-69 ASTM F1464-93 (Reapproved 2005) Extent of Standard Specification for recognition. Oxygen Concentrators for Domiciliary Use 1-70 ASTM F1246-91 (Reapproved 2005) Extent of Standard Specification for recognition. Electrically Powered Home Care Ventilators, Part 1--Positive- Pressure Ventilators and Ventilator Circuits 1-78 ASME PVHO-1-2007 Safety Extent of Standard for Pressure Vessels recognition. for Human Occupancy 1-81 CGA V-5:2008 (Reaffirmed 2013), Reaffirmation. Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications) 1-83 ISO 21647:2004 TECHNICAL Withdrawn. See CORRIGENDUM 1, Medical 1-96. electrical equipment-- Particular requirements for the basic safety and essential performance of respiratory gas monitors 1-84 ISO 5366-3:2001 Anaesthetic and Withdrawn. See Respiratory Equipment-- 1-95. Tracheostomy Tubes--Part 3: Pediatric Tracheostomy Tubes TECHNICAL CORRIGENDUM 1 1-86 ISO 8185 Third edition 2007-07- Extent of 01 Corrected versions 2008-06- recognition. 15 Respiratory tract humidifiers for medical use-- Particular requirements for respiratory humidification systems 1-88 1-98 ISO 80601-2-12 First edition Withdrawn and 2011-04-15 Medical electrical replaced with equipment--Part 2-12: newer version Particular requirements for the including safety of lung ventilators-- technical Critical care ventilators corrigendum. [Including: TECHNICAL CORRIGENDUM 1 Published 2011- 10-15] 1-89 ISO 80601-2-12 TECHNICAL Withdrawn. See CORRIGENDUM 1 Medical 1-98. electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators 1-90 ISO 8359 Second edition 1996- Withdrawn. See 12-15 AMENDMENT 1 2012-07-01 1-94. Oxygen concentrators for medical use--Safety requirements 1-92 ISO 17510-2 Second Edition Extent of 2007-10-01, Sleep apnoea recognition. breathing therapy--Part 2: Masks and application accessories 1-93 ISO 5361 Second edition 2012-10-01 Extent of Anaesthetic and respiratory recognition. equipment--Tracheal tubes and connectors B. Biocompatibility 2-123 2-204 ASTM F720-13 Standard Practice Withdrawn and for Testing Guinea Pigs for replaced with Contact Allergens: Guinea Pig newer version. Maximization Test 2-182 2-205 ISO 14155 Second edition 2011- Withdrawn and 02-01 Clinical investigations replaced with of medical devices for human newer version subjects--Good clinical including practices [Including TECHNICAL technical CORRIGENDUM 1:2011] corrigendum. 2-183 ISO 14155:2011 and TECHNICAL Withdrawn. See CORRIGENDUM 1 Published 2011- 2-205. 07-15 Clinical investigation of medical devices for human subjects--Good clinical practice 2-93 ASTM F763-04 (Reapproved 2010), Extent of Standard Practice for Short- recognition. Term Screening of Implant Materials 2-94 ASTM F981-04 (Reapproved 2010) Extent of Standard Practice for recognition. Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone 2-114 ASTM F1877-05 (Reapproved 2010) Extent of Standard Practice for recognition. Characterization of Particles 2-118 ANSI/AAMI/ISO 10993-11:2006/(R) Extent of 2010 Biological evaluation of recognition. medical devices--Part 11: Tests for systemic toxicity 2-120 ANSI/AAMI/ISO 10993-6:2007/(R) Extent of 2010 Biological evaluation of recognition. medical devices--Part 06: Tests for local effects after implantation 2-126 ASTM F748-06 (Reapproved 2010) Extent of Standard Practice for Selecting recognition. Generic Biological Test Methods for Materials and Devices 2-133 ASTM F1408-97 (Reapproved 2008) Extent of Standard Practice for recognition. Subcutaneous Screening Test for Implant Materials 2-134 ASTM F2065-00 (Reapproved 2010) Extent of Standard Practice for Testing recognition. for Alternative Pathway Complement Activation in Serum by Solid Materials 2-136 ASTM E1262-88 (Reapproved 2008) Extent of Standard Guide for Performance recognition. of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay 2-137 ASTM E1263-97 (Reapproved 2008) Withdrawn. Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes 2-138 ASTM E1280-97 (Reapproved 2008) Withdrawn. Standard Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell Mutagenicity 2-139 ASTM E1397-91 (Reapproved 2008) Withdrawn. Standard Practice for the In Vitro Rat Hepatocyte DNA Repair Assay 2-140 ASTM E1398-91 (Reapproved 2008) Withdrawn. Standard Practice for the In Vivo Rat Hepatocyte DNA Repair Assay 2-141 ASTM F1984-99 (Reapproved 2008) Extent of Standard Practice for Testing recognition. for Whole Complement Activation in Serum by Solid Materials 2-142 ASTM F1983-99 (Reapproved 2008) Extent of Standard Practice for recognition. Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Application 2-143 ASTM F1904-98 (Reapproved 2008) Extent of Standard Practice for Testing recognition. the Biological Responses to Particles in vivo 2-144 ASTMF619-03 (Reapproved 2008) Extent of Standard Practice for recognition. Extraction of Medical Plastics 2-145 ASTM F1439-03 (Reapproved 2008) Extent of Standard Guide for Performance recognition. of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials 2-153 ANSI/AAMI/ISO 10993-5:2009, Extent of Biological evaluation of recognition. medical devices--Part 5: Tests for In Vitro cytotoxicity 2-154 ASTM F756-08 Standard Practice Extent of for Assessment of Hemolytic recognition. Properties of Materials 2-155 ASTM F2147-01 (Reapproved 2010) Extent of Standard Practice for Guinea recognition. Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens 2-156 ANSI/AAMI/ISO 10993-1:2009 Extent of Biological evaluation of recognition. medical devices--Part 1: Evaluation and testing within a risk management 2-162 ASTM F1903-10 Standard Practice Extent of for Testing for Biological recognition. Responses to Particles in vitro 2-163 ANSI/AAMI/ISO 10993-9:2009 Extent of Biological evaluation of recognition. medical devices--Part 9: Framework for identification and quantification of potential degradation products 2-165 ANSI/AAMI/ISO 10993-14:2001/(R) Extent of 2011 Biological evaluation of recognition. medical devices--Part 14: Identification and quantification of degradation products from ceramics 2-167 ISO/TS 10993-19 First edition Extent of 2006-06-01 Biological recognition. evaluation of medical devices-- Part 19: Physico-chemical, morphological, and topographical characterization of materials 2-168 ISO 10993-9 Second edition Extent of 2009-12-15 Biological recognition. evaluation of medical devices-- Part 9: Framework for identification and quantification of potential degradation products 2-169 ISO 10993-13 Second edition Extent of 2010-06-15 Biological recognition. evaluation of medical devices-- Part 13: Identification and quantification of degradation products from polymeric medical devices 2-170 ISO 10993-14 First edition Extent of 2001-11-15 Biological recognition. evaluation of medical devices-- Part 14: Identification and quantification of degradation products from ceramics 2-171 ISO 10993-16 Second edition Extent of 2010-02-15 Biological recognition. evaluation of medical devices-- Part 16: Toxicokinetic study design for degradation products and leachables 2-172 ANSI/AAMI/ISO TIR 10993-19:2006 Extent of Biological evaluation of recognition. medical devices--Part 19: Physicochemical, morphological, and topographical characterization of materials 2-173 ANSI/AAMI/ISO 10993-10:2010 Extent of Biological evaluation of recognition. medical devices--Part 10: Tests for irritation and skin sensitization 2-174 ISO 10993-10:2010 Biological Extent of evaluation of medical devices-- recognition. Part 10: Tests for irritation and skin sensitization 2-175 ISO 10993-3 Second edition Extent of 2003-10-15 Biological recognition. evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity 2-176 ISO 10993-11 Second edition Extent of 2006-08-15 Biological recognition. evaluation of medical devices-- Part 11: Tests for systemic toxicity 2-177 ISO 10993-06 Second edition Extent of 2007-04-15 Biological recognition. evaluation of medical devices-- Part 6: Tests for local effects after implantation 2-179 ISO 10993-1 Fourth edition Extent of 2009-10-15 Biological recognition. evaluation of medical devices-- Part 1: Evaluation and testing within a risk management process 2-181 ANSI/AAMI/ISO 14155:2011, Extent of Clinical investigation of recognition. medical devices for human subjects--Good clinical practice 2-189 ASTM F895-11, Standard Test Extent of Method for Agar Diffusion Cell recognition. Culture Screening for Cytotoxicity 2-190 ANSI/AAMI/ISO 10993-13:2010, Extent of Biological evaluation of recognition. medical devices--Part 13: Identification and quantification of degradation products from polymeric medical devices 2-191 ISO 10993-12 Fourth edition Extent of 2012-07-01, Biological recognition. evaluation of medical devices-- Part 12: Sample preparation and reference materials C. Cardiovascular 3-41 ANSI/AAMI EC11:1991/(R)2007 Withdrawn. See Diagnostic electrocardiographic 3-106. devices 3-52 ANSI/AAMIEC12:2000/(R)2010 Extent of Disposable ECG electrodes recognition. 3-54 ANSI/AAMI/ISO Extent of 7198:1998/2001/(R)2010 recognition. Cardiovascular implants-- Tubular vascular prostheses 3-58 ANSI/AAMI/ISO 5840:2005/(R)2010 Extent of Cardiovascular implants-- recognition. Cardiac valve prostheses 3-63 ISO 11318 Second edition 2002- Extent of 08-01 Cardiac Defibrillators-- recognition. Connector assembly DF-1 for implantable defibrillators-- Dimensions and test requirements 3-72 ANSI/AAMI EC53:1995/(R) 2008 Extent of ECG cables and leadwires recognition. 3-73 3-118 ANSI/AAMI EC57:2012 Testing and Withdrawn and reporting performance results replaced with of cardiac rhythm and ST- newer version. segment measurement algorithms 3-75 ANSI/AAMI SP10:2002/(R) 2008 & Withdrawn. See ANSI/AAMI SP10:2002/A1:2003, 3-80, 3-122 and Manual, electronic or automated 3-123. sphygmomanometers 3-76 ASTM F2129-08 Standard Test Extent of Method for Conducting Cyclic recognition. Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices 3-78 ANSI/AAMI/IEC 80601-2-30:2009 Extent of Medical electrical equipment-- recognition. Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers 3-80 ANSI/AAMI/ISO 81060-1:2007/(R) Reaffirmation. 2013 Non-invasive sphygmomanometers--Part 1: Requirements and test methods for non-automated measurement type 3-83 ANSI/AAMI/ISO 14708-5:2010 Extent of Implants for surgery--Active recognition. implantable medical devices-- Part 5: Circulatory support devices 3-85 3-120 ANSI/AAMI/ISO 25539-2:2012 Withdrawn and Cardiovascular implants-- replaced with Endovascular devices--Part 2: newer version. Vascular stents 3-88 ASTM F2514-08 Standard Guide Extent of for Finite Element Analysis recognition. (FEA) of Metallic Vascular Stents Subjected to Uniform Radial 3-90 ISO 7198 First edition 1998-08- Extent of 01 Cardiovascular implants-- recognition. Tubular vascular prostheses 3-93 ISO 25539-1:2003 First edition Withdrawn. See 2001-11-13 AMENDMENT 1 2005-07- 3-121. 15 Cardiovascular implants-- Endovascular devices--Part 1: Endovascular prostheses Amendment 1: Test methods 3-97 3-122 ISO 81060-2 Second edition Withdrawn and 2013-05-01 Non-invasive replace with sphygmomanometers--Part 2: newer version. Clinical validation of automated measurement type 3-98 ISO 81060-2:2009 TECHNICAL Withdrawn. See CORRIGENDUM Published 2011-02- 3-122. 15 Non-invasive sphygmomanometers--Part 2: Clinical validation of automated measurement type 3-100 ANSI/AAMI/IEC 60601-2-27:2011 Withdrawn. See Medical electrical equipment-- 3-101. Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment 3-107 3-123 IEC 80601-2-30 Edition 1.1 Withdrawn and 2013-07 Medical electrical replaced with equipment--Part 2-30: newer version. Particular requirements for the basic safety and essential performance of automated non- invasive sphygmomanometers 3-108 IEC 80601-2-30 (First edition Withdrawn. See 2009) Medical electrical 3-123. equipment--Part 2-30: Particular requirements for the basic safety and essential performance of automated non- invasive sphygmomanometers CORRIGENDUM 1 3-113 3-124 ISO 7199 Second edition 2009- Withdrawn and 04-15 Cardiovascular implants replaced with and artificial organs--Blood- newer version gas exchangers (oxygenators) including [Including: AMENDMENT 1 amendment. (2012)] 3-114 3-119 ISO 5841-3 Third edition 2013- Withdrawn and 40-15 Implants for surgery-- replace with Cardiac pacemakers--Part 3: newer version. Low-profile connectors (IS-1) for implantable pacemakers D. Dental/ENT 4-50 ADA Specification No.18:1992 Extent of Alginate Impression Materials recognition. 4-62 ISO 1563 Second edition 1990- Withdrawn. 09-01 Dental alginate impression material 4-63 ISO 1564 Second edition 1995- Withdrawn. 11-01 Dental aqueous impression materials based on agar 4-86 ANSI/ADA Specification No. 38 Extent of 2000 (Reaffirmed 2010), Metal- recognition. Ceramic Dental Restorative Systems 4-89 ANSI/ADA Specification No. 53: Extent of 1999 (Reaffirmed 2008) Polymer- recognition. Based Crowns and Bridge Materials 4-91 ANSI/ADA Specification No. Reaffirmation 80/ISO 7491:2000 (Reaffirmed and extent of 2013) Dental Materials-- recognition. Determination of Color Stability 4-92 ANSI/ADA Specification No. Reaffirmation 88:2000 (Reaffirmed 2010) and extent of Dental Brazing Alloys recognition. 4-96 ANSI/ADA Specification No. Reaffirmation 30:2000 (Reaffirmed 2012) and extent of Dental Zinc Oxide-Eugenol and recognition. Zinc Oxide Non-Eugenol Cements 4-97 ANSI/ADA Specification No. 57: Extent of (Reaffirmed 2012) Endodontic recognition. Sealing Materials 4-105 ANSI/ADA Specification No. Extent of 75:1997 (Reapproved 2003) recognition. Resilient Lining Materials for Removable Dentures--Part 1: Short-Term Materials 4-109 ISO 13716 First edition 1999- Withdrawn. 05-01 Dentistry--reversible- irreversible hydrocolloid impression material system 4-126 ISO 10477 Second edition 2004- Extent of 10-01 Dentistry--Polymer-based recognition. crown and bridge materials 4-130 ADA Specification No. 17:1983 Extent of (Reaffirmed 2006) Denture Base recognition. Temporary Relining Resins 4-134 4-207 ISO 7494-1 Second edition 2011- Withdrawn and 08-15 Dentistry--Dental units-- replaced with Part 1: General requirements newer version. and test methods 4-135 4-213 ISO 10139-1 Second edition Withdrawn and 2005-02-15 Dentistry--Soft replaced with lining materials for removable newer version dentures--Part 1: Materials for including short-term use [Including: technical TECHNICAL CORRIGENDUM 1 corrigendum. (2006)] 4-137 ISO 6877 Second edition 2006- Extent of 04-01 Dentistry--Root-canal recognition. obturating points 4-139 ANSI/ADA Specification No. 48 Reaffirmation (Reaffirmed 2009) Visible Light and extent of Curing Units recognition. 4-143 4-208 ANSI/ADA Specification No. Withdrawn and 96:2012 Dental-Water-Based replaced with Cements newer version. 4-144 4-209 ISO 24234 First edition 2004- Withdrawn and 10-15 Dentistry--Mercury and replaced with alloys for dental amalgam newer version [Including: AMENDMENT 1 including (2011)] amendment. 4-146 ISO 22674 First edition 2006- Extent of 11-15 Dentistry--Metallic recognition. materials for fixed and removable restorations and appliances 4-149 ANSI/ADA Specification No. Reaffirmation 39/ISO 6874:2005 (Reaffirmed and extent of 2011) Pit and Fissure Sealants recognition. 4-150 ANSI/ADA Specification No. Extent of 19:2004/ISO 4823:2000 Dental-- recognition. Elastometric Impression Materials 4-151 ISO 22112 First edition 2005- Extent of 11-01 Dentistry--Artificial recognition. teeth for dental prostheses 4-153 ISO 9917-1 Second edition 2007- Extent of 10-01 Dentistry--Water-based recognition. cements--Part 1: Powder/liquid acid-base cements 4-154 4-210 ISO 4823 Third edition 2000-12- Withdrawn and 15 Dentistry--Elastometric replaced with impression materials newer version [Including: AMENDMENT 1 (2000) including TECHNICAL CORRIGENDUM 1(2004)] amendment and technical corrigendum. 4-155 ISO 4823: Technical Corrigendum Withdrawn. See 1 Published 2004-07-15-- 4-210. Dentistry--Elastometric impression materials--Third Edition 4-156 ISO 4823 Third edition 2000-12- Withdrawn. See 15 Amendment 1 2007-07-01 4-210. Dentistry--Elastometric impression materials--Third Edition 4-157 ISO 3107 Third edition 2004-10- Withdrawn. See 01 Dentistry--Zinc 4-198. oxide/Eugenol and zinc oxide/non-eugenol cements-- Third edition 4-159 4-211 ANSI/IEEE C63.19:2007 American Withdrawn and National Standard Methods of replaced with Measurement of Compatibility newer version. between Wireless Communications Devices and Hearing Aids 4-170 4-212 ANSI/ASA S3.36-2012 American Withdrawn and National Standard Specification replaced with for a Manikin for Simulated in newer version. situ Airborne Acoustic Measurements 4-178 ISO 6872 Third edition 2008-09- Extent of 01 Dentistry--Ceramic materials recognition. 4-179 ISO 7405 Second edition 2008- Extent of 12-15 Dentistry--Evaluation of recognition. biocompatibility of medical devices used in dentistry 4-180 ISO 9168 Third edition 2009-07- Extent of 15 Dentistry--Hose connectors recognition. for air driven dental handpieces 4-181 ISO 4049 Fourth edition 2009- Extent of 10-01 Dentistry--Polymer-based recognition. restorative materials 4-182 ISO 10139-2 Second edition Extent of 2009-08-01 Dentistry--Soft recognition. lining materials for removable dentures--Part 2: Materials for long-term use 4-188 ISO 9917-2 Second edition 2010- Extent of 04-15 Dentistry--Water-based recognition. cements--Part 2: Resin-modified cements 4-189 ISO 10139-1:2005 TECHNICAL Withdrawn. See CORRIGENDUM 1 2006-03-01 4-213. Dentistry--Soft lining materials for removable dentures--Part 1: Materials for short-term use 4-195 ISO 14801 Second edition 2007- Extent of 11-15 Dentistry--Implants- recognition. Dynamic fatigue test for endosseous dental implants 4-196 ANSI/ADA Specification Extent of No.69:2010/ISO 6872:2008 Dental recognition. Ceramic 4-198 ISO 3107 Fourth edition 2011- Extent of 03-01 Dentistry--Zinc recognition. oxide/eugenol and zinc oxide/non-eugenol cements 4-199 ISO 6876 Third edition 2012-06- Extent of 01 Dentistry--Root Canal recognition. Sealing Materials 4-200 ISO 24234 First edition 2004- Withdrawn. See 10-15 Dentistry--Mercury and 4-209. alloys for dental amalgam AMENDMENT 1 4-201 ISO 9693-2012 Dentistry-- Extent of Compatibility testing--Metal- recognition. ceramic systems 4-205 ISO 14457 First edition 2012- Withdrawn. See 09-15 Dentistry--Handpieces and 4-206. motors E. General 5-22 ISO 2768-1 First edition 1989- Extent of 11-15 General tolerances--Part recognition. 1: Tolerances for linear and angular dimensions without individual tolerance indications 5-23 ISO 2768-2 First edition 1989- Extent of 11-15 General Tolerances--Part recognition. 2: Geometrical tolerances for features without individual tolerance indications 5-36 ISO/TR 16142 Second edition Extent of 2006-01-15 Medical devices-- recognition. Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices 5-37 5-81 ISO 2859-1 Second edition 1999- Withdrawn and 11-15 Sampling procedures for replaced with inspection by attributes--Part newer version 1: Sampling schemes indexed by including acceptance quality limit (AQL) technical for lot-by-lot inspection corrigendum. [Including: TECHNICAL CORRIGENDUM 1 (2001)] 5-43 ANSI/ESD S20.20-2007 For the Extent of Development of an Electrostatic recognition. Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices) 5-45 5-79 ASTM D7386-12 Standard Practice Withdrawn and for Performance Testing of replaced with Packages for Single Parcel new version. Delivery Systems 5-46 ISO 2859-1:1999/Cor 1:2001 Withdrawn. See Sampling procedures for 5-81. inspection by attributes--Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection 5-47 ISO 10012 First edition 2003- Extent of 01-15 Measurement management recognition. systems--Requirements for measurement processes and measuring equipment 5-50 IEC 62366 Edition 1.0 2007-10 Extent of Medical devices--Application of recognition. usability engineering to medical devices 5-51 5-80 ASTM D-4332-13 Standard Withdrawn and Practice for Conditioning replaced with Containers, Packages, or new version. Packaging Components for Testing 5-53 IEC 60601-1-2 Edition 3.0 2007- Relevant 03 Medical electrical guidance. equipment--Part 1-2: General requirements for basic safety and essential performance-- Collateral standard: Electromagnetic compatibility-- Requirements and tests 5-54 ANSI/AAMI/IEC 60601-1- Reaffirmation 2:2007/(R)2012 Medical and relevant electrical equipment--Part 1-2: guidance. General requirements for basic safety and essential performance--Collateral standard: Electromagnetic compatibility--Requirements and tests 5-57 ANSI/AAMI HE75:2009 Human Extent of factors engineering--Design of recognition. medical devices 5-58 5-82 IEC 60601-1-11 Edition 1.0:2010 Withdrawn and Medical electrical equipment-- replaced with Part 1-11: General requirements newer version for basic safety and essential including performance--Collateral technical Standard: Requirements for corrigendum. medical electrical equipment and medical electrical systems used in the home healthcare environment [Including: TECHNICAL CORRIGENDUM 1 (2011)] 5-62 ANSI/ASQ Z1.4-2008 Sampling Extent of Procedures and Tables for recognition. Inspection by Attributes 5-66 IEC 60601-1-10 Edition 1.0: Extent of 2007-11 Medical electrical recognition. equipment--Part 1-10: General requirements for basic safety and essential performance-- Collateral Standard: Requirements for the development of physiologic closed-loop controllers 5-67 ANSI/AAMI/IEC Reaffirmation 62366:2007/(R)2013 Medical and extent of devices--Application of recognition. usability engineering to medical devices 5-69 IEC 60601-1-11 (First edition Withdrawn. See 2010) April 2011 Medical 5-82. 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 1F. General Hospital /General Plastic Surgery 6-13 ISO 595-1 First edition 1986- Withdrawn. 12-15 Reusable all-glass or metal-and-glass syringes for medical use--Part 1: Dimensions 6-14 ISO 595-2 First edition 1987- Withdrawn. 12-15 Reusable all-glass or metal-and-glass syringes for medical use--Part 2: Design, performance requirements and tests 6-117 ASTM F2172-02 (Reapproved 2011) Extent of Standard Specification for recognition. Blood/Intravenous Fluid/Irrigation Fluid Warmers 6-142 ANSI/AAMI II36:2004 Medical Withdrawn. See electrical equipment--Part 2: 6-230. Particular requirements for safety of baby incubators 6-143 ANSI/AAMI II51:2004 Medical Withdrawn. See electrical equipment--Part 2: 6-231. Particular requirements for safety of transport incubators 6-150 ASTM D7161-05 (Reapproved 2010) Withdrawn. Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions 6-161 6-301 ISO 10555-1 Second edition Withdrawn and 2013-06-15 Corrected version replaced with 2013-07-01 Intravascular newer version. catheters--Sterile and single- use catheters--Part 1: General requirements 6-163 ISO 9626 First edition 1991-09- Withdrawn. See 01 AMENDMENT 1 2001-06-01 6-302. Stainless steel needle tubing for the manufacture of medical devices 6-164 6-303 ISO 10555-5 Second edition Withdrawn and 2013-06-15 Intravascular replaced with catheters--Sterile and single- newer version. use catheters--Part 5: Over- needle peripheral catheters 6-170 6-304 ISO 7886-1 First edition 1993- Withdrawn and 10-01 Sterile hypodermic replaced with syringes for single use--Part newer version 1: Syringes for manual use including [Including: TECHNICAL technical CORRIGENDUM 1 Published 1995- corrigendum. 11-01] 6-171 6-305 ISO 10555-3 Second edition Withdrawn and 2013-06-15 Intravascular replaced with catheters--Sterile and single- newer version. use catheters--Part 3: Central venous catheters 6-176 ASTM D7103-06 (Reapproved 2013) Extent of Standard Guide for Assessment recognition. of Medical Gloves 6-187 6-306 ASTM F1671/F1671M-13 Standard Withdrawn and Test Method for Resistance of replaced with Materials Used in Protective newer version. Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System 6-233 IEC 60601-2-52 Edition 1.0 Withdrawn. See 2009-12 Medical electrical 6-321. equipment--Part 2-52: Particular requirements for basic safety and essential performance of medical beds 6-236 6-307 IEC 80601-2-59 Edition 1.0 Withdrawn and 2008-10 Medical Electrical replaced with Equipment--Part 2-59: newer version Particular requirements for the including basic safety and essential technical performance of screening corrigendum. thermographs for human febrile temperature screening [Including: CORRIGENDUM 1 (April 2009)] 6-237 IEC 80601-2-59 (First edition Withdrawn. See 2008) Medical Electrical 6-307. Equipment--Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening CORRIGENDUM 1 6-238 6-308 IEC 80601-2-35 Edition 2.0 Withdrawn and 2009-10 Medical electrical replaced with equipment--Part 2-35: newer version Particular requirements for the including basic safety and essential technical performance of heating devices corrigendum. using blankets, pads or mattresses and intended for heating in medical use [Including: CORRIGENDUM 1 (March 2012)] 6-245 ISO 8536-4 Fifth edition 2010- Withdrawn. See 10-01 Infusion equipment for 6-318. medical use--Part 4: Infusion sets for single use, gravity feed 6-253 ISO 10535 Second edition 2006- Extent of 12-15 Hoists for the transfer recognition. of disabled persons-- Requirements and test methods 6-264 ISO 10555-1 First edition 1995- Withdrawn. See 06-15 AMENDMENT 1 1999-07-15 6-301. Sterile, single-use intravascular catheters--Part 1: General requirements 6-265 ISO 10555-1 First edition 1995- Withdrawn. See 06-5 AMENDMENT 2 2004-05-15 6-301. Sterile, single-use intravascular catheters--Part 1: General requirements 6-266 ISO 10555-5 First edition 1996- Withdrawn. See 06-15 AMENDMENT 1 Sterile, 6-303. single-use intravascular catheters--Part 5: Over-needle peripheral catheters 6-267 ISO 10555-5 1996 TECHNICAL Withdrawn. See CORRIGENDUM 1 Published 2002- 6-303. 06-15 Sterile, single-use intravascular catheters--Part 5: Over-needle peripheral catheters 6-273 ISO 23908 First edition 2011- Extent of 06-11 Sharps injury recognition. protection--Requirements and test methods--Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling 6-279 IEC 60601-2-19 (Second Edition Withdrawn. See 2009) Medical electrical 6-319. equipment--Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators CORRIGENDUM 1 6-280 IEC 60601-2-20 (Second edition Withdrawn. See 2009) Medical electrical 6-320. equipment--Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators CORRIGENDUM 1 6-281 IEC 80601-2-35 (Second edition Withdrawn. See 2009) Medical electrical 6-308. 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 1 6-283 6-309 USP 36-NF31:2013 Sodium Withdrawn and Chloride Irrigation replaced with newer version. 6-284 6-310 USP 36-NF31:2013 Sodium Withdrawn and Chloride Injection replaced with newer version. 6-285 6-311 USP 36-NF31:2013 Nonabsorbable Withdrawn and Surgical Suture replaced with newer version. 6-286 3-312 USP 36-NF31:2013 <881> Tensile Withdrawn and Strength replaced with newer version. 6-287 6-313 USP 36-NF31:2013 <861> Withdrawn and Sutures--Diameter replaced with newer version. 6-288 6-314 USP 36-NF 31:2013 <871> Withdrawn and Sutures--Needle Attachment replaced with newer version. 6-289 6-315 USP 36-NF31:2013 Sterile Water Withdrawn and for Irrigation replaced with newer version. 6-290 6-316 USP 36-NF31:2013 Heparin Lock Withdrawn and Flush Solution replaced with newer version. 6-291 6-317 USP 36-NF31:2013 Absorbable Withdrawn and Surgical Suture replaced with newer version. 6-292 ISO 7886-1:1993 TECHNICAL Withdrawn. See CORRIGENDUM 1 Published 1995- 6-304. 11-01 Sterile hypodermic syringes for single-use--Part 1: Syringes for manual use 6-298 6-319 IEC 60601-2-19 Edition 2.0 Withdrawn and 2009-02 Medical electrical replaced with equipment--Part 2-19: newer version Particular requirements for the including basic safety and essential technical performance of infant corrigendum. incubators [Including: CORRIGENDUM 1 (2012)] 6-299 IEC 60601-2-20 Edition 2.0 Withdrawn. See 2009-02 Medical electrical 6-320. equipment--Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubatorsG. In Vitro Diagnostics 7-100 ISO 15197 First edition 2003- Withdrawn. 05-01 In Vitro diagnostic test systems--Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus 7-137 7-244 CLSI NBS01-A6 Blood Collection Withdrawn and on Filter Paper for Newborn replaced with Screening Programs; Approved newer version. Standard--Sixth Edition 7-239 CLSI EP32-R (Formerly X05-R) Designation Metrological Traceability and number. Its Implementation; A Report 7-226 CLSI QMS01-A4 (Formerly GP26- Designation A4) Quality Management System: number. A Model for Laboratory Services; Approved Guideline-- Fourth Edition 7-224 CLSI EP28-A3c (Formerly C28- Designation A3c) Defining, Establishing, number. and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline--Third Edition 7-223 CLSI QSM06-A3 (Formerly GP22- Designation A3) Quality Management System: number. Continual Improvement; Approved Guideline--Third Edition 7-92 7-245 CLSI EP09-A3 Measurement Withdrawn and Procedure Comparison and Bias replaced with Estimation Using Patient newer version. Samples; Approved Guideline-- Third Edition 7-210 CLSI H26-A2 Validation, Extent of Verification, and Quality recognition. Assurance of Automated Hematology Analyzers; Approved Standard--Second Edition 7-152 CLSI EP12-A2 User Protocol for Extent of Evaluation of Qualitative Test recognition. Performance; Approved Guideline--Second Edition 7-174 CLSI EP21-A Estimation of Total Extent of Analytical Error for Clinical recognition. Laboratory Methods; Approved Guideline 7-178 CLSI M22-A3 Quality Control for Extent of Commercially Prepared recognition. Microbiological Culture Media; Approved Standard--Third Edition 7-193 CLSI EP06-A Evaluation of the Extent of Linearity of Quantitative recognition. Measurement Procedures: A Statistical Approach; Approved Guideline 7-220 CLSI H59-A Quantitative D-dimer Extent of for the Exclusion of Venous recognition. Thromboembolic Disease; Approved Guideline H. Materials 8-67 8-344 ISO 7153-1 Second edition 1991- Withdrawn and 04-01 Surgical instruments-- replaced with Metallic materials--Part 1: newer version Stainless steel [Including: including AMENDMENT 1(1999)] amendment. 8-138 ASTM F745-07 Standard Withdrawn. Specification for 18 Chromium- 12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications 8-139 8-345 ASTM F1314-13 Standard Withdrawn and Specification for Wrought replaced with Nitrogen Strengthened 22 newer version. Chromium-13 Nickel-5 Manganese- 2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910) 8-140 8-346 ASTM F1813-13 Standard Withdrawn and Specification for Wrought replaced with Titanium-12 Molybdenum-6 newer version. Zirconium-2 Iron Alloy for Surgical Implant (UNS R58120) 8-141 8-347 ASTM F2146-13 Standard Withdrawn and Specification for Wrought replaced with Titanium-3 Aluminum-2.5 newer version. Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320) 8-169 8-348 ASTM F138-13 Standard Withdrawn and Specification for Wrought 18 replaced with Chromium-14 Nickel-2.5 newer version. Molybendum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) 8-176 8-349 ASTM F2503-13 Standard Practice Withdrawn and for Marking Medical Devices and replaced with Other Items for Safety in the newer version. Magnetic Resonance Environment 8-149 8-350 ISO 5832-1 Fourth edition 2007- Withdrawn and 06-15 Implants for surgery-- replaced with Metallic materials--Part 1: newer version Wrought stainless steel including [Including: TECHNICAL technical CORRIGENDUM 1(2008)] corrigendum. 8-196 ISO 5832-1: 2007 Implants for Withdrawn. See surgery--Metallic materials-- 8-350. Part 1: Wrought stainless steel TECHNICAL CORRIGENDUM 1 8-151 8-351 ISO 5832-12 Second edition Withdrawn and 2007-05-01 Implants for replaced with surgery--Metallic materials-- newer version Part 12: Wrought cobalt- including chromium-molybdenum alloy technical [Including: TECHNICAL corrigendum. CORRIGENDUM 1 2008] 8-197 ISO 5832-12:2007 TECHNICAL Withdrawn. See CORRIGENDUM 1 2008-09-05, 8-351. Implants for surgery--Metallic materials--Part 12: Wrought cobalt-chromium-molybdenum alloy TECHNICAL CORRIGENDUM 1 8-211 8-352 ISO 5834-1 Third edition 2005- Withdrawn and 06-01 Implants for surgery-- replaced with Ultra-high-molecular-weight newer version polyethylene--Part 1: Powder including form [Including: TECHNICAL technical CORRIGENDUM 1 2007] corrigendum. 8-212 ISO 5834-1:2005 Technical Withdrawn. See Corrigendum 1 Published 2007- 8-352. 05-01 Implants for surgery-- Ultra-high-molecular-weight polyethylene--Part 1: Powder form TECHNICAL CORRIGENDUM 1 8-228 8-353 ASTM F86-13 Standard Practice Withdrawn and for Surface Preparation and replaced with Marking of Metallic Surgical newer version. Implants 8-175 8-354 ASTM F1377-13 Standard Withdrawn and Specification for Cobalt-28 replaced with Chromium-6 Molybdenum Powder newer version. for Coating of Orthopedic Implants (UNS R30075) 8-163 8-355 ASTM F1586/F 1586M-13&egr;1 Withdrawn and Standard Specification for replaced with Wrought Nitrogen Strengthened newer version. 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675) 8-129 8-356 ASTM F67-13 Standard Withdrawn and Specification for Unalloyed replaced with Titanium, for Surgical Implant newer version. Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700) 8-208 8-357 ASTM F648-13 Standard Withdrawn and Specification for Ultra-High- replaced with Molecular-Weight Polyethylene newer version. Powder and Fabricated Form for Surgical Implants 8-103 ASTM F1801-97 (Reapproved 2009) Extent of &egr;1 Standard Practice for recognition. Corrosion Fatigue Testing of Metallic Implant Materials 8-107 ASTM F746-04 (Reapproved 2009) Extent of &egr;1 Standard Test Method for recognition. Pitting or Crevice Corrosion of Metallic Surgical Implant Materials 8-111 ASTM F1160-05 (Reapproved 2011) Extent of &egr;1 Standard Test Method for recognition. Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings 8-112 ASTM F1044-05 (Reapproved 2011) Extent of &egr;1 Standard Test Method for recognition. Shear Testing of Calcium Phosphate Coatings and Metallic Coatings 8-113 ASTM F1147-05 (Reapproved 2011) Extent of Standard Test Method for recognition. Tension Testing of Calcium Phosphate and Metal Coatings 8-114 ASTM F2255 (Reapproved 2010) Extent of Standard Test Method for recognition. Strength Properties of Tissue Adhesives in Lap Shear by Tension Loading 8-115 ASTM F2256-05 (Reapproved 2010) Extent of Standard Test Method for recognition. Strength Properties of Tissue Adhesives in T-Peel by Tension Loading 8-116 ASTM F2258-05 (Reapproved 2010) Extent of Standard Test Method for recognition. Strength Properties of Tissue Adhesives in Tension 8-121 ASTM F2005-05 (Reapproved 2010) Extent of Standard Terminology for recognition. Nickel-Titanium Shape Memory Alloys 8-123 ISO 5832-5 Third edition 2005- Extent of 10-15 Implants for surgery-- recognition. Metallic materials--Part 5: Wrought cobalt-chromium- tungsten-nickel alloy 8-124 ASTM F2052-06 &egr; Standard Extent of Test Method for Measurement of recognition. Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment 8-125 ASTM F2004-05 (Reapproved 2010) Extent of Standard Test Method for recognition. Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis 8-126 8-370 ASTM F561-13 Standard Practice Withdrawn and for Retrieval and Analysis of replaced with Medical Devices, and Associated newer version. Tissues and Fluids 8-128 ASTM F2213-06 (Reapproved 2011) Extent of Standard Test Method for recognition. Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment 8-132 ASTM F1088-04a (Reapproved Extent of 2010) Standard Specification recognition. for Beta-Tricalcium Phosphate for Surgical Implantation 8-134 ASTM F2082-06 Standard Test Extent of Method for Determination of recognition. Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery 8-135 ASTM F2392-04 (Reapproved 2010) Extent of Standard Test Method for Burst recognition. Strength of Surgical Sealants 8-136 ASTM F2458-05 (Reapproved 2010) Extent of Standard Test Method for Wound recognition. Closure Strength of Tissue Adhesives and Sealants 8-150 ISO 5832-9 Second edition 2007- Extent of 06-15 Implants for surgery-- recognition. Metallic materials--Part 9: Wrought high nitrogen stainless steel 8-157 ISO 9583 First edition 1993-10- Extent of 15 Implants for surgery--Non- recognition. destructive testing--Liquid penetrant inspection of metallic surgical implants 8-159 ISO 9584 First edition 1993-10- Extent of 15 Implants for surgery--Non- recognition. destructive testing-- Radiographic examination of cast metallic surgical implants 8-165 ASTM F1058-08&egr;1 Standard Extent of Specification for Wrought 40 recognition. Cobalt-20 Chromium-16 Iron-15 Nickel-7 Molybdenum Alloy Wire and Strip for Surgical Implant Applications (UNS R30003 and UNS R30008) 8-167 ASTM F1350-08 Standard Extent of Specification for Wrought 18 recognition. Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673) 8-168 ASTM F1472-08&egr;1 Standard Extent of Specification for Wrought recognition. Titanium-6 Aluminum-4 Vanadium Alloy for Surgical Implant Applications (UNS R56400) 8-170 ASTM F961-08 Standard Extent of Specification for 35 Cobalt-35 recognition. Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants (UNS R30035) 8-171 ASTM F1609-08 Standard Extent of Specification for Calcium recognition. Phosphate Coatings for Implantable Materials 8-173 ASTM F601-03 (Reapproved 2008) Extent of Standard Practice for recognition. Fluorescent Penetrant Inspection of Metallic Surgical Implants 8-177 ASTM F2129-08 Standard Test Extent of Method for Conducting Cyclic recognition. Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices 8-179 ASTM F754-08 Standard Extent of Specification for Implantable recognition. Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders 8-183 ASTM F560-08 Standard Extent of Specification for Unalloyed recognition. Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400) 8-184 ASTM F2516-07&egr;2 Standard Extent of Test Method for Tension Testing recognition. of Nickel-Titanium Superelastic Materials 8-185 ASTM F451-08 Standard Extent of Specification for Acrylic Bone recognition. Cement 8-187 ISO 13779-1 Second edition Extent of 2008-10-01 Implants for recognition. surgery--Hydroxyapatite--Part 1: Ceramic hydroxyapatite 8-188 ISO 13779-2 Second edition Extent of 2008-10-01 Implants for recognition. surgery--Hydroxyapatite--Part 2: Coatings of hydroxyapatite 8-189 ASTM F 1108-04 (Reapproved Extent of 2009) Standard Specification recognition. for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants (UNS R56406) 8-190 ASTM F 90-09 Standard Extent of Specification for Wrought recognition. Cobalt-20 Chromium-15 Tungsten- 10 Nickel Alloy for Surgical Implant Applications (UNS R30605) 8-192 ASTM F1854-09 Standard Test Extent of Method for Stereological recognition. Evaluation of Porous Coatings on Medical Implants 8-193 ASTM F2754/F 2754M-09 Standard Extent of Test Method for Measurement of recognition. Camber, Cast, Helix and Direction of Helix of Coiled Wire 8-194 ISO 6474-1 First edition 2010- Extent of 02-15 Implants for surgery-- recognition. Ceramic materials--Part 1: Ceramic materials based on high purity alumina 8-195 ASTM F2024-10 Standard Practice Extent of for X-Ray Diffraction recognition. Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings 8-199 ASTM F2633-07 Standard Extent of Specification for Wrought recognition. Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants ASTM F2118-10 Standard Test Extent of 8-204 Method for Constant Amplitude recognition. of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials 8-205 ASTM F1635-11 Standard Test Extent of Method for In Vitro Degradation recognition. Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants 8-206 ASTM F688-10 Standard Extent of Specification for Wrought recognition. Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035) 8-207 ASTM F1926/F1926M-10 Standard Extent of Test Method for Evaluation of recognition. the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and Coatings 8-213 ISO 5834-3 First edition 2005- Extent of 07-15 Implants for surgery-- recognition. Ultra-high-molecular-weight polyethylene--Part 3: Accelerated ageing methods 8-214 ISO 5834-4 First edition 2005- Extent of 05-01 Implants for surgery-- recognition. Ultra-high-molecular-weight polyethylene--Part 4: Oxidation index measurement method 8-215 ISO 5834-5 First edition 2005- Extent of 06-01 Implants for surgery-- recognition. Ultra-high-molecular-weight polyethylene--Part 5: Morphology assessment method 8-216 ASTM F1295-11 Standard Extent of Specification for Wrought recognition. Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700) 8-217 ASTM F620-11 Standard Extent of Specification for Alpha Plus recognition. Beta Titanium Alloy Forgings for Surgical Implants 8-218 ASTM F799-11 Standard Extent of Specification for Cobalt-28 recognition. Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539) 8-220 ASTM F629-11 Standard Practice Extent of for Radiography of Cast recognition. Metallic Surgical Implants 8-221 ASTM F2066-11 Standard Extent of Specification for Wrought recognition. Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150) 8-224 ASTM F2102-06&egr;1 Standard Extent of Guide for Evaluating the Extent recognition. of Oxidation in Ultra-High- Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants 8-225 ASTM F2003-02 (Reapproved 2008) Extent of Standard Practice for recognition. Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air 8-226 ASTM F603-12 Standard Extent of Specification for High-Purity recognition. Dense Aluminum Oxide for Medical Application 8-229 ASTM F75-12 Standard Extent of Specification for Cobalt-28 recognition. Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) 8-330 ASTM F1978-12 Standard Test Extent of Method for Measuring Abrasion recognition. Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser 8-331 ASTM F1580-12 Standard Extent of Specification for Titanium and recognition. Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants 8-333 ASTM F2393-12 Standard Extent of Specification for High-Purity recognition. Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications 8-334 ASTM F2459-12 Standard Test Extent of Method for Extracting Residue recognition. from Metallic Medical Components and Quantifying via Gravimetric Analysis I.Nanotechnology 18-1 ASTM E2490-09 Standard Guide Extent of for Measurement of Particle recognition. Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS) 18-2 ASTM E2535-07 (Reapproved 2013) Reaffirmation Standard Guide for Handling and extent of Unbound Engineered Nanoscale recognition. Particles in Occupational Settings J. Neurology 17-3 17-12 ISO 7197 Third edition 2006-06- Withdrawn and 01 Neurosurgical Implants-- replaced with Sterile, single-use newer version hydrocephalus shunts and including components [Including technical TECHNICAL CORRIGENDUM 1 corrigendum. (2007)] 17-7 ISO 7197: 2006 Neurosurgical Withdrawn. See implants--Sterile, single-use 17-12. hydrocephalus shunts and components TECHNICAL CORRIGENDUM 1 17-1 ANSI/AAMI NS28:1988/(R) 2010 Extent of Intracranial pressure recognition. monitoring devices 17-4 ASTM F647-94 (Reapproved 2006) Extent of Standard Practice for recognition. Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application 17-9 ASTM F2129-08 Standard Test Extent of Method for Conducting Cyclic recognition. Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices K. OB-GYN/Gastroenterology/Urology 9-34 9-82 ISO 4074 First edition 2002-02- Withdrawn and 15 Corrected version 2002-12-01 replaced with Natural latex rubber condoms-- newer version Requirements and test methods including [Including TECHNICAL technical CORRIGENDUM 1 (2002), TECHNICAL corrigendum. CORRIGENDUM 2 (2002)] 9-57 ISO 4074:2002 TECHNICAL Withdrawn. See CORRIGENDUM 2, Natural latex 9-82. rubber condoms--Requirements and test methods TECHNICAL CORRIGENDUM 2 9-75 9-84 ISO 8600-3 First edition 1997- Withdrawn and 07-01 Optics and Optical replaced with instruments--Medical endoscopes newer version and endoscopic accessories-- including Part 3: Determination of field amendment. of view and direction of view of endoscopes with optics [Including AMENDMENT 1 (2003)] 9-36 9-90 ISO 8009 First edition 2004-10- Withdrawn and 01 Mechanical contraceptives-- replaced with Reusable natural and silicone newer version rubber contraceptive including diaphragms--Requirements and amendment. tests [Including AMENDMENT 1(2012)] 9-37 9-83 ISO 8600-1 Third edition 2013- Withdrawn and 03-01 Endoscopes--Medical replaced with endoscopes and endotherapy newer version. devices--Part 1: General requirements 9-38 ISO 8600-3 First edition 1997- Withdrawn. See 07-01 AMENDMENT 1, Optics and 9-84. optical instruments--Medical endoscopes and endoscopic accessories Part 3: Determination of field of view and direction of view of endoscopes with optics 9-44 ASTM F623-99 (Reapproved 2006) Extent of Standard Performance recognition. Specification for Foley Catheter 9-54 9-85 ASTM D6976-13 Standard Withdrawn and Specification for Rubber replaced with a Contraceptives--Vaginal newer version. Diaphragms 9-56 ASTM D3492-08 Standard Extent of Specification for Rubber recognition. Contraceptives (Male Condoms) 9-65 9-91 ANSI/AAMI/ISO 8637:2010 Withdrawn and Cardiovascular implants and replaced with extracorporeal systems-- newer version Hemodialyzers, hemodiafilters, including hemofilters, and amendment. hemoconcentrators [Including AMENDMENT 1 (2013)] 9-66 ANSI/AAMI/ISO 8638:2010 Extent of Cardiovascular implants and recognition. Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofilters 9-67 ASTM D7661-10 Standard Test Extent of Method for Determining recognition. Compatibility of Personal Lubricants with Natural Rubber Latex Condoms 9-68 ISO 23409 First edition 2011- Extent of 02-15 Male Condoms-- recognition. Requirements and test methods for condoms made from synthetic materials 9-73 ANSI/AAMI/ISO 13958:2009 Extent of Concentrates for hemodialysis recognition. and related therapies 9-74 ISO 13958 Second edition 2009- Extent of 04-15 Concentrates for recognition. haemodialysis and related therapies 9-79 ISO 26722 First edition 2009- Extent of 04-15 Water treatment equipment recognition. for haemodialysis applications and related therapies L. Ophthalmic 10-41 10-81 ISO 11979-7 Second edition Withdrawn and 2006-05-01 Ophthalmic replaced with implants--Intraocular lenses-- newer version Part 7: Clinical investigations including [Including Amendment 1:2012] amendment. 10-75 ISO 11979-7/Amendment 1:2012 Withdrawn. See Ophthalmic implants-- 10-81. Intraocular lenses--Part 7: Clinical investigations 10-42 10-82 ISO 11979-2 First edition 1999- Withdrawn and 12-15 Ophthalmic implants-- replaced with Intraocular lenses--Part 2: newer version Optical properties and test including methods [Including TECHNICAL technical CORRIGENDUM 1 (2003)] corrigendum. 10-53 10-83 ISO 18369-1 First edition 2006- Withdrawn and 08-15 Ophthalmic optics-- replaced with Contact lenses--Part 1: newer version Vocabulary, classification including system and recommendations for amendment. labeling specifications [Including AMENDMENT 1 2009] 10-61 ISO 18369-1:2006 Ophthalmic Withdrawn. See optics--Contact lenses Part 1: 10-83. Vocabulary, classification system and recommendations for labeling specifications. ISO 18369-1 First edition 2006-08- 05 AMENDMENT 1 2009-02-15 10-58 10-84 ANSI Z80.11-2012 American Withdrawn and National Standard for replaced with Ophthalmics--Laser Systems for newer version. Corneal Reshaping 10-59 10-85 ISO 11980 Third edition 2012- Withdrawn and 11-15 Corrected version 2013- replaced with 12-01 Ophthalmic optics-- newer version. Contact lenses and contact lens care products--Guidance for clinical investigations 10-71 10-86 ISO 14729 First edition 2001- Withdrawn and 04-15 Ophthalmic optics-- replaced with Contact lens care products-- newer version Microbiological requirements including and test methods for products amendment. and regimens for hygienic management of contact lenses [Including: AMENDMENT 1 2010] 10-43 ISO 11979-8 Second edition Extent of 2006-07-01 Ophthalmic recognition. implants--Intraocular lenses-- Part 8: Fundamental requirements 10-54 ISO 18369-4 First edition 2006- Extent of 08-15 Ophthalmic optics-- recognition. contact lenses--Part 4: Physicochemical properties of contact lens materials 10-55 ISO 11979-6 Second edition Extent of 2007-07-15 Ophthalmic recognition. implants--Intraocular lenses-- Part 6: Shelf-life and transport stability 10-56 ANSI Z80.12-2007 (R2012) Reaffirmation American National Standard for and extent of Ophthalmics--Multifocal recognition. Intraocular Lenses 10-57 ANSI Z80.13-2007 (R2012) Reaffirmation American National Standard for and extent of Ophthalmics--Phakic Intraocular recognition. Lenses 10-60 ISO 11981 Second edition 2009- Extent of 07-01 Ophthalmic optics-- recognition. Contact lenses and contact lens care products--Determination of physical compatibility of contact lens care products with contact lenses 10-62 ANSI Z80.10-2009 Ophthalmic Extent of Instruments--Tonometers recognition. 10-64 10-89 ANSI Z80.7-2013 Ophthalmics-- Withdrawn and Intraocular Lenses replaced with newer version. 10-68 ISO 13212 Second edition 2011- Extent of 05-15 Ophthalmic optics-- recognition. Contact lens care products-- Guidelines for determination of shelf-life 10-69 ANSI Z80.18-2010 American Extent of National Standard for recognition. Ophthalmics--Contact Lens Care Products--Vocabulary, Performance Specifications and Test Methodology 10-74 ISO 10940 Second edition 2009- Extent of 08-01 Ophthalmic instruments-- recognition. Fundus Cameras M. Orthopedic 11-190 11-256 ISO 14243-3 First edition 2004- Withdrawn and 09-15 Implants for surgery-- replaced with Wear of total knee-joint newer version prostheses--Part 3: Loading and including displacement parameters for technical wear-testing machines with corrigendum. displacement control and corresponding environmental conditions for test [Including: TECHNICAL CORRIGENDUM 1(2006)] 11-218 ISO 14243-3:2004 TECHNICAL Withdrawn. See CORRIGENDUM 1 Implants for 11-256. 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 11-210 11-257 ASTM F543-13 Standard Withdrawn and Specification and Test Methods replaced with a for Metallic Medical Bone newer version. Screws 11-212 ASTM F1440-92 (Reapproved 2008) Withdrawn. Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion 11-241 ASTM F543-07 Standard Withdrawn Specification and Test Methods duplicate. for Metallic Medical Bone See 11-257. Screws 11-244 11-258 ASTM F2083-12 Standard Withdrawn and Specification for Knee replaced with a Replacement Prosthesis newer version. 11-74 ISO 5838-2 First edition 1991- Extent of 01-15 Implants for surgery-- recognition. Skeletal pins and wires--Part 2: Steinmann skeletal pins-- Dimensions 11-75 ISO 5838-3 First edition 1993- Extent of 09-15 Implants for surgery-- recognition. Skeletal pins and wires--Part 3: Kirschner skeletal wires 11-80 ISO 8828 First edition 1988-10- Extent of 15 Implants for surgery-- recognition. Guidance on care and handling of orthopaedic implants 11-83 ISO 13402 First edition 1995- Extent of 08-01 Surgical and dental hand recognition. instruments--Determination of resistance against autoclaving, corrosion and thermal exposure 11-168 ASTM F1781-03 (Reapproved 2009) Extent of Standard Specification for recognition. Elastomeric Flexible Hinge Finger Total Joint Implants 11-171 ASTM F1814-97a (Reapproved Extent of 2009) Standard Guide for recognition. Evaluating Modular Hip and Knee Joint Components 11-183 ASTM F1875-98 (Reapproved 2009) Extent of Standard Practice for Fretting recognition. Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface 11-184 ISO 8827 First edition 1988-10- Extent of 15 Implants for surgery-- recognition. Staples with parallel legs for orthopaedic use--General requirements 11-185 ASTM F2267-04 (Reapproved 2011) Extent of Standard Test Method for recognition. Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression 11-191 ISO 14879-1 First edition 2000- Extent of 06-01 Implants for surgery-- recognition. Total knee-joint prostheses-- Part 1: Determination of endurance properties of knee tibial trays 11-196 ASTM F1672-95 (Reapproved 2011) Extent of Standard Specification for recognition. Resurfacing Patellar Prosthesis 11-197 ASTM F983-86 (Reapproved 2013) Reaffirmation Standard Practice for Permanent and extent of Marking of Orthopaedic Implant recognition. Components 11-199 ASTM F565-04 (Reapproved 2013) Reaffirmation Standard Practice for Care and and extent of Handling of Orthopedic Implants recognition. and Instruments 11-203 ASTM F1541-02 (Reapproved 2011) Extent of *1 Standard Specification and recognition. Test Methods for External Skeletal Fixation Devices 11-207 ASTM F2193-02 (Reapproved 2007) Extent of Standard Specifications and recognition. Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System 11-211 ASTM F1798-97 (Reapproved 2008) Extent of Standard Guide for Evaluating recognition. the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants 11-214 ASTM F382-99 (Reapproved 2008) Extent of *1 Standard Specification and recognition. Test Method for Metallic Bone Plates 11-216 ASTM F1264-03 (Reapproved 2012) Extent of Standard Specification and Test recognition. Methods for Intramedullary Fixation Devices 11-220 ASTM F2068-09 Standard Extent of Specification for Femoral recognition. Prostheses--Metallic Implants 11-222 ISO 14243-1 Second edition Extent of 2009-11-15 Implants for recognition. 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 test 11-223 ISO 14243-2 Second edition Extent of 2009-11-15 Implants for recognition. surgery--Wear of total knee- joint prostheses--Part 2: Methods of measurement 11-224 ASTM F2706-08 Standard Test Extent of Methods for Occipital-Cervical recognition. and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model 11-225 ISO 7206-4 Third edition 2010- Extent of 06-15 Implants for surgery-- recognition. Partial and total hip-joint prostheses--Part 4: Determination of endurance properties and performance of stemmed femoral components 11-226 ASTM F1089-10 Standard Test Extent of Method for Corrosion of recognition. Surgical Instruments 11-227 ASTM F366-10 Standard Extent of Specification for Fixation Pins recognition. and Wires 11-228 ASTM F564-10 Standard Extent of Specification and Test Methods recognition for Metallic Bone Staples 11-231 ISO 7207-2 Second edition 2011- Extent of 07-01 Implants for surgery-- recognition. Components for partial and total knee joint prostheses-- Part 2: Articulating surfaces made of metal, ceramic and plastics materials 11-232 ISO 7207-1 Third edition 2007- Extent of 02-01 Implants for surgery-- recognition. Components for partial and total knee joint prostheses-- Part 1: Classification, definitions and designation of dimensions 11-234 ASTM F732-00 (Reapproved 2011) Extent of Standard Test Method for Wear recognition. Testing of Polymeric Materials Used in Total Joint Prostheses 11-235 ASTM F2077-11 Test Methods for Extent of Intervertebral Body Fusion recognition. Devices 11-237 ISO 7206-6 First edition 1992- Extent of 03-15 Implants for surgery-- recognition. Partial and total hip joint prostheses--Part 6: Determination of endurance properties of head and neck region of stemmed femoral components 11-238 ASTM F2033-12 Standard Extent of Specification for Total Hip recognition. Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials 11-239 ASTM F 2345-03 (Reapproved Extent of 2013) Standard Test Methods for recognition. Determination of Static and Reaffirmation. Cyclic Fatigue Strength of Ceramic Modular Femoral Heads 11-240 ASTM F382-99 (Reapproved 2008) Extent of *1 Standard Specification and recognition. Test Method for Metallic Bone Plates ASTM F2346-05 (Reapproved 2011) Extent of 11-243 Standard Test Methods for recognition. Static and Dynamic Characterization of Spinal Artificial Discs 11-245 ASTM F384-12 Standard Extent of Specifications and Test Methods recognition. for Metallic Angled Orthopedic Fracture Fixation Devices 11-247 ASTM F2789-10 Standard Guide Extent of for Mechanical and Functional recognition. Characterization of Nucleus Devices 11-248 ISO 14242-1 Second edition Extent of 2012-01-15 Implants for recognition. surgery--Wear of total hip- joint prostheses--Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test 11-249 ISO 14242-2 First edition 2000- Extent of 09-15 Implants for surgery-- recognition. Wear of total hip-joint prostheses--Part 2: Methods of measurement 11-250 ISO 14242-3 First edition 2009- Extent of 03-15 Implants for surgery-- recognition. Wear of total hip-joint prostheses--Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test N. Physical Medicine 16-25 ISO 7176-13 First edition 1989- Extent of 08-01 Wheelchairs--Part 13: recognition. Determination of coefficient of friction of test surfaces 16-27 ISO 7176-15 First edition 1996- Extent of 11-15 Wheelchairs--Part 15: recognition. Requirements for information disclosure, documentation and labeling 16-29 ISO 7176-6 Second edition 2001- Extent of 10-01 Wheelchairs--Part 6: recognition. Determination of maximum speed, acceleration and deceleration of electric wheelchairs 16-158 ISO 7176-1 Second edition 1999- Extent of 10-01 Wheelchairs--Part 1: recognition. Determination of static stability 16-159 ISO 7176-2 Second edition 2001- Extent of 06-15 Wheelchairs--Part 2: recognition. Determination of dynamic stability of electric wheelchairs 16-162 ISO 7176-4 Third edition 2008- Extent of 10-01 Wheelchairs--Part 4: recognition. Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range 16-163 ISO 7176-5 Second edition 2008- Extent of 06-01 Wheelchairs--Part 5: recognition. Determination of overall dimensions, mass and manoeuvring space 16-164 ISO 7176-10 Second edition Extent of 2008-11-01 Wheelchairs--Part recognition. 10: Determination of obstacle- climbing ability of electrically powered wheelchairs 16-165 ISO 7176-14 Second edition Extent of 2008-02-15 Wheelchairs--Part recognition. 14: Power and control systems for electrically powered wheelchairs and scooters-- Requirements and test methods 16-166 ISO 7176-21 Second edition Extent of 2009-04-01 Wheelchairs--Part recognition. 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers 16-167 ISO 7176-9: Third edition 2009- Extent of 11-15 Wheelchairs--Part 9: recognition. Climatic tests for electric wheelchairs 16-168 ANSI/RESNA WC-1:2009 American Extent of National Standard for recognition. Wheelchairs--Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1: Determination of static stability 16-169 ANSI/RESNA WC-2:2009 American Extent of National Standard for recognition. Wheelchairs--Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 2: Determination of dynamic stability of electrically powered wheelchairs 16-170 ANSI/RESNA WC-2:2009 American Extent of National Standard for recognition. Wheelchairs--Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 3: Determination of effectiveness of brakes 16-171 ANSI/RESNA WC-2:2009 Section 4: Extent of Energy consumption of recognition. electrically powered wheelchairs and scooters for determination of theoretical distance range 16-172 ANSI/RESNA WC-1:2009 American Extent of National Standard for recognition. Wheelchairs--Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 5: Determination of dimensions, mass and maneuvering space 16-173 ANSI/RESNA WC-2:2009 American Extent of National Standard for recognition. Wheelchairs--Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 6: Determination of maximum speed, acceleration and deceleration of electrically powered wheelchairs 16-174 ANSI/RESNA WC-1:2009 American Extent of National Standard for recognition. Wheelchairs Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 7: Method of Measurement of Seating and Wheel Dimensions 16-175 ANSI/RESNA WC-1:2009 American Extent of National Standard for recognition. Wheelchairs--Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and test methods for static, impact and fatigue strengths 16-176 ANSI/RESNA WC-2:2009 American Extent of National Standard for recognition. Wheelchairs--Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 9: Climatic tests for electrically powered wheelchairs 16-177 ANSI/RESNA WC-2:2009 American Extent of National Standard for recognition. Wheelchairs--Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 10: Determination of obstacle- climbing ability of electrically powered wheelchairs 16-178 ANSI/RESNA WC-1:2009 American Extent of National Standard for recognition. Wheelchairs--Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test dummies 16-179 ANSI/RESNA WC-1:2009 American Extent of National Standard for recognition. Wheelchairs--Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 13: Determination of coefficient of friction of test surfaces 16-180 ANSI/RESNA WC-2:2009 American Extent of National Standard for recognition. 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 methods 16-181 ANSI/RESNA WC-1:2009 American Extent of National Standard for recognition. Wheelchairs--Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for information disclosure, documentation and labeling 16-182 ANSI/RESNA WC-1:2009 American Extent of National Standard for recognition. Wheelchairs--Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to ignition of upholstered parts--Requirements and test methods 16-183 ANSI/RESNA WC-1:2009 American Extent of National Standard for recognition Wheelchairs--Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 20: Determination of the performance of stand-up type wheelchairs 16-184 ANSI/RESNA WC-1:2009 American Extent of National Standard for recognition. Wheelchairs--Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 22: Set-up procedures 16-185 ANSI/RESNA WC-2:2009,American Extent of National Standard for recognition. 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 scooters 16-187 ANSI/RESNA WC-1:2009 American Extent of National Standard for recognition. Wheelchairs--Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 26: Vocabulary O. Radiology 12-53 12-257 ISO 2919 Third edition 2012-02- Withdrawn and 15 Radiological protection-- replaced with Sealed radioactive sources-- newer version. General requirements and classification 12-59 IEC 61168 First edition 1993-12 Extent of Radiotherapy simulators-- recognition. Functional performance characteristics 12-66 AIUM MUS, Medical Ultrasound Extent of Safety recognition. 12-139 AIUM AOMS-2004, Acoustic Output Extent of Measurement Standard for recognition. Diagnostic Ultrasound Equipment 12-140 AIUM RTD2-2004 Standard for Withdrawn. See Real-Time Display of Thermal 12-209 and 12- and Mechanical Acoustic Output 258. Indices on Diagnostic Ultrasound Equipment Revision 2 12-145 12-259 IEC 61674 Edition 2.0 2012-11 Withdrawn and Medical electrical equipment-- replaced with Dosimeters with ionization newer version. chambers and/or semiconductor detectors as used in X-ray diagnostic imaging 12-149 12-260 IEC 60336 Fourth edition 2005- Withdrawn and 04 Medical electrical replaced with equipment--X-ray tube newer version assemblies for medical including diagnosis--Characteristics of technical focal spots [Including: corrigendum. Technical Corrigendum 1 (2006)] 12-150 ISO/IEC 10918-1:1994 TECHNICAL Withdrawn. See CORRIGENDUM 1:2005 Information 12-261. technology--Digital compression and coding of continuous-tone still image--Part 1: Requirements and guidelines 12-156 ISO 11670:2003 TECHNICAL Withdrawn. See CORRIGENDUM 1:2004 Lasers and 12-262. laser-related equipment--Test methods for laser beam parameters--Beam positional stability 12-157 ISO 13694:2000 TECHNICAL Withdrawn. See CORRIGENDUM 1:2005 Optics and 12-263. optical instruments--Lasers and laser-related equipment--Test methods for laser beam power (energy) density distribution 12-159 12-264 NEMA MS 11-2010 Determination Withdrawn and of Gradient-Induced Electric replaced with Fields In Diagnostic Magnetic newer version. Resonance Imaging 12-167 12-265 NEMA NU 2-2012 Performance Withdrawn and Measurements of Positron replaced with Emission Tomographs (PETs) newer version. 12-179 ANSI/IESNARP-27.3-2007, Extent of Recommended Practice for recognition. Photobiological Safety for Lamps--Risk Group Classification and Labeling 12-180 12-266 IEC 61689 Edition 3.0 2013-02 Withdrawn and Ultrasonic-Physiotherapy replaced with systems--Field specifications newer version. and methods of measurement in the frequency range 0. 5 MHz to 5 MHz 12-190 12-267 IEC 61217 Edition 2.0 2011-12 Withdrawn and Radiotherapy equipment-- replaced with Coordinates, movements and newer version. scales 12-194 ANSI/HPS N43.6-2007, Sealed Extent of Radioactive Sources-- recognition. Classification 12-207 12-271 IEC 60601-2-33 Edition 3.1 Withdrawn and 2013-04 Medical electrical replaced with equipment--Part 2-33: newer version. Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis 12-208 12-268 IEC 60601-2-22 Edition 3.1 Withdrawn and 2012-10 Medical electrical replaced with equipment--Part 2-22: newer version. Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment 12-210 12-269 IEC 60601-1-3 Edition 2.1 2013- Withdrawn and 04 Medical electrical replaced with equipment--Part 1-3: General newer version. requirements for basic safety and essential performance-- Collateral Standard: Radiation protection in diagnostic X-ray equipment 12-219 IEC 60336 (2005) Medical Withdrawn. See electrical equipment--X-ray 12-260. tube assemblies for medical diagnosis--Characteristics of focal spots 12-222 12-270 IEC 61223-3-5 First edition Withdrawn and 2004-08 Evaluation and routine replaced with testing in medical imaging newer version departments--Part 3-5: including Acceptance tests--Imaging technical performance of computed corrigendum. tomography X-ray equipment [Including: TECHNICAL CORRIGENDUM 1 (2006)] 12-223 IEC 61223-3-5 (First edition Withdrawn. See 2004) Evaluation and routine 12-270. testing in medical imaging departments--Part 3-5: Acceptance tests--Imaging performance of computed tomography X-ray equipment CORRIGENDUM 1 12-227 IEC 61391-1 First edition 2006- Extent of 07 Ultrasonics--Pulse-echo recognition. scanners--Part 1: Techniques for calibrating spatial measurement systems and measurement of system point- spread function response 12-228 IEC 61391-2 Edition 1.0 2010-01 Extent of Ultrasonics--Pulse-echo recognition. scanners--Part 2: Measurement of maximum depth of penetration and local dynamic range 12-233 12-262 ISO 11670 Second edition 2003- Withdrawn and 04-01 Lasers and laser-related replaced with equipment--Test methods for newer version laser beam parameters--Beam including positional stability technical [Including: TECHNICAL corrigendum. CORRIGENDUM 1 (2004)] 12-237 12-258 IEC 62359 Edition 2.0 2010-10 Withdrawn and Ultrasonics--Field replaced with characterization--Test methods newer version for the determination of including thermal and mechanical indices technical related to medical diagnostic corrigendum. ultrasonic fields [Including TECHNICAL CORRIGENDUM 1 (2011)] 12-243 12-263 ISO 13694 First edition 2000- Withdrawn and 04-01 Optics and optical replaced with instruments--Lasers and laser- newer version related equipment--Test methods including for laser beam power [energy] technical density distribution corrigendum. [Including: TECHNICAL CORRIGENDUM 1 (2005)] 12-244 IEC 62359 (Second edition 2010) Withdrawn. See March 2011 Ultrasonics--Field 12-258. characterization--Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields CORRIGENDUM 1 12-247 ISO 11990-1 First edition 2011- Extent of 08-01, Lasers and laser-related recognition. equipment--Determination of laser resistance of tracheal tubes--Part 1: Tracheal tube shaft P. Software/Informatics 13-4 ANSI/UL 1998 Standards for Extent of Safety Software in Programmable recognition. Components, Second Edition. [This Standard contains revisions through and including October 28, 2008.] Q. Sterility 14-143 14-395 ISO 14698-2 First edition 2003- Withdrawn and 09-15 Cleanrooms and associated replaced with controlled environments-- newer version Biocontamination control--Part including 2: Evaluation and technical interpretation of corrigendum. biocontamination data. [Including: TECHNICAL CORRIGENDUM 1 Published 2004- 11-01] 14-193 ANSI/AAMI/ISO 11607- Extent of 1:2006/(R)2010 Packaging for recognition and terminally sterilized medical relevant devices--Part 1: Requirements guidance. for materials, sterile barrier systems and packaging systems 14-194 ANSI/AAMI/ISO 11607- Extent of 2:2006/(R)2010 Packaging for recognition and terminally sterilized medical relevant devices--Part 2: Validation guidance. requirements for forming, sealing and assembly processes 14-195 ANSI/AAMI/ISO 11140- Extent of 1:2005(R)2010 Sterilization of recognition. health care products--Chemical indicators--Part 1: General requirements 14-201 14-396 ANSI/AAMI ST77:2013 Containment Withdrawn and devices for reusable medical replaced with device sterilization newer version. 14-214 14-397 AOAC 6.2.04:2013 Official Withdrawn and Method 955.15 Testing replaced with Disinfectants Against newer version. Staphylococcus aureus, Use- Dilution Method 14-218 14-398 AOAC 6.3.05:2013 Official Withdrawn and Method 966.04 Sporicidal replaced with Activity of Disinfectants newer version. Method I 14-219 14-399 AOAC 6.3.06:2012 Official Withdrawn and Method 965.12 Tuberculocidal replaced with Activity of Disinfectants newer version. 14-230 14-400 ASTM F2203-13 Standard Test Withdrawn and Method for Linear Measurement replaced with Using Precision Steel Rule newer version. 14-231 14-401 ASTM F2217/F2217M-13 Standard Withdrawn and Practice for Coating/Adhesive replaced with Weight Determination newer version. 14-235 14-402 ASTM F1140/F1140M-13 Standard Withdrawn and Test Methods for Internal replaced with Pressurization Failure newer version. Resistance of Unrestrained Packages 14-236 14-403 ASTM F2054/F2054M-13 Standard Withdrawn and Test Method for Burst Testing replaced with of Flexible Package Seals Using newer version. Internal Air Pressurization Within Restraining Plates 14-241 14-424 ISO 13408-6 First edition 2005- Withdrawn and 06-15 Aseptic processing of replaced with health care products--Part 6: newer version Isolator systems [Including including AMENDMENT 1 (2013)] amendment. 14-258 14-404 ASTM F2250-13 Standard Practice Withdrawn and for Evaluation of Chemical replaced with Resistance of Printed Inks and newer version. Coatings on Flexible Packaging Materials 14-260 14-405 ASTM F2252/F2252M-13&egr;1 Withdrawn and Standard Practice for replaced with Evaluating Ink or Coating newer version. Adhesion to Flexible Packaging Materials Using Tape 14-264 14-406 ANSI/AAMI ST8:2013 Hospital Withdrawn and steam sterilizers replaced with newer version. 14-274 ANSI/AAMI/ISO 15882:2008 Extent of Sterilization of health care recognition and products--Chemical indicators-- relevant Guidance for selection, use, guidance. and interpretation of results 14-285 ANSI/AAMI/ISO 14161:2009 Extent of Sterilization of health care recognition. products--Biological indicators--Guidance for the selection, use and interpretation of results 14-289 ISO 14698-2:2003 TECHNICAL Withdrawn. See CORRIGENDUM Cleanrooms and 14-395. associated controlled environments--Biocontamination control--Part 2: Evaluation and interpretation of biocontamination data 14-296 ANSI/AAMI/ISO 11138- Relevant 1:2006/(R)2010, Sterilization guidance. of health care products-- Biological indicators--Part 1: General requirements 14-300 ASTM D4169-09 Standard Practice Extent of for Performance Testing of recognition. Shipping Containers and Systems 14-326 14-407 ISO 11737-1 Second edition Withdrawn and 2006-04-01, Sterilization of replaced with medical devices-- newer version Microbiological methods--Part including 1: Determination of a technical population of microorganisms on corrigendum. products [Including: TECHNICAL CORRIGENDUM 1 Published 2007- 05-15] 14-328 14-428 ISO 11137-1 First edition 2006- Withdrawn and 04-15 Sterilization of health replaced with care products--Radiation--Part newer version 1: Requirements for including development, validation and amendment. routine control of a sterilization process for medical devices [Including AMENDMENT 1 (2013)] 14-334 ISO 15882 Second edition 2008- Extent of 09-01 Sterilization of health recognition, care products--Chemical title. indicators--Guidance for selection, use and interpretation of results 14-335 14-408 ISO 10993-7 Second edition Withdrawn and 2008-10-15 Biological replaced with evaluation of medical devices-- newer version Part 7: Ethylene oxide including sterilization residuals technical [Including: TECHNICAL corrigendum. CORRIGENDUM 1 Published 2009- 11-15] 14-336 ISO 14161 Second edition 2009- Extent of 09-15 Sterilization of health recognition. care products--Biological indicators--Guidance for the selection, use and interpretation of results 14-338 ISO 11138-1 Second edition Relevant 2006-07-01, Sterilization of guidance. health care products-- Biological indicators--Part 1: General requirements 14-352 14-425 ANSI/AAMI/ISO 13408-6:2005 Withdrawn and Aseptic processing of health replaced with care products--Part 6: Isolator newer version systems [Including AMENDMENT 1 including (2013)] amendment. 14-353 ISO 11140-1 Second edition Extent of 2005-07-15 Sterilization of recognition. health care products--Chemical indicators--Part 1: General requirements 14-355 ISO 11607-1 First edition 2006- Extent of 04-15 Packaging for terminally recognition and sterilized medical devices-- relevant Part 1: Requirements for guidance. materials, sterile barrier systems and packaging systems 14-356 ISO 11607-2 First edition 2006- Extent of 04-15 Packaging for terminally recognition. sterilized medical devices-- Part 2: Validation requirements for forming, sealing and assembly processes 14-357 ISO 11737-1:2006 TECHNICAL Withdrawn. See CORRIGENDUM 1 Published 2007- 14-407. 05-15 Sterilization of medical devices--Microbiological methods--Part 1: Determination of a population of microorganisms on products 14-360 ANSI/AAMI ST72:2011, Bacterial Relevant endotoxins--Test methods, guidance. routine monitoring, and alternatives to batch testing 14-362 14-412 AOAC 6.2.01:2013 Official Withdrawn and Method 955.14, Testing replaced with Disinfectants Against newer version. Salmonella choleraesuis, Use- Dilution Method 14-363 14-413 AOAC 6.2.06:2013 Official Withdrawn and Method 964.02, Testing replaced with Disinfectants Against newer version. Pseudomonas aeruginosa, Use- Dilution Method 14-365 14-409 ISO 11137-2 Third edition 2013- Withdrawn and 06-01 Sterilization of health replaced with care products--Radiation--Part newer version. 2: Establishing the sterilization dose 14-366 14-414 USP 36-NF31:2013 <61> Withdrawn and Microbiological Examination of replaced with Nonsterile Products: Microbial newer version. Enumeration Tests 14-367 14-415 USP 36-NF31:2013 <71> Sterility Withdrawn and Tests replaced with newer version. 14-368 14-416 USP 36-NF31:2013 <85> Bacterial Withdrawn and Endotoxins Test replaced with newer version. 14-369 14-417 USP 36-NF31:2013 <151> Pyrogen Withdrawn and Test (USP Rabbit Test) replaced with newer version. 14-370 14-418 USP 36-NF31:2013 <161> Withdrawn and Transfusion and Infusion replaced with Assemblies and Similar Medical newer version. Devices 14-371 14-419 USP 36-NF31:2013 Biological Withdrawn and Indicator for Steam replaced with Sterilization, Self-Contained newer version. 14-372 14-420 USP 36-NF31:2013 Biological Withdrawn and Indicator for Dry-Heat replaced with Sterilization, Paper Carrier newer version. 14-373 14-421 USP 36-NF31:2013 Biological Withdrawn and Indicator for Ethylene Oxide replaced with Sterilization, Paper Carrier newer version. 14-374 14-422 USP 36-NF31:2013 Biological Withdrawn and Indicator for Steam replaced with Sterilization, Paper Carrier newer version. 14-375 14-423 USP 36-NF31:2013 <62> Withdrawn and Microbiological Examination of replaced with Nonsterile Products: Tests for newer version. Specified Microorganisms 14-380 14-410 ASTM F17-13 Standard Withdrawn and Terminology Relating to replaced with Flexible Barrier Packaging newer version. 14-384 ISO 10993-7:2008 TECHNICAL Withdrawn. See CORRIGENDUM 1, Published 2009- 14-408. 11-15 Biological evaluation of medical devices--Part 7: Ethylene oxide sterilization residuals 14-385 14-426 ANSI/AAMI/ISO 13408-1:2008 Withdrawn and (R2011) Aseptic processing of replaced with health care products--Part 1: newer version General requirements including [Including AMENDMENT 1 amendment. (2013)] 14-386 14-427 ISO 13408-1 Second edition Withdrawn and 2008-06-15 Aseptic processing replaced with of health care products--Part newer version 1: General requirements including [Including AMENDMENT 1 amendment. (2013)] 14-393 14-411 ISO/ASTM 51818 Third edition Withdrawn and 2013-06-01 Practice for replaced with dosimetry in an electron beam newer version. facility for radiation processing at energies between 80 and 300 keV
III. Listing of New Entries
In table 2 of this document,
Table 2.--New Entries to the List of Recognized Standards Recognition No. Title of standard *1 Reference No. and date A. Anesthesia 1-96 Medical electrical equipment-- ISO 80601-2-55 First Part 2-55: Particular edition 2011-12-15. requirements for the basic safety and essential performance of respiratory gas monitors B. Cardiovascular 3-121 Cardiovascular implants-- ISO 25539-1 First Endovascular devices--Part 1: edition 2003-03-01. Endovascular prostheses [Including: Amendment 1 (2005)] 5-83 MEDICAL ELECTRICAL EQUIPMENT-- ANSI/AAMI HA60601-1- Part 1-11: General requirements 1:2011. 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) 5-84 Design of training and AAMI TIR49:2013. instructional materials for medical devices used in non- clinical environments 5-85 Medical electrical equipment-- IEC 60601-1-6 Edition Part 1-6: General requirements 3.0 2010-01. for basic safety and essential performance--Collateral standard: Usability 5-86 Medical electrical equipment-- IEC 60601-1-8 Edition Part 1-8: General requirements 2.0 2006-10. for basic safety and essential performance--Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systemsD. General Hospital /General Plastic Surgery 6-302 Stainless steel needle tubing for ISO 9626 First the manufacture of medical edition 1991-09-01. devices [Including: AMENDMENT 1 2001-06-01] 6-318 Infusion equipment for medical ISO 8536-4 Fifth use--Part 4: Infusion sets for edition 2010-10-01. single use, gravity feed [Including: AMENDMENT 1 2013-03- 01] 6-320 Medical electrical equipment-- IEC 60601-2-20 Part 2-20: Particular Edition 2.0 2009-02. requirements for the basic safety and essential performance of infant transport incubators [Including: CORRIGENDUM 1 (February 2012) and CORRIGENDUM 2 (February 2013)] 6-321 Medical electrical equipment-- IEC 60601-2-52 Part 2-52: Particular Edition 1.0 2009-12. requirements for basic safety and essential performance of medical beds [Including: CORRIGENDUM 1 (September 2010)] 6-322 Intravascular catheters--Sterile ISO 10555-4 Second and single-use catheters--Part 4: edition 2013-06-15. Balloon dilatation catheters 8-358 Standard Specification for ASTM F1855-00 Polyoxymethylene (Acetal) for (Reapproved 2011). Medical Applications 8-359 Standard Guide for Silicone ASTM F2038-00 Elastomers, Gels, and Foams Used (Reapproved 2011). in Medical Applications Part I-- Formulations and Uncured Materials 8-360 Standard Guide for Silicone ASTM F2042-00 Elastomers, Gels, and Foams Used (Reapproved 2011). in Medical Applications Part II-- Cross-Linking and Fabrication 8-361 Standard Specification for ASTM F755-99 Selection of Porous Polyethylene (Reapproved 2011). for Use in Surgical Implants 8-362 Standard Specification for Metal ASTM F2989-13. Injection Molded Unalloyed Titanium Components for Surgical Implant Applications 8-363 Standard Test Method for Tensile ASTM D638-10. Properties of Plastics 8-364 Standard Test Methods for Density ASTM D792-08. and Specific Gravity (Relative Density) of Plastics by Displacement 8-365 Standard Test Method for Density ASTM D1505-10. of Plastics by the Density- Gradient Technique 8-366 Ultra-high-molecular-weight ISO 11542-2 First polyethylene (PE-UHMW) moulding edition 1998-11-15. and extrusion materials--Part 2: Preparation of test specimens and determination of properties 8-367 Standard Test Method for ASTM E647-13&egr;1. Measurement of Fatigue Crack Growth Rates 8-368 Standard Test Method for ASTM F2625-10. Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High- Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry 8-369 Standard Practice for Accelerated ASTM F2003-02 Aging of Ultra-High Molecular (Reapproved 2008). Weight Polyethylene after Gamma Irradiation in Air F. OB-GYN/Gastroenterology/Urology 9-86 Rubber condoms for clinical ISO 16037 First trials--Measurement of physical Edition 2002-05-15. properties Including [AMENDMENT 1 2011-02-15)] 9-87 Female condoms--Requirements and ISO 25841 First test methods Edition 2011-07-15. 9-88 Prophylactic dams--Requirements ISO 29942 First and test methods Edition 2011-07-01. 9-89 Cardiovascular implants and ISO 8638 Third extracorporeal blood circuit for edition 2010-07-01. haemodialysers, haemodiafilters, and haemofilters 9-92 Cardiovascular implants and ISO 8637 Third extracorporeal systems-- edition 2010-07-01. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators Including [AMENDMENT 1 2013-04-01)] 10-87 Standard Test Method for Tensile ASTM D882-12. Properties of Thin Plastic Sheeting 10-88 Standard Test Methods for ASTM D790-10. Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials 11-259 Standard Specification For Total ASTM F2887-12. Elbow Prostheses 11-260 Standard Guide for Presentation ASTM F2943-13. of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty 11-261 Standard Specification for ASTM F1378-12 Shoulder Prostheses 11-262 Standard Specification for ASTM F2091-01 Acetabular Prostheses (Reapproved 2012). 11-263 Standard Test Methods for Dynamic ASTM F2028-08 Evaluation of Glenoid Loosening (Reapproved 2012) *1 or Disassociation . 11-264 Standard Test Method for ASTM F1820-13. Determining the Forces for Disassembly of Modular Acetabular Devices 11-265 Standard Practice for Evaluation ASTM F2580-13. of Modular Connection of Proximally Fixed Femoral Hip Prosthesis 11-266 Standard Specification for Total ASTM F2665-09. Ankle Replacement Prosthesis 11-267 Standard Test Method for ASTM F2009-00 Determining the Axial Disassembly (Reapproved 2011). Force of Taper Connections of Modular Prostheses 11-268 Standard Test Method for Static ASTM F1829-98 Evaluation of Glenoid Locking (Reapproved 2009). Mechanism in Shear 11-269 Standard Guide for Functional, ASTM F2423-11. Kinematic, and Wear Assessment of Total Disc Prostheses 11-270 Standard Specification and Test ASTM F2502-11. Methods for Absorbable Plates and Screws for Internal Fixation Implants 11-271 Standard Specification for ASTM F2180-02 Metallic Implantable Strands and (Reapproved 2011). Cables 11-272 Standard Guide for Gravimetric ASTM F1714-96 Wear Assessment of Prosthetic Hip (Reapproved 2013). Designs in Simulator Devices 11-273 Implants for surgery--Wear of ISO 18192-1 Second total intervertebral spinal disc edition 2011-03-01. prostheses--Part 1 Loading and displacement parameters for wear testing and corresponding environmental conditions for test 11-274 Implants for surgery--Wear of ISO 18192-2 First total intervertebral spinal disc edition 2010-06-15. prostheses--Part 2: Nucleus replacements 11-275 Standard Test Method for ASTM F2381-10. Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy I. Radiology 12-261 Information technology--Digital ISO/IEC 10918-1 First compression and coding of edition 1994-02-15. continuous-tone still images: Requirements and guidelines [Including: TECHNICAL CORRIGENDUM 1 (2005)] J. Software/Informatics 13-63 Application of risk management IEC/TR 80001-2-4 for IT-networks incorporating Edition 1.0 2012-11. medical devices--Part 2-4: Application guidance--General implementation guidance for healthcare delivery organizations 13-64 Application of risk management ANSI/AAMI/IEC for IT-networks incorporating TIR80001-2-4:2012. medical devices--Part 2-4: General implementation guidance for healthcare delivery organizations 14-429 Practice for use of a ISO/ASTM 51275 Third radiochromic film dosimetry edition 2013-06-01. system 14-430 Practice for use of an alanine- ISO/ASTM 51607 Third EPR dosimetry system edition 2013-06-01. 14-431 Guide for estimating ISO/ASTM 51707 Second uncertainties in dosimetry for edition 2005-05-15. radiation processing *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
V. Recommendation of Standards for Recognition by
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.
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
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.
Dated:
Assistant Commissioner for Policy.
[FR Doc. 2014-01847 Filed 1-29-14;
BILLING CODE 4160-01-P
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