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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
01/30/2014 Biocompatibility 2-205 ANSI AAMI ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice [Including: Technical Corrigendum 1 (2011)]
ISO 14155 Second edition 2011-02-01 Clinical investigation of medical devices for human subjects - Good clinical practice [Including: Technical Corrigendum 1 (2011)]
07/26/2016 Biocompatibility 2-213 ASTM F1904-14 Standard Practice for Testing the Biological Responses to Particles In Vivo
07/26/2016 Biocompatibility 2-214 ASTM F619-14 Standard Practice for Extraction of Medical Plastics
07/26/2016 Biocompatibility 2-222 ANSI AAMI ISO 10993-2:2006/(R)2014 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
ISO 10993-2 Second edition 2006-07-15 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
07/26/2016 Biocompatibility 2-227 ASTM F1983-14 Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
07/26/2016 Biocompatibility 2-228 ANSI AAMI ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
ISO 10993-3 Third edition 2014-10-1 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
07/26/2016 Biocompatibility 2-237 ANSI AAMI ISO 10993-17:2002/(R)2012 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
ISO 10993-17 First edition 2002-12-01 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
07/26/2016 Biocompatibility 2-238 ANSI AAMI BE83:2006/(R)2011 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
07/26/2016 Biocompatibility 2-240 ANSI AAMI ISO TIR 10993-20:2006 Biological Evaluation of Medical Devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
ISO /TS 10993-20 First edition 2006-08-01 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
07/26/2016 Biocompatibility 2-241 ANSI AAMI ISO /TR 37137:2014 Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
ISO /TR 37137 First edition 2014-05-15 Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
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