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U.S. Department of Health and Human Services

Recognized Consensus Standards

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12/23/2016 Biocompatibility 2-245 ANSI AAMI ISO 10993-5:2009/(R)2014 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
07/26/2016 Biocompatibility 2-122 ASTM F719-81 (Reapproved 2012) Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation
07/26/2016 Biocompatibility 2-124 ASTM F750-87 (Reapproved 2012) Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse
07/26/2016 Biocompatibility 2-133 ASTM F1408-97 (Reapproved 2013) Standard Practice for Subcutaneous Screening Test for Implant Materials
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
09/17/2018 Biocompatibility 2-255 ANSI AAMI ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
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
08/21/2017 Biocompatibility 2-247 ISO 10993-6 Third edition 2016-12-01 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
06/07/2018 Biocompatibility 2-249 ISO 10993-16 Third edition 2017-05 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
07/26/2016 Biocompatibility 2-167 ANSI AAMI ISO TIR 10993-19:2006 Biological evaluation of medical devices - Part 19: Physicochemical, morphological, and topographical characterization of materials
ISO /TS 10993-19 First edition 2006-06-01 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological, and topographical characterization of materials
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