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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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12/21/2020 Biocompatibility 2-288 Partial ISO 10993-15 Second edition 2019-11 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
07/06/2020 Biocompatibility 2-276 Partial ISO 10993-18 Second edition 2020-01 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process.
07/26/2016 Biocompatibility 2-191 Partial ISO 10993-12 Fourth edition 2012-07-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ANSI AAMI ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
12/19/2022 Biocompatibility 2-298 Partial ISO 10993-18 Second edition 2020-01 Amendment 1 2022-05 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process [Including Amendment 1 (2022)].
12/20/2021 Biocompatibility 2-294 Partial USP-NF M98834_01_01 <88> Biological Reactivity Tests, In Vivo
12/20/2021 Biocompatibility 2-295 Partial USP-NF M98900_01_01 <151> Pyrogen Test (USP Rabbit Test)
07/26/2016 Biocompatibility 2-237 Partial ISO 10993-17 First edition 2002-12-01 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
ANSI AAMI ISO 10993-17:2002/(R)2012 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
07/26/2016 Biocompatibility 2-228 Partial ISO 10993-3 Third edition 2014-10-1 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ANSI AAMI ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
12/18/2023 Biocompatibility 2-303 Partial ISO 10993-17 Second edition 2023-09 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents
07/26/2016 Biocompatibility 2-169 Partial ISO 10993-13 Second edition 2010-06-15 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
ANSI AAMI ISO 10993-13:2010/(R)2014 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
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