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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
12/23/2019 Biocompatibility 2-269 USP 42-NF37:2019 <87> Biological Reactivity Test, In Vitro - Direct Contact Test
12/23/2019 Biocompatibility 2-270 USP 42-NF37:2019 <87> Biological Reactivity Test, In Vitro - Elution Test
12/23/2019 Biocompatibility 2-271 USP 42-NF37:2019 <88> Biological Reactivity Tests, In Vivo
12/23/2019 Biocompatibility 2-272 USP 42-NF37:2019 <151> Pyrogen Test (USP Rabbit Test)
07/15/2019 Biocompatibility 2-265 ASTM F2901-19 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
07/26/2016 Biocompatibility 2-243 ISO /TR 10993-33 First Edition 2015-03-01 Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3
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 2-168 ANSI AAMI ISO 10993-9:2009/(R)2014 Biological evaluation of medical devices - Part 9: Framework for identification and quantitication of potential degradation products
ISO 10993-9 Second edition 2009-12-15 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
07/06/2020 Biocompatibility 2-274 ASTM F749-20 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
07/26/2016 Biocompatibility 2-197 ASTM F749-13 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
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