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U.S. Department of Health and Human Services

Recognized Consensus Standards

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07/06/2020 Biocompatibility 2-273 ISO 10993-9 Third edition 2019-11 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
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
07/06/2020 Biocompatibility 2-275 ISO 10993-7 Second edition 2008-10-15 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2020)]
01/30/2014 Biocompatibility 14-408 ANSI AAMI ISO 10993-7:2008(R)2012 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 10993-7 Second edition 2008-10-15 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009)]
07/06/2020 Biocompatibility 2-276 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 2-238 ANSI AAMI BE83:2006/(R)2011 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
07/15/2019 Biocompatibility 2-265 ASTM F2901-19 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
07/15/2019 Biocompatibility 2-263 ASTM F1903-18 Standard Practice for Testing for Cellular Responses to Particles in vitro
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