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U.S. Department of Health and Human Services

Recognized Consensus Standards

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01/14/2019 Biocompatibility 2-258 ANSI AAMI ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
07/15/2019 Biocompatibility 2-263 ASTM F1903-18 Standard Practice for Testing for Cellular Responses to Particles in vitro
07/15/2019 Biocompatibility 2-264 ASTM F2148-18 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA).
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 2-266 ASTM F2382-18 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
07/15/2019 Biocompatibility 2-267 ASTM F2888-19 Standard Practice for Platelet Leukocyte Count - An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials.
07/15/2019 Biocompatibility 2-268 ISO /TS 21726 First edition 2019-02 Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
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
07/06/2020 Biocompatibility 2-274 ASTM F749-20 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)]
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