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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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12/20/2021 Biocompatibility 2-294 Partial USP-NF M98834_01_01 <88> Biological Reactivity Tests, In Vivo
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 2-228 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
07/26/2016 Biocompatibility 2-222 Complete ISO 10993-2 Second edition 2006-07-15 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
ANSI AAMI ISO 10993-2:2006/(R)2014 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
07/26/2016 Biocompatibility 2-174 Complete ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ANSI AAMI ISO 10993-10:2010/(R)2014 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
12/18/2023 Biocompatibility 2-302 Complete ASTM F981-23 Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
12/23/2016 Biocompatibility 2-94 Complete ASTM F981-04 (Reapproved 2016) Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
07/26/2016 Biocompatibility 2-213 Complete ASTM F1904-14 Standard Practice for Testing the Biological Responses to Particles In Vivo
05/29/2023 Biocompatibility 2-299 Complete ASTM F1904-23 Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products in vivo
07/15/2019 Biocompatibility 2-266 Complete ASTM F2382-18 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
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