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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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07/15/2019 Biocompatibility 2-265 Complete ASTM F2901-19 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
07/26/2016 Biocompatibility 2-170 Complete ISO 10993-14 First edition 2001-11-15 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
ANSI AAMI ISO 10993-14:2001/(R) 2011 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products form ceramics
12/21/2020 Biocompatibility 2-280 Complete ASTM F1408-20a Standard Practice for Subcutaneous Screening Test for Implant Materials
07/15/2019 Biocompatibility 2-264 Complete ASTM F2148-18 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA).
12/21/2020 Biocompatibility 2-282 Complete ISO 14155 Third edition 2020-07 Clinical investigation of medical devices for human subjects - Good clinical practice
07/15/2019 Biocompatibility 2-263 Complete ASTM F1903-18 Standard Practice for Testing for Cellular Responses to Particles in vitro
12/21/2020 Biocompatibility 2-278 Complete ASTM F719-20 e1 Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
07/15/2019 Biocompatibility 2-267 Complete ASTM F2888-19 Standard Practice for Platelet Leukocyte Count - An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials.
12/21/2020 Biocompatibility 2-283 Complete ASTM F619-20 Standard Practice for Extraction of Materials Used in Medical Devices
07/06/2020 Biocompatibility 2-273 Complete ISO 10993-9 Third edition 2019-11 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
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