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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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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
08/21/2017 Biocompatibility 2-247 Complete ISO 10993-6 Third edition 2016-12-01 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
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).
01/14/2019 Biocompatibility 2-141 Complete ASTM F1984-99 (Reapproved 2018) Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
07/06/2020 Biocompatibility 2-275 Complete 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 (2019)]
12/21/2020 Biocompatibility 2-281 Complete ISO TS 10993-19 Second edition 2020-03 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
12/21/2020 Biocompatibility 2-280 Complete ASTM F1408-20a Standard Practice for Subcutaneous Screening Test for Implant Materials
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 2-282 Complete ISO 14155 Third edition 2020-07 Clinical investigation of medical devices for human subjects - Good clinical practice
12/21/2020 Biocompatibility 2-278 Complete ASTM F719-20 e1 Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
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