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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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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
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
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
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
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
08/21/2017 Biocompatibility 2-246 Complete ASTM F1877-16 Standard Practice for Characterization of Particles
07/15/2019 Biocompatibility 2-265 Complete ASTM F2901-19 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
12/21/2020 Biocompatibility 2-283 Complete ASTM F619-20 Standard Practice for Extraction of Materials Used in Medical Devices
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
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