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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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12/21/2020 Biocompatibility 2-283 Complete ASTM F619-20 Standard Practice for Extraction of Materials Used in Medical Devices
07/26/2016 Biocompatibility 2-213 Complete ASTM F1904-14 Standard Practice for Testing the Biological Responses to Particles In Vivo
12/21/2020 Biocompatibility 2-277 Complete ASTM F813-20 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
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)
12/20/2021 Biocompatibility 2-292 Complete USP-NF M98833_01_01 <87> Biological Reactivity Test, In Vitro - Direct Contact Test
12/20/2021 Biocompatibility 2-293 Complete USP-NF M98833_01_01 <87> Biological Reactivity Test, In Vitro - Elution Test
12/19/2022 Biocompatibility 2-297 Complete ASTM F763-22 Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
12/19/2022 Biocompatibility 2-289 Complete ISO 10993-12 Fifth edition 2021-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
09/17/2018 Biocompatibility 2-255 Complete ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ANSI AAMI ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
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
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