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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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07/06/2020 Tissue Engineering 15-63 Complete ASTM F2739-19 Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds
06/07/2021 Tissue Engineering 15-67 Complete ASTM F2212-20 Standard Guide for Characterization of Type I Collagen as Starting Materials for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
06/07/2021 Tissue Engineering 15-66 Complete ASTM F2260-18 Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1HNMR) Spectroscopy
04/04/2016 Tissue Engineering 15-44 Partial ASTM F2529-13 Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
12/21/2020 Tissue Engineering 15-64 Partial ISO 22442-1 Third edition 2020-09 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
07/15/2019 Sterility 14-533 Complete ISO TS 19930 First edition 2017-12 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
05/30/2022 Sterility 14-576 Complete ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
12/20/2021 Sterility 14-564 Complete USP-NF M98910_01_01 <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests
12/20/2021 Sterility 14-565 Complete USP-NF M98802_01_01 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
12/20/2021 Sterility 14-566 Complete USP-NF M98795_02_01 <55> Biological Indicators -- Resistance Performance Tests
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