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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Standard Designation
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08/21/2017 Tissue Engineering 15-49 ASTM F2027-16 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
12/23/2016 Tissue Engineering 15-48 ASTM F2605-16 Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
01/14/2019 Tissue Engineering 15-47 ISO 22442-3 First edition 2007-12-15 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) Agents.
06/27/2016 Tissue Engineering 15-46 ISO 22442-2 Second edition 2015-11-01 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling.
06/27/2016 Tissue Engineering 15-45 ISO 22442-1 Second edition 2015-11-01 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
04/04/2016 Tissue Engineering 15-44 ASTM F2529-13 Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
04/04/2016 Tissue Engineering 15-43 ASTM F2791-15 Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
07/09/2014 Tissue Engineering 15-41 ASTM F2602-13 Standard Test Method for Determining the Molar Mass of Chitosan and Chitosan Salts by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
07/09/2014 Tissue Engineering 15-40 ASTM F2211-13 Standard Classification for Tissue Engineered Medical Products (TEMPs)
07/09/2014 Tissue Engineering 15-39 ASTM F2150-13 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissued-Engineered Medical Products
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