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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
03/16/2012 Tissue Engineering 15-31 ASTM F2312-11 (Reapproved 2020) Standard Terminology Relating to Tissue Engineered Medical Products
07/15/2019 Tissue Engineering 15-58 ASTM F2103-18 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
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
12/21/2020 Tissue Engineering 15-64 ISO 22442-1 Third edition 2020-09 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
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
12/21/2020 Tissue Engineering 15-65 ISO 22442-2 Third edition 2020-09 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
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.
07/15/2019 Tissue Engineering 15-57 ASTM F2315-18 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
07/06/2020 Tissue Engineering 15-62 ASTM F2602-18 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)
10/04/2010 Tissue Engineering 15-19 ASTM F2450-10 Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical Products
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