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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Date of
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Standard Designation
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Title of Standard
 
 
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)
08/21/2017 Tissue Engineering 15-50 ASTM F2739-16 Standard Guide for Quantifying Cell Viability within Biomaterial Scaffolds
03/16/2012 Tissue Engineering 15-30 ASTM F2212-11 Standard Guide for Characterization of Type I Collagen as a Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPS)
03/16/2012 Tissue Engineering 15-36 ASTM F2383-11 Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)
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.
07/09/2014 Tissue Engineering 15-39 ASTM F2150-13 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissued-Engineered Medical Products
01/14/2019 Tissue Engineering 15-56 ASTM F3224-17 Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance Imaging
08/06/2013 Tissue Engineering 15-32 ASTM F2260-03 (Reapproved 2012)e1 Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy
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
06/07/2018 Tissue Engineering 15-51 ASTM F2347-15 Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
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