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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
 
 
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
09/17/2018 Tissue Engineering 15-55 ASTM F3259-17 Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds
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
04/04/2016 Tissue Engineering 15-24 ASTM F2721-09 (Reapproved 2014) Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
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)
03/16/2012 Tissue Engineering 15-27 ASTM F2315-11 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
03/16/2012 Tissue Engineering 15-28 ASTM F2103-11 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for use in Biomedical and Tissue-Engineered Medical Product Applications
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.
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
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