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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Date of
Recognition
 
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Standard Designation
Number and Date
 
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Title of Standard
 
 
06/07/2018 Tissue Engineering 15-52 ASTM F2064-17 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
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 15-40 ASTM F2211-13 Standard Classification for Tissue Engineered Medical Products (TEMPs)
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)
06/07/2018 Tissue Engineering 15-53 ASTM F3206-17 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
03/16/2012 Tissue Engineering 15-10 ASTM F2451-05 (Reapproved 2010) Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage
03/16/2012 Tissue Engineering 15-31 ASTM F2312-11 Standard Terminology Relating to Tissue Engineered Medical Products
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
08/06/2013 Tissue Engineering 15-29 ASTM F2259-10 (Reapproved 2012)e1 Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy
08/06/2013 Tissue Engineering 15-14 ASTM F2603-06 (Reapproved 2012) Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
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