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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
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Title of Standard
 
 
08/06/2013 Tissue Engineering 15-38 ASTM F2883-11 Standard Guide for Characterization of Ceramic and Mineral Based Scaffolds used for Tissue-Engineered Medical Products (TEMPS) and as Device for Surgical Implant Applications
03/16/2012 Tissue Engineering 15-36 ASTM F2383-11 Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)
03/16/2012 Tissue Engineering 15-35 ASTM F2900-11 Standard Guide for Characterization of Hydrogels used in Regenerative Medicine
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
03/16/2012 Tissue Engineering 15-31 ASTM F2312-11 Standard Terminology Relating to Tissue Engineered Medical Products
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)
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
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
03/16/2012 Tissue Engineering 15-27 ASTM F2315-11 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
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
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