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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
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
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
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
08/06/2013 Tissue Engineering 15-14 ASTM F2603-06 (Reapproved 2012) Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
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
07/06/2020 Sterility 14-549 ASTM F3004-13e1 Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound
07/06/2020 Sterility 14-548 USP 42-NF37:2019 <85> Bacterial Endotoxins Test
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