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U.S. Department of Health and Human Services

Recognized Consensus Standards

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09/17/2018 Tissue Engineering 15-55 ASTM F3259-17 Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds
12/23/2016 Tissue Engineering 15-48 ASTM F2605-16 Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
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
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
07/09/2014 Tissue Engineering 15-40 ASTM F2211-13 Standard Classification for Tissue Engineered Medical Products (TEMPs)
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
07/06/2020 Tissue Engineering 15-61 ASTM F2150-19 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
08/21/2017 Tissue Engineering 15-50 ASTM F2739-16 Standard Guide for Quantifying Cell Viability within Biomaterial Scaffolds
07/06/2020 Sterility 14-544 ISO 18472 Second edition 2018-08 Sterilization of health care products - Biological and chemical indicators - Test equipment
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