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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Standard Designation
Number and Date

Title of Standard
06/07/2018 Tissue Engineering 15-53 ASTM F3206-17 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
08/06/2013 Tissue Engineering 15-14 ASTM F2603-06 (Reapproved 2012) Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
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 15-43 ASTM F2791-15 Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
06/07/2018 Tissue Engineering 15-51 ASTM F2347-15 Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
09/17/2018 Sterility 14-512 ANSI AAMI ISO 13408-2:2018 Aseptic processing of health care products - Part 2:Sterilizing filtration
ISO 13408-2 Second edition 2018-01 Aseptic processing of health care products - Part 2: Sterilizing filtration.
09/17/2018 Sterility 14-275 ANSI AAMI ST41:2008/(R)2018 Ethylene oxide sterilization in health care facilities: Safety and effectiveness
06/27/2016 Sterility 14-483 ASTM ISO 52303 First edition 2015-07-15 Guide for absorbed-dose mapping in radiation processing facilities
01/30/2014 Sterility 14-412 AOAC 6.2.01:2013 Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method
06/27/2016 Sterility 14-481 ISO 14644-2 Second edition 2015-12-15 Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration