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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
 
 
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
12/23/2019 Sterility 14-538 ASTM F3357-19 Standard Guide for Designing Reusable Medical Devices for Cleanability
12/23/2019 Sterility 14-537 USP 42-NF37:2019 <1229.5> Biological Indicators for Sterilization
12/23/2019 Sterility 14-536 USP 42-NF37:2019 <55> Biological Indicators -- Resistance Performance Tests
12/23/2019 Sterility 14-535 USP 42-NF37:2019 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
12/23/2019 Sterility 14-534 USP 42-NF37:2019 <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests
12/23/2019 Sterility 14-533 USP 42-NF37:2019 <85> Bacterial Endotoxins Test
07/15/2019 Sterility 14-533 ISO /TS 19930 First edition 2017-12 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
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