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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Date of
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Recognition
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Standard Designation
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Title of Standard
 
 
01/14/2019 Sterility 14-522 USP 41-NF36:2018 <85> Bacterial Endotoxins Test
01/14/2019 Sterility 14-523 USP 41-NF36:2018 <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests
01/14/2019 Sterility 14-524 USP 41-NF36:2018 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
07/09/2014 Sterility 14-257 ASTM D3078-02 (Reapproved 2013) Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
01/15/2013 Sterility 14-313 ASTM F2475-11 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
01/14/2019 Sterility 14-519 ASTM F17-18 Standard Terminology Relating to Flexible Barrier Packaging
09/09/2008 Sterility 14-239 ANSI AAMI ISO 13408-3:2006/(R)2015 Aseptic processing of health care products - Part 3: Lyophilization
ISO 13408-3 First edition 2006-09-15 Aseptic processing of health care products - Part 3: Lyophilization
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
06/27/2016 Sterility 14-483 ASTM ISO 52303 First edition 2015-07-15 Guide for absorbed-dose mapping in radiation processing facilities
09/09/2008 Sterility 14-142 ISO 14698-1:2003 Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 1: General Principles and Methods
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