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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Standard Designation
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Title of Standard
 
 
08/06/2013 Sterility 14-383 ASTM ISO 51702 Third edition 2013-04-15 Practice for dosimetry in a gamma facility for radiation processing
09/17/2018 Sterility 14-293 ANSI AAMI ST50:2004/(R)2018 Dry heat (heated air) sterilizers
06/27/2015 Sterility 14-484 ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
01/30/2014 Sterility 14-403 ASTM F2054/F2054M-13 Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
01/30/2014 Sterility 14-411 ASTM ISO 51818 Third edition 2013-06-01 Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV
01/30/2014 Sterility 14-430 ASTM ISO 51607 Third edition 2013-06-01 Practice for use of an alanine-EPR dosimery system
07/15/2019 Sterility 14-528 ANSI AAMI ISO 11137-1:2006/(R)2010 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013)]
ISO 11137-1 First edition 2006-04-15 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)]
12/23/2019 Sterility 14-531 USP 42-NF37:2019 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
12/23/2019 Sterility 14-532 USP 42-NF37:2019 <71> Sterility Tests
12/23/2019 Sterility 14-533 USP 42-NF37:2019 <85> Bacterial Endotoxins Test
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