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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
06/07/2018 Sterility 14-511 ANSI AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
07/06/2020 Sterility 14-545 ASTM ISO 51276 Fourth edition 2019-08 Practice for use of a polymethylmethacrylate dosimetry system
07/06/2020 Sterility 14-549 ASTM F3004-13e1 Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound
07/06/2020 Sterility 14-540 ANSI AAMI ISO 11737-2:2019 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11737-2 Third edition 2019-12 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
04/04/2016 Sterility 14-327 ANSI AAMI ISO 11737-2:2009/(R)2014 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11737-2 Second edition 2009-11-15 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
07/06/2020 Sterility 14-541 ANSI AAMI ST72:2019 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
12/23/2016 Sterility 14-360 ANSI AAMI ST72:2011/(R)2016 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
12/21/2020 Sterility 14-555 USP 43-NF38:2020 <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests
12/21/2020 Sterility 14-556 USP 43-NF38:2020 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
12/21/2020 Sterility 14-557 USP 43-NF38:2020 <55> Biological Indicators -- Resistance Performance Tests
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