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U.S. Department of Health and Human Services

Recognized Consensus Standards

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07/15/2019 Sterility 14-529 ANSI AAMI ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices.
ISO 11135 Second edition 2014-07-15 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
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)]
07/15/2019 Sterility 14-527 ASTM F2638-18 Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
01/14/2019 Sterility 14-526 USP 41-NF36:2018 <1229.5> Biological Indicators for Sterilization
01/14/2019 Sterility 14-525 USP 41-NF36:2018 <55> Biological Indicators -- Resistance Performance Tests
01/14/2019 Sterility 14-524 USP 41-NF36:2018 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
01/14/2019 Sterility 14-523 USP 41-NF36:2018 <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests
01/14/2019 Sterility 14-522 USP 41-NF36:2018 <85> Bacterial Endotoxins Test
01/14/2019 Sterility 14-521 USP 41-NF36:2018 <71> Sterility Tests
01/14/2019 Sterility 14-520 USP 41-NF36:2018 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
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