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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
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
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
07/15/2019 Sterility 14-532 ASTM F3287-17e1 Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method
07/15/2019 Sterility 14-531 ISO 11607-2 Second edition 2019-02 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
07/15/2019 Sterility 14-530 ISO 11607-1 Second edition 2019-02 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
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)2015 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 (2019)]
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)]
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