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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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12/23/2016 Sterility 14-500 Complete ISO 14644-1 Second edition 2015-12-15 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
08/14/2015 Sterility 14-464 Complete ISO ASTM 51649 Third edition 2015-03-15 Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV
08/14/2015 Sterility 14-465 Complete ISO ASTM 51707 Third edition 2015-03-15 Guide for estimating uncertainties in dosimetry for radiation processing
07/15/2019 Sterility 14-529 Complete 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)]
ANSI AAMI ISO 11135:2014/A1:2018 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release
05/29/2023 Sterility 14-586 Complete ISO 22441 First edition 2022-08 Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
05/30/2022 Sterility 14-579 Complete ISO 17664-2 First edition 2021-02 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices.
07/06/2020 Sterility 14-541 Complete ANSI AAMI ST72:2019 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
07/06/2020 Sterility 14-543 Complete ISO 11139 First edition 2018-08 Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards
07/06/2020 Sterility 14-544 Complete ISO 18472 Second edition 2018-08 Sterilization of health care products - Biological and chemical indicators - Test equipment
12/23/2019 Sterility 14-538 Complete ASTM F3357-19 Standard Guide for Designing Reusable Medical Devices for Cleanability
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