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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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12/19/2022 Sterility 14-582 Complete AAMI ISO TIR11137-4:2022 Sterilization of health care products - Radiation - Part 4: Guidance on process control
ISO TS 11137-4 First edition 2020-06 Sterilization of health care products - Radiation - Part 4: Guidance on process control
12/19/2022 Sterility 14-583 Complete ANSI AAMI ST98:2022 Cleaning validation of health care products - Requirements for development and validation of a cleaning 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.
06/07/2021 Sterility 14-562 Complete ANSI AAMI ST79:2017 & 2020 Amendments A1, A2, A3, A4 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities
12/18/2023 Sterility 14-591 Complete ISO 14644-10 Second edition 2022-05 Cleanrooms and associated controlled environments - Part 10: Assessment of surface cleanliness for chemical contamination
01/27/2015 Sterility 14-390 Complete ISO 14644-10 First edition 2013-03-01 Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration
12/18/2023 Sterility 14-592 Complete ISO 13408-1 Third edition 2023-08 Aseptic processing of health care products - Part 1: General requirements
12/19/2022 Sterility 14-580 Complete ISO 11137-2 Third edition 2013-06 [Including AMD1:2022] Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose [Including Amendment 1 (2022)]
01/30/2014 Sterility 14-427 Complete ISO 13408-1 Second edition 2008-06-15 Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)]
12/18/2023 Sterility 14-593 Complete ASTM F3039-23 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
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