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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Specialty Task Group Area: Sterility
 
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12/22/2025 Sterility 14-612 Complete USP-NF M16015_02_01 <86> Bacterial Endotoxins Test Using Recombinant Reagents
05/26/2025 Sterility 14-610 Complete ISO 11138-7 First edition 2019-03 Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results
05/26/2025 Sterility 14-611 Complete ISO 11137-1 Second edition 2025-04 Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
12/23/2024 Sterility 14-606 Complete ANSI AAMI ST24:2024 General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities
12/23/2024 Sterility 14-607 Complete ANSI AAMI ST58:2024 Chemical sterilization and high-level disinfection in health care facilities
12/23/2024 Sterility 14-608 Complete AAMI TIR106:2024 Microbiological methods - Understanding and use of product bioburden data
12/23/2024 Sterility 14-609 Complete AAMI TIR17:2024 Compatibility of materials subjected to sterilization
09/09/2024 Sterility 14-460 Complete ISO 11140-1 Third edition 2014-11-01 Sterilization of health care products - Chemical indicators - Part 1: General requirements
ANSI AAMI ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements
09/09/2024 Sterility 14-604 Complete ISO 11737-3 First Edition 2023-06 Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing
09/09/2024 Sterility 14-605 Complete ISO 13004 First edition 2022-10 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD
ANSI AAMI ISO 13004:2022 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD
05/29/2024 Sterility 14-598 Complete ISO 14644-3 Second edition 2020-06 Cleanrooms and associated controlled environments - Part 3: Test methods
05/29/2024 Sterility 14-599 Complete ISO 14644-9 Second edition 2022-05 Cleanrooms and associated controlled environments - Part 9: Assessment of surface cleanliness for particle concentration
05/29/2024 Sterility 14-600 Complete ASTM F1929-23 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
05/29/2024 Sterility 14-601 Complete ISO 17665 First edition 2024-03 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
05/29/2024 Sterility 14-602 Complete AAMI TIR12:2020/(R)2023 Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
05/29/2024 Sterility 14-603 Complete AAMI TIR28:2016/(R)2020 Product adoption and process equivalence for ethylene oxide sterilization
12/18/2023 Sterility 14-589 Complete ISO 14644-4 Second edition 2022-11 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up
12/18/2023 Sterility 14-590 Complete ISO 14644-8 Third edition 2022-06 Cleanrooms and associated controlled environments - Part 8: Assessment of air cleanliness by chemical concentration (ACC)
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
12/18/2023 Sterility 14-592 Complete ISO 13408-1 Third edition 2023-08 Aseptic processing of health care products - Part 1: General requirements
12/18/2023 Sterility 14-593 Complete ASTM F3039-23 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
12/18/2023 Sterility 14-594 Complete ISO 11607-1 Second edition 2019-02 [Including AMD1:2023] Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including Amendment 1 (2023)]
12/18/2023 Sterility 14-595 Complete ISO 11607-2 Second edition 2019-02 [Including AMD1:2023] Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes [Including Amendment 1 (2023)].
12/18/2023 Sterility 14-596 Complete ASTM F88/F88M-23 Standard Test Method for Seal Strength of Flexible Barrier Materials
12/18/2023 Sterility 14-597 Complete AAMI ANSI ST108:2023 Water for the processing of medical devices
05/29/2023 Sterility 14-584 Complete ASTM F2391-22 Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
05/29/2023 Sterility 14-585 Complete AAMI ISO TIR16775:2023 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
ISO TS 16775 Second edition 2021-11 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
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
05/29/2023 Sterility 14-587 Complete AAMI TIR104:2022 Guidance on transferring health care products between radiation sterilization sources
05/29/2023 Sterility 14-588 Complete AAMI TIR17:2017/(R)2020 Compatibility of materials subjected to sterilization
02/20/2023 Sterility 14-575 Complete ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
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)]
12/19/2022 Sterility 14-581 Complete ASTM F2638-22 Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
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 14-572 Partial ANSI AAMI ST91:2021 Flexible and semi-rigid endoscope processing in health care facilities
05/30/2022 Sterility 14-574 Complete ASTM F1608-21 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
05/30/2022 Sterility 14-576 Complete ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
05/30/2022 Sterility 14-577 Complete ISO 11737-1 Third edition 2018-01 [Including AMD1:2021] Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product [Including Amendment 1 (2021)]
05/30/2022 Sterility 14-578 Partial ISO 17664-1 First edition 2021-07 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical 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.
12/20/2021 Sterility 14-563 Complete ISO 13408-6 Second edition 2021-04 Aseptic processing of health care products - Part 6: Isolator systems
12/20/2021 Sterility 14-564 Complete USP-NF M98910_01_01 <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests
12/20/2021 Sterility 14-565 Complete USP-NF M98802_01_01 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
12/20/2021 Sterility 14-566 Complete USP-NF M98795_02_01 <55> Biological Indicators -- Resistance Performance Tests
12/20/2021 Sterility 14-567 Complete USP-NF M7414_01_01 <1229.5> Biological Indicators for Sterilization
12/20/2021 Sterility 14-568 Complete USP-NF M98800_01_01 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
12/20/2021 Sterility 14-569 Complete USP-NF M98810_01_01 <71> Sterility Tests
12/20/2021 Sterility 14-570 Complete USP-NF M98830_02_01 <85> Bacterial Endotoxins Test
12/20/2021 Sterility 14-571 Complete ISO 11138-8 First edition 2021-07 Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator
 
 
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