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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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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
05/29/2024 Sterility 14-603 Complete AAMI TIR28:2016/(R)2020 Product adoption and process equivalence for ethylene oxide sterilization
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 14-601 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 14-598 Complete ISO 14644-3 Second edition 2020-06 Cleanrooms and associated controlled environments - Part 3: Test methods
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)].
05/29/2023 Sterility 14-588 Complete AAMI TIR17:2017/(R)2020 Compatibility of materials subjected to sterilization
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 14-584 Complete ASTM F2391-22 Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
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
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