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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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01/27/2015 Sterility 14-379 Complete ISO 14644-8 Second edition 2013-02-15 Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC)
09/17/2018 Sterility 14-516 Complete ASTM F3039-15 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)]
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
12/18/2023 Sterility 14-592 Complete ISO 13408-1 Third edition 2023-08 Aseptic processing of health care products - Part 1: General requirements
12/23/2016 Sterility 14-169 Complete ASTM F2391-05 (Reapproved 2016) Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
05/29/2023 Sterility 14-588 Complete AAMI TIR17:2017/(R)2020 Compatibility of materials subjected to sterilization
07/15/2019 Sterility 14-530 Complete ISO 11607-1 Second edition 2019-02 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ANSI AAMI ISO 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
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)].
07/15/2019 Sterility 14-531 Complete ISO 11607-2 Second edition 2019-02 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ANSI AAMI ISO 11607-2:2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
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