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  1. MOST RECENT

    AAMI/ISO 13408-1:2023▹

    Aseptic processing of health care products—Part 1: General requirements

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 08/01/2024.

    Languages: English

    Historical Editions: AAMI/ISO 13408-1:2008/(R)2017 & A1:2013/(R)2017

    Priced From:

  2. MOST RECENT

    AAMI/ISO 11607-2:2019/A1:2023▹

    Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes Amendment 1: Application of risk management

    Amendment by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 2024.

    Languages: English

    Priced From:

  3. MOST RECENT

    AAMI/ISO 11607-1:2019/A1:2023▹

    Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems Amendment 1: Application of risk management

    Amendment by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 2024.

    Languages: English

    Priced From:

  4. MOST RECENT

    AAMI/ISO 20417:2021▹

    Medical devices—Information to be supplied by the manufacturer

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 07/18/2024.

    Languages: English

    Priced From:

  5. MOST RECENT

    AAMI/ISO 13004:2022▹

    Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 02/09/2024.

    Languages: English

    Historical Editions: AAMI/ISO TIR13004:2013/(R)2016 [HISTORICAL]

    Priced From:

  6. MOST RECENT

    AAMI/ISO 11140-6:2024▹

    Sterilization of health care products—Chemical indicators—Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 02/09/2024.

    Languages: English

    Priced From:

  7. MOST RECENT

    AAMI/ISO 11737-1:2018/A1:2021▹

    Amendment 1 to Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products

    Amendment by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 02/09/2024.

    Languages: English

    Priced From:

  8. MOST RECENT

    AAMI/ISO TIR10993-19:2020▹

    Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 02/04/2024.

    Languages: English

    Historical Editions: AAMI/ISO TIR10993-19:2006

    Priced From:

  9. MOST RECENT

    AAMI/ISO TIR21387:2023▹

    Sterilization of health care products—Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 08/27/2023.

    Languages: English

    Priced From:

  10. MOST RECENT

    AAMI/ISO TIR16775:2023▹

    Packaging for terminally sterilized medical devices—Guidance on the application of ISO 11607-1 and ISO 11607-2

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 08/18/2023.

    Languages: English

    Historical Editions: AAMI/ISO TIR16775:2014, AAMI TIR22:2007/A1:2008, AAMI TIR22:2007 and TIR22:2007/A1:2008, AAMI TIR22:2007, AAMI/ISO TIR 22:1998 + Amendment 1

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