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  1. MOST RECENT

    2582834

    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

  2. MOST RECENT

    2581816

    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]

  3. MOST RECENT

    2901900

    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

  4. MOST RECENT

    2580814

    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

  5. MOST RECENT

    2572350

    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

  6. MOST RECENT

    2570533

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

  7. MOST RECENT

    2562683

    AAMI/ISO 15223-1:2022

    Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 01/09/2023.

    Languages: English

    Historical Editions: AAMI/ISO 15223-1:2016AAMI/ISO 15223-1:2012AAMI/ISO 15223-1:2007/(R)2012AAMI/ISO 15223:2000 + Amendments 1 and 2AAMI/ISO 15223:2000 + Amendment 1AAMI/ISO 15223-2000

  8. MOST RECENT

    2562684

    AAMI/ISO TIR22456: 2022

    Sterilization of health care products—Microbiological methods—Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 12/27/2022.

    Languages: English

  9. MOST RECENT

    2564966

    AAMI/ISO 17664-2:2022

    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

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 12/21/2022.

    Languages: English

  10. MOST RECENT

    2564965

    AAMI/ISO 17664-1:2022

    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

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 12/21/2022.

    Languages: English

    Historical Editions: AAMI/ISO 17664:2017AAMI ST81:2004/(R)2016