Sterilization Standards

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  1. AAMI/ISO 13408-4:2005/(R)2014▹

    Aseptic processing of health care products - Part 4: Clean-in-place technologies

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 09/23/2008.

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  2. AAMI/ISO 13408-5:2006/(R)2015▹

    Aseptic processing of health care products - Part 5: Sterilization in place

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 09/23/2008.

    Languages:

  3. AAMI/ISO 13408-6:2005/A1:2013▹

    Aseptic processing of health care products - Part 6: Isolator systems, Amendment 1

    Amendment by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 03/11/2013.

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  4. AAMI/ISO 13408-6:2005/(R)2013 & A1:2013▹

    Aseptic processing of health care products - Part 6: Isolator systems

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 09/23/2008.

    Languages:

    Amendments, rulings, and supplements: AAMI/ISO 13408-6:2005/A1:2013

  5. AAMI CR513:2024▹

    Guidance on radiation validation and routine maintenance for single-use systems used for pharmaceutical and biopharmaceutical manufacturing

    standard by Association for the Advancement of Medical Instrumentation, 07/16/2024.

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  6. AAMI ITCOL-CD▹

    IT Collection

    standard by Association for the Advancement of Medical Instrumentation, 2014.

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  7. HISTORICAL

    AAMI ST91:2015▹

    This document has been replaced. View the most recent version.

    Flexible and semi-rigid endoscope processing in health care facilities

    standard by Association for the Advancement of Medical Instrumentation, 04/10/2015.

    Languages:

    Historical Editions: AAMI ST91:2021

  8. AAMI ST91:2021▹

    Flexible and semi-rigid endoscope processing in health care facilities

    standard by Association for the Advancement of Medical Instrumentation, 12/21/2021.

    Languages:

    Historical Editions: AAMI ST91:2015

  9. AAMI STBK03-2▹

    AAMI Standards and Recommended Practices - Vol. 1.2 - Sterilization - Part 2: Sterilization Equipment

    standard by Association for the Advancement of Medical Instrumentation, 05/01/2003.

    Languages:

    Historical Editions: AAMI STBK9-2, AAMI STBK8-2

  10. HISTORICAL

    AAMI STBK06-1▹

    This document has been replaced. View the most recent version.

    Standards and Recommended Practices: Sterilization, Part 1 -- Sterilization in Health Care Facilities, 2006/2007 edition

    standard by Association for the Advancement of Medical Instrumentation, 01/01/2006.

    Languages:

    Historical Editions: AAMI STBK13-1/STBK13-1-CD, AAMI STBK12-1/STBK12-1-CD, AAMI STBK11-1