EO and Chemical Disinfection

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  1. MOST RECENT

    AAMI/ISO 10993-7:2008/(R)2012▹

    Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals, includes Errata (2010)

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 12/10/2007.

    Languages: English

    Amendments, rulings, and supplements: AAMI/ISO 1099307E

    Historical Editions: AAMI/ISO 10993-7

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  2. HISTORICAL

    AAMI/ISO 11135-1:2007▹

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

    Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 07/25/2007.

    Languages: English

    Historical Editions: AAMI/ISO 11135:2014, AAMI/ISO 11135-1 / 11135-2 SET, AAMI/ISO TIR11135-2:2008, AAMI 11135:1994

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  3. HISTORICAL

    AAMI 11135:1994▹

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

    Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization - Includes Errata

    standard by Association for the Advancement of Medical Instrumentation, 05/01/1994.

    Languages: English

    Historical Editions: AAMI/ISO 11135:2014, AAMI/ISO 11135-1 / 11135-2 SET, AAMI/ISO TIR11135-2:2008, AAMI/ISO 11135-1:2007

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  4. MOST RECENT

    AAMI/ISO 11135:2014▹

    Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 07/27/2015.

    Languages: English

    Historical Editions: AAMI/ISO 11135-1 / 11135-2 SET, AAMI/ISO TIR11135-2:2008, AAMI/ISO 11135-1:2007, AAMI 11135:1994

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  5. HISTORICAL

    AAMI/ISO 11138-2:2006/(R)2015▹

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

    Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 12/09/2005.

    Languages: English

    Historical Editions: AAMI/ISO 11138-2:2017/(R)2024, AAMI ST21-99

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  6. MOST RECENT

    AAMI/ISO 11138-2:2017/(R)2024▹

    Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 08/01/2017.

    Languages: English

    Historical Editions: AAMI/ISO 11138-2:2006/(R)2015, AAMI ST21-99

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  7. MOST RECENT

    AAMI/ISO 12417-1:2015▹ [ Withdrawn ]

    Cardiovascular implants and extracorporeal systems - Vascular device-drugcombination products - Part 1: General requirements

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 11/15/2015.

    Languages: English

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  8. HISTORICAL

    AAMI/ISO 14160:1998/(R)2008▹

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

    Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilants

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 12/03/2008.

    Languages: English

    Historical Editions: AAMI/ISO 14160:2011/(R)2016

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  9. MOST RECENT

    AAMI/ISO 14160:2011/(R)2016▹

    Sterilization of health care products - liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - requirements for characterization, development, validation and routine control of a sterilization process for medical devices

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 12/05/2011.

    Languages: English

    Historical Editions: AAMI/ISO 14160:1998/(R)2008

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  10. MOST RECENT

    AAMI/ISO 80369-3:2016▹

    Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 06/05/2016.

    Languages: English

    Amendments, rulings, and supplements: AAMI/ISO 80369-3:2016/A1:2019

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