Sterilization Standards

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  1. MOST RECENT

    AAMI/ISO 1099307E▹

    Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals, Errata (22-Jan-2010)

    Amendment by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 01/22/2010.

    Languages: English

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  2. MOST RECENT

    AAMI/ISO 10993-4:2002/A1:2006/(R)2013▹

    Amendment 1 to Biological Evaluation of Medical Devices - Part 4: Selection of tests for interaction with blood

    Amendment by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 07/11/2006.

    Languages: English

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  3. HISTORICAL

    AAMI/ISO 10993-4:2002/(R)2013 & A1:2006/(R)2013▹ [ Withdrawn ]

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

    Biological Evaluation of Medical Devices - Part 4: Selection of tests for interaction with blood

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 10/01/2002.

    Languages:

    Amendments, rulings, and supplements: AAMI/ISO 10993-4:2002/A1:2006/(R)2013

    Historical Editions: AAMI/ISO 10993-4:2017

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  4. MOST RECENT

    AAMI/ISO 10993-4:2017▹

    Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 04/27/2020.

    Languages: English

    Historical Editions: AAMI/ISO 10993-4:2002/(R)2013 & A1:2006/(R)2013

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  5. HISTORICAL

    AAMI/ISO 10993-6:2007/(R)2014▹

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

    Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 04/11/2007.

    Languages: English

    Historical Editions: AAMI/ISO 10993-6:2016

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  6. MOST RECENT

    AAMI/ISO 10993-6:2016▹

    Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 01/10/2017.

    Languages: English

    Historical Editions: AAMI/ISO 10993-6:2007/(R)2014

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  7. HISTORICAL

    AAMI/ISO 10993-7▹

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

    Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals - SAME AS ISO 10993-7

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 09/01/1995.

    Languages: English

    Historical Editions: AAMI/ISO 10993-7:2008/(R)2012

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  8. 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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  9. HISTORICAL

    AAMI/ISO 10993-9:1999/(R2005)▹

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

    Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 06/27/2000.

    Languages: English

    Historical Editions: AAMI/ISO 10993-9:2009/(R)2014

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  10. MOST RECENT

    AAMI/ISO 10993-9:2009/(R)2014▹

    Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 08/17/2010.

    Languages: English

    Historical Editions: AAMI/ISO 10993-9:1999/(R2005)

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