Biological Evaluation

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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 10993-10:2010/(R)2014▹

    Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 09/04/2010.

    Languages: English

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  3. HISTORICAL

    AAMI/ISO 10993-11:2006/(R)2014▹ [ Withdrawn ]

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

    Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 10/19/2006.

    Languages:

    Historical Editions: AAMI/ISO 10993-11:2017/(R)2023

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  4. MOST RECENT

    AAMI/ISO 10993-11:2017/(R)2023▹

    Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

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

    Languages: English

    Historical Editions: AAMI/ISO 10993-11:2006/(R)2014

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  5. HISTORICAL

    AAMI/ISO 10993-1:2003▹

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

    Biological Evaluation of Medical Devices Part 1: Evaluation and Testing

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 12/01/2003.

    Languages: English

    Historical Editions: AAMI/ISO 10993-1:2018, AAMI/ISO 10993-1:2009/(R)2013

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  6. MOST RECENT

    AAMI/ISO 10993-1:2009 Erratum▹

    Erratum for Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

    Amendment by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 06/10/2013.

    Languages: English

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  7. HISTORICAL

    AAMI/ISO 10993-1:2009/(R)2013▹ [ Withdrawn ]

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

    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process; Includes Erratum (2013)

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 09/03/2009.

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    Amendments, rulings, and supplements: AAMI/ISO 10993-1:2009 Erratum

    Historical Editions: AAMI/ISO 10993-1:2018, AAMI/ISO 10993-1:2003

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  8. MOST RECENT

    AAMI/ISO 10993-1:2018▹

    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

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

    Languages: English

    Historical Editions: AAMI/ISO 10993-1:2009/(R)2013, AAMI/ISO 10993-1:2003

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  9. HISTORICAL

    AAMI/ISO 10993-12:2002▹

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

    Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 03/27/2003.

    Languages: English

    Historical Editions: AAMI/ISO 10993-12:2012, AAMI/ISO 10993-12:2007

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  10. HISTORICAL

    AAMI/ISO 10993-12:2007▹

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

    Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 11/08/2007.

    Languages: English

    Historical Editions: AAMI/ISO 10993-12:2012, AAMI/ISO 10993-12:2002

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