Radiation

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  1. HISTORICAL

    1534685

    AAMI/ISO 11137-1:2006/(R)2010▹

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

    Sterilization of health care products - Radiation - Part 1: 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, 12/23/2005.

    Languages: English

    Amendments, rulings, and supplements: AAMI/ISO 11137-1:2006/(R)2010/A1:2013

    Historical Editions: AAMI/ISO 11137-1:2006/(R)2015 & A1:2003 & A2:2019 (Consolidated Text), AAMI/ISO 11137:1994 + Amendment 1, AAMI TIR 15843, AAMI ST1137-94

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  2. MOST RECENT

    1879045

    AAMI/ISO 11137-1:2006/(R)2010/A1:2013▹

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

    Amendment by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 12/30/2013.

    Languages: English

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  3. MOST RECENT

    1879044

    AAMI/ISO 11137-1:2006/(R)2015 & A1:2003 & A2:2019 (Consolidated Text)▹

    Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices, Includes A1:2013 & A2:2019

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 12/30/2013.

    Languages: English

    Amendments, rulings, and supplements: AAMI/ISO 11137-1:2006/(R)2015 A2:2019

    Historical Editions: AAMI/ISO 11137-1:2006/(R)2010, AAMI/ISO 11137:1994 + Amendment 1, AAMI TIR 15843, AAMI ST1137-94

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  4. MOST RECENT

    2077373

    AAMI/ISO 11137-1:2006/(R)2015 A2:2019▹

    A2:2019 to Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

    Amendment by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 05/01/2019.

    Languages: English

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  5. HISTORICAL

    1126346

    AAMI/ISO 11137:1994 + Amendment 1▹

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

    Sterilization of Health Care Products: Requirements for Validation and Routine Control, Radiation Sterilization, 3ed.

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

    Languages: English

    Historical Editions: AAMI/ISO 11137-1:2006/(R)2015 & A1:2003 & A2:2019 (Consolidated Text), AAMI/ISO 11137-1:2006/(R)2010, AAMI TIR 15843, AAMI ST1137-94

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  6. HISTORICAL

    1616645

    AAMI/ISO 11137-2:2006▹

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

    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (Corrected 21 April 2009)

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 04/21/2009.

    Languages: English

    Historical Editions: AAMI/ISO 11137-2:2013 (R2019), AAMI/ISO 11137-2:2012, AAMI/ISO 11137-2:2006

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  7. HISTORICAL

    1839208

    AAMI/ISO 11137-2:2012▹

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

    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 05/03/2012.

    Languages: English

    Historical Editions: AAMI/ISO 11137-2:2013 (R2019), AAMI/ISO 11137-2:2006, AAMI/ISO 11137-2:2006

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  8. MOST RECENT

    1863009

    AAMI/ISO 11137-2:2013 (R2019)▹

    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 07/10/2013.

    Languages: English

    Historical Editions: AAMI/ISO 11137-2:2012, AAMI/ISO 11137-2:2006, AAMI/ISO 11137-2:2006

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  9. HISTORICAL

    1534686

    AAMI/ISO 11137-3:2006/(R)2010▹

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

    Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 05/31/2006.

    Languages: English

    Historical Editions: AAMI/ISO 11137-3:2017 (R)2023

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  10. MOST RECENT

    2006290

    AAMI/ISO 11137-3:2017 (R)2023▹

    Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 10/06/2017.

    Languages: English

    Historical Editions: AAMI/ISO 11137-3:2006/(R)2010

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