TC 198: Sterilization of health care products

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  1. HISTORICAL

    ISO 11135-1:2007▹ [ Withdrawn ]

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

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

    standard by International Organization for Standardization, 05/01/2007.

    Languages: English

    Historical Editions: ISO 11135:2014, ISO/TS 11135-2:2008, ISO 11135:1994

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  2. MOST RECENT

    ISO 11135:2014▹

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

    standard by International Organization for Standardization, 07/15/2014.

    Languages: English

    Amendments, rulings, and supplements: ISO 11135:2014/Amd.1:2018

    Historical Editions: ISO/TS 11135-2:2008, ISO 11135-1:2007, ISO 11135:1994

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  3. MOST RECENT

    ISO 11135:2014/Amd.1:2018▹

    Amendment 1: Revision of Annex E, Single batch release

    Amendment by International Organization for Standardization, 10/01/2018.

    Languages: English

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  4. ISO 11135:2014 Draft▹

    - Amendment 1: Revision of Annex E, Single batch release

    standard by International Organization for Standardization, 10/01/2018.

    Languages:

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  5. HISTORICAL

    ISO/TS 11135-2:2008▹ [ Withdrawn ]

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

    Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1

    standard by International Organization for Standardization (Technical Standard), 08/01/2008.

    Languages: English

    Corrigenda: ISO/TS 11135-2/Cor1:2009

    Historical Editions: ISO 11135:2014, ISO 11135-1:2007, ISO 11135:1994

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  6. MOST RECENT

    ISO/TS 11135-2/Cor1:2009▹

    Corrigendum

    Corrigenda by International Organization for Standardization (Technical Standard), 02/15/2009.

    Languages: English

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  7. HISTORICAL

    ISO 11137-1:2006▹

    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 International Organization for Standardization, 04/15/2006.

    Languages: English

    Amendments, rulings, and supplements: ISO 11137-1:2006/Amd2:2018, ISO 11137-1:2006/Amd1:2013, ISO 11137-1:2006/Amd1:2013

    Historical Editions: ISO 11137-1:2025, ISO 11137:1995

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  8. HISTORICAL

    ISO 11137-1:2006/Amd1:2013▹ [ Withdrawn ]

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

    - Amendment 1

    Amendment by International Organization for Standardization, 07/15/2013.

    Languages: English

    Historical Editions: ISO 11137-1:2006/Amd1:2013

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  9. MOST RECENT

    ISO 11137-1:2006/Amd2:2018▹ [ Withdrawn ]

    - Amendment 2: Revision to 4.3.4 and 11.2

    Amendment by International Organization for Standardization, 11/01/2018.

    Languages: English

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  10. MOST RECENT

    ISO 11137-1:2025▹

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

    standard by International Organization for Standardization, 04/01/2025.

    Languages: English

    Historical Editions: ISO 11137-1:2006, ISO 11137:1995

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