Std

NS-EN 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 (ISO 11135:2014)

standard by Standards Norway NS-EN ISO , 10/01/2014

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Full Description

ADOPTED_FROM:EN ISO 11135:2014 ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.
 

Product Details

Published:
10/01/2014
Number of Pages:
92
 

Document History

  1. NS-EN ISO 11135:2014

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    Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)

    • Most Recent

  2. SN-CEN ISO/TS 11135-2:2008/AC:2009


    Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008/Cor 1:2009)

    • Historical Version

  3. SN-CEN ISO/TS 11135-2:2008


    Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008)

    • Historical Version

  4. NS-EN ISO 11135-1:2007


    Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)

    • Historical Version

  5. NS-EN 550:1994


    Sterilization of medical devices — Validation and routine control of ethylene oxide sterilization

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. NS-EN ISO 11135:2014/A1:2019


    Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)