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About This Item

 

Full Description

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.

 

Document History

  1. 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

    • Most Recent
  2. ISO/TS 11135-2:2008


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

    • Historical Version
  3. 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

    • Historical Version
  4. ISO 11135:1994


    Medical devices -- Validation and routine control of ethylene oxide sterilization

    • Historical Version
 

Amendments & Errata

  1. ISO 11135:2014/Amd.1:2018


    Amendment 1: Revision of Annex E, Single batch release