ISO 11135:2014 Preview

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 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.


General information

  • Status :  Published
    Publication date : 2014-07
  • Edition : 2
    Number of pages : 78
  • :
    ISO/TC 198
    Sterilization of health care products
  • 11.080.01
    Sterilization and disinfection in general

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal:

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