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 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.

Sterilization processes validated and controlled in accordance with the requirements of ISO 11135-1:2007 are not assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld Jacob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.


General information

  • Current status : Withdrawn
    Publication date : 2007-05
    Corrected version : 2007-10-22
  • Edition : 1
  • :
    ISO/TC 198
    Sterilization of health care products
  • 11.080.01
    Sterilization and disinfection in general

Got a question?

Check out our FAQs


Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)