ISO 11135-1:2007
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ISO 11135-1:2007
43185

Status : Withdrawn

This standard has been revised by ISO 11135:2014

Abstract

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

  •  : Withdrawn
     : 2007-05
     : 2007-10
     : 2007-10
    : Withdrawal of International Standard [95.99]
  •  : 1
     : 41
  • ISO/TC 198
    11.080.01 
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