ÖNORM EN ISO 11135

This International Standard 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. This International Standard does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. This International Standard does not detail a specified requirement for designating a medical device as sterile. This International Standard does not specify a quality management system for the control of all stages of production of medical devices. This International Standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities. This International Standard does not cover sterilization by injecting EO or mixtures containing EO directly into packages or a flexible chamber. This International Standard does not cover analytical methods for determining levels of residual EO and/or its reaction products.