Over deze norm
This part of ISO 11135 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 this part of ISO 11135 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. This part of ISO 11135 does not detail a specified requirement for designating a medical device as sterile. This part of ISO 11135 does not specify a quality management system for the control of all stages of production of medical devices. This part of ISO 11135 does not specify requirements for occupational safety associated with the design and operation of ethylene oxide sterilization facilities. This part of ISO 11135 does not cover sterilization by injecting ethylene oxide or mixtures containing ethylene oxide directly into individual product packages, or continuous sterilization processes. This part of ISO 11135 does not cover analytical methods for determining levels of residual ethylene oxide and/or its reaction products.
|Nederlandse titel||Sterilisatie van producten voor de gezondheidszorg - Ethyleenoxide - Deel 1: Eisen voor de ontwikkeling, validatie en routine controle van een sterilisatieproces voor medische hulpmiddelen (corrected and reprinted)|
|Engelse titel||Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (corrected and reprinted)|