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ONORM EN ISO 11135:2020
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 + Amd 1:2018) (consolidated version)
This International Standard lays down requirements for the development, validation and management of the application of an ethylene oxide sterilisation process for medical devices in industry and health care institutions and recognises the similarities and differences between the two applications. This International Standard does not specify requirements for the development, validation and management of the use of a method of inactivation of the pathogens spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. In some countries, specific recommendations have been developed for the treatment of possibly using these pathogens of contaminated materials. This International Standard does not specify the definition of a requirement for the designation of a medical device marked as sterile. This International Standard does not lay down a quality management system for the management of all ...
Austrian Standards Institute [on]