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ONORM EN ISO 11137-1:2020
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006 + Amd.1:2013 + Amd.2:2018) (consolidated version)
This part of ISO 11137 lays down requirements for the development, validation and management of the application of a radiation sterilisation process for medical devices. Radiation sterilization methods covered by this part of ISO 11137 use irradiation systems(s) which use radionuclides 60Co and 137Cs, b) in which accelerated electrons are produced or (c) in which X-Rays (X-rays) are used by accelerated electrons. This part of ISO 11137 does not specify requirements for the development, validation and management of the use of a process for inactivating the perpetrators of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. In certain countries, specific recommendations for the treatment of potentially contaminated materials have been developed. This part of ISO 11137 does not lay down a detailed requirement for the identification of an M ...
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