
Sterilization Of Health-Care Products - Ethylene Oxide - Requirements For The Development, Validation And Routine Control Of A Sterilization Process For Medical Devices
出版:Nederlands Normalisatie Instituut

专家解读视频
Defines 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.
Supersedes NEN EN ISO 11135-1 and NEN NPR CEN ISO/TS 11135-2. (07/2014)