ISO 11135:2014 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. A sterile medical device is one that is free of viable microorganisms. ... ISO 11135 describes requirements that, if met, will provide an ethylene oxide sterilization process intended to sterilize medical devices, which has appropriate microbial activity.
