
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)
出版:Standardiserings-Kommissionen I Sverige

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 SS EN ISO 11135-1 & SIS CEN ISO/TS 11135-2. (08/2014)