
Sterilization Of Health-Care Products - Ethylene Oxide - Requirements For The Development, Validation And Routine Control Of A Sterilization Process For Medical Devices (Iso/Dis 11135:2011)
出版:Comite Europeen de Normalisation

专家解读视频
Gives 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.
NEN EN ISO 11135:2011 - Identical
NEN EN ISO 11135:2012 - Identical
NF EN ISO 11135:2012 - Identical