Published
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.
PUBLISHED
ISO 11135:2014
90.92
Standard to be revised
Jul 22, 2024
PUBLISHED
ISO 11135:2014/Amd 1:2018
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)
60.60 Standard published