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.
| CSA Group | |
|---|---|
| Product Category | Standards and Technical Documents |
| Product Number | ISO 11135:2014 |
| Product Name | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices |
