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.
PROJECT
ISO/FDIS 11135
50.60
Close of voting. Proof returned by secretariat
Nov 12, 2026
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/FDIS 11135:2026)
50.60 Close of voting. Proof returned by secretariat