ISO 11135:2014 — Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control

Specifies requirements for the development, validation, and routine control of an ethylene oxide (EO) sterilization process for medical devices. Covers process definition, equipment qualification (IQ/OQ/PQ), parametric release criteria, and routine monitoring. EO sterilization is the most widely used sterilization method for heat- and moisture-sensitive medical devices.

Standard Details

• Standard Number: ISO 11135:2014
• Type: Sterilization Standard
• Published by: ISO
• Official Link: https://www.iso.org/standard/56587.html

This standard is referenced in the harmonized standards lists for the EU Medical Device Regulation (MDR) 2017/745, EU In Vitro Diagnostic Regulation (IVDR) 2017/746, and is recognized by regulatory authorities worldwide including the FDA, Health Canada, and TGA.