EN ISO 11135 – Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices – specifies requirements, and provides guidance, for development, validation and routine control of ethylene oxide (EO) sterilization processes. EN ISO 11135 was published in 2014 and an amendment to the standard was adopted in 2019.

New guidance on parametric release for ethylene oxide sterilisation