ISO/AWI TS 25462

Sterilization of health care products — Ethylene oxide — Guidance on the validation and routine processing of sterilization processes using alternative approach to parametric release ISO/AWI TS 25462

Scope

This document provides guidance on an alternative approach to parametric release which would be supplemental to the method described in the requirements of ISO 11135:2014 that apply when parametric release is used to release the product after exposure to the ethylene oxide sterilization process It provides a path for transition of existing ethylene oxide sterilization cycles, as well as a path for the development and implementation of a parametric release specification for a new ethylene oxide sterilization cycle.
Additionally, it highlights the advantages/disadvantages of this method versus the existing ISO 11135 requirements and the application of risk assessment.