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

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.