Sterilization of medical devices — Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release

This document provides guidance on the requirements of ISO 11135 that apply when parametric release is used to release the product after exposure to the sterilization process. It provides a path for transition of existing cycles, as well as a path for the development and implementation of a parametric release specification for a new cycle. Additionally, it highlights the importance and interrelationship of other process factors, i.e. load configuration and equipment performance, which influence reproducibility of an ethylene oxide (EO) sterilization process.

NOTE For ease of reference, the numbering of clauses in this document corresponds to that in the normative parts of ISO 11135.

No additional guidance is offered for processes where the declaration of adequacy of the validated sterilization cycle includes a requirement for no growth in biological indicators (BIs) exposed to that process.