Ethylene Oxide EO Sterilization Validation Procedure | ISO 13485 | FDA QMSR

The Ethylene Oxide (EO) Sterilization Validation Procedure guides validation, revalidation, product adoption and routine EO sterilization of medical devices. It addresses ISO 11135:2014 with Amendment 1:2018 and ISO 10993-7:2026 for EO residual evaluation.

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Supplied as one editable Microsoft Word document in a digital download.

EO validation, product adoption and routine controls

It describes EO validation protocols, test considerations, selection of a master challenge device and placement of biological indicators. It also covers product families and processing categories, routine monitoring, contract-sterilizer oversight, and the records needed to evaluate adoption into an existing validated cycle.

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.

For load preparation and final release, see the Sterile Load Preparation and Release Procedure. For adopting another device into an existing validated EO cycle, see the separately sold EO Product Adoption Protocol. This validation procedure is also included in the Medical Device Sterilization Procedure Bundle.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read EO and Gamma Sterilization: Validation, Product Adoption and Load Release for workflow guidance, a checklist and common mistakes.

Part of a procedure bundle

This document is also included in Medical Device Sterilization Procedure Bundle. Explore the bundle for the related documents.