Ethylene Oxide Product Adoption Protocol

Document whether a candidate medical device can be adopted into an existing qualified ethylene oxide (EO) sterilization process with the A.P. Lyon EO Product Adoption Protocol. The revised document supports a reasoned comparison of the new product with the qualified product family and process challenge device.

Included: one editable Microsoft Word (.docx) protocol, supplied in a ZIP file as a digital download.

What the protocol covers

• Product, materials, packaging and load comparisons, including relevant bioburden and sterilization challenges.

• A documented decision on whether existing evidence is sufficient or additional studies are needed.

• Conditional comparative-resistance, temperature/humidity and residual-assessment studies.

• Escalation to further qualification when adoption evidence is insufficient, with separate treatment of equipment equivalence and alternative validation routes.

• Supporting reports, specialist review, approval and continued product-family maintenance.

Standards addressed

The revised adoption framework addresses AAMI TIR28:2016/(R)2024 and ISO 11135:2014 with Amendment 1:2018.

Make it specific to your product and cycle

Customize the comparison, study selection, sampling rationale and decision criteria for your existing validated process. Assess EO/ECH residuals and product functionality separately from microbial lethality. Approval requires suitable evidence and qualified review; this document does not itself validate a sterilization cycle.