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.
Adopting a device into an existing EO process
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.
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.
The adoption assessment compares the candidate device with products already represented in a validated EO cycle. It prompts review of design, materials, sterile-barrier construction, load configuration and other characteristics that may affect sterilant penetration or removal. The documented comparison and supporting test evidence provide the rationale for including a new product in an existing cycle, with differences or gaps addressed before routine processing.
The revised adoption framework addresses AAMI TIR28:2016/(R)2024 and ISO 11135:2014 with Amendment 1:2018.
The revised protocol also references ISO 10993-7:2026 for ethylene oxide residuals, ISO 13485:2016 and FDA QMSR (21 CFR Part 820).
For validating the EO sterilization process itself, see the separately sold EO Sterilization Validation Procedure. The adoption protocol is not 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.
