Work Item
ASTM WK86546

New Guide for Stored Energy Device Design for Ethylene Oxide Sterilization

1. Scope

Device design, limits of acceptability, risk severity tool, failure mode probability


Ethylene Oxide Sterilization; stored energy device, EO sterilization


The guidance document is needed to provide insight on design limits for medical devices that contain stored energy and are sterilized using ethylene oxide gas.

The title and scope are in draft form and are under development within this ASTM Committee.


Developed by Subcommittee: E61.06

Committee: E61

Staff Manager: Stephen Mawn

Work Item Status

Date Initiated: 05-24-2023

Technical Contact: Kenneth Aston

Item: 000