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
Keywords
Ethylene Oxide Sterilization; stored energy device, EO sterilization
Rationale
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.
Work Item Status
Date Initiated: 05-24-2023
Technical Contact: John Logar
Item: 000
Ballot:
Status: