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.
Date Initiated: 05-24-2023
Technical Contact: Kenneth Aston
Item: 000
Ballot:
Status: