WK86546 - New Guide for Stored Energy Device Design for Ethylene Oxide Sterilization

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.

Details

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

Ballot:

Status: