WK94501 - New Guide for Standard Guide for Real Time Aging of Sterile Barrier Systems and Medical Devices

Work Item

ASTM WK94501

New Guide for Standard Guide for Real Time Aging of Sterile Barrier Systems and Medical Devices

1. Scope

This guide provides information for developing real time aging protocols to confirm the effects of the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607–1: 2019 and the physical properties of their component packaging materials.

Keywords

material stability; degredation

Rationale

No standard currently exists for real time aging protocols. This leads to variation in the approaches used for real time aging of medical devices and associated packaging.

Details

Developed by Subcommittee: F02.50

Committee: F02

Staff Manager: W Scott Orthey

Work Item Status

Date Initiated: 04-09-2025

Technical Contact: Dan Burgess