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Work Item

ASTM WK94053

Revision of F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices

Rationale

There is a scientific mistake in the standard that needs to be revised, the Q10 of 2 was calculated at temperatures well above the glass transition temperature of the polymer materials. This value cannot be applied to room temperature conditions, it becomes unnecessarily conservative.

Details

Developed by Subcommittee: F02.50

Committee: F02

Staff Manager: W Scott Orthey

Work Item Status

Date Initiated: 03-01-2025

Technical Contact: Nazli Ozdemir

Item: 000

Ballot: 

Status: 

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