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.
Work Item Status
Date Initiated: 03-01-2025
Technical Contact: Nazli Ozdemir
Item: 000
Ballot:
Status: