ASTM F1980 PDF
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Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
Published by | Publication Date | Number of Pages |
ASTM | 12/15/2021 | 8 |
ASTM F1980 – Standard Guide forAccelerated Aging of Sterile Barrier Systems and Medical Devices
1.1”This guide provides information for developing accelerated aging protocols to model the possible 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. Guidance for developing accelerated aging protocols may also be used for medical devices and medical device materials.
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