F1980 Accelerated Aging of Sterile Barrier Systems
Normative References
ASTM F1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
This guide provides information for developing accelerated aging protocols to rapidly determine the effects, if any, due to the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607–1:2006 and the physical properties of their component packaging materials.
EndoLab® uses an up to date climate chamber to guarantee constant and reproducible aging conditions.
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