ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Accelerated aging is a theoretical calculation of how a sterile packaging system will degrade over time. FDA and ISO 11607 permit medical device manufacturers to go to market using accelerated aging data. The caveat is that real-time aging testing must be run in parallel, to confirm accelerated aging findings. The typical temperatures used to test by most medical engineers are 50C, 55C and 60C. It is important, however, to consider the materials of construction when determining the test specifications. Our Aging Calculator is a great tool to estimate how many days your study will require. We are ready discuss your project to recommend the best course of action.