A Test Lab’s Guide to Accelerated Aging

Wednesday, December 8, 2021 2:30 PM to 3:15 PM
Tech Theater
Sponsored Session

Information

We will discuss the key points and theory supporting test protocol ASTM F1980 ‘Accelerated Aging of Sterile Barrier Systems for Medical Devices’, its relationship with real-time aging, its role in securing a 510k, and its importance in ensuring patient safety.

Our discussion will include the typical accelerated aging temperatures, accelerated aging factor calculation, how to develop an accelerated aging and real-time test plan, and tests to consider performing after accelerated aging concludes.

Questions regarding the recommended and maximum temperatures for medical packaging polymers, how medical devices may be affected by heat and humidity, and the use of humidity during accelerated aging will be discussed.