ASTM F1980 - 16

Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

Loss of sterile barrier system integrity can occur due to deterioration of the physical properties of materials and adhesive or adhesive bonds over time, and dynamic events during shipping and handling.

The packaging system must provide physical protection and ensure the integrity of the sterile barrier system. The sterile barrier system must maintain sterility until the point of use or expiration date. Stability testing should demonstrate that the sterile barrier system maintains integrity over time.

Real-time aging programs provide the best data to ensure that sterile barrier system materials and sterile barrier system integrity do not degrade over time. However, due to market conditions where products become obsolete in a short time and the need to introduce new products to the market as soon as possible, real-time aging studies cannot meet this goal. So accelerated aging studies may provide an alternative route.

When conducting accelerated aging programs to determine expiration date claims, it should be recognized that data from the study are based on conditions that simulate the effects of aging on materials. Information obtained through this guide can be used to support expiration date requests for medical device sterile barrier systems.