Accelerated Aging (AA) and Real-Time Aging (RTA) based on standard ASTM F1980

What is the goal of accelerated aging and real-time aging storage?

Both methods of medical device testing aim to ensure that the product and packaging comply with requirements and quality standards, and meet customer needs.

This medical device test simulates the natural aging process and checks certain parameters or properties of the product. This allows for a faster assessment of the product's shelf life and quality, enabling manufacturers to identify and address potential issues or weaknesses early on, or to obtain early market approval.

What happens during an accelerated aging test and a real-time aging test?

In accelerated aging, medical devices are stored at elevated temperatures with controlled humidity to speed up the chemical reaction rate and thus the aging process.

The Arrhenius equation is used to calculate accelerated aging duration by storage at elevated temperatures. We perform this medical device testing according to the standard at 55°C in our qualified temperature chambers; other temperatures according to customer specification are also possible.

Accelerated aging data must be verified by real-time aging, in which products are stored under realistic conditions, e.g., 25 °C/ 60 % rH, to simulate the actual aging process.

In which areas is this test used?

Storage for accelerated aging and real-time aging is performed to test aging effects of medical devices and to prove shelf life.
It finds application where materials are exposed to certain external influences.
Standards: ASTM F1980

ASTM F1980 Standard Test Method

ASTM F1980 describes accelerated ageing methods for medical packaging to assess its long-term integrity and protective function. Real-world ageing processes are simulated using defined temperature and humidity conditions to ensure that the packaging retains its barrier properties over the intended storage period. This method allows efficient prediction of shelf life without the need for years of real-time studies. ASTM F1980 is particularly important for sterile medical devices, as it ensures the integrity of the packaging and therefore the safety of the product.