Accredited
Test Laboratory
What is the goal of accelerated aging and real-time aging?
Both methods of testing medical devices aim to ensure that the device and packaging meet the requirements and quality standards and satisfy customer requirements.
In this medical device test, the natural aging process is simulated and certain parameters or properties of the product are tested. This enables a faster assessment of the shelf life and quality of the device and allows manufacturers to identify and rectify potential problems or weaknesses at an early stage or to obtain early market approval for their devices.
What happens during an accelerated aging test and a real-time aging test?
In accelerated aging, the medical devices are stored under increased temperature and humidity conditions or other stressful environmental conditions in order to accelerate chemical reactions and thus the aging process. This enables a faster assessment of the shelf life and quality of the product and allows manufacturers to identify and rectify potential problems or weak points at an early stage or to obtain early approval for their products.
With storage at increased temperature, an accelerated aging period can be calculated using the Arrhenius equation. In accordance with the standard, we carry this medical device test out at 55 °C in our qualified temperature chambers. Other temperatures according to customer specifications are also possible.
Accelerated aging data must be verified by real-time aging, where 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?
Accelerated Aging (AA) and Real-Time Aging (RTA) is carried out in order to test aging effects of medical devices and verify durability.
It is used where materials are exposed to certain external influences.
Standard: ASTM F1980
Standard ASTM F1980
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.
Accreditations of our Test Laboratories
Accredited test laboratory PAConsult
Experience & Expertise
96
Test Methods
+
8
Industries
49
Employees
5
Locations
