Accelerated Ageing Test for Medical Devices
An accelerated ageing test for medical devices is used to simulate real shelf-life ageing and is, therefore, conducted to validate shelf-life claims. Accelerated ageing (sometimes known as accelerated aging) is carried out according to ASTM F1980 - Standard Guide for Accelerated Ageing of Sterile Medical Device Packages.
During an accelerated ageing (or accelerated aging) test for medical devices, packs are usually stored at 55°C and a 6 week period is equivalent to 1 year of real-time ageing under normal conditions. This method is suitable for pouches and blisters and for porous and non-porous packs.
The time when packs are admitted into ageing ovens usually triggers a "Time Zero" assessment of another group of products from the same non-aged batch in order to obtain benchmark data. This includes visual inspection, and any combination of burst testing, dye penetration testing and peel testing. Post-ageing inspection and tests are repeated, and a comparative analysis is conducted between the non-aged and aged samples at the time period(s) the client has requested.
Ageing temperatures and protocols to be used in an accelerated ageing test for medical devices can be custom-designed to meet your particular requirements. You can even use our online accelerated ageing calculator to calculate your own customised ageing period based on ASTM F1980.
For more information on shelf life validation click below.