Accelerated Ageing

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.

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For more information on shelf life validation click below.

Shelf Life validation

 

 

 

Accelerated Ageing Duration of Incubation Calculator

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