Ageing and shelf life

For medical devices, a shelf life must be specified after which the functionality and safety of the product can still be guaranteed. For this purpose, the product's requirement parameters are checked on aged samples or samples stored for the shelf life.
 

Since no experience or test values for batches stored in real time are yet available for new or modified products, accelerated aging is used to simulate real time aging for the shelf life of the medical devices. In an accelerated aging test for medical devices per ASTM F1980 (Standard Guide for Accelerated Aging of Packaging for Sterile Medical Devices), packages are stored at an elevated temperature. For example, a storage period of 2 years can be reduced to a few weeks.

We offer

  • Accelerated ageing due to storage in the climatic chamber
  • Real-time storage under standard conditions

We would be pleased to check the function and biocompatibility of your medical device comparatively in new condition and after aging. We would be happy to work with you to create an individual test plan for your product.

Example medical face masks

Hohenstein offers testing of product requirements for medical masks in new condition as well as after accelerated ageing and real-time storage. For accelerated ageing, the masks are stored at 55 °C in a constant climate chamber, which shortens testing of aged masks - depending on the manufacturer's information on storage temperature and shelf life - to approx. 8 - 12 weeks.

Regular sampling of test samples, screening tests on the requirement parameters and photo documentation allow the influence of storage/ageing of the material on product safety and life to be estimated during the course and at the end of simulated ageing. This serves to collect rapid experimental data on the product's durability and supports quality assurance until real-time durability data is available (e.g. after 2 years of storage).

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Hohenstein Medical