Medical devices expire.

Medical devices must specify a shelf life, 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 specified shelf life.

Since no storage test results would be available for new or modified products, accelerated aging is used to simulate real time aging. 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 verify performance of aged samples.

  • Accelerated aging via storage in the climatic chamber
  • Real-time storage under standard conditions

We check the function and biocompatibility of medical devices comparatively - in new condition and after aging.

Example: Medical Face Masks

Hohenstein offers testing of product requirements for medical masks in new condition, after accelerated aging and after real-time storage. For accelerated aging, the masks are stored at 55 °C in a constant climate chamber. Depending on the manufacturer's instructions for storage temperature and shelf life, this shortens testing time to about 8 - 12 weeks.

Throughout the course of testing, we conduct regular testing of samples, screening tests on the requirement parameters and photo documentation. We can estimate the influence of material aging and storage on a product's safety and life - during the test period and at the end of simulated aging. This allows for rapid collection of data on the product's durability and supports quality assurance until real-time data is available (e.g. after 2 years of storage).

Contact
Ben Mead
Managing Director
Hohenstein Institute America