Our controlled environments deliver reliable aging data that meets FDA, EU MDR and international standards.
Real-Time Aging Studies
Long-term storage studies under standard conditions provide shelf life validation data. We monitor package integrity, sterile barrier performance and device functionality over time.
Evaluation of maximum service life for reusable medical devices through repeated reprocessing cycles. We assess biological safety and functionality throughout the complete product lifecycle to determine when devices reach end-of-life specifications.
We check the function and biocompatibility of medical devices comparatively - in new condition and after aging.
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).