Using both accelerated aging in climatic chambers and real-time storage under standard conditions, we evaluate function and biocompatibility in comparison to new, unaged samples. This confirms that your device remains stable, safe and effective throughout its intended shelf life.
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.
Hohenstein evaluates medical face masks in new condition, after accelerated aging and after real-time storage to confirm long-term safety and performance.
For accelerated aging, masks are stored at 55 °C in a constant climate chamber, reducing test time to approximately 8–12 weeks, depending on the manufacturer’s specified storage temperature and intended shelf life.
During testing, we perform regular sample evaluations, requirement screening and photo documentation. These assessments help estimate how material aging and storage conditions affect mask safety, performance and durability - during testing and after simulated aging.
This approach enables faster data collection on product stability and supports ongoing quality assurance until real-time aging data (e.g., after two years of storage) becomes available.