Glossary Term
Accelerated Aging Studies
Definition
Accelerated Aging Studies are testing methodologies used to estimate the shelf life or functional lifespan of a medical device or its packaging under controlled conditions that simulate the effects of long-term use and storage. These studies accelerate the aging process by exposing materials to elevated environmental factors, such as temperature and humidity, to validate product performance and safety over a shorter timeframe.
Relevance to the MedTech Industry
Accelerated Aging Studies are essential for ensuring that medical devices and their packaging maintain their intended functionality, sterility, and safety throughout their shelf life. These studies provide predictive data that help manufacturers establish expiration dates, validate packaging integrity, and ensure compliance with regulatory standards such as ISO 11607.
Additional Information & Related Terms
Sterility Assurance Level Validates the ability of packaging systems to maintain sterility over the intended shelf life.
Packaging Validation Uses accelerated aging to ensure packaging durability and integrity.
ISO 11607 Governs packaging standards for terminally sterilized medical devices.
Material Compatibility Testing Ensures materials used in devices and packaging withstand aging effects.