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What is Accelerated Aging Protocol for Medical Devices about?

This document provides guidance on developing accelerated aging protocols for medical device packaging to support shelf-life and expiration date claims. It discusses accelerated aging theory, which assumes chemical degradation reactions follow the Arrhenius equation allowing temperatures to be elevated to accelerate aging. However, the document cautions that reaction rates may not be linear and different materials may react at different rates. It provides examples of accelerated aging calculations and recom

Author

Peter Perez-Castro

Language

EN