The introduction of new or modified medical devices requires evidence that they can be stored or used without any deleterious effects on performance that may impact patient safety and efficacy.
Note: Real time studies should be performed in parallel to Accelerated Studies
By exposing or “stressing” the product to higher temperatures than would be used for ambient aging, an increased reaction rate is correlated to normal ranges.
A simplified protocol based on the Arrhenius equation, also called the 10 degree rule, is used where it is assumed that a ten degree temp increase results in a 2 fold increase in reaction rate.
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