Standard guide for shelf life determination of non sterile component with degradation materials

D

DesignAssurance

Starting to get Involved
Hi,

We have a non sterile single use component that is attached to the medical device which has materials that degrades with time. We are intending to perform real time and accelerated aging testing. What standard should I use for aging conditions? ASTM F1980 is for sterile devices. Is there any for non-sterile ones?
 
Ronen E

Ronen E

Problem Solver
Moderator
ASTM F1980 is intended for the sterile barrier. It has little to do with sterility itself.
There is no other accelerated ageing published standard that I'm aware of.
Do you understand the mechanism of degradation in the subject component? That's the key. If it's a chemical reaction of order 0 or 1 you may be able to use the Arrhenius equation or the simplified Q10 model that is based on it (i.e. generally follow F1980). Otherwise you'll have to develop and validate your own rational model.
No, actually you may elect to act irrationally... When it comes to accelerated ageing, this seems to be the norm.
 
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