Shelf life of non sterile class IIb product.

D

Dhruvaraj

Registered
#1
#1
Recently I have joined a medical device industry which is dealing in implantable orthopedic medical devices. Here I found shelf life has defined of Non-Sterile product in SOP. Is it possible to define shelf life of non-sterile product? As per any standard (Like: ISO 13485, CE, USFDA, Indian MDR etc.)

Please guide me about this.
 
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planB

planB

Super Moderator
#2
#2
Yes, it is possible to define a shelf life for a non-sterile product, typically when product characteristics are prone to non-acceptable change over time, such as potential degradation.
 
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