Shelf Life Test for IFU and Implant Card

#1
Hi everyone,

Is shelf life (real time and AA) test required for packaging components like IFU and implant card for Class III medical device?

The SBS with medical device is sterilized. The sterilized SBS, an IFU, and an implant card are packaged into the carton (protective packaging) post sterilization. I understand shelf life test is required for SBS and protective packaging. However, the IFU and implant card are not intended to protect the medical device/SBS from damage, so should/can they be out of scope for the shelf life testing?

Appreciate any guidance on this.
 
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#2
It’s good to include things like legibility of information on the labeling as part of shelflife study. You can just check this through visual inspection. Sometimes inks used on packaging materials may fade or smudge during shelflife, so you want to make sure this kind of thing is included in a shelflife study

Also from a business or marketing perspective you may want to check that all the branding and graphics appear as they should be throughout shelf life.
 
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