Reference Standard for Shelf Life Testing of Packaging for Sterilized Medical Device

E

Ethan Loh

#1
Hi,

May I know what types of testing or standards I can refer to if I want to conduct an end of shelf life testing?

The purpose of this testing is to determine the packaging is still intact after the shelf life (5 years) and the medical device inside is still in a sterilized condition.
 
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E

Ethan Loh

#3
Re: Reference Standard for Shelf Life testing of Sterilized Medical Device

Hi Harry,

Thanks for the link.

However what I want is to know what type of tests can my company perform to prove that our packaging and medical device is as good as 5 years ago. So that we can claim a longer expire date.
 
M

MIREGMGR

#4
Re: Reference Standard for Shelf Life Testing of Packaging for Sterilized Medical Dev

For the packaging, repeat the same test series that you did as your original packaging validation.

For the product, evaluate it for clinical functionality and for deterioration or other changes from aging or other reasons.
 
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