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Frequency of shelf life/sterilization/bench studies conducted on a medical device

Harini17

Involved In Discussions
#1
Dear experts,

I would like to understand how frequently medical devices are subjected to shelf life/sterilization/bench studies, is it carried out only during production stage or how is it? Does it depends on the Classification of the product? If the medical device is subjected to shelf life and sterilization/bench studies how frequently and why it needs to be performed. Kindly explain with reason.

Many thanks in advance!
 
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chris1price

Trusted Information Resource
#2
Hi, for Medical Devices validation of shelf-life and sterilisation are usually performed in full, just once, as part of the Design Verification process. It is expected that a partial revalidation or verification of sterilisation be performed on an annual basis, or document a good rationale for not performing one. Other types of test, bench tests, bioburden, pyrogenicity, etc. are usually performed in Design Verification, but may also be part of IPC or release testing. Revalidation should always be considered as part of any design changes.
 
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