Use of parts in gamma sterilization validation - Reprocessing implants

QANowatzke

Registered
Hello,
Does anyone out there have experience reprocessing implants that have been through gamma sterilization validation? We are curious about the wash that is used in the testing (Diluting Fluid D) that contains a peptic enzyme/digest of animal tissue. If the parts are taken through a validated cleaning method and then re-sterilized, are they considered to be "medical devices containing derived animal sources"?

Any thoughts on this would be appreciated. :bonk:
 

Marc

Fully vaccinated are you?
Leader
A quick "Bump" - My Thanks in advance to anyone who can help with this one.
 
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