Studies conducted on the amount of autoclave sterilization of a PEEK implant

#1
Does anyone know or provide a link to studies conducted on the amount of autoclave sterilization a PEEK implant can withstand before material degeneration or other complications could occur?

I'm searching for data to justify a given life expectancy for a PEEK spinal implant that could theoretically see an infinite number of autoclave cycles. The implants are provided as a set in a Radel caddy, within an aluminum case only with a 17-4PH inserter and 17-4PH sizing instruments. The set is provided non-sterile to the surgical centers and is then sterilized via autoclave.

Thanks for any assistance.
 
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shimonv

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#2
Hi Jason,
Such studies are part of the 'in-house' verification activities. You are not likely to find this kind of information in the public domain. Perhaps a test lab can help you with templates.
I also recommend to look at User's manual for similar products; they might include some helpful informaion.
Perhaps the raw material manufacturer can help you or even run the tests on your behalf.

Shimon
 
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