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

[Jason3312003]

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.

 

[shimonv]

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