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Hello,
We are developing an articulated extra-discal implant made from 3 materials which - if taken individually - are all biocompatible. Basically, our implant is made from the assembly of Part A, Part B and Part C. With Part A made from Material 1, Part B made from Material 2 and so forth.
We are struggling to prove that during normal operation (and under wear) the resulting debris are still biocompatible. And it does not make any sense for us to go after ISO 10993, since the material used are mutually amorphous to each other. For information, the materials we are talking about are PEEK, Titanium and PE.
A literature search does not yield much in terms of 'State of the Art' for the 3 materials, and some of the methods we are considering do not make any sense (perform a wear test in an ultrapure solution, characterize the molecules in there, synthesize the unknown molecule to perform an ISO 10993.
Any hints would be appreciated.
Thanks,
We are developing an articulated extra-discal implant made from 3 materials which - if taken individually - are all biocompatible. Basically, our implant is made from the assembly of Part A, Part B and Part C. With Part A made from Material 1, Part B made from Material 2 and so forth.
We are struggling to prove that during normal operation (and under wear) the resulting debris are still biocompatible. And it does not make any sense for us to go after ISO 10993, since the material used are mutually amorphous to each other. For information, the materials we are talking about are PEEK, Titanium and PE.
A literature search does not yield much in terms of 'State of the Art' for the 3 materials, and some of the methods we are considering do not make any sense (perform a wear test in an ultrapure solution, characterize the molecules in there, synthesize the unknown molecule to perform an ISO 10993.
Any hints would be appreciated.
Thanks,