Question

You have designed a bone plate that is manufactured via rolling under cold working conditions, and tests show good biocompatibility results for the device. The Manufacturing Department has put in a request to change the processing method to rolling under hot working conditions, in an effort to reduce the total manufacturing cost. Since the material from which the device is fabricated will not change, do you need to rerun the biocompatibility tests? Why or why not? (10 points)

Answer 1

Answer:

No need to rerun the biocompatibility tests

Explanation:

There is no need to regenerate because we use the same material and hot work results to eliminate or reduce chemical-symmetry due to enhanced dispersion at higher temperatures and may reduce size during deformation and this has a positive impact on biochemical reliability.

so No need to rerun the biocompatibility tests