GB/T 16886.15-2022 Biological evaluation of medical devices—Part 15:Identification and quantification of degradation products from metals and alloys

Scope

This document specifies the general requirements for the design of qualitative and quantitative tests on the degradation products of final metal medical devices or corresponding material samples available for clinical use. This document applies to materials that are expected and unexpected to degrade in vivo, as well as degradation products generated by chemical changes in final metal devices during in vitro degradation tests. This document does not apply to the evaluation of degradation caused by purely mechanical processes; the methodology for generating such degradation products is described in specific product standards (if available). This document does not include the biological activity of degradation products.

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