GB/T 16886.9-2022 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products

Scope

This document specifies the basic principles for the design and implementation of in vitro degradation studies of medical devices, and for a systematic evaluation of their potential and observed degradation. The information obtained from these studies can be used for the biological evaluation described in the GB/T (Z) 16886 series of standards. This document applies to materials intended to degrade in vivo, as well as materials with unintended degradation. This document does not apply to: a) the evaluation of degradation caused by purely mechanical processes; the methodology for generating such degradation products can be found in the specific product standards (if available);

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