GB/T 16886.9-2001

Biological evaluation of medical devices-Part 9:Framework for identification and quantification of potential degradation products (TEXT OF DOCUMENT IS IN CHINESE)

This part of GB/T 16886 provides general principles for systematic evaluation of medical devices' potential and observed biological degradation as well as general principles for design and proceeding of studies on microbial degradation.

This part of GB/T 16886 does not apply to the followings:

a) Engineered living tissue products;

b) Methodology of evaluation or study on generating degradation products in the mechanical process. Methods for generating this kind of degradation product can be established in specific product standards under circumstances;

c) Leachable components of non-degradation products.

When product standards provide methods which are applicable to for identification and quantification of degradation products of certain kind of product, these standards are prior to this part of GB/T 16886.