GB/T 16886.15-2003

Biological eveluation of medical devices--Part 15: Identification and quantification of degradation products from metals and alloys (TEXT OF DOCUMENT IS IN CHINESE)

The part provides guidance for test design of general requirements for identification and quantification of degradation products from finished metal medical devices or from relative material samples which are ready for clinical use. This part only applies to degradation products from chemical change of those finished metal devices in vitro accelerated degradation tests. Because these tests are accelerated tests, the results of them may not show the character of implants or materials presented in bodies. The described chemical method is one means of generating degradation products so as to further evaluate these degradation products.

This part of GB 16886 is not applicable to degradation caused by mechanical stress.

Because the range of metal materials used for medical devices is very wide, analytical techniques for quantification of degradation products are not established. This part does not establish identification of trace elements (<10-6) in certain kind of metal or alloy. This part does not establish specific requirements for the acceptable level of degradation products, either.

This part of GB 16886 does not discuss about biological activity of degradation products, evaluation of which can be made according to the rules in applicable sections of GB/T 16886.1 and ISO 16886-17.