The approach to be assessment of degradation vries with the nature of the  material under investigation, the medical device, the local enviroment and the anatomic location of the specific device. When a specific device is to be evaluated, and where the details of the chemistry of the service environment for that device are known, the evaluation should be carried out in an environment appropriate to these conditions.

 Bio-degrade test include

Identification and quantification of degradation products from polymeric medical devices,

Identification and quantification of degradation products from ceramics

Up：Immunotoxicity test

Down：None