[An exploratory discussion on biological evaluation and risks for medical devices].
Biological evaluation of medical devices before clinical usage has become one of the necessary procedure. But many of medical devices which have already passed a series of biological safety evaluation do not mean that they are absolutely safe and harmless. And there are still application risks in these medical devices, because of the deficient knowledge about the interaction of biomedical materials and human tissue, limitation of the existent technology level, the indefiniteness of the evaluation system, the imperfections of present standards and so on. This essay is trying to analyze the relationship between the biological evaluation of medical devices and their application risks, and to discuss how to make a risk analysis related to biological evaluation in order to acquire a better and exact understanding of biological evaluation for medical devices.
Sun
Jiao
J
Medical School of Shanghai Jiaotong University/Shanghai Biomaterials Research and Testing Center.
D018795:Device Approval / Q000592:standards*; D004869:Equipment Safety / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D006801:Humans; D008422:Materials Testing; D012015:Reference Standards; D012308:Risk Management; D013673:Technology Assessment, Biomedical / Q000379:methods / Q000592:standards; D018675:Toxicity Tests