新型经皮植入材料的生物学性能评价研究

Biological Evaluation of New Percutaneous Implanting Materials

参照ISO 10993系列标准,通过细胞毒性试验、刺激试验和致敏试验对阳极氧化表面改性纯钛作为经皮植入材料进行了生物学性能评价研究。试验结果表明,此种改性纯钛无细胞毒性,皮肤刺激反应属于极微弱类型,不存在致敏潜能,是生物学性能优良的经皮植入材料。

According to ISO 10993 standard series, the biological safety of surface modified pure titanium was studled as a percutaneous device by the test of cytotoxicity in vitro, as well as by the tests of irritation and sensitization. The result from the examination of cytotoxicity in vitro was negative, the skin irritation response was negligible, and the result of test on skin sensitization in guinea pigs was also negligible. So the rex_trace modified pure titanium in this study can he safely used as percutaneous implanting materials.