Objective: To evaluate the biological safety of a composite material made of Ti alloy/MWCNTsHAP in the ratio of 10:1.7: 1 (vol) fabricated by microwave sintering. Methods: According to the GB/T16886.5-2003, GB/T16886. 10-2005, YY/T 0127. 1-93 and YY/T0279-1995 standards, the samples were prepared and tested with general cytotoxicity test, sensitisation test, he-molysis test and oral mucous membrane irritation test. Results:The composite material showed no cytotoxicity, no sensitization and no mucous membrane irritation, the hemolytic rate of the composite was 3. 2% . Conclusion: The composite material possesses good biological safety.%目的:初步评价微波烧结工艺制作由钛合金/多壁碳纳米管/纳米羟基磷灰石体积比10:1.7:1烧结而成的复合材料的生物安全性.方法:参照国标GB/T16886.5-2003、GB/T16886.10-2005以及医疗行业标准YY/T 0127.1-93、YY/T0279-1995所规定的方法,对复合材料进行体内与体外试验,分别为细胞毒性试验、致敏试验、溶血试验以及黏膜刺激试验.结果:体外细胞毒性试验结果显示复合材料无明显细胞毒性作用,致敏试验显示无皮肤致敏性,溶血率3.2％,口腔黏膜刺激试验结果显示对仓鼠颊黏膜无刺激作用.结论:采用微波快速烧结工艺处理的钛合金/多壁碳纳米管/纳米羟基磷灰石(体积比10∶1.7∶1)复合涂层材料显示了良好的生物安全性.
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