普通大气热氧化处理后镍钛诺合金的生物安全性评价  

Biological Safety Evaluation of Nitinol Treated by Atmospheric Thermal Oxidation

作　　者：林钟石 黄虹蓉 臧德跃 徐炜区 林柏佑 袁丽欣 徐良 刘尧 LIN Zhongshi;HUANG Hongrong;ZANG Deyue;XU Weiqu;LIN Baiyou;YUAN Lixin;XU Liang;LIU Yao(Department of In-vitro Diagnostic Reagent Testing,Shenzhen Institute for Drug Control,Shenzhen Guangdong 518057,China;Department of Passive Medical Device Testing,Shenzhen Institute for Drug Control,Shenzhen Guangdong 518057,China;Medical Device Testing Center,Shenzhen Institute for Drug Control,Shenzhen Guangdong 518057,China)

机构地区：[1]深圳市药品检验研究院体外诊断试剂检测部,广东深圳518057 [2]深圳市药品检验研究院无源医疗器械检测部,广东深圳518057 [3]深圳市药品检验研究院医疗器械检测中心,广东深圳518057

出　　处：《中国医疗设备》2020年第4期27-32,共6页China Medical Devices

摘　　要：对经常规塑形处理的镍钛诺合金材料进行全面的生物安全性评价,为该材料在医用产品制造和应用尤其是植入介入器械领域的应用提供安全依据。为了模拟镍钛诺合金在医疗器械生产中的常规应用,对镍钛诺合金材料进行塑形处理为镍钛合金丝,然后基于一系列GB/T 16886医疗器械生物学评价标准,对该镍钛合金丝进行热原试验、细胞毒性试验、皮内反应试验、迟发性超敏反应试验、溶血试验、血栓形成试验、亚慢性全身毒性试验、肌肉植入试验、急性全身毒性试验、遗传毒性试验等一系列生物安全性评价试验研究。结果表明,镍钛诺合金材料在普通大气下热氧化处理后的生物安全性符合现有标准规范的要求。Nitinol materials with routine modeling procedure was subjected to comprehensive biosecurity evaluation to provide safe basis for the production and application of medical products,especially in the area of implant interventional devices.To simulate the routine application of nitinol in the production of medical devices,nitinol material was molded into nitinol wire.Then,based on a series of GB/T 16886 medical equipment biology evaluation standards,nitinol wire was subjected to a series of tests,including pyrogen test,cytotoxicity test,intradermal reaction test,late-onset hypersensitivity test,hemolysis test,thrombosis test,sub-chronic systemic toxicity test,muscular implantation test,acute systemic toxicity test,and genotoxicity test.The result showed that the biological safety of nitinol materials after thermal oxidation treatment under common atmosphere conforms to the requirements of current standards.

关 键 词：镍钛诺合金 医疗器械 生物安全性 生物相容性 

分 类 号：R318[医药卫生—生物医学工程]