镍钛记忆合金带膜食道内支架生物学安全性评价研究  

The Biological Safety Evaluation of Memory Ni-Ti Alloy Esophagus Stent

作　　者：姜华[1,2] 祝君梅 高萍[1,2] 贾文英[1,2] 史弘道 

机构地区：[1]天津医药科学研究所,天津300070 [2]天津市医用生物材料监测研究中心,天津300070

出　　处：《中国医疗器械杂志》2003年第2期110-113,共4页Chinese Journal of Medical Instrumentation

摘　　要：使用医疗器械修复病损部位,其安全与否直接关系到人体的健康,在修复的同时又要避免新的危害产生,因此对其进行生物学安全性评价尤为重要。依据国家标准选择四项试验对镍钛记忆合金带膜支架(食道内支架)进行了安全性评价,结果表明,该支架的血液相容性良好,无全身毒性和细胞毒性,也无热源性,是一种生物相容性优良的食道内支架。The safety of using medical devices to repair damaged body parts directly affects the human health. In order to avoid new harm to the damaged parts, safety evaluation of the devices is of particular importance. We conducted 4 experiments to evaluate the biological safety of the Memory Ni-Ti Alloy Esophagus Stent according to the national standard. The experimental results demonstrate that this Esophagus Stent has good hemo-compatibility, no systemic toxicity, no cellular toxicity and no pyretogen. Therefore, we conclude that the Memory Ni-Ti Alloy Esophagus Stent is a good stent with fine biocompatibility.

关 键 词：镍钛记忆合金带膜食道内支架 生物学评价 血液相容性 细胞毒性 全身毒性 

分 类 号：R318.08[医药卫生—生物医学工程]