摘要
目的探讨将3D打印多孔钽作为外科植入材料的生物安全性。方法按照GB/T 16886《医疗器械生物学评价》标准对3D打印多孔钽进行遗传毒性、溶血、体外细胞毒性、植入后局部反应、皮内反应、皮肤致敏、急性全身毒性、亚慢毒性试验等生物安全性评价。结果3D打印多孔钽的遗传毒性、溶血、体外细胞毒性、植入后局部反应、皮内反应、皮肤致敏、急性全身毒性和亚慢毒性试验结果均符合GB/T 16886的要求。结论将3D打印多孔钽作为外科植入材料具有良好的生物相容性。
Objective The biosafety of 3D printing porous tantalum as surgical implant material was explored.Methods According to GB/T 16886 Biological evaluation of medical devices,the genotoxicity test,hemolysis test,in vitro cytotoxicity test,test for local effects after implantation,intradermal stimulation test,skin sensitization test,acute systemic toxicity test and subchronic systemic toxicity test were studied on 3D printing porous tantalum samples.Results The results of genotoxicity test,hemolysis test,in vitro cytotoxicity test,test for local effects after implantation,intradermal stimulation test,skin sensitization test,acute systemic toxicity test and subchronic systemic toxicity test of 3D printing porous tantalum were in accordance with GB/T 16886.Conclusion 3D printing porous tantalum has good biocompatibility as surgical implant material.
作者
张璞
蒋波
张玲
王旖
曾荣荣
杨柳
王富友
范能全
Zhang Pu;Jiang Bo;Zhang Ling;Wang Yi;Zeng Rongrong;Yang Liu;Wang Fuyou;Fan Nengquan(Chongqing Institute for Food and Drug Control,Chongqing 401121,China;Center for Joint Surgery,Southwest Hospital of AMU,Chongqing 400038,China)
出处
《医疗装备》
2022年第9期44-49,共6页
Medical Equipment
基金
重庆市科研机构绩效激励引导专项--3D打印多孔钽生物学评价技术研究(cstc2019jxjl130040)。
关键词
3D打印多孔钽
外科植入材料
生物相容性
安全性评价
3D printing porous tantalum
Surgical implant material
Biocompatibility
Safety evaluation
