外科植入物钛及钛合金阳极氧化杂质元素分析方法及结果统计分析  

Methods for Analysis of Anodized Impurity Elements in Titanium and Titanium Alloys and Statistical Analysis of the Results

作　　者：朱进清[1] 李沅[1] 张晨[1] 付瑞芝[1] 张路[1] 董双鹏[1] 马金竹[1] ZHU Jin-qing;LI Yuan;ZHANG Chen;FU Rui-zhi;ZHANG Lu;DONG Shuang-peng;MA Jin-zhu(Tianjin Medical Devices Quality Supervision and Testing Center of China Food and Drug Administration,Tianjin 300384)

机构地区：[1]国家食品药品监督管理局天津医疗器械质量监督检验中心,天津300384

出　　处：《中国医疗器械信息》2021年第11期18-20,共3页China Medical Device Information

基　　金：国家重点研发计划课题(项目编号:2018YFB1105600)。

摘　　要：钛及钛合金通过阳极氧化进行表面改性,可以提高基体的物理性能及生物相容性。但是若阳极氧化工艺引入与基体不一致的杂质元素,生物安全性能则存在一定的风险。文章基于扫描电镜及能谱仪,依据相关的国家标准和行业标准,建立一种分析钛及钛合金表面阳极氧化层杂质元素的分析方法。收集国内外不同生产商提供的约200件试验样品,对发现的杂质元素种类及其数量进行统计分析,并分析杂质元素产生的可能原因,有助于促进该领域技术水平的进步。The surface modification of titanium and titanium alloy by anodic oxidation can improve the physical properties and biocompatibility of matrix.However,if the impurity elements inconsistent with the substrate are introduced into the anodic oxidation process,the biosafety performance has some risks.Based on scanning electron microscope and energy spectrometer,a method for the analysis of impurity elements in the anodic oxide layer on the surface of titanium and titanium alloy was developed according to relevant national and industrial standards.About 200 test samples provided by different manufacturers at home and abroad were collected,and the types and quantities of impurity elements found were analyzed statistically,and the possible causes for the generation of impurity elements were analyzed,which is helpful to promote the progress of the technical level in this field.

关 键 词：钛及钛合金 阳极氧化 杂质元素 

分 类 号：R197.39[医药卫生—卫生事业管理]