虞崇庆,何涛,贾晓航,张莉,文燕.外科植入物微弧氧化层中引入元素定量检测方法的研究[J].表面技术,2017,46(5):28-33.
YU Chong-qing,HE Tao,JIA Xiao-hang,ZHANG Li,WEN Yan.Quantitative Detection Method of Introduced Elements in Micro-arc Oxi-dation Layer of Surgical Implants[J].Surface Technology,2017,46(5):28-33 |
| 外科植入物微弧氧化层中引入元素定量检测方法的研究 |
| Quantitative Detection Method of Introduced Elements in Micro-arc Oxi-dation Layer of Surgical Implants |
| 投稿时间：2016-11-18 修订日期：2017-05-20 |
| DOI：10.16490/j.cnki.issn.1001-3660.2017.05.006 |
| 中文关键词: 外科植入物 表面改性 微弧氧化 电解液 引入元素 X射线荧光能谱 |
| 英文关键词:surgical implant surface modification micro-arc oxidation electrolyte introduced elements X-ray fluorescence |
| 基金项目:浙江省科技计划项目（2014F30029） |
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| Author | Institution |
| YU Chong-qing | Zhejiang Institute of Medical Device Testing, Hangzhou 310019, China |
| HE Tao | Zhejiang Institute of Medical Device Testing, Hangzhou 310019, China |
| JIA Xiao-hang | Zhejiang Institute of Medical Device Testing, Hangzhou 310019, China |
| ZHANG Li | Zhejiang Institute of Medical Device Testing, Hangzhou 310019, China |
| WEN Yan | Zhejiang Institute of Medical Device Testing, Hangzhou 310019, China |
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| 中文摘要: |
| 目的 建立外科植入产品微弧氧化层中P、Si等引入元素定量检测的方法，以作为表面微弧氧化改性安全性评价的一部分。方法 从工艺角度分析表面微弧氧化层引入元素的种类和来源，通过X射线荧光能谱基本参数法，检测钛及钛合金表面微弧氧化层中由加工工艺引入的元素成分，并进行定量检测。结果 设置X射线荧光能谱仪基本实验参数，借助标准样块建立了定量检验方法。该方法的相关系数为0.998以上，线性良好。该方法的检测下限Si为30 μg/g，P为10 μg/g。在精密度测试中，结果的相对标准偏差（RSD，n=6）在3%以内。在准确度实验中，标准物质检测结果的平均值与标称值的偏差在2%以内。将该方法应用于市面上不同厂家的外科植入物产品中，A厂家的产品检测出P元素，B厂家的产品检测出Si元素。分别重复检测6次，所得检测结果的相对标准偏差（RSD）均在2%以内。结论 该方法具有操作方便、检出限低、精密度高、测试时间短等特点，是目前外科植入物表面微弧氧化定量检测及评价较为理想的实验方法。 |
| 英文摘要: |
| The work aims to establish a method for quantitative detection of introduced elements including Si and P in micro-arc oxide layer of surgical implants as a part of safety evaluation of surface micro-arc oxidation. Types and sources of introduced elements in the micro-arc oxide layer were analyzed from the point of technological process, and X-ray fluorescence spectrometry with fundamental parameter (FP) method was selected for quantitative detection of the introduced elements from technological process into the micro-arc oxidation layer on the surface of titanium and titanium alloy. Basic experimental parameters of the X-ray fluorescence spectrometer were defined, and quantitative detection method was established by using standard sample piece. The linearity was good, and correlation coefficient of this method was above 0.998. LODs of this detection method were Si of 30 μg/g and P of 10 μg/g. In precision test, relative standard deviation (RSD, n=6) of the results was within 3%. In accuracy experiment, deviation between average value of reference material and nominal value was within 2%. This method was applied to surgical implant products from different manufacturers in the market. For example, element P was detected in products from manufacturer A, and element Si was detected in products from manufacturer B. The relative standard deviation (RSD) of the result was below 2% in 6 repeated detections. This method featuring in convenient operation, low detection limit, high precision, short test time, etc. is an ideal experimental method for the quantitative detection and evaluation of micro-arc oxidation of surgical implants at present. |
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