| 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],46(5):28-33 |
| Quantitative Detection Method of Introduced Elements in Micro-arc Oxi-dation Layer of Surgical Implants |
| Received:November 18, 2016 Revised:May 20, 2017 |
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| DOI：10.16490/j.cnki.issn.1001-3660.2017.05.006 |
| KeyWord:surgical implant surface modification micro-arc oxidation electrolyte introduced elements X-ray fluorescence |
| Author | Institution |
| YU Chong-qing |
Zhejiang Institute of Medical Device Testing, Hangzhou , China |
| HE Tao |
Zhejiang Institute of Medical Device Testing, Hangzhou , China |
| JIA Xiao-hang |
Zhejiang Institute of Medical Device Testing, Hangzhou , China |
| ZHANG Li |
Zhejiang Institute of Medical Device Testing, Hangzhou , China |
| WEN Yan |
Zhejiang Institute of Medical Device Testing, Hangzhou , China |
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| Abstract: |
| 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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