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Huang S.,Shanghai Testing and Inspection Institute for Medical Devices | Ding B.,Shanghai Testing and Inspection Institute for Medical Devices | Zou F.,Shanghai Testing and Inspection Institute for Medical Devices
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation | Year: 2013

Vickers hardness is widely used in the performance testing of the metallic medical devices. It discusses the relationship between different test force and the uncertainty by mathematical simulation and experiment. With the increase of test force its uncertainty becomes smaller at 400 times magnification. If you can, you should try to choose a large test force, in order to improve the accuracy and repeatability. In the actual testing process, it is best not to use the micro vickers hardness test.


Huang J.-H.,Shanghai Testing and Inspection Institute for Medical Devices | Lin F.,Shanghai Testing and Inspection Institute for Medical Devices | Yao T.-P.,Shanghai Testing and Inspection Institute for Medical Devices
Yiyong Shengwu Lixue/Journal of Medical Biomechanics | Year: 2014

For implantable medical devices, traditional mechanical property testing is achieved by mechanical testing devices, while such method is lack of pertinence during sampling of series of products, and also time-consuming during experimental testing. With the complete development of finite element analysis (FEA) techniques, introducing FEA to quality supervision and inspection will become a scientific method for saving resources and time, and also improve the pertinence. In this study, the creditability of FEA in application of highest risk sample selection, failure analysis of marketed products and auxiliary optimization of fatigue test testing was verified through case study and experimental testing. The feasibility of FEA during implants inspection was illustrated. In order to ensure the accuracy and reliability of FEA in the application of implants inspection, the essentials of establishing related finite element standards were proposed.

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