应用有限元检测植入器械的可行性分析
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上海市科学技术委员会科研计划项目课题(11441900600)


Feasibility of finite element analysis in the application of quality inspection on implantable medical devices
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    摘要:

    传统的植入器械机械性能检测,主要通过力学试验装置完成;而这种方式抽样时对系列产品缺少针对性,在实际测试中耗时耗力。随着有限元计算分析技术的日益完善和成熟,将有限元方法引入质量监督检测,将成为一种节约资源、缩短时间、并能提高针对性的科学手段。本文通过实际检测案例及试验,证实了有限元分析在系列产品中最危险样本选择、已上市产品失效原因分析及辅助优化疲劳试验中的可信性,说明了在植入器械检测中建立有限元分析检测能力的可行性;同时为保证有限元方法在植入器械检测中应用的准确性和可靠性,提出了建立有限元法相关标准的要点。

    Abstract:

    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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黄嘉华,林峰,姚天平.应用有限元检测植入器械的可行性分析[J].医用生物力学,2014,29(1):1-6

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  • 收稿日期:2014-01-01
  • 最后修改日期:2014-02-20
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  • 在线发布日期: 2014-02-24
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