中国医疗设备2018，Vol.33Issue(9)：1-5,18,6.DOI:10.3969/j.issn.1674-1633.2018.09.001
心室辅助装置可靠性试验设计和接受准则的研究
Study on Experimental Platform Parameters and Acceptance Criteria in Reliability Evaluation of Ventricular Assist Devices
摘要
Abstract
Objective Reliability is a prerequisite for clinical use of left ventricular assist devices. It is a key factor that affects patient safety and determines the expected clinical outcome for patients. In this paper, two key factors (experimental platform parameters and acceptance criteria) determining the success of LVAD reliability test were discussed. The former defined the external environment and platform for the left ventricular assist device in reliability testing, and the latter provided the criteria for evaluating the left ventricular assist reliability. Methods The paper first analyzed the human load stress in the reliability test of the left ventricular assist device, and determined the threshold and distribution of the key stress under the low, middle and high load conditions of the reliability test. Secondly, the acceptance criteria of reliability test were discussed. The acceptance criteria not only included the evaluation analysis strategy after the reliability test, but also included the possible failures in the reliability test. Results The reliability test platform was successfully built to verify the system. According to the risk, the faults were divided into four categories, and the acceptance criteria were clearly defined. After the test, the key indicators of the performance evaluation were set up. Conclusion This platform can solve the problem that there is no unified evaluation platform and standard for high-risk ventricular assist devices in China, and improve the scientific evaluation ability of reliability of this kind of products.关键词
心室辅助装置/可靠性/试验平台设计/人体负载/接受准则Key words
ventricular assist devices/reliability evaluation/experimental platform parameters/body load stress/acceptance criteria分类
医药卫生引用本文复制引用
李澍,王浩,任海萍..心室辅助装置可靠性试验设计和接受准则的研究[J].中国医疗设备,2018,33(9):1-5,18,6.基金项目
国家重点研发计划(2016YFC0103201). （2016YFC0103201）
