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.
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.
LI Shu, WANG Hao, REN Haiping. Study on Experimental Platform Parameters and Acceptance Criteria in
Reliability Evaluation of Ventricular Assist Devices. China Medical Devices, 2018, 33(9): 1-5.
