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本文根据七个医院应用埋藏式心脏起搏器的失效数据,使用失效树方法分析了国产起搏器的失效原因及其临界失效率;用边缘性能分析法举例计算了电子元器件在有参数公差且公差带分布又是时间的函数的情况下,由元器件组装成的电路可能发生的边缘状态。本文还根据具体的现场反馈数据证明起搏器的失效率为威布尔分布,并用无偏估计法对它们的寿命作出点估计,求出它们的统计特征寿命为16.6个月,并给出任何时间的可靠度及失效率的计算公式。本文讨论了产品的保用期,提出了一种求保用期的计算方法. 最后,作者根据起搏器的特点,国内外有关标准及现状,提出了不应当根据失效率来确定起搏器质量等级的意见。
Based on the failure data of the implanted pacemakers in seven hospitals, this paper analyzes the failure causes and the critical failure rate of domestic pacemakers by using the failure tree method. By using the edge analysis method, And the distribution of the tolerance band is again a function of time, edge states that may occur in circuits assembled from components. This paper also proves that the failure rate of pacemaker is Weibull distribution according to the specific on-site feedback data, and makes a point estimation of their life expectancy by unbiased estimation method, finding their statistical characteristic life is 16.6 months and gives any time The reliability and failure rate of the formula. This article discusses the warranty period of the product and proposes a method of calculating the warranty period.Finally, according to the characteristics of the pacemaker and relevant standards at home and abroad, the author puts forward that the pacemaker should not be determined according to the failure rate Quality rating advice.