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Formal Verification and Safety Assessment of a Hemodialysis Machine

机译:血液透析机的正式验证和安全评估

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Given the safety-critical nature of healthcare systems, their rigorous safety assessment, in terms of studying their behavior in the presence of potential faults and how the malfunctioning components cause system failures, is of paramount importance. Traditionally, the safety assessment of a system is done analytically or using simulation based tools. However, the former is prone to human error and the later does not provide a complete analysis, which makes them inappropriate for the safety assessment of healthcare systems. These limitations can be overcome by using formal methods based safety assessment. This paper presents our experience of applying model based safety assessment and system verification tools on a hemodialysis machine. In particular, we use the nuXmv model checker to formally verify a formal model of the given hemodialysis machine. The formal model of the given system is then extended with various fault modes of the system components and the eXtended Safety Assessment Platform is used to check various undesired behaviors of the system using invariant properties defined as Top Level Events. This way, we can automatically generate the FTA and FMEA to do the safety assessment of the given hemodialysis machine.
机译:鉴于医疗保健系统的安全性,他们严格的安全评估,在潜在故障存在下的行为和故障组件的存在下,是至关重要的。传统上,系统的安全评估是在分析或使用基于仿真的工具进行的。然而,前者易于人为错误,后来不提供完整的分析,这使得它们不适合医疗保健系统的安全评估。可以使用基于正式的安全评估来克服这些限制。本文介绍了我们在血液透析机上应用基于模型的安全评估和系统验证工具的经验。特别是,我们使用NUXMV模型检查器正式验证给定血液透析机的正式模型。然后使用系统组件的各种故障模式扩展给定系统的正式模型,并且扩展安全评估平台用于使用定义为顶级事件的不变性属性来检查系统的各种不期望的行为。这样,我们可以自动生成FTA和FMEA,以对给定的血液透析机的安全评估。

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