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A Certification-Based Modeling Approach of Medical Cyber-Physical Systems: An Insulin Infusion Pump Case Study

机译:医疗网络系统的认证 - 医学网络 - 物理系统的建模方法:胰岛素输注泵箱案例研究

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Medical Cyber-Physical Systems (MCPS) are safety-critical systems composed of hardware and software components that interact one each other and with the environment. Interactions of system and environment generate emergent properties that manufacturers should analyze to avoid hazard situations. The main contribution presented in this paper is a certification-based modeling approach of MCPS described by means of an insulin infusion pump case study. The modeling approach combines assurance cases in modular Goal Structuring Notation (GSN) and formal modeling tools to carry out a model-driven and goal-oriented requirements engineering. Assurance case models in modular GSN are specified along with requirements of an infusion pump system based on formal methods, and an Arduino prototype was designed during the case study. Manufacturers may reuse the approach as a source of safety and effectiveness evidence during a certification process.
机译:医疗网络 - 物理系统(MCP)是由硬件和软件组件组成的安全关键系统,它互相交互和环境。 系统和环境的相互作用产生了制造商应分析以避免危险情况的紧急性质。 本文提出的主要贡献是通过胰岛素输液泵壳体研究描述的基于MCP的基于MCP的建模方法。 建模方法在模块化目标结构质符号(GSN)和正式建模工具中结合了保证情况,以执行模型驱动和面向目标的需求工程。 模块化GSN中的保证案例模型以及基于正式方法的输液泵系统的要求,以及在案例研究期间设计了Arduino原型。 制造商可以在认证过程中重用该方法作为安全和有效证据的源。

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