Formal safety analysis and the software engineering process in the pacemaker industry

D. Santel, C. Trautmann, W. Liu
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引用次数: 3

Abstract

The increasing application of software-based systems to safety-critical processes has necessitated the integration of safety into the software-development process. An example from the cardiac pacemaker industry of this safety-oriented software design methodology is provided. Safety considerations begin on product description with the hazard analysis, whereby potential hazards are classified according to their criticality and qualitative probability of occurrence. The completed hazard analysis determines the software safety requirements, which specify what the system will not do. A system hazard cross-check matrix is defined that serves to direct the design team to those areas requiring more scrutiny. Finally, traceability matrices provide a verifiable link from safety requirements through design to the actual code. This methodology should serve to minimize hazards in the final software product.<>
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起搏器行业的正式安全分析和软件工程流程
基于软件的系统越来越多地应用于安全关键过程,这使得将安全集成到软件开发过程中成为必要。以心脏起搏器行业为例,给出了这种以安全为导向的软件设计方法。安全考虑从产品描述开始,进行危害分析,根据潜在危害的严重性和发生的定性概率对其进行分类。完成的危害分析确定了软件安全需求,它指定了系统不会做的事情。定义了一个系统危害交叉检查矩阵,用于指导设计团队到那些需要更多检查的领域。最后,可追溯性矩阵提供了从安全需求到设计到实际代码的可验证链接。这种方法应该用于最小化最终软件产品中的危害。
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Formal safety analysis and the software engineering process in the pacemaker industry Predicting computer behavior An approach to software safety analysis in a distributed real-time system A case study of system integrity for alcohol taxation Present and future safety challenges of computer control
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