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Towards Safety Case Integration with Hazard Analysis for Medical Devices

  • Andrzej Wardziński
  • Aleksander Jarzębowicz
Conference paper
Part of the Lecture Notes in Computer Science book series (LNCS, volume 9923)

Abstract

Safety case is one of system safety lifecycle products and should be consistent with other lifecycle products like hazard analysis results. In this paper we present a method of safety case integration with hazard tables based on the use of parametrized argument patterns. We describe a hazard table metamodel, a safety argument pattern and a mechanism of pattern instantiation using a linking table which represents references to system lifecycle artefacts. We report and comment results of a feasibility study of pattern application for medical device hazard analysis. Finally we discuss the opportunities of applying such solution to safety case development and maintenance and the perspectives of further development of this approach.

Keywords

Safety case Hazard table Safety argument pattern Infusion pump Medical device 

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Copyright information

© Springer International Publishing Switzerland 2016

Authors and Affiliations

  • Andrzej Wardziński
    • 1
    • 2
  • Aleksander Jarzębowicz
    • 1
    • 2
  1. 1.Department of Software Engineering, Faculty of Electronics, Telecommunications and InformaticsGdańsk University of TechnologyGdańskPoland
  2. 2.Argevide sp. z o.o.GdańskPoland

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