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Towards Safety Case Integration with Hazard Analysis for Medical Devices

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Computer Safety, Reliability, and Security (SAFECOMP 2016)

Part of the book series: Lecture Notes in Computer Science ((LNPSE,volume 9923))

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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.

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Authors and Affiliations

  1. Department of Software Engineering, Faculty of Electronics, Telecommunications and Informatics, Gdańsk University of Technology, Narutowicza 11/12, 80-233, Gdańsk, Poland

    Andrzej Wardziński & Aleksander Jarzębowicz

  2. Argevide sp. z o.o., Gdańsk, Poland

    Andrzej Wardziński & Aleksander Jarzębowicz

Authors
  1. Andrzej Wardziński
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  2. Aleksander Jarzębowicz
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Corresponding author

Correspondence to Aleksander Jarzębowicz .

Editor information

Editors and Affiliations

  1. Norwegian University of Science and Technology, Trondheim, Norway

    Amund Skavhaug

  2. University of Toulouse, Toulouse, France

    Jérémie Guiochet

  3. Austrian Institute of Technology GmbH, Wien, Austria

    Erwin Schoitsch

  4. Thales Transportation Systems GmbH, Ditzingen, Germany

    Friedemann Bitsch

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Wardziński, A., Jarzębowicz, A. (2016). Towards Safety Case Integration with Hazard Analysis for Medical Devices. In: Skavhaug, A., Guiochet, J., Schoitsch, E., Bitsch, F. (eds) Computer Safety, Reliability, and Security. SAFECOMP 2016. Lecture Notes in Computer Science(), vol 9923. Springer, Cham. https://doi.org/10.1007/978-3-319-45480-1_8

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  • DOI: https://doi.org/10.1007/978-3-319-45480-1_8

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-45479-5

  • Online ISBN: 978-3-319-45480-1

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