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Towards Safety Case Integration with Hazard Analysis for Medical Devices

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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Copyright (Springer International Publishing Switzerland 2016)

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Category:
Conference activity
Type:
materiały konferencyjne indeksowane w Web of Science
Title of issue:
COMPUTER SAFETY, RELIABILITY, AND SECURITY, SAFECOMP 2016 strony 87 - 98
Publication year:
2016
Bibliographic description:
Wardziński A., Jarzębowicz A..: Towards Safety Case Integration with Hazard Analysis for Medical Devices, W: COMPUTER SAFETY, RELIABILITY, AND SECURITY, SAFECOMP 2016, 2016, Springer International Publishing,.
DOI:
Digital Object Identifier (open in new tab) 10.1007/978-3-319-45480-1_8
Verified by:
Gdańsk University of Technology

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