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.