Software controlling medical devices is safety-critical since human safety depends upon its correct operation. Although different standards exist for the certification of medical device software, they are quite general and do not indicate which methods and techniques must be adopted to guarantee system safety and reliability. In this paper, we present a rigorous development approach, based on the Abstract State Machine formal method, which helps the designer in formalizing the requirements and mapping them to the implementation. In particular, we show how the proposed process permits to check that the implementation behaves as expected; for this purpose, we present two model-based testing techniques, working offline and online. We show the application of these two techniques to the implementation of a medical device component used to measure stereoacuity.

Model-based offline and online testing for medical software / P. Arcaini, E. Riccobene, A. Gargantini - In: Industrial Proceedings of the 23rd European & Asian System, Software & Service Process Improvement & Innovation (EuroAsiaSPI2 2016)[s.l] : WHITEBOX, 2016 Sep. - ISBN 9788799811663. - pp. 11-20 (( Intervento presentato al 23. convegno EuroAsiaSPI tenutosi a Graz nel 2016.

Model-based offline and online testing for medical software

E. Riccobene
Primo
;
2016

Abstract

Software controlling medical devices is safety-critical since human safety depends upon its correct operation. Although different standards exist for the certification of medical device software, they are quite general and do not indicate which methods and techniques must be adopted to guarantee system safety and reliability. In this paper, we present a rigorous development approach, based on the Abstract State Machine formal method, which helps the designer in formalizing the requirements and mapping them to the implementation. In particular, we show how the proposed process permits to check that the implementation behaves as expected; for this purpose, we present two model-based testing techniques, working offline and online. We show the application of these two techniques to the implementation of a medical device component used to measure stereoacuity.
Medical software; certification; formal methods; model-based testing; runtime verification
Settore INF/01 - Informatica
set-2016
Book Part (author)
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/457263
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