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2017 | OriginalPaper | Chapter

A Hazard Analysis Method for Systematic Identification of Safety Requirements for User Interface Software in Medical Devices

Authors : Paolo Masci, Yi Zhang, Paul Jones, José C. Campos

Published in: Software Engineering and Formal Methods

Publisher: Springer International Publishing

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Abstract

Formal methods technologies have the potential to verify the usability and safety of user interface (UI) software design in medical devices, enabling significant reductions in use errors and consequential safety incidents with such devices. This however depends on comprehensive and verifiable safety requirements to leverage these techniques for detecting and preventing flaws in UI software that can induce use errors. This paper presents a hazard analysis method that extends Leveson’s System Theoretic Process Analysis (STPA) with a comprehensive set of causal factor categories, so as to provide developers with clear guidelines for systematic identification of use-related hazards associated with medical devices, their causes embedded in UI software design, and safety requirements for mitigating such hazards. The method is evaluated with a case study on the Gantry-2 radiation therapy system, which demonstrates that (1) as compared to standard STPA, our method allowed us to identify more UI software design issues likely to cause use-related hazards; and (2) the identified UI software design issues facilitated the definition of precise, verifiable safety requirements for UI software, which could be readily formalized in verification tools such as Prototype Verification System (PVS).

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previous chapter On Approximate Diagnosability of Metric Systems

next chapter Modular Verification of Information Flow Security in Component-Based Systems

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Title: A Hazard Analysis Method for Systematic Identification of Safety Requirements for User Interface Software in Medical Devices
Authors: Paolo Masci
Yi Zhang
Paul Jones
José C. Campos
Publisher: Springer International Publishing
Book: Software Engineering and Formal Methods
Print ISBN: 978-3-319-66196-4

Electronic ISBN: 978-3-319-66197-1

Copyright Year: 2017
DOI: https://doi.org/10.1007/978-3-319-66197-1_18

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