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Demonstrating that medical devices satisfy user related safety requirements

Lookup NU author(s): Professor Michael HarrisonORCiD


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One way of contributing to a demonstration that a medical device is acceptably safe is to show thatthe device satisfies a set of requirements known to mitigate hazards.This paper describes experience using formal techniques to model an IV infusion device andto prove that the modelled device captures a set of requirements. The requirements chosen forthe study are based on a draft proposal developed by the US Food and Drug Administration (FDA). Amajor contributor to device related errors are (user) interaction errors. For this reason the chosen models andrequirements focus on user interface related issues.

Publication metadata

Author(s): Harrison MD, Masci P, Campos JC, Curzon P

Editor(s): Huhn, M; Williams, L

Publication type: Book Chapter

Publication status: Published

Book Title: Software Engineering in Health Care: proceedings of FHIES 2014 / SEHC 2014

Year: 2017

Volume: 9062

Pages: 113-128

Online publication date: 27/07/2017

Acceptance date: 12/07/2014

Series Title: Lecture Notes in Computer Science

Publisher: Springer


DOI: 10.1007/978-3-319-63194-3_8

Library holdings: Search Newcastle University Library for this item

ISBN: 9783319631936