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Demonstrating that medical devices satisfy user related safety requirements

Lookup NU author(s): Professor Michael Harrison

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Abstract

© Springer International Publishing AG 2017. One way of contributing to a demonstration that a medical device is acceptably safe is to show that the device satisfies a set of requirements known to mitigate hazards. This paper describes experience using formal techniques to model an IV infusion device and to prove that the modelled device captures a set of requirements. The requirements chosen for the study are based on a draft proposal developed by the US Food and Drug Administration (FDA). A major contributor to device related errors are (user) interaction errors. For this reason the chosen models and requirements focus on user interface related issues.


Publication metadata

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

Publication type: Conference Proceedings (inc. Abstract)

Publication status: Published

Conference Name: 4th International Symposium, FHIES 2014, and 6th International Workshop, SEHC 2014

Year of Conference: 2017

Pages: 113-128

Online publication date: 27/07/2017

Acceptance date: 02/04/2016

Publisher: Springer Verlag

URL: https://doi.org/10.1007/978-3-319-62392-4_38

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

Library holdings: Search Newcastle University Library for this item

Series Title: Lecture Notes in Computer Science (including subseries Lecture Notes in Artificial Intelligence and Lecture Notes in Bioinformatics)

ISBN: 9783319631936


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