Please use this identifier to cite or link to this item: http://repositorio.inesctec.pt/handle/123456789/4636
Title: Demonstrating that Medical Devices Satisfy User Related Safety Requirements
Authors: Harrison,MD
Paolo Masci
José Creissac Campos
Curzon,P
Issue Date: 2014
Abstract: 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. © Springer International Publishing AG 2017.
URI: http://repositorio.inesctec.pt/handle/123456789/4636
http://dx.doi.org/10.1007/978-3-319-63194-3_8
metadata.dc.type: conferenceObject
Publication
Appears in Collections:HASLab - Articles in International Conferences

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