<?xml version="1.0" encoding="UTF-8"?><xml><records><record><source-app name="Biblio" version="6.x">Drupal-Biblio</source-app><ref-type>47</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Michael Harrison</style></author><author><style face="normal" font="default" size="100%">Paolo Masci</style></author><author><style face="normal" font="default" size="100%">José Creissac Campos</style></author><author><style face="normal" font="default" size="100%">Paul Curzon</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Demonstrating that medical devices satisfy user related safety requirements</style></title><secondary-title><style face="normal" font="default" size="100%">Software Engineering in Healthcare (FHIES/SEHC 2014)</style></secondary-title><tertiary-title><style face="normal" font="default" size="100%">Lecture Notes in Computer Science</style></tertiary-title></titles><dates><year><style  face="normal" font="default" size="100%">2017</style></year><pub-dates><date><style  face="normal" font="default" size="100%">July</style></date></pub-dates></dates><urls><related-urls><url><style face="normal" font="default" size="100%">https://haslab.uminho.pt/sites/default/files/jccampos/files/harrison-fhies14.pdf</style></url></related-urls></urls><publisher><style face="normal" font="default" size="100%">Springer</style></publisher><pub-location><style face="normal" font="default" size="100%">Washington, DC, USA</style></pub-location><volume><style face="normal" font="default" size="100%">9062</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;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.&lt;/p&gt;
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