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|Title:||Demonstrating that Medical Devices Satisfy User Related Safety Requirements|
José Creissac Campos
|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.|
|Appears in Collections:||HASLab - Articles in International Conferences|
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