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 |
Files in This Item:
File | Description | Size | Format | |
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P-00M-WV1.pdf | 432.8 kB | Adobe PDF | View/Open |
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