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.
@InProceedings{HarrisonMCC:2014, author = {M.D. Harrison and P. Masci and J.C. Campos and P. Curzon}, title = {Demonstrating that medical devices satisfy user related safety requirements}, booktitle = {Software Engineering in Healthcare (FHIES/SEHC 2014)}, series = {Lecture Notes in Computer Science}, volume = {9062}, pages = {113-128}, publisher = {Springer}, year = {2017}, doi = {10.1007/978-3-319-63194-3_8}, 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.}, paperurl = {http://www.di.uminho.pt/~jfc/publications/HarrisonCC17-FHIES2014-postprint.pdf} }
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