Demonstrating that medical devices satisfy user related safety requirements
Lecture Notes in Computer Science 9062
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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.
AuthorsHarrison, MD; MASCI, P; Campos, JC; CURZON, P; Software Engineering in Health Care, Proceedings of the 4th Symposium on Foundations of Health Information Engineering and Systems (FHIES) and the 6th International Workshop on Software Engineering in Healthcare (SEHC)
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