Demonstrating that medical devices satisfy user related safety requirements

Harrison, MD; Masci, P; Campos, JC; Curzon, P

doi:10.1007/978-3-319-63194-3_8

Demonstrating that medical devices satisfy user related safety requirements

Lookup NU author(s): Professor Michael Harrison ORCiD

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Abstract

One way of contributing to a demonstration that a medical device is acceptably safe is to show thatthe device satisfies a set of requirements known to mitigate hazards.This paper describes experience using formal techniques to model an IV infusion device andto prove that the modelled device captures a set of requirements. The requirements chosen forthe study are based on a draft proposal developed by the US Food and Drug Administration (FDA). Amajor contributor to device related errors are (user) interaction errors. For this reason the chosen models andrequirements focus on user interface related issues.