Demonstrating that medical devices satisfy user related safety requirements

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.FEDER - Federación Española de Enfermedades Raras(000062)This work has been funded by the EPSRC research grant EP/G059063/1: CHI+MED (Computer–Human Interaction for Medical Devices). J. C. Campos was funded by project NORTE-07-0124-FEDER-00006

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This paper was published in Universidade do Minho: RepositoriUM.

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