Demonstrating that medical devices satisfy user related safety requirements

Citation:
Harrison M, Masci P, Campos JC, Curzon P.  2017.  Demonstrating that medical devices satisfy user related safety requirements. Software Engineering in Healthcare (FHIES/SEHC 2014). 9062 copy at www.tinyurl.com/ydd94a5h

Tertiary Title:

Lecture Notes in Computer Science

Date Presented:

July

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.

Citation Key:

HarrisonMCC:2014
PreviewAttachmentSize
harrison-fhies14.pdf307.36 KB