Developing and Verifying User Interface Requirements for Infusion Pumps: A Refinement Approach

Abstract

It is common practice in the description of criteria for the acceptable safety of systems for the regulator to describe safety requirements that should be satisfied by the system. These requirements are typically described precisely but in natural language and it is often unclear how the regulator can be assured that the given requirements are satisfied. This paper is concerned with a rigorous refinement process that demonstrates that a precise requirement is satisfied by the specification of a given device. It focuses on a particular class of requirements that relate to the user interface of the device. For user interface requirements, refinement is made more complex by the fact that systems can use different interaction devices that have very different characteristics. The described refinement process recognises an input/output hierarchy.