Requirements for a trace property language for medical devices

Abstract

The verification of software intensive medical devices can largely benefit from the analysis of their execution traces. Trace points can easily be added to the software, and traces can be used at several stages of the development and maintenance process. In this paper we focus on the TKA system and identify 15 representative properties that should be fulfilled by its traces. We also identify several stages in the product lifecycle where these properties should be evaluated. These properties put requirements on what should be expressible in a trace property language for medical devices.

Formal requirements modeling for cyber-physical systems engineering: an integrated solution based on FORM-L and Modelica

“…Another research effort regarding properties representation was conducted in the context of medical devices [29]. In particular, the authors discussed the need of having automated management of requirements by focusing on a system, called total knee arthroplasty (TKA).…”

An Environment for the ParTraP Trace Property Language (Tool Demonstration)

“…We identied 15 properties, listed in [19], representative of such medical devices for assisted surgery. These properties specify the TKA traces.…”

“…In [19], we discussed how the language can be used during development to express and check properties of traces produced by system tests, but also during exploitation in order to identify how the system is used or mis-used.…”