Safetrace

Abstract

Requirements management and safety analysis have been the key foundations of the successful development of life-critical systems, and the traceability of safety-related artifacts across such systems is becoming ever more important. Unless safety analysts can trace when and how requirements and design change, their analysis will become inconsistent, and eventually fail as proof that a given system can mitigate certain faults during certification processes. However, most prior research on traceability has focused on requirements, design and source code changes, rather than the integration of safety analysis by considering device interactions such as the Medical Device plug-and-play (MD PnP) into traceability and change-impact analysis. To help fill this gap, this paper proposes a safety-driven requirement traceability framework, SafeTrace, that traces the relations between safety requirements, design, and safety analysis, and the impact of requirement and design changes on safety analysis for life-critical systems with a focus on medical device interaction hazards.