Error type refinement for assurance of families of platform-based systems

Abstract

Medical Application Platforms (MAPs) are an emerging paradigm for developing interoperable medical systems. Existing assurance-related concepts for conventional medical devices including hazard analyses, risk management processes, and assurance cases need to be enhanced and reworked to deal with notions of interoperability, reuse, and compositionality in MAPs. In this paper, we present the motivation for a framework for defining and refining error types associated with interoperable systems and its relevance to safety standards development activities. This framework forms the starting point for the analysis and documentation of faults, propagations of errors related to those faults, and their associated hazards and mitigation strategies—all of which need to be addressed in risk management activities and assurance cases for these systems.