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Error Type Refinement for Assurance of Families of Platform-Based Systems

  • Sam Procter
  • John Hatcliff
  • Sandy Weininger
  • Anura Fernando
Conference paper
Part of the Lecture Notes in Computer Science book series (LNCS, volume 9338)

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.

Keywords

Interoperable medical systems Hazard analyses Faults Errors Reusable components and assurance 

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Copyright information

© Springer International Publishing Switzerland 2015

Authors and Affiliations

  • Sam Procter
    • 1
  • John Hatcliff
    • 1
  • Sandy Weininger
    • 2
  • Anura Fernando
    • 3
  1. 1.Kansas State UniversityManhattanUSA
  2. 2.United States Food and Drug AdministrationSilver SpringUSA
  3. 3.Underwriters LaboratoriesChicagoUSA

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