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Association-Based Process Integration for Compliance with Core Standards in Development of Medical Software

  • DongYeop Kim
  • Ye-Seul Park
  • Byungjeong Lee
  • Jung-Won Lee
Conference paper
Part of the Lecture Notes in Electrical Engineering book series (LNEE, volume 474)

Abstract

Several standards for medical software require systematic development to ensure safety and performance. Core standards for medical software include IEC 60601-1, IEC 62034, and ISO 14971. And they present different activities. In this case, standards consist of contents related to development by referring to contents of one another. Therefore, it is difficult for a developer to identify reference-relationships with other standards for complying with one standard. For this, there are rules and studies that assist in the reference-association, but they do not provide the requirements at a view of developer. Therefore, we propose an integrated process to comply with the core standards. The proposed process is defined by analyzing the relationship between development process and so on. Then it includes the requirements and artifacts at each stage of the integrated process. This enables systematic development of medical software by providing the activities and requirements in terms of developer’s view.

Keywords

Medical software Process integration Standard compliance 

Notes

Acknowledgments

This research was supported by Next-Generation Information Computing Development Program through the National Research Foundation of Korea (NRF) funded by the Ministry of Science, ICT & Future Planning (NRF-2014M3C4A7030504).

References

  1. 1.
    IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (2005)Google Scholar
  2. 2.
    ISO 14971:2007, Medical devices - Application of risk management to medical devicesGoogle Scholar
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    IEC 62304:2015.6, Medical device software - Software life cycle processes (2015)Google Scholar
  4. 4.
    OD-2044 Ed. 2.2. – Evaluation of Risk Management in Medical electrical equipment according to the IEC 60601-1 & IEC/ISO 80601-1 Series of Standards (2013)Google Scholar
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    Clarke, P., Lepmets, M., McCaffery, F., Finnegan, A., Dorling, A., Eagles, S.: Characteristics of a medical device software development framework. In: EuroSPI (2014)Google Scholar
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    Lepmets, M., Clarke, P., McCaffrey, F., Finnegan, A.: Development of a process assessment model for medical device software development. In: EuroSPI, Luxembourg, June 2014Google Scholar
  7. 7.
    Kim, D.Y., Park, Y.S., Lee, J.W.: Development life cycle-based association analysis of requirements for risk management of medical device software. In: KIPS, Jeju, April 2017Google Scholar

Copyright information

© Springer Nature Singapore Pte Ltd. 2018

Authors and Affiliations

  • DongYeop Kim
    • 1
  • Ye-Seul Park
    • 1
  • Byungjeong Lee
    • 2
  • Jung-Won Lee
    • 1
  1. 1.Department of Electrical and Computer EngineeringAjou UniversitySuwonRepublic of Korea
  2. 2.Department of Computer Science and EngineeringThe University of SeoulSeoulRepublic of Korea

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