Browse > Article
http://dx.doi.org/10.3837/tiis.2019.08.020

Building a Rule-Based Goal-Model from the IEC 62304 Standard for Medical Device Software  

Kim, DongYeop (Department of Electrical and Computer Engineering, Ajou University)
Lee, Byungjeong (Department of Computer Science and Engineering, The University of Seoul)
Lee, Jung-Won (Department of Electrical and Computer Engineering, Ajou University)
Publication Information
KSII Transactions on Internet and Information Systems (TIIS) / v.13, no.8, 2019 , pp. 4174-4190 More about this Journal
Abstract
IEC 62304 is a standard for the medical device software lifecycle. Developers must develop software that complies with all specifications in the standard for licensing. However, because the standard contains not only a large number of specifications, but also domain-specific information and association relationships between specifications, it requires considerable effort and time for developers to understand and interpret the standard. To support developers, this paper presents a method for extracting the contents of the IEC 62304 standard as a goal model, which is the core methodologies of requirements engineering. The proposed method analyzes the grammar of the standard to robustly extract complex structures and various information from standard specifications and define rules that extract goals and links from syntactic element units. We validated the actual extraction process for the standard document experimentally. Based on the extracted goal model, developers can intuitively and efficiently comply with the standard and track specific information within the medical software and standard domains.
Keywords
Goal Model; IEC 62304; Medical Device; Software; Requirements Engineering;
Citations & Related Records
연도 인용수 순위
  • Reference
1 Fayoumi, Amjad, Evangelia Kavakli, and Pericles Loucopoulos, "Towards a unified meta-model for goal oriented modelling," in Proc. of the 12th European, Mediterranean & Middle Eastern Conference on Information Systems (EMCIS), 2015.
2 Acher, Mathieu, et al., "On extracting feature models from product descriptions," in Proc of the Sixth International Workshop on Variability Modeling of Software -Intensive Systems. ACM, pp. 45-54, 2012.
3 Rauf, Rehan, Michal Antkiewicz, and Krzysztof Czarnecki, "Logical structure extraction from software requirements documents," in Proc. of IEEE 19th International Requirements Engineering Conference, 2011.
4 Arora, Chetan, et al., "Extracting domain models from natural-language requirements: approach and industrial evaluation," in Proc. of the ACM/IEEE 19th International Conference on Model Driven Engineering Languages and Systems. ACM, pp. 250-260, 2016.
5 Shimada, Hironori, Hiroyuki Nakagawa, and Tatsuhiro Tsuchiya, "Constructing a Goal Model from Requirements Descriptions Based on Extraction Rules," in Proc. of Asia Pacific Requirements Engineering Conference. Springer, pp. 175-188, 2017.
6 Lee, Jonathan, Nien-Lin Xue, and Jong-Yih Kuo, "Structuring requirement specifications with goals," Information and Software Technology, Vol 43. No.2, pp. 121-135, 2001.   DOI
7 Nguyen, Tuong Huan, John Grundy, and Mohamed Almorsy, "Rule-based extraction of goal-use case models from text," in Proc. of the 2015 10th Joint Meeting on Foundations of Software Engineering. ACM, pp. 591-601, 2015.
8 Halliday, Michael Alexander Kirkwood, Christian Matthiessen, and Michael Halliday, An introduction to functional grammar, Routledge, 2014.
9 IEC, IEC 62304 - Medical Device Software Life-Cycle Processes, IEC, Geneva, 2015.
10 Imagawa, Kuniki, Yoshiaki Mizukami, and Seiko Miyazaki, "Regulatory convergence of medical devices: a case study using ISO and IEC standards," Expert review of medical devices, Vol 15, No.7, pp.497-504, 2018.   DOI
11 GSN Working Group, GSN COMMUNITY STANDARD, GSN, UK, 2011.
12 DongYeop Kim, Byungjeong Lee, Jung-Won Lee, "Methods for Providing and Evaluating Software R&D Documentation Guideline based on Extracting Requirements of ISO/IEC 12207," KSII 2018, Vol 19, No.1, pp 1-2, April 28, 2018   DOI
13 Stirbu, Vlad, and Tommi Mikkonen, "Towards Agile Yet Regulatory-Compliant Development of Medical Software," in Proc. of 2018 IEEE International Symposium on Software Reliability Engineering Workshops (ISSREW). IEEE, 2018.
14 Laukkarinen, Teemu, Kati Kuusinen, and Tommi Mikkonen, "Regulated software meets DevOps," Information and Software Technology, Vol 97, pp 176-178, May, 2018   DOI
15 DongYeop Kim, Ye-Seul Park, Byungjeong Lee, Jung-Won Lee, "Methods of Extracting and Providing R&D Documentation Guideline for Licensing Medical Device Software," in Proc. of KSII The 13th Asia Pacific International Conference on Information Science and Technology(APIC-IST), pp.1-3, Jung 24-27, 2018.
16 Weber-Jahnke, Jens H., and Adeniyi Onabajo, "Mining and analysing security goal models in health information systems," in Proc. of the 2009 ICSE Workshop on Software Engineering in Health Care. IEEE Computer Society, 2009.
17 ISO and IEC, ISO/IEC 15504-4:2004, Information technology - Process assessment - Part 4: Guidance on use for process improvement and process capability determination, ISO and IEC, Geneva, 2004.
18 Lepmets, M., Clarke, P., McCaery, F., Finnegan, A., & Dorling, A., "Development of MDevSPICE the medical device software process assessment framework," Journal of Software: Evolution and Process, 27(8), 565-572, 2015.   DOI
19 Cleland-Huang, Jane, et al., "Automated classification of non-functional requirements," Requirements Engineering, Vol 12. No.2, pp. 103-120, 2007.   DOI
20 Ghosh, Shalini, et al., "Automatically extracting requirements specifications from natural language," CoRR, abs/1403.3142, 2014.