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.
A preliminary version of this paper appeared in KSII The 10th International Conference on Internet (ICONI) 2018, December 16-19, Phnom Penh, Cambodia. This version includes a concrete analysis and supporting implementation results on extracting Goal-Model from IEC 62304. 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) and supported by the MSIT(Ministry of Science and ICT), Korea, under the ITRC(Information Technology Research Center) support program(IITP-2019-2016-0-00309) supervised by the IITP(Institute for Information & communications Technology Promotion).
