• KSII Transactions on Internet and Information Systems (TIIS)
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• v.13 no.8
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• pp.4174-4190
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• 2019

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.

• Journal of Internet Computing and Services
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• v.20 no.3
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• pp.69-75
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• 2019

The safety and performance of medical device software is managed through life-cycle processes, which represent the entire process of research and development (R&D). The life-cycle process of medical device software is represented by an international standard called IEC 62304, ISO/IEC 12207. In order to license the product, the manufacturer must have document artifacts that comply with the IEC 62304 standard. However, these standards only describe the content of the activity and do not provide a method or procedure for documentation. Therefore, this paper suggests R&D documentation guidelines that assist medical device software developers to have R&D documents conforming to the standards. For this purpose, this study identifies the requirements related to documentation among the requirements existing in the standard and extracts them in the form of guidelines showing only the core information of the requirements. In addition, through the Web framework implemented based on this research, the developer can evaluate whether the technical documents are written in accordance with the R&D document guidelines. Medical device software manufacturers can efficiently produce high-quality research and development documents through R&D documentation guidelines, and they can have standards-compliantresearch and development documentation required for licensing procedures.

• Proceedings of the Korea Information Processing Society Conference
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• 2006.11a
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• pp.571-574
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• 2006

2006년 5월 국제전기기술위원회(International Electrotechnical Commission, IEC) TC62(의료용전기기기기술위원회) SC62A(의료용전기기기 공통특성에 관한 세부분과위원회)에서 의료기기 소프트웨어의 생명주기 프로세스에 관한 국제규격인 IEC 62304, Ed.1을 제정하였다. 전체 내용은 크게 일반적인 요구사항(General requirements)과 소프트웨어 개발과 유지보수에 대한 프로세스(Software development & maintenance process)로 구성되어 있다. 그리고 소프트웨어 개발과 유지보수 프로세스가 진행되는 동안에 기본적으로 확보되어야 하는 소프트웨어 위험관리와 형상관리에 대한 프로세스 Software risk management & configuration management process)를 규정하고, 또한 문제 발생 시 이를 해결하기 위한 소프트웨어 문제 해결 프로세스(Software problem resolution process)를 규정하고 있다. 이는 기존의 정보통신 분야에서 사용되던 소프트웨어 생명주기 프로세스인 ISO/IEC 12207 규격과 외형상 많은 차이를 나타내고 있다. 이에 본 논문에서는 의료기기 소프트웨어의 생명주기 프로세스에 관한 국제규격인 IEC 652304를 분석하여 실제 의료용 소프트웨어 개발 및 유지보수 작업들이 어떠한 방식으로 이루어지는지를 분석하고, 또한 기존의 소프트웨어 생명주기 프로세스인 ISO/IEC 12207 규격과의 차이점을 비교 분석하여 본 규격에 대한 근본적인 활용 방안을 모색하고자 한다.

• Journal of Multimedia Information System
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• v.2 no.2
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• pp.241-248
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• 2015

The safety-critical software in healthcare systems needs more and more perceptive excess among human observation and computer support. It is a challenging conversion that we are fronting in confirming security in healthcare systems. Held in the center are the patients-the most important receivers of care. Patient injuries and fatalities connected to health information technologies commonly show up in the news, contrasted with tales of how health experts are being provided financial motivation to approve the products that may be generating damage. Those events are unbelievable and terrifying, however they emphasize on a crucial issue and understanding that we have to be more careful for the safety and protection of our patients.