• 제목/요약/키워드: Medical Device Software

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의료기기 소프트웨어 테스트 위험관리 적용 방안 연구 (A Study on the Application of Risk Management for Medical Device Software Test)

  • 김세훈;이종록;정동훈;박희병
    • 한국정보통신학회:학술대회논문집
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    • 한국정보통신학회 2012년도 추계학술대회
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    • pp.495-497
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    • 2012
  • 의료기기 소프트웨어 테스트 위험관리 적용 방안에 대해 연구하였다. 먼저 설문조사를 통해 의료기기 제조업체의 소프트웨어 밸리데이션 및 위험관리 현황을 분석하고 두 번째로 블랙박스 테스트와 화이트 박스 테스트를 비교하여 차이점을 분석하였다. 세 번째로 소프트웨어 분석 도구를 활용한 코드 분석 후 잠재적인 위해요인을 도출하고 이를 정량화 하였으며, 마지막으로 도출된 위해요인을 FMEA 기법을 이용하여 의료기기 위험관리 프로세스에 적용할 수 있도록 프레임워크를 구축하였다. 이를 통해 의료기기 품질관리(GMP) 업무 중 소프트웨어 밸리데이션 및 위험관리 프로세스를 구축하기 어려운 제조업체를 위한 업무 지원에 활용하고자 한다.

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인공호흡기 원격 통합 모니터링 및 제어 시스템 개발을 위한 소프트웨어 위험관리 및 사이버보안 (Software Risk Management and Cyber Security for Development of Integrated System Remotely Monitoring and Controlling Ventilators)

  • 정지용;김유림;장원석
    • 대한의용생체공학회:의공학회지
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    • 제44권2호
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    • pp.99-108
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    • 2023
  • According to the COVID-19, development of various medical software based on IoT(Internet of Things) was accelerated. Especially, interest in a central software system that can remotely monitor and control ventilators is increasing to solve problems related to the continuous increase in severe COVID-19 patients. Since medical device software is closely related to human life, this study aims to develop central monitoring system that can remotely monitor and control multiple ventilators in compliance with medical device software development standards and to verify performance of system. In addition, to ensure the safety and reliability of this central monitoring system, this study also specifies risk management requirements that can identify hazardous situations and evaluate potential hazards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have serious consequences for patient safety. As a result, we obtained medical device software manufacturing certificates from MFDS(Ministry of Food and Drug Safety) through technical documents about performance verification, risk management and cybersecurity application.

의료기기 소프트웨어 위험관리를 위한 개발생명주기 기반 위험관리 요구사항 연관성 분석 (Development Life Cycle-Based Association Analysis of Requirements for Risk Management of Medical Device Software)

  • 김동엽;박예슬;이정원
    • 정보처리학회논문지:소프트웨어 및 데이터공학
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    • 제6권12호
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    • pp.543-548
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    • 2017
  • 최근에는 의료기기의 구성 요소 중 소프트웨어의 기능과 역할이 커지고, 의료기기 소프트웨어의 작동이 사용자의 생명과 안전에 직결되는 특성으로 인해 의료기기 소프트웨어의 안전성 보장에 대한 중요함은 더욱 강조되고 있다. 이를 위해 의료기기의 안전성을 효과적으로 보장할 수 있는 활동과 각각의 요구사항들을 제시하고 있는 여러 표준이 제정되었다. 표준들이 의료기기 소프트웨어의 안전성을 보장하기 위해 제시하는 활동으로는 크게 의료기기 소프트웨어의 개발생명주기와 위험관리 프로세스로 나뉜다. 이 두 활동은 개발 과정 중 동시에 진행되어야 하지만, 의료기기 소프트웨어 개발생명주기의 각 단계에서 수행되어야하는 위험관리 요구사항들은 분류되어있지 않다는 한계점이 있다. 이로 인해 개발자들은 의료기기 개발 중에 직접 표준들의 연관성을 분석하여 위험관리 활동을 수행해야한다. 따라서 본 논문에서는 의료기기 소프트웨어 개발생명주기와 위험관리 프로세스의 연관성을 분석하고, 위험관리 요구사항 항목들을 추출한다. 그리고 분석한 연관성을 토대로 추출된 위험관리 요구사항 항목을 개발생명주기에 대응시킴으로서, 의료기기 소프트웨어의 개발 중 효과적이고 체계적인 위험관리를 가능하게 한다.

기능 안전 관점에서의 의료기기 소프트웨어 신뢰성 평가 방법에 관한 연구 (Study on Reliability Assessment for the Medical Device Software from the Viewpoint of Functional Safety)

  • 김성민;고병각;도경훈;김혜진;함중걸
    • 한국신뢰성학회지:신뢰성응용연구
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    • 제16권3호
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    • pp.216-223
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    • 2016
  • Purpose: This paper suggests the procedure to enhance the reliability of the software of the medical device that is to cure, treat, diagnose, and prevent a disease or an abnormal health conditions. Methods: After test requirements are classified by the software requirements specification for safety and backgrounds, reliability assessment methods are suggested. Results: Verification and validation for function and safety can be performed whether the medical device software are implemented as intended. Conclusion: Procedure on the static analysis, unit test, integration test, and system test are provided for the medical device software.

Methods of Extracting and Providing R&D Documentation Guideline for Licensing Medical Device Software

  • Kim, DongYeop;Lee, Byungjeong;Lee, Jung-Won
    • 인터넷정보학회논문지
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    • 제20권3호
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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.

인공호흡기 중앙감시시스템 소프트웨어의 사용적합성 총괄평가 (Summative Usability Assessment of Software for Ventilator Central Monitoring System)

  • 정지용;김유림;장원석
    • 대한의용생체공학회:의공학회지
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    • 제44권6호
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    • pp.363-376
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    • 2023
  • According to the COVID-19, development of various medical software based on IoT(Internet of Things) was accelerated. Especially, interest in a central software system that can remotely monitor and control ventilators is increasing to solve problems related to the continuous increase in severe COVID-19 patients. Since medical device software is closely related to human life, this study aims to develop central monitoring system that can remotely monitor and control multiple ventilators in compliance with medical device software development standards and to verify performance of system. In addition, to ensure the safety and reliability of this central monitoring system, this study also specifies risk management requirements that can identify hazardous situations and evaluate potential hazards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have serious consequences for patient safety. As a result, we obtained medical device software manufacturing certificates from MFDS(Ministry of Food and Drug Safety) through technical documents about performance verification, risk management and cybersecurity application.The purpose of this study is to conduct a usability assessment to ensure that ergonomic design has been applied so that the ventilator central monitoring system can improve user satisfaction, efficiency, and safety. The rapid spread of COVID-19, which began in 2019, caused significant damage global medical system. In this situation, the need for a system to monitor multiple patients with ventilators was highlighted as a solution for various problems. Since medical device software is closely related to human life, ensuring their safety and satisfaction is important before their actual deployment in the field. In this study, a total of 21 participants consisting of respiratory staffs conducted usability test according to the use scenarios in the simulated use environment. Nine use scenarios were conducted to derive an average task success rate and opinions on user interface were collected through five-point Likert scale satisfaction evaluation and questionnaire. Participants conducted a total of nine use scenario tasks with an average success rate of 93% and five-point Likert scale satisfaction survey showed a high satisfaction result of 4.7 points on average. Users evaluated that the device would be useful for effectively managing multiple patients with ventilators. However, improvements are required for interfaces associated with task that do not exceed the threshold for task success rate. In addition, even medical devices with sufficient safety and efficiency cannot guarantee absolute safety, so it is suggested to continuously evaluate user feedback even after introducing them to the actual site.

의료기기 공용기술 활용 촉진을 위한 개방형 의료기기 플랫폼 개발 및 구현 (Development and Implementation of an open Medical Device Platform)

  • 김대관;홍주현;이효진
    • 대한임베디드공학회논문지
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    • 제16권6호
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    • pp.313-321
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    • 2021
  • The global market for medical devices is huge, and it will continue showing remarkable growth in the future. However, due to the entry barrier to develop medical devices, many domestic companies have technical problems in entering the medical device industry. In this paper, we introduce an open platform that can help with research and development for companies in the healthcare industry. This open platform consists of a hardware part and a software part. A hardware part is combined into CPU, base and other modules that are easy to replace and assemble. A software part is based on application software for development developed by Bionet. We test the performance of the open medical device platform using a biosignal processing algorithm.

의료용 소프트웨어생명주기 프로세스 분석 (A Analysis of Medical Device Software Life Cycle Processes)

  • 최민용;강영규;허찬회;이정림;박기정;박해대;이인수;김혁주
    • 한국정보처리학회:학술대회논문집
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    • 한국정보처리학회 2006년도 추계학술발표대회
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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.

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SaMD의 사이버보안 규제에 대한 소프트웨어 국제표준의 적용 가능성에 대한 연구 (A study on the Applicability of Software International Standards for SaMD's Cybersecurity Regulation)

  • 김이영;정영주;류규하;조백환
    • 한국IT서비스학회지
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    • 제22권4호
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    • pp.21-35
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    • 2023
  • Software as Medical Devices (SaMD) is a growing category of medical devices that are composed of software to perform one or more medical purposes. SaMD is less likely to cause physical harm compared to conventional medical devices, particularly medical electrical equipments, and may be more vulnerable to privacy issues. This difference was acknowledged and resulted in introducing new regulation guidance specifically for cybersecurity of SaMD. It guides stakeholders of SaMD what to consider in what context in terms of cybersecurity. This study examines the current guidance of how cybersecurity is considered for SaMD by analyzing current medical device standards, then suggest which concept or details beyond current medical device standards may be applicable through analysis of international standards documents published for software in general.

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

  • Kim, DongYeop;Lee, Byungjeong;Lee, Jung-Won
    • KSII Transactions on Internet and Information Systems (TIIS)
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    • 제13권8호
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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.