[논문]인공호흡기 원격 통합 모니터링 및 제어 시스템 개발을 위한 소프트웨어 위험관리 및 사이버보안

정지용; 김유림; 장원석

doi:10.9718/jber.2023.44.2.99

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 원문보기

Journal of biomedical engineering research : the official journal of the Korean Society of Medical & Biological Engineering, v.44 no.2, 2023년, pp.99 - 108

정지용 (연세대학교 대학원 의료기기산업학과) , 김유림 (연세대학교 대학원 의료기기산업학과) , 장원석 (연세대학교 대학원 의료기기산업학과)

Abstract ▼ AI-Helper

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.

주제어

표/그림 (9)

그림 그림 1. 모니터링 시스템의 서버 구성도 Fig. 1. Server Structure of Monitoring System
그림 그림 2. 시스템 기능 (a) 호흡 파라미터 모니터링 (b) 데이터 트랜드 리뷰 (c) 이벤트 알람 리뷰 (d) 파라미터 알람 한도 원격 제어 Fig. 2. System Function (a) Respiratory Parameter Monitoring (b) Data Trend Review (c) Event Alarm Review (d) Parameter Alarm Limit Remote Control
표 표 1. 식약처 환자중앙감시장치[2] 안전성 정보 Table 1. MFDS Central Monitoring System[2] Safety Information
표 표 2. 소프트웨어 밸리데이션 관련 규격 Table 2. Software validation relevant standards
표 표 3. 성능 평가 결과 Table 3. Result of Performance Evaluation
표 표 4. 위험 평가 결과 Table 4. Results of risk assessment
표 표 5. 소프트웨어 항목별 각 위험스러운 상황 및 위해의 심각도와 발생가능성 Table 5. The Severity and Probability of Failure of each Hazardous Situation by Software Items.
표 표 6. 의료기기 사이버보안 요구사항 체크리스트 검토 결과 Table 6. Result of the Reviewing Medical Device Cybersecurity Requirements Checklist
표 표 6. Continued Table 6. Continued

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