대한의용생체공학회:의공학회지 (Journal of Biomedical Engineering Research)

  • 제44권3호
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  • Pages.190-203
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  • 2023
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  • 1229-0807(pISSN)
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  • 2288-9396(eISSN)
대한의용생체공학회 (The Korean Society of Medical and Biological Engineering)
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하지 로봇재활의료기기의 안전성 및 필수성능 평가 기준 개발

The Development of Safety and Essential Performance Criteria for Lower Extremity Robotic Assisted Gait Training System

  • 강용완 (충북대학교 일반대학원 의용생체공학협동과정) ;
  • 권지연 (동국대학교 의료기기산업학과)
  • Yong Wan Kang (Interdisciplinary Program in Biomedical Engineering, Graduate School of Chungbuk National University) ;
  • Ji Yean Kwon (Department of Medical Device and Healthcare, Graduate School of Dongguk University )
  • 투고 : 2023.05.17
  • 심사 : 2023.06.19
  • 발행 : 2023.06.30
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초록

The purpose of this study is to provide basic data to ensure the safety and essential performance of a Lower Extremity robotic assisted gait training system and to provide advanced technology and technical basis to the industry handling the system. Based on IEC 60601-1:2012/AMD2:2020 (Medical Electrical Equipment - General requirements for basic safety and essential performance of medical electrical equipment), IEC 62366-1:2015/AMD1:2020 (Medical devices - Part 1: Application of usability engineering to medical devices) and EN ISO 14971:2019 (Medical devices - Application of risk management to medical devices), the requirements for ensuring the safety and essential performance of the Lower Extremity robotic assisted gait training system were derived. Through the Delphi survey method and scenario analysis, which reflects the opinions and knowledge of experts in the fields of development, testing and review of technical documents, and quality assurance of medical devices, validity and reliability were conducted and obtained results with adequate content validity ratio (CVR; 0.7≤) and excellent reliability (Cronbach's α; 0.9≤). As a result, it was confirmed that the reliability and validity of the risk management process to ensure the safety and essential performance of the Lower Extremity robotic assisted gait training system are required a model can be established to provide measures to reduce risks according to the level of risk exposure caused by usage.

키워드

과제정보

본 연구는 한국보건산업진흥원의 의료기기산업특성화대학원 지원사업의 지원을 받아 수행되었으며 이에 감사드립니다.

참고문헌

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