한국신뢰성학회지:신뢰성응용연구 (Journal of Applied Reliability)

  • 제15권1호
  • /
  • Pages.27-32
  • /
  • 2015
  • /
  • 1738-9895(pISSN)
  • /
  • 2733-8320(eISSN)
한국신뢰성학회 (The Korean Reliability Society)
권호 표지

필수성능 분석을 통한 효율적인 의료기기 기능안전 접근 방안

Efficient Approaches of Functional Safety for Medical Equipment using Essential Performance Analysis

  • 김기영 (아주대학교 산업공학과) ;
  • 유기훈 (아주대학교 산업공학과) ;
  • 박호준 (한국산업기술시험원 의료기기평가센터) ;
  • 장중순 (아주대학교 산업공학과)
  • Kim, Gi-Young (Department of Industrial Engineering, Ajou University) ;
  • Yoo, Ki-Hoon (Department of Industrial Engineering, Ajou University) ;
  • Park, Ho-Joon (Medical Device Evaluation Center, Korea Testing Laboratory) ;
  • Jang, Joong-Soon (Department of Industrial Engineering, Ajou University)
  • 투고 : 2014.11.17
  • 심사 : 2015.01.14
  • 발행 : 2015.03.25
PDF 다운로드
⟨ 이전 논문 다음 논문 ⟩

초록

Functional safety is part of the overall safety relating to the equipment under control (EUC) and the EUC control system that depends on the correct functioning of the electrical/electronic/programmable electronic (E/E/PE) safety-related systems. Since the complexity of the medical equipment is increased, manufactures have to obtain functional safety as well as basic safety. This study proposes a perspective for applying functional safety to medical equipment. The research is carried out with respect to overall safety life-cycle of functional safety and essential performance of the medical equipment. The relationship between functional safety and essential performance is identified centered on the safety function. The essential performance using E/E/PE systems is defined as a safety function of functional safety. This approach is applied to a ultrasound imaging system as a case study.

키워드

참고문헌

  1. Burton, J., McCaffery, F., and Richardson, I. (2006), A risk management capability model for use in medical device companies, Proceedings of the 2006 international workshop on Software quality, pp. 3-8.
  2. Chadwick, L., Fallon, E. F., van der Putten, W. J. and Kirrane, F. (2012), Functional safety of health information technology, Health informatics journal, Vol. 18, No. 1, pp. 36-49. https://doi.org/10.1177/1460458211432587
  3. International Electrotechnical Commission(IEC) (2006), IEC 62304 ed1.0 Medical device software - Software life cycle processes.
  4. International Electrotechnical Commission(IEC) (2007), IEC 60601-2-37 ed2.0 Medical electrical equipment-Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
  5. International Electrotechnical Commission(IEC) (2010), IEC 61508-1 ed2.0 Functional safety of electrical/electronic/ programmable electronic safety-related systems-Part 1: General requirements.
  6. International Electrotechnical Commission(IEC) (2012), IEC 60601-1 ed3.1 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance.
  7. International Electrotechnical Commission(IEC) (2012), IEC 60601-2-4 ed3.0 Medical electrical equipment-Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators.
  8. International Organization for Standardization(ISO) (2007), ISO 14971, Medical devices-Application of risk management to medical devices.
  9. Jordan, P. (2006), Standard IEC 62304-Medical device software-Software lifecycle processes, In Software for Medical Devices, 2006. The Institution of Engineering and Technology Seminar on (pp. 41-47). IET.
  10. Kim, G. Y., Ko, B. G., Chan, S. I., and Jang, J. S. (2010), Assessment Procedure of Safety Integrity Level(SIL) Based on Flowchart, Journal of Applied Reliability, Vol. 10, No. 2, pp. 107-122.
  11. Klumper, M. and Vollebregt, E. (2009), Navigating the New EU Rules for Medical Devices Software, RAJ Devices, Vol. 17, pp. 1-8.
  12. McCaffery, F., Clarke, P., and Lepmets, M. (2014), A Lightweight Assessment Method for Medical Device Software Processes, In Software Process Improvement and Capability Determination (pp. 144-156). Springer International Publishing.
  13. Nabeshima, C., Kawamoto, H., and Sankai, Y. (2011), Typical risks and protective measures of wearable walking assistant robots, In System Integration (SII), 2011 IEEE/SICE International Symposium on (pp. 914-919), IEEE.
  14. Newnham, J. P., Evans, S. F., Michael, C. A., Stanley, F. J., and Landau, L. I. (1993), Effects of frequent ultrasound during pregnancy: a randomised controlled trial, The Lancet, Vol. 342, No. 8876, pp. 887-891. https://doi.org/10.1016/0140-6736(93)91944-H
  15. Silberberg, J. L. (2010), Experience with EMC Problem Reports, Standards, and Guidance. US Food and Drug Administration(FDA) Center for Devices and Radiological.
  16. Tomizawa, Y. (2005), Clinical benefits and risk analysis of topical hemostats: a review, Journal of Artificial Organs, Vol. 8, No. 3, pp. 137-142. https://doi.org/10.1007/s10047-005-0296-x
  17. Weininger, S., Kapur, K. C., and Pecht, M. (2010), Exploring medical device reliability and its relationship to safety and effectiveness, Components and Packaging Technologies, IEEE Transactions on, Vol. 33, No. 1, pp. 240-245. https://doi.org/10.1109/TCAPT.2010.2044093