DOI QR코드

DOI QR Code

수지형 체외식 초음파 프로브의 성능 평가 가이드라인 개발

Development of a Guideline for Performance Evaluation of External Hand-Held Ultrasonic Probe

  • 김산 ;
  • 황윤수 (식품의약품안전평가원 의료기기연구과) ;
  • 손대웅 (한국화학융합시험연구원 의료전기팀) ;
  • 윤순종 (한국화학융합시험연구원 의료전기팀) ;
  • 이재원 (식품의약품안전평가원 의료기기연구과) ;
  • 김혁주
  • 투고 : 2014.07.04
  • 심사 : 2014.10.13
  • 발행 : 2014.10.31

초록

세계적인 인구 고령화와 생활수준의 향상에 따른 국민들의 건강에 대한 관심이 커지면서 최근 전자의료기기의 시장도 증대되고 있다. 수지형체외식초음파프로브는 허가 신청 건수가 높은 다빈도 허가 심사 대상 의료기기이며 최근 병원 등의 임상분야에서 그 활용도가 높다. 하지만, 수지형체외식초음파프로브의 성능 평가를 위한 국내 기준은 명확하게 마련되지 않은 실정이고, 허가심사 및 품질평가 등을 위한 가이드라인 조차 마련되어 있지 않다. 따라서 본 연구에서는 수지형체외식초음파프로브의 특성, 허가 및 시장현황을 조사하고, 관련 국내 외 규격을 검토하여 성능평가 시험항목, 기준 및 방법을 도출하였으며, 시험검증을 통하여 최종적으로 국제조화되고 국내 실정에 적합한 성능 평가 가이드라인을 마련하였다. 향후 본 연구결과를 의료기기 관련 업체에서 활용함으로써 수지형체 외식초음파프로브의 품질 및 성능 향상을 도모하고, 허가를 위한 심사 평가의 일관성을 확보할 수 있을 것으로 기대된다.

The electrical medical device market have been expanded since the public interest in healthy living that has deepened together with the global health trend of the aging population. The external hand-held ultrasonic probe is a frequently approved medical device and it is commonly used in the clinical field. However, there is no obvious standard or a guideline in Korea on regarding evaluation of performance of such external hand-held ultrasonic probe for approval and quality management. In this study, local and foreign reference standards were reviewed to propose performance test standards and methods after conducting characteristic of probe, market, and permission status. In addition, such proposed test items were validated to develop a draft guideline that is internationally harmonized for performance evaluation. This study is expected not only improve the quality and performance of the external hand-held ultrasonic probe but also contribute to securing consistency of permission and evaluation works for approval.

키워드

참고문헌

  1. H. S. Shim, Diagnostic ultrasound physics, Hanmibook, pp. 94-98, 2011.
  2. Korea Health Industry Development Institute, KHISS Korea Health Industry Statistics System, from http://www.khiss.go.kr, 2014.
  3. Ministry of Food and Drug Safety, Current ap proved medical devices by Ministry of Food a nd Drug Safety, from http://portal.mfds.go.kr/kfda, 2013.
  4. Ministry of Food and Drug Safety, Regulations for Product Classification of Medical Device and Class by Product (MFDS Notification No. 2014-110), 2014.
  5. IEC 60601-2-37, Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, 2007.
  6. IEC 62359, Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2010.
  7. IEC 61266, Ultrasonics - Hand-held probe Doppler foetal heartbeat detectors - Performance requirements and methods of measurement and reporting, 1994.
  8. IEC 60854, Methods of measuring the performance of ultrasonic pulse-echo diagnostic equipment, 1986.
  9. BS EN 61266, Ultrasonics. Hand-held probe Doppler foetal heartbeat detectors. Performance requirements and methods of measurement and reporting, 1995.
  10. JIS T 1506, Ultrasonics-Hand-held probe Doppler foetal heartbeat detectors - Performance requirements and methods of measurement and reporting, 2005.
  11. JIS Z 2350, Method for measurement of performance characteristics of ultrasonic probes, 2002.
  12. AS/NZS 4374, Ultrasonics - Hand-held probe Doppler foetal heartbeat detectors - Performance requirements and methods of measurement and reporting, 1996.
  13. GB/T 27664.2, Non-destructive testing - Characterization and verification of ultrasonic test equipment - Part 2: Probe, 2011.
  14. KS C IEC 60854, Methods of measuring the performance of ultrasonic pulse-echo diagnostic equipment, 1995.
  15. KS C 6710, General methods of measuring the performances of ultrasonic pulse-echo diagnostic equipment, 1986.
  16. Consolidated Review of Submissions for Diagnostic Ultrasound Equipment, Accessories and Related Measurement Devices #G90-2, 1990.
  17. Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, 2008.
  18. H. J. Kim, The study for development evaluation & approval guideline of 8 electrical medical devices : Electroencephalograph etc, Ministry of Food and Drug Safety Report, 2013.