Journal of the Institute of Electronics and Information Engineers (전자공학회논문지)

The Institute of Electronics and Information Engineers (대한전자공학회)
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A study on Evaluation Methods for Safety and Performance of Electrical Stimulations for Home Use

개인용전기자극기 성능 및 안전성 평가 방법 연구

  • Kim, San (Fusion Technology Medical Devices Team, National Institute of Food and Drug Safety Evaluation, Korea Food & Drug Administration) ;
  • Jang, Moo-Young (Fusion Technology Medical Devices Team, National Institute of Food and Drug Safety Evaluation, Korea Food & Drug Administration) ;
  • Hwang, Yoon Su (Fusion Technology Medical Devices Team, National Institute of Food and Drug Safety Evaluation, Korea Food & Drug Administration) ;
  • Lee, Ki-Hun (Department of Medical Devices Testing and Certification, Foundation for Korea Institute of Medical Technology) ;
  • Hur, Chan-Hoi (Medical Device Management Division, Medical Device Safety Bureau, Korea Food & Drug Administration) ;
  • Hong, Choongman (Fusion Technology Medical Devices Team, National Institute of Food and Drug Safety Evaluation, Korea Food & Drug Administration)
  • 김산 (식품의약품안전청 식품의약품안전평가원 융합기기팀) ;
  • 장무영 (식품의약품안전청 식품의약품안전평가원 융합기기팀) ;
  • 황윤수 (식품의약품안전청 식품의약품안전평가원 융합기기팀) ;
  • 이기훈 (재)한국의료기기기술원 의료기기시험원) ;
  • 허찬회 (식품의약품안전청 의료기기안전국 의료기기관리과) ;
  • 홍충만 (식품의약품안전청 식품의약품안전평가원 융합기기팀)
  • Received : 2012.11.30
  • Published : 2013.03.25
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Abstract

The electronic medical device industry and the relevant market have been greatly expanded owing to various factors, such as the advent of the aged society and the spread of the desire for well-being in developed countries, and rapid development of China, India and other emerging markets. The electrical stimulator is one of electronic medical devices most commonly used in homes. The electrical stimulator is widely used for pain relief, rehabilitation, muscle conditioning and others. Since it is mainly used in homes, it is very important to assure the safety and performance for protection of users. However, there is no guideline on evaluation of safety and performance of such electrical stimulator for home use. In this study, various local and foreign references were reviewed to develop the internationally harmonized procedures for safety and performance evaluation of the electrical stimulator and test items, specifications and methods are proposed. In addition, such proposed test items were validated to decide the internationally harmonized tests for safety and performance evaluation. This study will contribute to improvement of quality and safety of electrical stimulators for home use and help the Korean medical device industry have the international competitiveness.

선진국의 고령사회 도래 및 웰빙 확산, 중국, 인도 등 후발 공업국의 급성장에 따라 최근 전자의료기기시장이 크게 확대 되고 있다. 이중 다소비 생활밀착형 전자의료기기중 하나인 개인용전기자극기는 통증완화, 재활치료, 근육운동 등의 목적으로 사용되는 전기자극기로써 가정에서 개인적으로 사용하는 만큼 그 안전성 및 성능 확보는 사용자의 측면에서 매우 중요하다고 볼 수 있다. 그러나 현재 개인용전기자극기에 대한 안전성과 유효성을 평가하는 가이드라인이 아직 마련되지 않은 실정이다. 따라서 본 연구에서는 국제수준에 부합하는 개인용전기자극기의 안전성과 성능을 평가하기위해 관련 국내외 규격을 검토하였고 시험항목, 기준 및 방법을 제안하였다. 또한 제안된 시험항목에 대한 시험검증을 통하여 최종적으로 국제 조화된 안전성 및 성능 평가 항목을 도출하였다. 본 연구 결과를 통하여 개인용전기자극기의 품질 및 안전성 향상을 도모함으로써 국내 전자의료기기산업의 국제 경쟁력 확보에 기여할 수 있을 것으로 기대된다.

Keywords

References

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