Journal of Biomedical Engineering Research (대한의용생체공학회:의공학회지)

The Korean Society of Medical and Biological Engineering (대한의용생체공학회)
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Guideline Development to Evaluate the Safety and Performance of Intense Pulsed Light(IPL)

Intense Pulsed Light의 안전성 및 성능평가를 위한 시험 항목 및 시험방법(안) 연구

  • Kang, Dong-Yeon (Department of Biomedical Engineering, Yonsei University) ;
  • Son, Tae-Yoon (Department of Biomedical Engineering, Yonsei University) ;
  • Joo, Yea-Il (Department of Biomedical Engineering, Yonsei University) ;
  • Choi, Eung-Ho (Department of Dermatology, Yonsei University Wonju College of Medicine) ;
  • Jung, Byung-Jo (Department of Biomedical Engineering, Yonsei University)
  • 강동연 (연세대학교 보건과학대학 의공학부) ;
  • 손태윤 (연세대학교 보건과학대학 의공학부) ;
  • 주예일 (연세대학교 보건과학대학 의공학부) ;
  • 최응호 (연세대학교 원주 의과대학 피부과학교실) ;
  • 정병조 (연세대학교 보건과학대학 의공학부)
  • Received : 2009.12.09
  • Accepted : 2010.03.08
  • Published : 2010.04.30
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Abstract

Intense pulsed light(IPL) is a photo-therapeutic medical device using xenon lamps with optical characteristics of incoherence, defocusing, and polychromatic. IPL has been recognized as a representative medical therapeutic device with growth of domestic skin care market. However, there is no standard regulation manual and guideline to evaluate the safety and performance of IPL. International Electrotechnical Commission(IEC) is being statued "Technical Report IEC TR 60825-16" which is a guidelines for the safe use of intense light source equipment on humans and animals. In this study, a standard Korea Food & Drug Administration (KFDA) regulation for the safety and performance of IPL was suggested by developing minimal evaluation methods for optical parameters of IPL such as output energy density, pulse mode, spot size, wavelength and uniformity of output light. We expect that this study may be a step to statue a standard regulation manual and guideline for IPLs used in domestic.

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References

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