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KMID : 1137820100310020129
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의공학회지
2010 Volume.31 No. 2 p.129 ~ p.133
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Guideline Development to Evaluate the Safety and Performance of Intense Pulsed Light(IPL)
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Kang Dong-Yeon
Son Tae-Yoon
Joo Yea-Il
Choi Eung-Ho
Jung Byung-Jo
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Abstract
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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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KEYWORD
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Intense pulsed light, Medical device standard, Medical device testing
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