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KMID : 1142220170120010093
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Regulatory Research on Food, Drug & Cosmetic
2017 Volume.12 No. 1 p.93 ~ p.100
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Development of Evaluation Methods for the Performance of Infrared Light Irradiator by Personal
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Lee Seung-Youl
Lee Tae-Hee
Ju Cho-Long
Na Hyeon-Su
Lee In-Su
Park Chang-Won
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Abstract
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This study is intended to provide the safety and performance test method guidelines of the infrared light irradiator whose demands have increased for skin treatment along with the recent improvements in living standards. Ensuring the safety and performance of the infrared light irradiator is essential since the devices are directly used on the skin by any people. To develop the guidelines, technical information such as the principle and constitution of the medical device was identified. The applicable standards and the established test items for guidelines and licenses were surveyed and analyzed, and necessary items for evaluating the safety and performances were derived. Moreover, the deduced test items and standards were reviewed by a council consisting of experts from testing institutions and the relevant industries to secure the expertise of research results. Especially, the applicability to the actual quality management and the license process was verified by implementing safety and performance assessments in order to apply the deduced test items and standards to the field according to the relevant type. The infrared light irradiator were set up and applied in accordance with the Standards for Electrical/ Mechanical Safety and the Electromagnetic Safety, satisfying the requirements in the test item and standard for each clinical specimen. And setting up the items such as the output accuracy of the light source, stability, wavelength, etc. is required, and the test results satisfied the relevant criteria. The safety and performance test
method guidelines of the infrared light irradiator developed in this study are expected to aid civil affairs for
authorization and examination, to enhance public health by securing medical devices with consistent quality, and
to strengthen the competitiveness of the domestic medical device industry.
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KEYWORD
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Infrared Light Irradiator, safety and performance evaluation, Guideline
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