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KMID : 1142220120070010059
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Regulatory Research on Food, Drug & Cosmetic
2012 Volume.7 No. 1 p.59 ~ p.68
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A Study on the Development of the Standard for a Phototherapy Unit
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Park Sung-Yong
Han Jae-Pil
Lee Byung-Woo
Cha Ji-Hun
Cho Eun-Jeong
Kwon Tae-Hee
Lee Jae-Won
Oh Hyeon-Joo
Park Ho-Joon
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Abstract
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Infant·childhood is the time to experience a big change physically and physiologically. Because there would be high possibility to cause a harmful influence in the long term if the exposure to hazards, it is required to manage the medical devices for an infant and a child strictly by preparing the standards to be applied the characteristics of an infant and a child. Among these medical electrical equipment, a Phototherapy unit is one of most important equipment to be used frequently in the hospitals in order to treat infant so that the standard for a Phototherapy unit is required to evaluate the safety and performance of the equipment. To develop the standard of a Phototherapy unit, the following international standards were examined; KS C 60601-2-50 a Phototherapy unit, IEC 60601-2-50(2000): a Phototherapy unit, EN 60601-2-50(2000): a Phototherapy unit, KFDA guideline for a Phototherapy, the standards of manufacturers. In this study, through survery and inspection of international standards and guideline for a phototherapy unit, survery and inspection of international and domestic manufacturers' test items, proposals standards for the product by technical review, we suggest the standard for a Phototherapy Unit.
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KEYWORD
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A Phototherapy unit, Standard, Safety, Performance
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