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KMID : 0357520090320010001
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Journal of Radiological Science and Technology
2009 Volume.32 No. 1 p.1 ~ p.15
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The Recent Trend of the National and International Standard of Manufacturing Quality Control for Diagnostic X-ray Equipment
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Choi In-Seok
Kim Jung-Min
Min Jung-Whan
Kim Jung-Min
Jeong Hoi-Woun
Lee In-Su
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Abstract
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Newly published IEC 60601-1-3 ; 2008 2nd Edition has two important meanings. First, Radiation Quality and Dose should make sure for safety of patient and staff in manufacturing diagnostic X-ray equipment. Second, it should be minimized of Leakage Radiation, Residual Radiation, and Stray Radiation. The requirement to make enactment or revision of national standard for diagnostic X-ray Equipment is as follows : 1. It should be adjusted the new standard to the recent IEC Publication under the consideration of the Korea medical circumstances. 2. For focus to the Radiation Safety, IEC 60601-1-3 (General requirements for radiation protection in diagnostic X-ray equipment) could be applied to the new regulation. It should be compact sentence. 3. A sudden Notification change should not be desired. It needs a enough time to make easy the circumstances.
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KEYWORD
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Diagnostic X-ray Equipment, Manufacturing Quality Control, KFDA Standards, IEC Publication
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