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KMID : 1142220100050010045
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Regulatory Research on Food, Drug & Cosmetic
2010 Volume.5 No. 1 p.45 ~ p.50
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A Study for Standard Development of Electrocardiograph
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Ryeom Tai-Kyung
Hui Chan-Hoi
Lee Byung-Young
Kim Eun-Ju
Cha Ji-Hun
Kim Dong-Sup
Park Ki-Jung
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Abstract
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Electrocardiograph used examination for cardiovascular disease including stroke, myocardial infarction was basic and indispensable medical device. Electrocardiograph penetration rate of medical institution was higher than in any other electronic medical device. Now each medical institution possessed more than one unit in general. There was an urgent need for establishing internationally harmonized standard on this equipment to make sure the safety and performance of the device. In this study, to establish internationally harmonized standards of electrocardiograph, we compared requirement of KFDA's electronic medical device standard and international standards. As a results, in order to establish internationally harmonized standard of electrocardiograph, it should be added or complemented following requirements for safety and performance ; ‘recovery time of the electrocardiograph form electrode polarization after defibrillation’, ‘electrostatic discharge’, ‘electrosurgery interference’, etc. It will be applied to enact the revise the electronic medical device standard of electrocardiograph.
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KEYWORD
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electrocardiograph, standard, safety, performance
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