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KMID : 1142220110060010079
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Regulatory Research on Food, Drug & Cosmetic
2011 Volume.6 No. 1 p.79 ~ p.84
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Study on the Test for Implantable U-Health Device
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Jeong Jae-Hoon
Park Sung-Yun
Cho Eun-Jeong
Hur Chan-Hoi
Park Ki-Jung
Kim Dong-Sub
Kim Sung-Min
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Abstract
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The purpose of this study is to survey the technology and to investigate the standard about the 'Implantable u-health devices (implantable cardiac pacemakers, implantable defibrillators) in domestic and foreign. As results, the evaluation guideline has been made for each device (implantable cardiac pacemakers, implantable defibrillators). The evaluation guideline is included scope, normative references, term and definitions, method of performance evaluation, test configuration, figure of test result. We have taken a detailed assessment of safety and effectiveness about the guideline for performance evaluation. The evaluation guideline has made based on the international guideline which have internationally credibility.
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KEYWORD
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Implantable Medical Device, Implantable Cardiac Pacemaker, Implantable Cardioverter Defibrillator, Safety, Performance, Test Methods
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