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KMID : 0357520130360010001
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Journal of Radiological Science and Technology
2013 Volume.36 No. 1 p.1 ~ p.10
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Features and Trends of IEC Particular Standards for Medical Equipment Related to Diagnostic X-ray Based on IEC 60601-1:2005 Ed. 3.0
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Kim Hyun-Ji
Kim Jung-Min
Choi In-Seok
Yoon Yong-Su
Seo Deok-nam
Kim Jung-Su
Kim Dae-Young
Park Sung-Yong
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Abstract
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IEC publications have applied in many countries all over the world such as Europe or Japan and these also have been published as in dustrial standards (KS) and notifications of Korea Food and Drug Administration (KFDA) in Korea. As the general standard of IEC 60601 series for medical electric (ME) equipment was revised as $3^{rd}$ 수식 이미지 edition in 2005, additional and particular standards have been revised or established newly. Under these circumstances, it is importance for manufacturing and assembling companies or authorized testing companies to understand the trend for revisions of IEC publications. Therefore in this study, the latest version of 3 IEC standards related to medical X-ray equipment : IEC 60601-2-44 for X-ray equipment for computed tomography (CT), IEC 60601-2-45 for mammographic X-ray equipment and IEC 60601-2-54 for X-ray equipment for radiography or radioscopy were covered and analyzed for trends and features accompanied by revision based on IEC 60601-1 $3^{rd}$ 수식 이미지 Ed. As KFDA notifications in force have referred to the particular standards based on 2nd edition of IEC 60601-1, those revised version of 3 particular standards were compared to KFDA notifications in force. The features of the latest standards applying IEC 60601-1 $3^{rd}$ 수식 이미지 Ed were shown as following: 1) Requirements for mechanical hazards, especially (motorized) moving parts were emphasized. 2) Indication and recording of patient dose were required. 3) Risk management process was introduced and enabled to monitor potential risks systematically. 4) DR system (digital radiography system) as well as analogue system (film-screen system) was included in the scope. Presently, KFDA will revise the notifications applying the particular standards based on IEC 60601-1 $3^{rd}$ 수식 이미지 Ed in a few years. Therefore the features of particular standards applying IEC 60601-1 $3^{rd}$ 수식 이미지 Ed was expected to help manufacturers, assemblers or testing companies of medical electric equipment understand IEC publications or KFDA notifications slated to be published.
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KEYWORD
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IEC publications, IEC 60601-1, X-ray equipment for radiography or radioscopy, X-ray equipment for computed tomography (CT), mammographic X-ray equipment
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FullTexts / Linksout information
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Listed journal information
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