• Journal of Digital Convergence
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• v.12 no.2
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• pp.555-561
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• 2014

For five diagnostic X-ray generators (DR), four units turned out to be appropriate in tests on the reproducibility of radiation output suggested in the IEC 60601-2-54 standard, but in one unit of the X-ray equipment, an item measured in a combination of 50% of the highest tube voltage of the diagnostic X-ray equipment, the test setting of Group C with authorized output doses between $1{\mu}Gy$ and $5{\mu}Gy$ of mAs turned out to be inappropriate. As a result, the radiation dose to the IEC 60601-2-54 standard for quantification standards proposed by the radiation output from diagnostic X-ray imaging device reproducibility of performance management should be aware that an important evaluation factor.

• Journal of the Korean Society of Radiology
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• v.6 no.5
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• pp.389-394
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• 2012

In this study, based on IEC 60601-2-54 standard load conditions presented in the limited interval over the air kerma at the absolute linearity closely evaluated by measuring the X-ray results were as follows: 10 units targeted all Diagnostic X-ray generating device (DR) presented in the IEC 60601-2-54 standard linearity of air kerma emerged as inappropriate, the general evaluation of the dose linearity from four in the top 50% and 80 kVp % of the two measurement series were as irrelevant all the rest from six of the top tube voltage of 50% and 80% of the two measurement series, appeared in all suitable. Presented in IEC 60601-2-54 standard dose linearity testing and conventional linearity tests showed many differences. IEC 60601-2-54 standard linearity in the proposed international standards of air kerma is the recommendation of the existing dose linearity considerably more feasible, and to quantify the amount of radiation as the standard suggested by the standard IEC 60601-2-54 air kerma of a diagnostic X-ray imaging device linearity performance management is considered key elements in the critical appraisal.

• Journal of radiological science and technology
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• v.36 no.1
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• pp.1-10
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• 2013

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 $3^{rd}$ 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 $3^{rd}$ 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 $3^{rd}$ 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 $3^{rd}$ Ed in a few years. Therefore the features of particular standards applying IEC 60601-1 $3^{rd}$ Ed was expected to help manufacturers, assemblers or testing companies of medical electric equipment understand IEC publications or KFDA notifications slated to be published.

• Journal of Digital Convergence
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• v.12 no.3
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• pp.339-344
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• 2014

The quality control items of mammography devices in South Korea do not include the linearity, which is required by international standards. The linearity is a requirement for the adjustment of radiation dose and radiation quality. This study tested the linearity, which was suitable for the IEC 60601-2-45 standard, of the 5 mammography devices. All showed adequate results. Consistent measurement management is required for more developed quality control in the future.