• 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.

• 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 radiological science and technology
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• v.37 no.1
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• pp.1-6
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• 2014

Breast shooting performance management and quality control of the generator is applied to the amount of current IEC(International Electrotechnical Commission) 60601-2-45 tube voltage and tube current are based on standards that were proposed in the analysis of the test results were as follows. Tube voltage according to the value of the standard deviation by year of manufacture from 2001 to 2010 as a 42-3.15 showed the most significant, according to the year of manufacture by tube amperage value of the standard deviation to 6.38 in the pre-2000 showed the most significant, manufactured after 2011 the standard deviation of the devices, the PAE(Percent Average Error) was relatively low. This latest generation device was manufactured in the breast of the tube voltage and tube diagnosed shooting the correct amount of current to maintain the performance that can be seen. The results of this study as the basis for radiography diagnosed breast caused by using the device's performance and maintain quality control, so the current Food and Drug Administration "about the safety of diagnostic radiation generator rule" specified in the test cycle during three years of self-inspection radiation on a radiation generating device ensure safety and performance of the device using a coherent X-ray(constancy) by two ultimately able to keep the radiation dose to the public to reduce the expected effect is expected.