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

• The Transactions of the Korean Institute of Electrical Engineers P
• /
• v.67 no.1
• /
• pp.52-56
• /
• 2018

Extracorporeal shockwave therapy has been widely spread out showing an excellent efficacy compared to traditional medicinal treatments, interventional procedures or surgeries for diseases of tendons and musculoskeletal system. Major performance tests of extracorporeal shockwave therapy consist of pressure, energy flux, concentration, and effective amount of energy on the focus area of shockwave according to IEC 61846. Shockwave should be irradiated accurately to the lesion area to improve the performance of extracorporeal shockwave therapy, which makes it necessary to add the relevant section, IEC 60601-2-36 (12.1.101. Precision of Target Markers and Target Locations). International standards of extracorporeal shockwave therapy have been prepared based on European and western people. Thus, we need to conduct many studies on Korean patients to improve the quality of extracorporeal shockwave therapy and to develop the medical industry. In addition, the performance evaluation of extracorporeal shockwave therapy which has been prepared according to international standards should be additionally modified and supplemented corresponding to the Korean circumstances.

• Journal of Biomedical Engineering Research
• /
• v.36 no.3
• /
• pp.69-78
• /
• 2015

Ultrasonic physiotherapy systems should comply with IEC 60601-2-5(particular requirements for safety of ultrasonic physiotherapy equipment) standard for safety of patients and clinical performances. One of the most important parameters in the standard is the effective radiating area ($A_{ER}$). It has to be measured in accordance with IEC 61689 (field specifications and methods of measurement in the frequency range 0.5MHz to 5MHz). Typical ultrasonic physiotherapy system works in the frequency range 1MHz ~ 3MHz to comply with the IEC 61689. However, ultrasonic physiotherapy system using frequencies over 5MHz is out of the IEC 61689's scope. That is, even if such ultrasonic physiotherapy systems are developed by demands of the market, there is no standard to apply. It is the motivation for this study. Whereas there are other parameters to be considered, this study focuses on the effective radiating area and shows effectiveness of applying IEC 61689 in measuring effective radiating area of ultrasonic physiotherapy systems using frequency range over 5MHz by comparing the results of computer simulation and experiment. Results of this study shows that applying the IEC 61689 standard to ultrasonic physiotherapy system using frequency range over 5MHz is possible.

• Journal of Biomedical Engineering Research
• /
• v.36 no.4
• /
• pp.86-94
• /
• 2015

In order for medical devices to be used outside hospital, they have to be not only of small size but also power consumption has to be kept at low level. This study investigates the feasibility of application of ADS1298 ECG single-chip solution developed by Texas Instruments Inc. for use in development of a new platform for diagnostic resting ECG. To prove the feasibility of commercial products based on the ADS1298 chip, the performance of the ADS1298 chip was measured in terms of input impedance, common mode rejection, frequency response, and input dynamic range using the testing method under the suitability criteria of the IEC 60601-2-25 standard. Result of the this study shows that commercialization of the ECG products based on the ADS1298 ECG single-chip solution that satisfies the international standards would be possible, if the manufactures take the filter characteristics into account in building a new platform for diagnostic resting ECG.