• 대한방사선기술학회지:방사선기술과학
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• 제36권1호
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• pp.1-10
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• 2013

IEC 규격은 유럽, 일본 등 해외 여러 나라에서 자국의 규격으로서 이용되고 있으며, 우리나라에서는 현재 산업표준인 KS 형태와 더불어 강제성을 갖는 식품의약품안전청 고시로서도 발행되고 있다. 전자의료기기에 관한 IEC 규격인 IEC 60601 시리즈의 공통규격(IEC 60601-1:2005)이 3판으로 개정됨에 따라, 보조규격과 개별규격 또한 그에 맞추어 제 개정이 필요하다. IEC 규격의 변화 동향을 파악하는 것은 국내 의료기기 제조 수입업체 및 시험검사기관에서 매우 중요하다. 따라서 본 연구에서는, 진단용X선기기와 관련한 3개 규격 IEC 60601-2-44(CT의 기본안전과 필수성능에 관한 규격), IEC 60601-2-45(유방촬영용X선장치의 기본안전과 필수성능에 관한 규격), IEC 60601-2-54(진단용 X선장치의 기본안전과 필수성능에 관한 개별규격)에 대하여 IEC 60601-1의 3판에 맞추어 제 개정된 최신판의 동향 및 특징을 살펴보고자 하였다. 또한 현행 식품의약품안전청 고시가 IEC 60601-1의 2판이 적용된 개별규격을 참고로 하고 있어, 현행 식품의약품안전청 고시와 대비하여 그 특징을 살펴보았다. IEC 60601-1의 3판이 적용된 진단용X선장치 외 2개의 IEC 개별규격의 특징은 다음과 같다. 1) 기계적 위해요인, 특히 움직이는 부분에 대한 내용이 강화되었다. 2) 환자 선량을 표시 및 기록하도록 명시하고 있다. 3) 잠재적인 위험요소에 대해 체계적으로 관리가 가능한 위험관리 프로세스를 도입하고 있다. 4) 과거 Film-Screen System과 더불어 DR system(digital radiography system)에 대해서도 적용하고 있다. 현재 IEC 60601-1의 3판이 적용된 개별규격이 식품의약품안전청 고시로 개정될 예정이므로, 국내 시험 검사기관 및 의료기기 제조 수입업체 등에 유용한 자료가 되기를 기대한다.

• 전기학회논문지P
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• 제67권1호
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• pp.52-56
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• 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.

• 대한의용생체공학회:의공학회지
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• 제36권3호
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• pp.69-78
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• 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.

• 대한의용생체공학회:의공학회지
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• 제36권4호
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• pp.86-94
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• 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.