• 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.38 no.4
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• pp.331-336
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• 2015

Medical electrical equipment - Part 1: General requirement for basic safety and essential performance of MFDS was revised as 3th edition and Medical electrical equipment Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment will be expected to be announced as notification. Therefore this technical report was written to introduce provision of the particular requirements, replacement, addition, amendment. The purpose of this particular requirements is to secure requirements for basic safety and essential performance of X-ray equipment for radiography and radioscopy. X-ray high voltage generator, mechanical protective device, protection against radiation is included in this particular requirements. Medical electrical equipment - Part 1, Part 1-2, Part 1-3 is applied to this particular requirements. If the requirements is announced as notification, It is expected to widen understanding for basic safety and essential performance of X-ray equipment for radiography and radioscopy and play a part to internationalize of medical equipments.

• 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 radiological science and technology
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• v.32 no.1
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• pp.1-15
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• 2009

Newly published IEC 60601-1-3 ; 2008 2nd Edition has two important meanings. First, Radiation Quality and Dose should make sure for safety of patient and staff in manufacturing diagnostic X-ray equipment. Second, it should be minimized of Leakage Radiation, Residual Radiation, and Stray Radiation. The requirement to make enactment or revision of national standard for diagnostic X-ray Equipment is as follows : 1. It should be adjusted the new standard to the recent IEC Publication under the consideration of the Korea medical circumstances. 2. For focus to the Radiation Safety, IEC 60601-1-3 (General requirements for radiation protection in diagnostic X-ray equipment) could be applied to the new regulation. It should be compact sentence. 3. A sudden Notification change should not be desired. It needs a enough time to make easy the circumstances.

• Proceedings of the KIEE Conference
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• 2015.07a
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• pp.1433-1434
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• 2015

의료기기 무선통신 기능을 포함한 유헬스케어형 기기들이 지속적으로 개발됨에 따라 전기 및 기계적 안전에 관한 공통기준규격 IEC 60601-1(3rd)과 개별규격에 더불어 추가적인 안전성 시험 항목이 요구되고 있다. 유헬스케어형 의약품주입펌프의 적합성을 평가하기 위하여 IEC60601-1-11와 IEC60601-2-24 규격을 기반으로 하여 부품 및 분류방법, 필수성능에 대한 시험항목을 도출하였다. 본 연구에서는 국제규격에 기반하여 적합성 평가기술을 개발하여 헬스케어형 의료기기의 안전성 확보와 선도적 평가기술 방안을 마련하였다.

• Korean Journal of Digital Imaging in Medicine
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• v.11 no.2
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• pp.69-77
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• 2009

This study gives an account of the collateral standards in IEC 60601-1-3: 2008 specifying the general requirements for basic safety and essential performance of diagnostic X-ray equipment regarding radiation protection as it pertains to the production of X-rays. The collateral standards establish general requirements for safety regarding ionization radiation in diagnostic radiation systems and describe a verifiable evaluation method of suitable requirements regarding control over the lowest possible dose equivalent for patients, radiologic technologists, and others. The particular standards for each equipment can be determined by the general requirements in the collateral standard and the particular standard is followed in the risk management file. The guidelines for radiation safety of diagnostic radiation systems is written up in ISO 13485, ISO 14971, IEC 60601-1-3(2002)1st edition, medical electric equipment part 1-3, and the general requirements for safety-collateral standards: programmable electrical medical systems. Therefore the diagnostic radiation system protects citizens' health rights with the establishment and revisions of laws and standards for diagnostic radiation systems as a background for the general requirements of radiation safe guards applies, as an international trend, standards regarding the medical radiation safety management. The diagnostic radiation system will also assure competitive power through a conforming evaluation unifying the differing standards, technical specifications, and recognized processes.

• Journal of the Korean Society of Radiology
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• v.12 no.6
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• pp.769-776
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• 2018

According IEC 60601-1 ed3.1 and IEC 60601-2-45 regulation, diagnostic X-ray equipment should be display to measured and calculated air kerma area product. On the clinical X ray equipment, air kerma area product dosimeter would like to have an evidence for dosimeter accuracy and energy dependency. This study was performed to indirect calibration and energy dependency test for attached type air kerma area product (KAP) dosimeter by RQR standards beam quality. On the RQR5 beam quality, attached KAP dosimeter error showed -7.5%, respectably. On the RQR9 beam quality, attached KAP dosimeter error showed -10.4%, respectably. All RQR beam quality, average absolute error was $8.30%{\pm}2.85%$, respectably. On this study, attached KAP dosimeter was satisfied to IEC 60580 and AAPM TG 190. This calibration method of KAP dosimeter will help to performance maintain for clinical KAP dosimeter.

• The Transactions of the Korean Institute of Electrical Engineers P
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• v.67 no.1
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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.

• The Transactions of the Korean Institute of Electrical Engineers P
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• v.64 no.3
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• pp.175-181
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• 2015

In this paper, the neuromuscular electrical stimulation medical devices for non-implantable incontinence treatment other than vaginal insertion type was developed and commercialized. The structure of medical devices for electrical stimulation based on the anatomy of the pelvic floor muscle designed. Then, the optimum parameters that may be effective in pelvic floor muscle electrical stimulation was set. The circuit system based on the optimum parameters were designed and manufactured. The frequency of the pulse voltage for electrical stimulation is 75[Hz], the pulse width is 300[${\mu}s$], the development of medical devices was to have seven program functions to the various treatments. The circuit system of medical devices was composed of microcontroller, comparator and converter. The performance of the developed circuit system in KTC(Korea Testing Certification) were carried out medical equipment inspection test. Test results, test specifications were satisfied with the medical device, the performance was verified to be commercialized as a medical device. The development of medical devices were validated risk assessment and product performance through a software validation. Commercialization of medical equipment was acquired to enable the certification standards of the international standard IEC 60601-1.

• Journal of radiological science and technology
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• v.41 no.5
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• pp.493-504
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• 2018

The diagnostic radiation equipment is managed in accordance with the "Rules for Safety Management of Diagnostic Radiation Equipment" enacted in 1995. The equipments should be inspected before use and every three years after use in accordance with the [Appendix 1] of the same rule. The inspection standard has been maintained without particular revision since enacted. But, over the past two decades new types of equipments have been manufactured and used. So, it is necessary to revise [Appendix 1] by making inspection items and inspection standards. In this study, we revised the classification system of equipments and reviewed international standards of IEC 60601 series, IEC 61223 series and AAPM TG 18 On-line Report No.03. And identified the problem of current inspection standards. Through this, we revised, deleted and added the inspection items and inspection standard of each equipment to meet the domestic circumstances. As a result of the study, we reorganized the classification system of equipment which are current classified as 5 classes into 22 classes as X-ray system etc. (7 classes), CT system etc. (5 classes) and Dental X-ray system etc. (10 classes). And then, we developed 70 inspection items for 6 types of equipments according to the reorganized classification system of equipments. The inspection items and inspection standards derived from this study have been proposed to the KCDC and will be applied to the revision of the Rule's [Appendix 1]. Therefore, we expect to be used as reference materials for domestic medical center, inspection institutions, and equipment manufacturing import companies.