• Proceedings of the Korean Institute of Surface Engineering Conference
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• 2018.06a
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• pp.22-22
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• 2018

의료기기는 사용목적과 사용 시 인체에 미치는 잠재적 위해성의 정도에 따라 4개의 등급으로 분류하며, 두 가지 이상의 등급에 해당되는 제품의 경우에는 가장 높은 등급으로 분류하게 된다. 의료기기 품목허가를 위해서는 기술문서를 작성하여야 하며, 이를 위해서는 기술문서 심사를 신청하는 절차를 이해하여야 한다. 의료기기 기술문서란 의료기기의 성능과 안전성 등 품질에 관한 자료로서 해당 품목의 원자재, 구조, 사용목적, 사용방법, 작용원리, 사용 시 주의사항, 시험규격 등이 포함되는 문서를 말하며, '의료기기 허가 신청서'와 '첨부자료(임상시험자료 포함)'로 구성되어 있다. 의료기기 품목허가 시 제출되는 기술문서를 통하여 해당 의료기기의 안전성 및 성능이 충분히 입증되어야 하며, 인체 삽입되는 표면처리 임플란트를 포함한 인체 접촉 의료기기의 안전성의 경우 '의료기기의 생물학적 안전에 관한 공통 기준규격'에 따라 평가 후 제조 수입품목 허가를 진행해야 한다. 또한 성능의 경우는 해당 규격 또는 자사의 기준 및 시험방법에 따른 성능에 관한 자료, 물리 화학적 특성에 관한 자료를 통하여 평가되어야 하며, 기허가 인증된 제품에 한 번도 사용되지 않은 원재료 또는 적용부위 및 적용방법이 달라 안전성 및 유효성 확인이 필요한 경우 임상시험에 관한 자료가 요구될 수 있다. 본 발표에서는 이러한 인체 삽입용 표면처리 임플란트의 전반적인 인허가 절차에 대해서 안내하고자 한다.

• Journal of rehabilitation welfare engineering & assistive technology
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• v.3 no.1
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• pp.35-40
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• 2009

Electrically operated hospital bed and operating table are useful devices to care patients and to keep postures of them in medical treatment. However they have the risk of physical injury due to various functions and mechanisms consisting of them. In this paper we propose particular requirements for the safety and test methods of electrically operated hospital beds and operating table classified into medical devices. Each items are developed based on international standards. The results of this study can be used for developing internationally harmonized standards for the approval of Korea Food and Drug Administration (KFDA).

• 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.

• 재활복지
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• v.16 no.3
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• pp.421-437
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• 2012

The goal of this study is to provide the basic information for improvement of domestic standards on the powered scooter and the electric wheelchair considering using environments in the nation. The international standards and domestic standards have been analyzed and compared, in order to propose improved domestic standards. Based on the research, the items and standards for general and functional recommendations, electric features, and other suggestions have been reexamined so that the improvements on test item and standards have been identified, corrected, and summarized including max. speed, brake system, lights and so on. We have been preparing the reference data for the improvement of standards on the powered scooter and the electric wheelchair through the comparison & analysis on the international and domestic standards.

• The monthly packaging world
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• s.144
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• pp.154-170
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• 2005

• Journal of radiological science and technology
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• v.39 no.2
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• pp.263-271
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• 2016

The market size of the bone absorptiometric X-ray system and the number of its approval by Ministry of Food and Drug Safety (MFDS) has annually increased, with a trend of increasing aging population and osteoporosis patients. For approval of manufactured or imported medical devices in Republic of Korea, it is required to submit its technical document. Therefore, it is need to develop the technical document guideline for the bone absorptiometric X-ray system for manufacturers, importers and reviewers. First of all, the technical documents which were already approved were examined and analyzed through MFDS approval administration system. Second, safety and performance test standards and methods that match international standards were drawn after conducting survey of the market status and the technology development trend for it, with examination and analysis of applicable domestic and overseas standards. Third, by operating industry-research-government cooperation, the guideline draft on writing technical document for the bone absorptiometric X-ray system was discussed, collecting their opinion. As a result, it is suitable to international and domestic condition, includes test evaluation methods and offer various information with appropriate examples to civil petitioner, when they write the technical documents.

• 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.

• Journal of rehabilitation welfare engineering & assistive technology
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• v.4 no.1
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• pp.9-14
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• 2010

According to graying of population and income enlargement of people, interest about U-Healthcare of new form fusing with IT technology are enlarged. Need a estimation technology and standard of test method for safety and performance considering usage environment of U-Healthcare medical device. In this research, developed the standard of test method for usage environment safety and performance of U-Healthcare medical device referring IEC standards and KS standards.

• Journal of radiological science and technology
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• v.39 no.4
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• pp.651-660
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• 2016

Due to recent population aging, the number of check-up for senior citizens has increased steadily. According to this trend, the market size of dental X-ray equipment and the number of approval and review for these devices have simultaneously increased. The technical document of medical device is required for approval and review for medical device, and medical device companies needs to have work comprehension and expertise, as the document needs to include the overall contents such as performances, test criteria, etc.. Yet, since most of domestic manufacturers or importers of medical devices are small businesses, it is difficult for them to recruit professional manpower for approval of medical devices, and submission of inaccurate technical documents has increased. These problems lead to delay of the approval process and to difficulties in quick entering into the market. Especially, the Ministry of Food and Drug safety (MFDS) standards of a dental extra-oral X-ray equipment, a dental intra-oral X-ray equipment, an arm-type computed tomography, and a portable X-ray system have been recently enacted or not. this guideline of dental X-ray equipment adjusting revised standards was developed to help relative companies and reviewers. For this study, first, the methods to write technical document have been reviewed with revised international and domestic regulations and system. Second, the domestic and foreign market status of each item has been surveyed and analyzed. Third, the contents of technical documents already approved by MFDS have been analyzed to select the correct example, test items, criteria, and methods. Finally, the guideline has been developed based on international and domestic regulation, through close review of a consultative body composed of academic, industrial, research institute and government experts.

• The Journal of Korea Institute of Information, Electronics, and Communication Technology
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• v.14 no.5
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• pp.394-402
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• 2021

The entry of an aging society and the extension of human life expectancy, the increasing interest in women's social advancement and men's appearance, and the natural interest in K-culture through media media, while receiving worldwide attention, Focus on K-Bueaty. Recently, looking at the occupation of the medical tourism field, in the case of aesthetic medicine tourism such as molding and dermatology, it has gained popularity not only in Asia such as China and Japan, but also in North America and Europe. The first external confirmation of human aging is the wrinkles on the skin of the face. Clean, wrinkle-free, elastic and healthy skin is a desire of most people. Skin condition and condition such as focused ultrasonic stimulation (HIFU: High Intensity Focused Utrasound) and low frequency, high frequency (RF: Radio Frequency), galvanic therapy using microcurrent, cryotherapy using rapid cooling, etc. Depending on the method of management, the effect of the treatment differs depending on the output and the stimulation site, etc., even in the treatment of medical equipment and beauty equipment using the same mechanism. In this research, in order to develop invasive high-frequency dermatological devices using a large number of beauty medical devices and microneedles of beauty devices, the international standards IEC 60601-2 (standards for individual medical devices) and MFDS (Ministry of) We designed and developed a high-frequency output device in compliance with the high-frequency stimulation standard announced in the Food and Drug Safety (Ministry of Food and Drug Safety). The circuit design consists of an amplifier (AMP: Amplifier) using Class-A Topology and a power supply device using Half-Bridge Topology. As a result of measuring the developed high-frequency output device, an average efficiency of 63.86% was obtained, and the maximum output was measured at 116.7W and 50.67dBm.