• 대한의용생체공학회:의공학회지
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• 제32권2호
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• pp.151-157
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• 2011

Tattooing is a performance for decorative and cosmetic marking by placing permanent ink into the skin. As the cultural meaning of tattoo in Korea is changing, the tattoo machines are widely spread n permanent cosmetic market. Though the use of the tattoo machine was increased, the evaluation standards of tattoo machine were not existed. Korea Food and Drug Association regulated the electrical and mechanical safety standards which were founded on the IEC 601-1 second edition. Also they regulated he biological safety standards which were derived from the ISO 10993 series, however, these general valuations of common medical device were insufficient for evaluating tattoo machine. We developed the standards of tattoo machine for safety and performance evaluation for tattoo machine by preliminary hazard analysis in ISO 14971. The evaluation criteria of tattoo machines are focused on the mechanical invasion. We suggested the additional evaluation items of the needle speed, length, vibration with general valuation criteria of common medical device. We anticipate that this research may be a primary stage to figure a standard regulation and evaluation for tattoo machine.

• 무역상무연구
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• 제59권
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• pp.181-205
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• 2013

This study has analyzed the international trade flow of medical devices in Korea, China, and U.S. more theoretically and systematically through a mutual connection of the medical device export structure of Korea and the import structure of China and U.S. organically, with an intensity approach on the bilateral international trade flow. Also, it is meaningful to find a solution to boost exports of Korea to China and U.S.. Therefore in this study, we recognize the importance of the medical device market in China and U.S., which is the main competition for Korea and its market, and look into the trade situation of these three countries. We also look into the relative market stream and the trade intensity of the main medical devices in Korea, China and U.S., and seek measures for the steady growth of the medical device market in these three countries.

• 무역상무연구
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• 제64권
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• pp.213-237
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• 2014

The medical-device market of Myanmar in the recent Asian region is where the influences of Thailand, China, India and Singapore are being shown considerably with the lift-up of economic sanctions by America and the West. However, although the global capital and liberalization have widened the openness and the international concerns, the relative Myanmar's medical environment demands an active assistance and improvement. The study, recognizing the importance of Medical-Devices and their market conditions emerging as key business for knowledge-based industry, aims to obtain consequential meaningful suggestions, pursuant to relative export-concentration and sustainable market growth of Medical Devices, by analyzing inter-nation trade intensity for key Medical Device items. To do so, this study selected 8 nations in total by reviewing three points: core Medicine-advanced countries, geographically adjacent countries to Myanmar, and relative export-concentration.

• 한국IT서비스학회지
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• 제22권4호
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• pp.21-35
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• 2023

Software as Medical Devices (SaMD) is a growing category of medical devices that are composed of software to perform one or more medical purposes. SaMD is less likely to cause physical harm compared to conventional medical devices, particularly medical electrical equipments, and may be more vulnerable to privacy issues. This difference was acknowledged and resulted in introducing new regulation guidance specifically for cybersecurity of SaMD. It guides stakeholders of SaMD what to consider in what context in terms of cybersecurity. This study examines the current guidance of how cybersecurity is considered for SaMD by analyzing current medical device standards, then suggest which concept or details beyond current medical device standards may be applicable through analysis of international standards documents published for software in general.

• 대한방사선기술학회지:방사선기술과학
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• 제22권2호
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• pp.33-39
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• 1999

This paper included a data analysis of the unit of medical devices using mainternance recording card that had medical devices of unit failure mode, hospital of failure mode and MTBF. The results of the analysis were as follows : 1. Medical devices of unit failure mode was the highest in QC/PM such A hospital as 33.9%, B hospital 30.9%, C hospital 30.3%, second degree was the Electrical and Electronic failure such A hospital as 23.5%, B hospital 25.3%, C hospital 28%, third degree was mechanical failure such A hospital as 19.5%, B hospital 22.5%, C hospital 25.4%. 2. Hospital of failure mode was the highest in Mobile X-ray device(A hospital 62.5%, B hospital 69.5%, C hospital 37.4%), and was the lowest in Sono devices(A hospital 16.76%, B hospital 8.4%, C hospital 7%). 3. Mean time between failures(MTBT) was the highest in SONO devices and was the lowest in Mobile X-ray devices which have 200 - 400 failure hours. 4. Anverage failure ratio was the highest in Mobile X-ray devices(A hospital 31.3%, B hospital 34.8%, C hospital 18.7%), and was the lowest in Sono(Ultrasound) devices (A hospital 8.4%, B hospital 4.2%, C hospital 3.5%). 5. Failure ratio results of medical devices according to QC/PM part of unit failure mode were as follows ; A hospital was the highest part of QC/PM (50%) in Mamo X-ray device and was the lowest part of QC/PM(26.4%) in Castro X-ray. B hospital was the highest part of QC/PM(56%) in Mobile X-ray device, and the lowest part of QC/PM(12%) in Gastro X-ray. C hospital was the highest part of QC/PM(60%) in R/F X-ray device, and the lowest a part of QC/PM(21%) in Universal X-ray. It was found that the units responsible for most failure decreased by systematic management. We made the preventive maintenance schedule focusing on adjustement of operating and dust removal.

• 한국임상수의학회지
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• 제35권1호
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• pp.1-6
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• 2018

This study reviewed the regulatory safety management system for prevention of side effects of veterinary medical devices in Korea based on data obtained through analyses of those medical devices. In order to ensure the safety of medical devices, Ministry of Food and Drug Safety has established the management system include licensing, test inspection (134 designated clinical trial agencies) and post management. In addition, it was introduce the good manufacture practice (GMP) certification system and device tracking requirements. In contrast, it is necessary to establish regulations for side effects report and awareness on veterinary medical devices in Korea. The center for veterinary medicine of FDA in the United States has been operated side effects reporting system of veterinary medical devices from user, manufactures and distributor. Due to increase the use of various kinds of veterinary medical devices for animals, it should be required to improve regulation related to the licensing procedures, GMP system, and the side effects reporting system in our country.

• 대한의용생체공학회:의공학회지
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• 제29권2호
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• pp.164-171
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• 2008

Recently, many of hospitals have hurried to computerize the resulting data from medical devices, in order to introduce Electric Medical Record(EMR). In terms of the linkage between medical devices and hospital information systems, however, many difficulties have arisen due to some reasons such as the variety of prescription input, the format difference of the resulting data sheet, and the interface difference between medical devices from different companies. To solve these problems, many researches on standardization of the resulting data of medical devices have been performed. In this study, the linkage between hospital information systems and resulting datum in Electrocardiogram(ECG) generating biosignal waveform was tested by applying Medical waveform Format Encoding Rules(MFER) Version 1.02, which has more advantages than existing global standard. MFER viewer, in addition, was made to display the resulting data on a screen. The MFER viewer was tested and compared to the existing Scalable Vector Graphics (SVG) Viewer. The results showed that this method is more effective in the interface the data storage and application, because of simplicity and easiness in data applications. And the results show that the MFER is convenience and effective for physician. It is considered that the role of MFER as the interface in biosignal waveform including Electrocardiogram medical devices would expand in the near future.

• 한국임상수의학회지
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• 제36권1호
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• pp.1-6
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• 2019

This study reviewed the trends and prospect of the market for veterinary medical devices in Korea. The registration of veterinary medical devices has sharply increased since 2013, and a total of 2,133 products from 348 companies were registered by 2018. Of these products, the proportion of the instrument, in vitro diagnostic (IVD) reagents, medical only used for animal and supplies were 51.6%, 35.7%, 7.6% and 5.1%, respectively. The sales amount of veterinary medical devices is approximately 95.8 billion won in 2017. The sales of domestic consumption and imports were 53.9 and 41.9 billion won, respectively. They are increasing 14.9% (CAGR) in the domestic consumption, and 44.0% (CAGR) in the export from 2011 to 2017, respectively. The proportion of IVD reagents, instrument, medical only used for animal and supplies were 54.2%, 41.0%, 3.8%, and 1.0%, respectively. The top 10 items with high sales were IVD reagents for clinical immunochemistry, visceral function testing instrument, hematological testing apparatus, syringes, IVD reagents for molecular genetics, etc. They are widely used from 3,926 animal hospitals in 2017. This study suggested that registration and sales of veterinary medical devices have gradually increased since 2013 as the demand of health care services for various animals. Therefore, the veterinary medical devices industry is expected to grow in the future.

• 한국안광학회지
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• 제12권3호
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• pp.143-149
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• 2007

본 논문에서는 한국, 미국과 유럽연합의 의료기기의 정의, 분류, 안경테를 다루는 직종, 관리, 판매 등에 대하여 비교 분석하였다. 한국은 시력보정용 안경테를 공산품으로 지정한 반면 유럽연합과 미국은 의료기기로 분류하였다. 선글라스의 경우 한국과 유럽연합에서는 공산품이지만 미국에서는 의료기기이다. 안경테와 선글라스의 공산품 지정은 여러 가지 문제점을 유발한다. 시력보정용 안경테와 선글라스의 의료기기지정은 이러한 문제를 해결할 수 있을 것으로 본다.

• 재활복지공학회논문지
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• 제11권4호
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• pp.299-306
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• 2017

국산 의료기기 산업에 대한 다양한 투자와 신기술 도입에 따라 국내의료기기 산업은 비약적인 증가를 하고 있으나 국내 대형의료기관의 국산의료기기 사용률은 여전히 저조한 것으로 조사되고 있다. 본 논문에서는 국내 대형병원에서의 국산 의료기기 사용률과 사용자 및 관리자의 인식조사를 수행하여 국산의료기기의 개선점을 제시하였다. 이를 위해 국내 4곳의 국립대학교병원을 대상으로 전체 의료기기의 종류와 국산 의료기기 사용률에 대한 조사를 진행하고 이를 바탕으로 의료기기 중 중점조사 대상 의료기기를 선정하였다. 중점조사대상 의료기를 대상으로 고장통계와 사용자 인식조사를 수행하였으며 이를 통해 중점조사대상 의료기기의 개선사항을 제시하였다.