• Journal of Biomedical Engineering Research
• /
• v.32 no.2
• /
• pp.151-157
• /
• 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.

• THE INTERNATIONAL COMMERCE & LAW REVIEW
• /
• v.59
• /
• pp.181-205
• /
• 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.

• THE INTERNATIONAL COMMERCE & LAW REVIEW
• /
• v.64
• /
• pp.213-237
• /
• 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.

• Journal of Information Technology Services
• /
• v.22 no.4
• /
• pp.21-35
• /
• 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.

• Journal of radiological science and technology
• /
• v.22 no.2
• /
• pp.33-39
• /
• 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.

• Journal of Veterinary Clinics
• /
• v.35 no.1
• /
• pp.1-6
• /
• 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.

• Journal of Biomedical Engineering Research
• /
• v.29 no.2
• /
• pp.164-171
• /
• 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.

• Journal of Veterinary Clinics
• /
• v.36 no.1
• /
• pp.1-6
• /
• 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.

• Journal of Korean Ophthalmic Optics Society
• /
• v.12 no.3
• /
• pp.143-149
• /
• 2007

We have compared and analyzed the definition of medical devices, classification, who treats, controls and sales the spectacle frames in South Korea, USA and European Union in this paper. South Korea classifies the spectacle frames as an industrial products while EU and USA regards it them as the medical devices. Sunglasses are industrial products in South Korea and EU but they are still the medical devices in USA. Assignment of spectacle frames and sunglasses as an industrial products could bring into several problems. Restricted classification of medical devices on spectacle frames and sunglasses will resolve the problem mentioned.

• Journal of rehabilitation welfare engineering & assistive technology
• /
• v.11 no.4
• /
• pp.299-306
• /
• 2017

The Korean medical device industry has increased dramatically due to various investments in the domestic medical device industry and the introduction of new technologies, but the domestic medical device usage rate in great hospital is still low. In this paper, improvement point for domestic medical device was suggested by domestic medical device usage rate and user and manager's perception survey in great hospitals in Korea. To do this, a survey on the types of medical devices and domestic medical device usage rates were conducted at four national university hospitals in Korea. From this results, the priority survey medical devices were selected. Improvements of Korean medical devices were suggested by failure mode analysis and user awareness surveys for the priority survey medical devices.