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A Study on the Establishment and Operation of a Regulatory Response Framework in connection with the Regulatory Strength of the Licensing Policy for New Medical Devices -Focusing on the Application of FMEA- (의료기기 신제품의 인허가정책 규제강도에 연계한 규제대응 프레임워크 수립 및 운영에 관한 연구 - FMEA 적용을 중심으로 -)

  • Kim, Gyosu;Ru, Gyuha;Kim, Yeonhee
    • Journal of Technology Innovation
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    • v.28 no.4
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    • pp.1-26
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    • 2020
  • Due to the spread of Corona 19 around the world, Infectious Disease Medicine and New Medical Devices such as Diagnostic Agent are being rapidly developed and launched, and for the fast supply and demand of these, each country has eased import regulations or has implemented policies for fast approval(NIDS, 2020). On the other hand, New Developed Medical Devices that are not related to New Infectious Diseases, they are still entering the market through strict licensing and licensing regulations, such as delay and cancellation in the test inspection process, etc. Therefore, This Study specialized in the government-managed laws encountered when New Medical Devices enter the market, derive Factors influencing the Strength of Regulations, analyzes the Strength of Regulations, and proposes a Regulatory Response Framework. The Research Method was conducted by Literature Research, was applied by Failure Mode and Effects Analysis(FMEA) Method, Expert Interview(1st): Idea Collection, Expert Interview(2nd): Validation, and Priority through the Application Process of FMEA Method. A Method of Quantifying the Intensity of Regulation was proposed by multiplying the Impact of the Influencing Factors for each stage of regulation and the Burden Impact for each type of Regulatory Affairs to find the Importance of the Regulatory Factors and multiplying the Severity of the Regulatory Impact. The Implications are that major overseas countries and the Korean government are actively responding with Special Regulatory Policies and Mitigation Policies for fast licensing of New Developed Medical Devices in accordance with Corona 19. It is expected that the direction for improvement of regulations and measures to respond to regulations will be implemented so that a more proactive and preemptive response to the regulatory process of the licensing policy for New Devices can be achieved.

Study on Standardization of the Environmental Impact Evaluation Method of Extremely Low Frequency Magnetic Fields near High Voltage Overhead Transmission Lines (고압 가공송전선로의 극저주파자기장 환경영향평가 방법 표준화에 관한 연구)

  • Park, Sung-Ae;Jung, Joonsig;Choi, Taebong;Jeong, Minjoo;Kim, Bu-Kyung;Lee, Jongchun
    • Journal of Environmental Impact Assessment
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    • v.27 no.6
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    • pp.658-673
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    • 2018
  • Social conflicts with extremely low frequency magnetic field(ELF-MF) exposures are expected to exacerbate due to continued increase in electric power demand and construction of high voltage transmission lines(HVTL). However, in current environmental impact assessment(EIA) act, specific guidelines have not been included concretely about EIA of ELF-MF. Therefore, this study conducted a standardization study on EIA method through case analysis, field measurement, and expert consultation of the EIA for the ELF-MF near HVTL which is the main cause of exposures. The status of the EIA of the ELF-MF and the problem to be improved are derived and the EIA method which can solve it is suggested. The main contents of the study is that the physical characteristics of the ELF-MF affected by distance and powerload should be considered at all stages of EIA(survey of the current situation - Prediction of the impacts - preparation of mitigation plan ? post EIA planning). Based on this study, we also suggested the 'Measurement method for extremely low frequency magnetic field on transmission line' and 'Table for extremely low frequency magnetic field measurement record on transmission line'. The results of this study can be applied to the EIA that minimizes the damage and conflict to the construction of transmission line and derives rational measures at the present time when the human hazard to long term exposure of the ELF-MF is unclear.

A Study of Waterproofing Evaluation and Effect of UV Protection (UVB/UVA) of Multiple Emulsion Sunblock Cream using Sensory Engeeneering Science (감성공학을 적용한 다중에멀젼 선블록크림의 자외선차단(UVA/B) 효과와 내수성 평가 연구)

  • Kim, In-Young
    • Journal of the Korean Applied Science and Technology
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    • v.37 no.6
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    • pp.1517-1527
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    • 2020
  • This study is about the UV protection effect and water resistance of a multiple emulsion (W/O/W) sunblock cream applied with emotional engineering and reports an actual industrial case. Multiple emulsion system of sunblock cream has the characteristics of changing to a W/O type that is soft and moist when applied, and has excellent water resistance after absorption. Multiple emulsion cream is a highly functional sunblock cream that has both moisture and water resistance. It is a stable milky white cream with a viscosity of 36,000 cps. The organic sunscreen used for the sunscreen was ethylhexylmethoxycinnamate and bisethylhexyloxyphenolmethoxyphenyltriazine. Hexagonal zinc oxide and titanium dioxide that block both UVB and UVA were used. As a result of measuring the UV protection effect by the in-vitro method, the UV protection effect (SPF) is 78.9 for multiple emulsion cream, 76.7 for W/O cream, and 71.3 for O/W cream. It was found that the blocking effect was different. This obtained the highest effect value in the multiple emulsion. As a clinical (in-vivo) result of the UV protection effect, the SPF value representing the UV protection effect of the sunblock cream developed with a multiple emulsion system was 85.7, and the PA-value that blocks the UVA area was 26.5, and ++++. It was found that it has a corresponding high blocking effect. As a result of the water resistance test, the W/O/W formulation had a high waterproofing resistance of 93.8% even after 4 hours, W/O had 75.4%, and O/W had a low water resistance of 25.3%. In the results of the HUT test, it was found in the order of multiple emulsion sun block cream > hydrophilic cream > lipophilic cream. Based on the research results of this multiple emulsion, it is expected to be highly active as a sunblock cream dedicated to outdoor activities by improving the feeling of use, UV protection index, and water resistance. Therefore, in this study, a multiple emulsion system of sunblock cream is developed and has a characteristic that changes to a W/O type that has a soft and moist feeling when applied, and has excellent water resistance after absorption.

Review of Erosion and Piping in Compacted Bentonite Buffers Considering Buffer-Rock Interactions and Deduction of Influencing Factors (완충재-근계암반 상호작용을 고려한 압축 벤토나이트 완충재 침식 및 파이핑 연구 현황 및 주요 영향인자 도출)

  • Hong, Chang-Ho;Kim, Ji-Won;Kim, Jin-Seop;Lee, Changsoo
    • Tunnel and Underground Space
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    • v.32 no.1
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    • pp.30-58
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    • 2022
  • The deep geological repository for high-level radioactive waste disposal is a multi barrier system comprised of engineered barriers and a natural barrier. The long-term integrity of the deep geological repository is affected by the coupled interactions between the individual barrier components. Erosion and piping phenomena in the compacted bentonite buffer due to buffer-rock interactions results in the removal of bentonite particles via groundwater flow and can negatively impact the integrity and performance of the buffer. Rapid groundwater inflow at the early stages of disposal can lead to piping in the bentonite buffer due to the buildup of pore water pressure. The physiochemical processes between the bentonite buffer and groundwater lead to bentonite swelling and gelation, resulting in bentonite erosion from the buffer surface. Hence, the evaluation of erosion and piping occurrence and its effects on the integrity of the bentonite buffer is crucial in determining the long-term integrity of the deep geological repository. Previous studies on bentonite erosion and piping failed to consider the complex coupled thermo-hydro-mechanical-chemical behavior of bentonite-groundwater interactions and lacked a comprehensive model that can consider the complex phenomena observed from the experimental tests. In this technical note, previous studies on the mechanisms, lab-scale experiments and numerical modeling of bentonite buffer erosion and piping are introduced, and the future expected challenges in the investigation of bentonite buffer erosion and piping are summarized.

Case study on flood water level prediction accuracy of LSTM model according to condition of reference hydrological station combination (참조 수문관측소 구성 조건에 따른 LSTM 모형 홍수위예측 정확도 검토 사례 연구)

  • Lee, Seungho;Kim, Sooyoung;Jung, Jaewon;Yoon, Kwang Seok
    • Journal of Korea Water Resources Association
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    • v.56 no.12
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    • pp.981-992
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    • 2023
  • Due to recent global climate change, the scale of flood damage is increasing as rainfall is concentrated and its intensity increases. Rain on a scale that has not been observed in the past may fall, and long-term rainy seasons that have not been recorded may occur. These damages are also concentrated in ASEAN countries, and many people in ASEAN countries are affected, along with frequent occurrences of flooding due to typhoons and torrential rains. In particular, the Bandung region which is located in the Upper Chitarum River basin in Indonesia has topographical characteristics in the form of a basin, making it very vulnerable to flooding. Accordingly, through the Official Development Assistance (ODA), a flood forecasting and warning system was established for the Upper Citarium River basin in 2017 and is currently in operation. Nevertheless, the Upper Citarium River basin is still exposed to the risk of human and property damage in the event of a flood, so efforts to reduce damage through fast and accurate flood forecasting are continuously needed. Therefore, in this study an artificial intelligence-based river flood water level forecasting model for Dayeu Kolot as a target station was developed by using 10-minute hydrological data from 4 rainfall stations and 1 water level station. Using 10-minute hydrological observation data from 6 stations from January 2017 to January 2021, learning, verification, and testing were performed for lead time such as 0.5, 1, 2, 3, 4, 5 and 6 hour and LSTM was applied as an artificial intelligence algorithm. As a result of the study, good results were shown in model fit and error for all lead times, and as a result of reviewing the prediction accuracy according to the learning dataset conditions, it is expected to be used to build an efficient artificial intelligence-based model as it secures prediction accuracy similar to that of using all observation stations even when there are few reference stations.

Grouting Improvement through Correlation Analysis of Hydrogeology and Discontinuity Factors in a Jointed Rock-Mass (절리 암반의 수리지질 및 불연속면 특성 간 상관분석을 통한 그라우팅 계획 수립의 개선 방안)

  • Kwangmin Beck;Seonggan Jang;Seongwoo Jeong;Minjune Yang
    • The Journal of Engineering Geology
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    • v.34 no.2
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    • pp.279-294
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    • 2024
  • Large-scale civil engineering structures such as dams require a systematic approach to jointed rock-mass grouting to prevent water leakage into the foundations and to ensure safe operation. In South Korea, rock grouting design often relies on the experience of field engineers that was gained in similar projects, highlighting the need for a more systematic and reliable approach. Rock-mass grouting is affected mainly by hydrogeology and the presence of discontinuities, involving factors such as the rock quality designation (RQD), joint spacing (Js), Lugeon value (Lu), and secondary permeability index (SPI). This study, based on data from field investigations of 14 domestic sites, analyzed the correlation between hydrogeological factors (Lu and SPI), discontinuity characteristics (RQD and Js), and grout take, and systematically established a design method for rock grouting. Analysis of correlation between the variables RQD, Js, Lu, and SPI yielded Pearson correlation (r) values as follows: Lu-SPI, 0.92; RQD-Lu, -0.75; RQD-Js, 0.69; RQD-SPI, -0.65; Js-Lu, -0.47; and SPI-Js, -0.41. The grout take increases with Lu and SPI values, but there is no significant correlation between RQD and Js. The proposed approach for grouting design based on SPI values was verified through analysis and comparison with actual curtain-grouting construction, and is expected to be useful in practical applications and future studies.

Evaluation of Hydrogeological Characteristic of Natural Barrier in Korea for Establishing Safety Guidelines of Deep Geological High-Level Radioactive Waste Disposal Site (고준위방사성폐기물 심층처분 부지 수리 지질 안전 규제를 위한 국내 지질환경 수리 특성 평가)

  • Suwan So;Jiho Jeong;Jaesung Park;Hyeongmok Lee;Subi Lee;Sujin Kim;Sinda Mbarki;Jina Jeong
    • Economic and Environmental Geology
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    • v.57 no.4
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    • pp.397-416
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    • 2024
  • This study assessed the hydrogeological properties of the deep geological environment to develop safety criteria for the natural barriers used in the deep geological disposal of high-level radioactive waste in Korea. The assessment focused on the distribution and trends of hydraulic conductivity and permeability properties appropriate for the domestic geological environment, using various in-situ hydraulic test data collected for groundwater development and management. To develop a depth-hydrogeological property relationship model suitable for domestic conditions, the study reviewed various international research examples and applied a representative model that explains the trends of hydraulic conductivity and permeability with depth. The development of the model suitable for Korea involved applying ensemble regression analysis to account for the uncertainty of various factors in the collected data. The results confirmed that existing international depth-hydrogeological property relationship models adequately describe the characteristics of the domestic geological environment. Considering the preferred hydrogeological criteria suggested by countries like Sweden, Germany, and Canada, there is a high likelihood that a suitable geological environment exists in Korea. Additionally, the application of hydrogeological criteria indicative of low-permeability environments showed that suitable conditions for disposal construction increase at depths greater than 300 m, where the influence of fractures on groundwater flow might be minimal at depths exceeding 500 m. This research can serve as foundational information for establishing hydrogeological safety standards for natural barriers in Korea according to international regulatory guidelines.

Example of Legislation on the Space Relations of Every Countries in the World and Main Contents of the Space Exploration Promotion Act and Future Task in Korea (세계 각국의 우주관계 입법례와 우리나라 우주 개발진흥법의 주요내용 및 앞으로의 과제)

  • Kim, Doo-Hwan
    • The Korean Journal of Air & Space Law and Policy
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    • v.20 no.1
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    • pp.9-43
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    • 2005
  • The Korean government established her first "National Space Program" in 1996, and revised it in 2000 and 2005. As embedded in the National Space Program, Korea aims to become one of the world's top countries in space technology by 2010. All of 13 satellites are planned to be put into orbit as schematized, which include 7 multi-purpose satellites, 4 science satellites and 2 geostationary orbit satellites. The Space Center in Korea is to be built at Woinara-Do, Bongrae-Myon, Koheung-Goon, Junlanam Province on the southern coast of the Korean peninsular. The first phase of the construction of the space center will be finished by 2007 for launch of KSLV-l. This will make Korea be the 13th advanced country in space development having a launching site in the world. The "Space Center" will serve as the infrastructure for the development of space technology and related technology, and plan to launch a low earth orbit satellite in 2007. A second science satellite made in Korea will be launched from the space center by 2007. From 2010, the center will be operated on a commercial basis operating launch facilities for low-to mid-altitude orbit satellites. Since the 'Aircraft Industry Promotion Act' was replaced by the 'Aerospace Industry Development Promotion Acf of 1987, this Act had been amended seven times from 1991 year to 2004. Most of developed countries has been enacted the space law including the public or private items such as an (1)DSA, (2)Russia, (3)the United Kingdom, (4)Germany, (5)France, (6)Canada, (7)Japan, (8)Sweden, (9)Australia, (10)Brazil, (11)Norway, (12)South Africa, (13)Argentina, (14)Chile, (15)Ukrainian etc. As the new Space Exploration Promotion Act was passed by the resolution of the Korean Congress on May 3, 2005, so the Korean government has made the public proclamation the abovementioned Act on May 31, this year. This Act takes effect on December 1, 2005 after elapsing six months from the date of promulgation. The main contents of Space Exploration Promotion Act of 2005 is as the following (1)establishing a basic plan for promoting space exploration, (2)establishment and function of national space committee, (3)procedure and management of domestic and international registration of space objects, (4)licensing of launch by space launch vehicles, (5)lability for damages caused by space accidents and liability insurance, (6) organizing and composition of the space accident investigation committee, (7)Support of non-governmental space exploration project, (8)Requesting Support and Cooperation of Space Exploration, (9)Rescue of Astronauts and Restitution of Space Objects, etc.. In oder to carry out successfully the medium and long basic plan for promoting space exploration and to develope space industry in Korea, I think that it is necessary for us to enlarge and to reorganize the function and manpower of the Space Technology Development Division of the Ministry of Science & Technology and the Korea Aerospace Research Institute. Korea has been carrying out its space program step by step according to the National Space Program. Korea also will continually strengthen the exchange and cooperation with all the countries in the world under the principle of equality, friendship relations and mutual benefits. Together with all other peoples around the globe, Korea will make due contribution towards the peaceful utilization of space resources and promotion of human progress and prosperity.

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[ $^1H$ ] MR Spectroscopy of the Normal Human Brains: Comparison between Signa and Echospeed 1.5 T System (정상 뇌의 수소 자기공명분광 소견: 1.5 T Signa와 Echospeed 자기공명영상기기에서의 비교)

  • Kang Young Hye;Lee Yoon Mi;Park Sun Won;Suh Chang Hae;Lim Myung Kwan
    • Investigative Magnetic Resonance Imaging
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    • v.8 no.2
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    • pp.79-85
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    • 2004
  • Purpose : To evaluate the usefulness and reproducibility of $^1H$ MRS in different 1.5 T MR machines with different coils to compare the SNR, scan time and the spectral patterns in different brain regions in normal volunteers. Materials and Methods : Localized $^1H$ MR spectroscopy ($^1H$ MRS) was performed in a total of 10 normal volunteers (age; 20-45 years) with spectral parameters adjusted by the autoprescan routine (PROBE package). In all volunteers, MRS was performed in a three times using conventional MRS (Signa Horizon) with 1 channel coil and upgraded MRS (Echospeed plus with EXCITE) with both 1 channel and 8 channel coil. Using these three different machines and coils, SNRs of the spectra in both phantom and volunteers and (pre)scan time of MRS were compared. Two regions of the human brain (basal ganglia and deep white matter) were examined and relative metabolite ratios (NAA/Cr, Cho/Cr, and mI/Cr ratios) were measured in all volunteers. For all spectra, a STEAM localization sequence with three-pulse CHESS $H_2O$ suppression was used, with the following acquisition parameters: TR=3.0/2.0 sec, TE=30 msec, TM=13.7 msec, SW=2500 Hz, SI=2048 pts, AVG : 64/128, and NEX=2/8 (Signa/Echospeed). Results : The SNR was about over $30\%$ higher in Echospeed machine and time for prescan and scan was almost same in different machines and coils. Reliable spectra were obtained on both MRS systems and there were no significant differences in spectral patterns and relative metabolite ratios in two brain regions (p>0.05). Conclusion : Both conventional and new MRI systems are highly reliable and reproducible for $^1H$ MR spectroscopic examinations in human brains and there are no significant differences in applications for $^1H$ MRS between two different MRI systems.

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Review of 2015 Major Medical Decisions (2015년 주요 의료판결 분석)

  • Yoo, Hyun Jung;Lee, Dong Pil;Lee, Jung Sun;Jeong, Hye Seung;Park, Tae Shin
    • The Korean Society of Law and Medicine
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    • v.17 no.1
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    • pp.299-346
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    • 2016
  • There were also various decisions made in medical area in 2015. In the case that an inmate in a sanatorium was injured due to the reason which can be attributable to the sanatorium and the social welfare foundation that operates the sanatorium request treatment of the patient, the court set the standard of fixation of a party in medical contract. In the case that the family of the patient who was declared brain dead required withdrawal of meaningless life sustaining treatment but the hospital rejected and continued the treatment, the court made a decision regarding chargeable fee for such treatment. When it comes to the eye brightening operation which received measure of suspension from the Ministry of Health and Welfare for the first time in February, 2011, because of uncertainty of its safety, the court did not accept the illegality of such operation itself, however, ordered compensation of the whole damage based on the violation of liability for explanation, which is the omission of explanation about the fact that the cost-effectiveness is not sure as it is still in clinical test stage. There were numerous cases that courts actively acknowledged malpractices; in the cases of paresis syndrome after back surgery, quite a few malpractices during the surgery were acknowledged by the court and in the case of nosocomial infection, hospital's negligence to cause such nosocomial infection was acknowledged by the court. There was a decision which acknowledged malpractice by distinguishing the duty of installation of emergency equipment according to the Emergency Medical Service Act and duty of emergency measure in emergency situations, and a decision which acknowledged negligence of a hospital if the hospital did not take appropriate measures, although it was a very rare disease. In connection with the scope of compensation for damage, there were decisions which comply with substantive truth such as; a court applied different labor ability loss rate as the labor ability loss rate decreased after result of reappraisal of physical ability in appeal compared to the one in the first trial, and a court acknowledged lower labor ability loss rate than the result of appraisal of physical ability considering the condition of a patient, etc. In the event of any damage caused by malpractice, in regard to whether there is a limitation on liability in fee charge after such medical malpractice, the court rejected the hospital's claim for setoff saying that if the hospital only continued treatments to cure the patient or prevent aggravation of disease, the hospital cannot charge Medical bills to the patient. In regard to the provision of the Medical Law that prohibit medical advertisement which was not reviewed preliminarily and punish the violation of such, a decision of unconstitutionality was made as it is a precensorship by an administrative agency as the deliberative bodies such as Korean Medical Association, etc. cannot be denied to be considered as administrative bodies. When it comes to the issue whether PRP treatment, which is commonly performed clinically, should be considered as legally determined uninsured treatment, the court made it clear that legally determined uninsured treatment should not be decided by theoretical possibility or actual implementation but should be acknowledged its medical safety and effectiveness and included in medical care or legally determined uninsured treatment. Moreover, court acknowledged the illegality of investigation method or process in the administrative litigation regarding evaluation of suitability of sanatorium, however, denied the compensation liability or restitution of unjust enrichment of the Health Insurance Review & Assessment Service and the National Health Insurance Corporation as the evaluation agents did not cause such violation intentionally or negligently. We hope there will be more decisions which are closer to substantive truth through clear legal principles in respect of variously arisen issues in the future.

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