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A Study on Development of Guideline on Writing Technical Document for Electrical Medical Devices: Dental X-ray Equipment (치과용엑스선장치의 기술문서 작성을 위한 가이드라인 개발 연구)

  • Lee, Seung-Youl;Kim, Jae-Ryang;Lee, Jun-Ho;Park, Chang-Won
    • 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.

Seasonal Variations of Environmental Factors and Distribution of Anabaena cylindrica Growth-Inhibiting Bacteria in the Lower Daechung Reservoir (대청호 하류에서 환경요인과 Anabaena cylindrica 생장억제세균의 계절별 분포 변화)

  • Lee, Jung-Ho;Kim, Chul-Ho
    • Korean Journal of Ecology and Environment
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    • v.33 no.2 s.90
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    • pp.128-135
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    • 2000
  • The authors surveyed the seasonal variations of environmental factors, the distributions of heterotrophic bacteria and Anabaena cylindrica growth-inhibiting bacteria at each water layer in Daechung Reservoir to verify the role of bacteria during the extinction of bloom. Average water depth at site 1, 2, and 3 were 25.5 m, 15.0 m and 12.3 m, respectively. Water temperature showed a typical pattern seasonally. The variation of DO was relatively inverse proportional to that of water temperature, although it was irregular during summer time. DO decreased gradually to early May, fluctuated sharply after then, and followed by gradual increasement after middle of September. This variation pattern was notable at surface layer. There was remarkable difference in DO concentraion between surface layer and the other water layers during the period in which DO irregulary varied. The variation range of chlorophyll-a concentraion at surface layer in summer time was broad, and it was relatively high when DO was high. The population size of heterotrophic bacteria was high from Spring to Autumn, an declined after September when the water temperature droped rapidly. Especially this variation pattern was prominent at the surface layer. Bacteria that inhibit the growth of A. cylindrica was almost not detected by June, and its distribution increased in July. Afterward, it showed different variation pattern between each site. The distribution of A. cylindrica growth-inhibiting bacteria was higher at the middle and bottom layer than the surface layer in July and October, when it was larger at all sites for the study period. This result suggests that the antagonistic bacteria exhibit higher activity when host activity drops. These results also suggest that natural water bacteria control the distirbution of cyanobacteria, especially its activity as controller is remarkable when cyanobacterial growth declines.

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The Exposure Status and Biomarkers of Bisphenol A in Shipyard Workers (일부 조선업 근로자들의 bisphenol A 노출실태와 생물학적 지표)

  • Kim, Cheong-Sik;Park, Jun-Ho;Cha, Bong-Suk;Park, Jong-Ku;Kim, Heon;Chang, Soung-Hoon;Koh, Sang-Baek
    • Journal of Preventive Medicine and Public Health
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    • v.36 no.2
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    • pp.93-100
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    • 2003
  • Objectives : Because shipyard workers are involved with various manufacturing process, they are exposed to many kinds of hazardous materials. Welders especially, are exposed to bisphenol-A (BPA) during the welding and flame cutting of coated steel, This study was conducted to assess the exposure status of the endocrine disrupter based on the job-exposure matrix. The effects of the genetic polymorphism of xenobiotic enzyme metabolisms involved in the metabolism of BPA on the levels of urinary metabolite were investigated. Methods : The study population was recruited from a shipyard company in the f province. A total of 84 shipbuilding workers 47 and 37 in the exposed and control groups, respectively, were recruited for this study. The questionnaire variables included, age, sex, use of personal protective equipment, smoking, drinking and work duration. The urinary metabolite was collected in the afternoon and correction made for the urinary creatinine concentration. The of the CYP1A1, CYP2E1 and UGT1A6 genotypes were investigated using polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) methods with the DNA extracted from venous blood. Results : The urinary BPA level in the welders group was significantly higher than in the control group (p<0.05). The urinary BPA concentration with the wild type UGT1A6 was higher than the other UGT1A6 genotypes, but with no statistical significant. From themultiple regression analysis of the urinary BPA, the regression coefficient for job grade was statistically significant (p<0.05). Conclusions : The grade of exposure to BPA affected the urinary BPA concentration was statistically significant. However, the genetic polymorphisms of xenobiotics enzyme metabolism were not statistically significant. Further investigation of the genetic polymorphisms with a larger sample size is needed.

Nodal Status of the Head and Neck Cancer Patients (두경부 암 환자의 경부 림프절 전이 분석)

  • Yang, Dae-Sik;Choi, Myung-Sun;Choi, Jong-Ouck
    • Radiation Oncology Journal
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    • v.15 no.4
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    • pp.321-329
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    • 1997
  • Purpose : It is well known that the risk of lymph nodes metastases to head and neck cancers are influenced by the location and size of the Primary tumor. as well as the degree and types of histological differentiation. However, data on the statistical analyses of lymph node metastases from the head and neck cancers among Korean Population are not available at present. In order to obtain current status of such data, we have analyzed cancer patients at the department of radiation oncology, korea universityhospital for radiation treatment. Materials and Methods : We have evaluated nine-hundred and ninetyseven (997) head and neck cancer Patients who visited to the Department of radiation oncology, between November 1981 to December 1995. After careful physical examinations and CAT scan, Patients were divided into two groups, those with positive lymph node metastases and with negative lymph node metastases. The nodal status were classified according to the TNM system of American Joint Committee on Cancer (AJCC) Besults : Four-hundred and sixteen Patients out of the 997 patients were lymph node positive $(42\%)$ and 581 patients were lymph node negative $(58\%)$ when they were first presented at the department of radiation oncelogy. According to the AJCC classification, the distribution of positive lymph node is as follow: Nl:106 $(25.5\%),\;N2a:100\;(24\%),\;N2b:68\;(16.4\%),\;N2c:69\;(16.6\%),\;3:73\;(15\%).$ respectively. The frequency of lymph node metastases according to the primary sites is as follow : larynx 283 $(28.5\%)$, paranasal sinuses: 182 $(18\%),\;oropharynx:144\;(14.5\%)\;nasopharynx:122(12\%),\;oral\;cavity\;92\;(9\%),\;hypopharynx:71\;(7\%),\;falivary\;gland:58\;(6\%)$ unknown primary:31 $(3\%),\;skin:\;14(2\%)$,. The most frequent Primary site for the positive Iymph node metastases was nasopharynx $(71\%)$ followed by hypopharynx $(69\%),\;oropharynx\;(64\%),\;oral\;cavity\;(39\%)$ The most common histologic type was squamous cell carcinoma (652/997: $65.4\%$). followed by malignant lymphoma $(109/997:11\%)$. Conclusion : Statistical results of lymph node metastases from head and neck cancer at our department were very similar to those obtained from other countries. It is concluded that the location of Primary cancer influences sites of metastases on head and neck, and stage of the primary cancer also influences the development of metastatic lesions. Since the present study is limited on the data collected from one institute. further statistical analyses on Korean cancer Patients are warrented.

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Establishment Strategies and Location Analysis of Convention Center for Regional Development of The Yosu Peninsular Area (여수반도권 지역발전을 위한 컨벤션센터의 입지분석 및 건립전략)

  • Lee, Jeong-Rock
    • Journal of the Korean association of regional geographers
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    • v.2 no.2
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    • pp.133-157
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    • 1996
  • Recently, international convention competition has greatly expanded with the globalization and expand of world economy. As the conventions market has grown, so have the number of places and facilities of convention competing for business, and numerous trade show and the related meetings held the several cities toward world city such as the United States, Europeans Countries, Japan, and Singapore. Convention, in general, are defined as an assembly, often periodical, of members or delegates, as a political, social, professional or religious group. Convention center means the place that hold several social, political, economic conferences and meetings, trade show, exhibitions, and events. Convention center are consisted the several facilities such as meeting room, exhibition hall, event hall. Historically, meetings, conventions, and trade show have been serviced primarily by hotel and convention centers. With the expand of world trade and flow in recent, the conventions, expositions, and meetings industry (CEMI), however, is one of the most rapidly growing industries in hospitality and tourism, and CEMI provides import effect on regional economy and regional development including regional tourism industry. This study focuses on the establishment strategies and location analysis of convention center as a agent for regional development in a case of Yosu Peninsular Area (YPA). YPA is one of the major industrial area of our country, and displays the rapid regional urbanization and social change with the construction such as Kwangyang container port facilities, Yulchon industrial complex, and the extension planning of industrial estate related to Kwangyang Iron and Steel Company, and population size of this area will be reached about two million peoples in 2011. This area, particularly, will be functioned as a major container & export port of our country after the completion of Kwangyang container port facilities in 1988. If the planned industrial estate is constructed, the convention center for conference exhibition, information exchange, and resort facilities for exhibition, international communication will be needed. In addition, resort and leisure facilities for conventions' participants need. This area, therefore, has to make the establishment of convention center for regional development in future. Thus, the major strategies and idea for establishment of convention center as follows: first, this area has requirements for resort convention center, because this area will be functioned as a major export port and industrial district in 21 century; second, in the location analysis of convention center site, Sinwol & Woongchon district, Soho district, and Yongju & Hodu district are selected as developing possible sites; third, the convention center of this area has to consist of two functions such as convention facilities and marine resort facilities; fourth, in order to establish convention center, the selection of main group, financial raising strategies, and the organization of propulsion committee for establishment of convention center are required.

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Spawning Behavior and Early Life History of Korea Freshwater Goby (Rhinogobius brunneus) (밀어 (Rhinogobius brunneus)의 산란행동 및 초기생활사)

  • Moon, Woon-Ki;Na, Young-Eun;An, Kwang-Guk
    • Korean Journal of Ecology and Environment
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    • v.38 no.1 s.110
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    • pp.83-94
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    • 2005
  • The objective of the study was to elucidate early life history of Rhinogobius brunneus, based on laboratory observations and field works, along with its courtship and spawning behaviors. The male and female fish matured were sampled for the lab experiments from Gap-Stream, which is one of the tributaries of Geum-River, Korea. The spawning behaviors and courtship of matured adults had a typical pattern; matured males of Rhinogobius brunneus built up spawning nests and had their own territory before the spawning, and the behavior then triggered the egg spawning of female with active courtship. The females attached elliptic egg mass as a single layer, on the stones below the spawning nest. After the spawning, the egg mass was guarded by males only until the hatching. The size of egg fertilized, measured by microscope was about 1.5${\pm}$0.1mm in length and 0.7${\pm}$0.1 mm in the egg's width. According to the lab experiments conducted under four temperature regime, the lapsed time for the hatching was shortened as temperatures increased in the treatments. On the contrary to the hatching time, the average length of newly hatched larvae showed a reverse relation with water temperature. The larvae, considered a final stage of the early life history was about 3.6 mm in total length for water temperature of $18^{\circ}C$, whereas they were between 3.1 mm and 3.2 mm for over $25^{\circ}C$. This indicates that higher water temperature may decrease the growth rate in the early life history. These results may provide valuable information for the population conservation and ecosystem protection under accelerated water pollution and habitat degradations in Korea.

The Association between Types of Smoking and Periodontal Disease according to the Survey Year Using the Fourth and Fifth Korea National Health and Nutrition Examination Surveys (조사연도에 따른 흡연 유형과 치주질환의 관련성 분석: 제4기, 제5기 국민건강영양조사를 이용하여)

  • Kim, Myoung-Hee;Yoon, Mi-Sook;Lim, Youn-Hee;Lee, Sae-Rom;Kim, So-Yeon;Park, Seon-Ju;Shin, Sun-Jung
    • Journal of dental hygiene science
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    • v.17 no.6
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    • pp.487-494
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    • 2017
  • There is little evidence on the effects of environmental tobacco smoke (ETS) on prevalence of periodontal disease. The aims of this study were to explore the trends of prevalence of periodontal disease and types of exposure to smoke, including ETS according to the survey year, identify factors affecting periodontal disease, and compare the effect size of periodontal disease between active smokers and secondhand smokers. Data on 11,643 individuals were obtained from the fourth and fifth Korean National Health and Nutritional Examination Surveys. Information on exposure to ETS at home and work was self-reported. Severity of periodontal disease was evaluated using the community periodontal index. A multivariate logistic regression analysis was performed to model periodontal disease using types of smoking and the survey year. Overall, the prevalence of periodontal disease was 26.0% (n=3,029) and about 9% of the study population were secondhand smokers. The prevalence of periodontal disease among smokers was significantly increased according to smoking types by year. Active smokers showed a statistically significant adjusted odds ratio (aOR) for having periodontal disease except in the year 2007, whereas secondhand smokers had significant associations only in 2010 (aOR, 1.68; 95% confidence interval, 1.05 to 2.70) compared to non-smokers. For secondhand smokers, the statistical relationship of predicting periodontal disease was weaker than that of active smokers. However, ETS should separately be considered as an important risk factor for periodontal disease. This study suggested the need for further investigation of the impact of ETS on prevalence of periodontal disease using in-depth research designs and objective measurements for assessing periodontal disease and ETS.

Characteristics of $Malassezia$ $pachydermatis$ Isolated from Dogs and Antifungal Effect of Essential Oils (개에서 분리된 $Malassezia$ $pachydermatis$의 특성과 Essential Oil의 항진균 효과)

  • Kim, Joo-Yeon;Olivry, Thierry;Son, Won-Geun
    • Journal of Veterinary Clinics
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    • v.29 no.2
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    • pp.141-147
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    • 2012
  • This work describes the characteristics of $Malassezia$ $pachydermatis$ isolated from dog ear canals and the effect of essential oils on the growth of this organism. Sterile cotton swabs were used to collect specimens from the external ear canal and culture tests were performed to detect the population size of $Malassezia$ yeast. Using three different isolation media, included Sabouraud dextrose agar (SDA) to isolate common $M.$ $pachydermatis$, and SDA supplemented with olive oil (SDAO) and Leeming's medium (LM) to detect lipophilic yeast, $Malassezia$ spp were isolated from 14 of 18 dogs (77.8%); isolation rates were 33.3% in SDA, 72.2% in SDAO and 66.7% in LM media. All $Malassezia$ spp isolates were identified as $M.$ $pachydermatis$ according to results of PCR amplification, but gross colony morphology and SDA growth rates suggested four different subtypes. Large (LC) and medium colony (MC) types respectively describe large colony (diameter > 3 mm) and medium colony (around 2 mm) after 72 hour incubation, and small (SC) type refers to smaller colony (< 1 mm) even after 5 days incubation; lipid dependent colonies did not grow onto SDA. Large Colony type strains were isolated from 4, 11, and 11 samples, MC type strains from 2, 3 and 1 and SC type strains from 1, 2 and 1 in SDA, SDAO and LM, respectively. Lipid-dependent $M.$ $pachydermatis$ (Lipo) were isolated from 3 samples each in SDAO and LM. Anti-$M.$ $pachydermatis$ activity testing was done using disc-diffusion assays and well diffusion tests. Most essential oils inhibited the growth of $M.$ $pachydermatis$ in a range from 0.5% to 1.0% of essential oils. MIC90 and MIC50 were variable depending upon the nature of essential oils. Thyme oil was found to be highly effective in inhibiting the growth of $M.$ $pachydermatis$ in a range from 0.125% to 0.0625% while marjoram and then tea tree oil exhibited lower inhibitory capacity.

Quaternary Geology of the Conjunction Area of the Yeongsan and Sampo rivers (영산강 하류와 삼포강 합류부 일대 제4기 지질 연구)

  • Kim, Ju-Yong;Yang, Dong-Yoon;Hong, Sei-Sun;Nahm, Wook-Hyun;Lee, Heon-Jong;Lee, Jin-Young;Kim, Jin-Kwan;Oh, Keun-Chang
    • The Korean Journal of Quaternary Research
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    • v.19 no.1
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    • pp.1-17
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    • 2005
  • This study aims to study the distribution and formation age of Quaternary deposits in the downstream of Yeongsan Estuarine River, encompassing Muan, Illo and Donggang counties. For this purpose the authors examine several borehole data, and step trench survey for excellent profiles was studied in connection with grain size population and magnetic susceptibility. As a result, it is interpreted that the coastal plain of the Yeongsan River was formed by sea level rise after Last Glacial Maximum(LGM). The fore edge/escarpment of coastal terraces distributed 7-10 m asl is assumed to be formed during the last glacial period, while the coastal terraces distributed above 7-10m asl formed during MIS 5a. In addition, the fore edge/escarpment of coastal terraces distributed above 15 m asl is presumed to be have been formed during the stadial of last interglacial period, while the formation age of coastal terraces distributed above 15m(asl) is assumed to be MIS 5e. This formation age can be estimated by the coastal terrace ages of the southeastern coast of Korean Peninsula. The characteristics of Quaternary deposits linked to paleolithic culture will eventually lead to the reconstruction of ecosystem environment of paleolithic peoples.

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Development of Intelligent ATP System Using Genetic Algorithm (유전 알고리듬을 적용한 지능형 ATP 시스템 개발)

  • Kim, Tai-Young
    • Journal of Intelligence and Information Systems
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    • v.16 no.4
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    • pp.131-145
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    • 2010
  • The framework for making a coordinated decision for large-scale facilities has become an important issue in supply chain(SC) management research. The competitive business environment requires companies to continuously search for the ways to achieve high efficiency and lower operational costs. In the areas of production/distribution planning, many researchers and practitioners have developedand evaluated the deterministic models to coordinate important and interrelated logistic decisions such as capacity management, inventory allocation, and vehicle routing. They initially have investigated the various process of SC separately and later become more interested in such problems encompassing the whole SC system. The accurate quotation of ATP(Available-To-Promise) plays a very important role in enhancing customer satisfaction and fill rate maximization. The complexity for intelligent manufacturing system, which includes all the linkages among procurement, production, and distribution, makes the accurate quotation of ATP be a quite difficult job. In addition to, many researchers assumed ATP model with integer time. However, in industry practices, integer times are very rare and the model developed using integer times is therefore approximating the real system. Various alternative models for an ATP system with time lags have been developed and evaluated. In most cases, these models have assumed that the time lags are integer multiples of a unit time grid. However, integer time lags are very rare in practices, and therefore models developed using integer time lags only approximate real systems. The differences occurring by this approximation frequently result in significant accuracy degradations. To introduce the ATP model with time lags, we first introduce the dynamic production function. Hackman and Leachman's dynamic production function in initiated research directly related to the topic of this paper. They propose a modeling framework for a system with non-integer time lags and show how to apply the framework to a variety of systems including continues time series, manufacturing resource planning and critical path method. Their formulation requires no additional variables or constraints and is capable of representing real world systems more accurately. Previously, to cope with non-integer time lags, they usually model a concerned system either by rounding lags to the nearest integers or by subdividing the time grid to make the lags become integer multiples of the grid. But each approach has a critical weakness: the first approach underestimates, potentially leading to infeasibilities or overestimates lead times, potentially resulting in excessive work-inprocesses. The second approach drastically inflates the problem size. We consider an optimized ATP system with non-integer time lag in supply chain management. We focus on a worldwide headquarter, distribution centers, and manufacturing facilities are globally networked. We develop a mixed integer programming(MIP) model for ATP process, which has the definition of required data flow. The illustrative ATP module shows the proposed system is largely affected inSCM. The system we are concerned is composed of a multiple production facility with multiple products, multiple distribution centers and multiple customers. For the system, we consider an ATP scheduling and capacity allocationproblem. In this study, we proposed the model for the ATP system in SCM using the dynamic production function considering the non-integer time lags. The model is developed under the framework suitable for the non-integer lags and, therefore, is more accurate than the models we usually encounter. We developed intelligent ATP System for this model using genetic algorithm. We focus on a capacitated production planning and capacity allocation problem, develop a mixed integer programming model, and propose an efficient heuristic procedure using an evolutionary system to solve it efficiently. This method makes it possible for the population to reach the approximate solution easily. Moreover, we designed and utilized a representation scheme that allows the proposed models to represent real variables. The proposed regeneration procedures, which evaluate each infeasible chromosome, makes the solutions converge to the optimum quickly.