• 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.

• Journal of the Korean Society of Marine Environment & Safety
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• v.26 no.3
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• pp.286-296
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• 2020

Sandwich structures are general-purpose structures that can reduce the structural weight of composite ships. Core materials are essential for these structures, with polyvinyl chloride (PVC) foams being the most popular. These foam core materials are subjected to various tests in the development process, and must satisfy the performance requirements of several ISO and ASTM standards. Therefore, a procedure for evaluating the performance of foam core materials was proposed in this paper. In addition, prototypes were fabricated using a commercial PVC foam core product in accordance with the structural design of an 11 m fiber-reinforced plastic yacht. Then, a case study was conducted on the proposed evaluation procedure. The proposed procedure facilitates the understanding of the performance requirements and evaluation of core materials used in composite ships and is expected to be utilized in developing core materials for marine structures.

• Fire Science and Engineering
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• v.22 no.4
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• pp.61-64
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• 2008

This paper studied on the response characteristics depending on service life of ionization smoke detector. The experimental samples used ionization smoke detectors (360 EA) for over 5 years which were influenced by environment set up with fire objects. The experimental method performed operate and non-operate test according to 'Type Approval and Technical Regulation of Detector (KOFEIS 0301)', for estimate the response characteristics of ionization smoke detector depending on service life. The results showed that their response characteristics were rapidly decreasing when the longer their using period. Accordingly, it is desirable that ionization smoke detector has to be changed for early fire detection when passed their service life.

• Journal of Environmental Impact Assessment
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• v.32 no.5
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• pp.353-362
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• 2023

TOC, which can measure more than 90% of organic substances, can be measured quickly and easily,replacing BOD and COD, which were indicators of organic pollutants. According to water quality pollution control standards, when measuring TOC, if the inorganic carbon ratio in the sample is over 50%, the NPOC (Non-Purgeable Organic Carbon) method should be used. If volatile organic compounds (VOCs) are present at a certain concentration, the TC-IC (subtracting inorganic carbon from total carbon) method should be used. To validate the limitations of these analytical conditions, experiments were conducted by varying the ratio of TOC to IC in purified water and measuring the concentration of TOC in test solutions. The results showed no significant difference between the TC-IC method and the NPOC method. When measuring samples with added VOC standard solutions, it was observed that the carbon loss due to purging was not significant when using the NPOC method. Therefore, it is concluded that the choice of analytical method does not lead to significant differences when VOCs are present in the sample. To account for potential variations in results based on water quality pollution control standards and regulations regarding the approval and testing of environmental measurement devices, a comparison of field sample concentration values was made using two widely used types of TOC analyzers in Korea. The results showed variations of 0.02 to 0.83 mg/L between methods depending on the manufacturer, highlighting the need for caution when selecting an instrument.

• Fire Science and Engineering
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• v.29 no.2
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• pp.13-19
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• 2015

Real scale fire tests was carried out for extinguishing performance evaluation of the wetting agent. The experiment was conducted in accordance with a Class A fire extinguishing test methods specified in the 'Type Approval of the Manual System Fire Extinguisher and Technical Standards of Test'. In addition, the subjects of this experiment were the wood flour and rice husk. Fire-fighting water, the three kinds of wetting agents used in the country and this study was used, was undertaken to determine a clear discrimination of the water and wetting agent. In the experimental results, it was confirmed that the internal temperature is maintained long time in the case of water. The internal temperature were rapidly lowered in the experiment of wetting agents. Therefore, the discrimination of extinguishing ability was confirmed by the temperature distribution in accordance with time. Based on the results of this experiment, this study is expected to be used as a underlying material on presenting a method of optimized performance evaluation of wetting extinguishing agent.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.17 no.4
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• pp.34-42
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• 2016

In order to prepare for the type approval test for the United States Coast Guard (USCG) Phase-II of Ballast Water Treatment System (BWTS), a phytoplankton mass culture was conducted in a mesocosm enclosure. We evaluated the response of the phytoplankton community after nutrient addition (+N, +P, and +NP) and investigated the development of the species with increasing culture time. After nutrient dosing, the phytoplankton population significantly (p < 0.05) increased from day 1 to day 3, depending on the nutrient treatments In particular, the specific growth rate of the phytoplankton community in the case of +NP treatment and + N treatment were estimated to be $2.47d^{-1}$ and $1.98d^{-1}$, respectively. The phytoplankton population density in the case of + NP treatment was approximately 50 times higher than that of the control group, suggesting that these treatments could be useful for mass culturing phytoplankton (> 75% of natural community) for the approval regulation of USCG Phase-II. In the phytoplankton community of the mesocosm, Pseudo-nitzchia spp. dominated in the logarithmic growth phase. The cell density decreased significantly (p < 0.05) with increasing time, coinciding with the nutrient limitation. At that time, the dominance of Pseudo-nitzchia spp. shifted to that of Cylindrotheca closterium. Therefore, the optimum nutrient concentration ($N:30{\mu}M$, $P:3{\mu}M$) and reasonable harvesting time (after 3 days in summer) found in this study for the mass culturing of phytoplankton may be helpful to meet the USCG Phase-II biological criteria to be used in BWTS.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.17 no.3
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• pp.136-143
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• 2016

To provide a type approval test for Ballast Water Treatment System (BWTS) of United States Coast Guard (USCG) Phase-II, this study examined the concentrating efficiency of nets for ${\geq}10{\mu}m$ and ${\leq}50{\mu}m$ sized phytoplanktonic organisms using different mesh sized nets ($5{\mu}m$ or $7{\mu}m$), different injection methods (hand breaker as semi-continuous assessment or pump as continuous assessment), and different filterability for the water volume. As a result of the t-test, the net concentrated efficiency between $5{\mu}m$ and $7{\mu}m$ mesh size was not significant (p > 0.05). The difference in the net concentrated efficiency for filtered natural water volume was not significant (p > 0.05). On the other hand, the Chl.a concentration in the continuous water injection method was significantly (p < 0.05) higher than that of semi-continuous water injection (t-test: t: -4.058). In the natural phytoplankton community, a total of 36 species were identified, including Bacillariophyta (17 species), Dinophyta (15 species), Euglenophyta (1 species), Dictyochophyta (2 species), and unidentified taxa (1 species). Among them, diatom Pseudo-nitzchia spp. was remarkably dominant. In particular, the net concentrated efficiency in all assessments was underestimated to be approximately 20-25%, which was caused by the small size Pseudo-nitzchia spp.. A width size of these genus might have passed through the $5{\mu}m$ or $7{\mu}m$ mesh size of the net. Therefore, net concentrated efficiency is dependent on the size of the observed species in natural water. This issue should be considered when determining the net volume for the type approval test of BWTS.

• Communications for Statistical Applications and Methods
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• v.25 no.4
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• pp.341-354
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• 2018

The one of the principles described in ICH E9 is that only results obtained from pre-specified statistical methods in a protocol are regarded as confirmatory evidence. However, in multi-regional clinical trials, even when results obtained from pre-specified statistical methods in protocol are significant, it does not guarantee that the test treatment is approved by regional regulatory agencies. In other words, there is no so-called global approval, and each regional regulatory agency makes its own decision in the face of the same set of data from a multi-regional clinical trial. Under this situation, there are two natural methods a regional regulatory agency can use to estimate the treatment effect in a particular region. The first method is to use the overall treatment estimate, which is to extrapolate the overall result to the region of interest. The second method is to use regional treatment estimate. If the treatment effect is completely identical across all regions, it is obvious that the overall treatment estimator is more efficient than the regional treatment estimator. However, it is not possible to confirm statistically that the treatment effect is completely identical in all regions. Furthermore, some magnitude of regional differences within the range of clinical relevance may naturally exist for various reasons due to, for instance, intrinsic and extrinsic factors. Nevertheless, if the magnitude of regional differences is relatively small, a conventional method to estimate the treatment effect in the region of interest is to extrapolate the overall result to that region. The purpose of this paper is to investigate the effects produced by this type of extrapolation via estimations, followed by hypothesis testing of the treatment effect in the region of interest. This paper is written from the viewpoint of regional regulatory agencies.

• Fire Science and Engineering
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• v.27 no.1
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• pp.52-59
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• 2013

In this study, tests were conducted to establish a fire engine of relay waterproof and utilization in order to maintain the pressure in a situation that require high-pressure water-resistant such as a high-rise building fire, etc. As a result of test on the change of a relay waterproof pressure, the measurement result with the hydrant intake of a fire engine opened has reduced approximately 20 % compared to the measurement result with the hydrant intake closed. Similar efficiency showed in the test result that change the pressure of 2 fire engines respectively to use them more efficiently at a fire fighting activity site. A fire engine operation and utilization is proposed based on this study result in order to cope effectively with a fire site requiring high-pressure stream in a high-rise building fire, etc. by using a fire engine held at present because there is no fire pump with high-pressure stream ability arranged at the fire station and there is no regulation on high-pressure fire-fighting pumps in a type approval and verification technology criterion for a fire engine.

• Journal of Korean Academy of Nursing
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• v.44 no.5
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• pp.459-470
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• 2014

Purpose: The purpose of this study was to evaluate the quality of meta-analysis regarding exercise using Assessment of Multiple Systematic Reviews (AMSTAR) as well as to compare effect size according to outcomes. Methods: Electronic databases including the Korean Studies Information Service System (KISS), the National Assembly Library and the DBpia, HAKJISAand RISS4U for the dates 1990 to January 2014 were searched for 'meta-analysis' and 'exercise' in the fields of medical, nursing, physical therapy and physical exercise in Korea. AMSTAR was scored for quality assessment of the 33 articles included in the study. Data were analyzed using descriptive statistics, t-test, ANOVA and ${\chi}^2$-test. Results: The mean score for AMSTAR evaluations was 4.18 (SD=1.78) and about 67% were classified at the low-quality level and 30% at the moderate-quality level. The scores of quality were statistically different by field of research, number of participants, number of databases, financial support and approval by IRB. The effect size that presented in individual studies were different by type of exercise in the applied intervention. Conclusion: This critical appraisal of meta-analysis published in various field that focused on exercise indicates that a guideline such as the PRISMA checklist should be strongly recommended for optimum reporting of meta-analysis across research fields.