• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.73-79
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• 2023

The purpose of this study is to derive medical devices with different management systems through comparison of domestic and overseas medical device product classification systems and to propose management conversion measures for the products. The definitions of medical devices were compared and the scope of medical devices defined by each country was confirmed through surveys of the Medical Device Act, Federal Food, Drug & Cosmetics Act (FD&C) in the U.S., and Medical Device Regulations (MDR) in Europe. Using the Ministry of Food and Drug Safety's regulations on medical device products and grades, 21 CFR part 860-892 and product code classification files in U.S., and EMDN in Europe as basic data to compare medical device products and derive medical devices with different management systems. As a result of comparing the definition and product classification systems of medical devices in Korea, the U.S. and Europe, medical device accessories, prosthetic limbs and aids among assistive devices for persons with disabilities, drugs, quasi-drugs and industrial products that are not managed by medical devices in Korea are managed as medical devices in the U.S. and Europe. This study aims to improve public health by securing systematic product safety management and essential performance under medical device regulations. Management within a single medical device system will increase the efficiency of licensing work of domestic medical device manufacturers and related organizations. It is also expected to help advance the system according to the international harmony of the item classification system and enhance smooth import and export competitiveness.

• Proceedings of the Korean Institute of Building Construction Conference
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• 2014.05a
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• pp.78-79
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• 2014

This study is concerned with the VS shear reinforcement that it can be installed easily in filed as product at the factory and seismic performance can be achieved. The method of study is as follows. first, we researched constructability and economy of existing construction method. Secondly, we made specimen and were examined structural performance tests in order to verify the performance of the shear reinforcement for lateral force like seismic load. As a result, developed VS shear reinforcement increased in shear strength and stiffness of reinforcement, structural safety is judged to be increased.

• Proceedings of the Korean Institute of Building Construction Conference
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• 2012.05a
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• pp.173-174
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• 2012

This study is concerned with the VSTUD shear reinforcement that it can be installed easily in filed as product at the factory and seismic performance can be achieved. The method of study is as follows. first, we researched constructability and economy of existing method. Secondly, we made specimen and were examined structural performance tests in order to verify the performance of the shear reinforcement. As a result, developed SL shear reinforcement increased in shear strength and stiffness of reinforcement, structural safety is judged to be increased.

• Aerospace Engineering and Technology
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• v.6 no.1
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• pp.97-102
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• 2007

Satellite performance can be evaluated by satellite product. When satellite development technology is in developing, most of efforts focus on success of satellite operation and safety. But, more and more efforts are focused on satellite performance and mission success. Especially quality of the image which is delivered to user is very important factor. In this paper, generating method for simulated image in the point of MTF is described.

• Journal of the Korean Society of Radiology
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• v.12 no.6
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• pp.769-776
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• 2018

According IEC 60601-1 ed3.1 and IEC 60601-2-45 regulation, diagnostic X-ray equipment should be display to measured and calculated air kerma area product. On the clinical X ray equipment, air kerma area product dosimeter would like to have an evidence for dosimeter accuracy and energy dependency. This study was performed to indirect calibration and energy dependency test for attached type air kerma area product (KAP) dosimeter by RQR standards beam quality. On the RQR5 beam quality, attached KAP dosimeter error showed -7.5%, respectably. On the RQR9 beam quality, attached KAP dosimeter error showed -10.4%, respectably. All RQR beam quality, average absolute error was $8.30%{\pm}2.85%$, respectably. On this study, attached KAP dosimeter was satisfied to IEC 60580 and AAPM TG 190. This calibration method of KAP dosimeter will help to performance maintain for clinical KAP dosimeter.

• Journal of the Korean Society of Manufacturing Process Engineers
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• v.9 no.5
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• pp.20-27
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• 2010

In this study, we improved problems in the existing product by PARKER and developed the swivel valve tube couplers that can be produced by a low price in Korea. The major development was that a modulized production method was implemented by introducing a part assembling method that uses a cocking jig, and the production cost was reduced by operating the production process more simply than that of PARKER. Also, it was possible to avoid the patient registered by PARKER through the differences in the number of grooving processes and the type of o-ring. In the results of the rotation test by varying its application angle after installing it to a vehicle, it was verified that the structure proposed in this study can endure the eccentric torque and transformation pressure for various angles that have been considered as the problem in the existing fixed tube couplers. In addition, the structure was developed to adopt the problem that represents differences in the installation position of an air tank or the length and direction of hoses according to the type of vehicles produced in vehicle manufacturers. Furthermore, it was possible to verify that the product developed in this study was more excellent than that of PARKER through comparing the performance according to the Federal Motor Vehicle Safety Standard.

• Natural Product Sciences
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• v.28 no.4
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• pp.168-180
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• 2022

Ephedra is a genus of the Ephedraceae family and is found in temperate regions, such as Central Asia and Europe. Among the various ephedra species, Ma Huang (Ephedra herb) is derived from the aerial parts of Ephedra sinica S tapf, Ephedra equisetina Bunge, and Ephedra intermedia Schrenk & C.A. Mey. Ma Huang contains various ephedra alkaloids, including (-)-ephedrine, (+)-pseudoephedrine, (-)-norephedrine, (+)-norpseudoephedrine, (-)-methylephedrine, and (+)-methylpseudoephedrine, which are found naturally as single enantiomers, although they can be prepared as racemates. Although the use of Ma Huang in foods is prohibited in Korea, products containing Ma Huang can be imported, and so it is necessary to develop a suitable analytical technique for the detection of Ma Huang in foods. Herein, we report the development of analytical methods for the detection of ephedra alkaloids in products containing Ma Huang. Following sample purification by solid phase extraction, quantitative analysis was performed using ultra-performance liquid chromatography-triple quadrupole mass spectrometry (UPLC-MS/MS). Additionally, the enantiomers were successfully separated using HPLC-DAD. We successfully analyzed various food samples, where the ephedra alkaloids were qualitatively and quantitatively determined, and the enantiomers were separated. It is expected that these methods may contribute toward preventing the distribution of illegal products containing Ma Huang.

• Safety and Health at Work
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• v.12 no.2
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• pp.147-153
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• 2021

Background: In this study, the association of work and demographic characteristics with different traffic offenses committed by food delivery riders in Greece was examined. Previous research has identified various factors related to risky driving however, there is a need for exploring the complex interrelationship of work-related factors underlying risky driving behavior. Materials and Methods: A 2-items uestionnaire was used exploring delivery riders demographic characteristics, terms of employment, issues of concern during work and type of traffic offenses committed. In total, uestionnaires were analyzed using logistic regression in order to identify characteristics independently associated with serious traffic offenses, namely, red-light running and helmet non-use. Results: The analysis showed that: (i) typical health and safety measures had no effect on serious traffic offenses, (ii) young age was related to both offenses however (iii) different sets of work conditions were associated with reports of red-light running (i.e. low work experience, use of personal vehicle for work, and payment by hour) and helmet non-use respectively (i.e. intense work pace, high tip income per day and low concern about vehicle condition). Conclusion: The above findings provide evidence that serious traffic offenses are manifestations of underlying conflict experienced by the riders between safety and various performance criteria. Each one of the two offenses is related to different rider profiles aiming to satisfy different goals, namely, those mainly trying to maximize profit non-helmet users and those, mostly inexperienced ones, trying to cope with work pressure red light runners. Potential regulatory measures to alleviate risky practices are discussed.

• Nuclear Engineering and Technology
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• v.54 no.5
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• pp.1825-1834
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• 2022

Performing high-fidelity computational fluid dynamics (HF-CFD) to predict the flow and heat transfer state of the coolant in the reactor core is expensive, especially in scenarios that require extensive parameter search, such as uncertainty analysis and design optimization. This work investigated the performance of utilizing a multi-fidelity reduced-order model (MF-ROM) in PWR rod bundles simulation. Firstly, basis vectors and basis vector coefficients of high-fidelity and low-fidelity CFD results are extracted separately by the proper orthogonal decomposition (POD) approach. Secondly, a surrogate model is trained to map the relationship between the extracted coefficients from different fidelity results. In the prediction stage, the coefficients of the low-fidelity data under the new operating conditions are extracted by using the obtained POD basis vectors. Then, the trained surrogate model uses the low-fidelity coefficients to regress the high-fidelity coefficients. The predicted high-fidelity data is reconstructed from the product of extracted basis vectors and the regression coefficients. The effectiveness of the MF-ROM is evaluated on a flow and heat transfer problem in PWR fuel rod bundles. Two data-driven algorithms, the Kriging and artificial neural network (ANN), are trained as surrogate models for the MF-ROM to reconstruct the complex flow and heat transfer field downstream of the mixing vanes. The results show good agreements between the data reconstructed with the trained MF-ROM and the high-fidelity CFD simulation result, while the former only requires to taken the computational burden of low-fidelity simulation. The results also show that the performance of the ANN model is slightly better than the Kriging model when using a high number of POD basis vectors for regression. Moreover, the result presented in this paper demonstrates the suitability of the proposed MF-ROM for high-fidelity fixed value initialization to accelerate complex simulation.

• Journal of the Korean Society of Manufacturing Process Engineers
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• v.10 no.3
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• pp.1-6
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• 2011

This study focused on the localization of swivel type tube couplers, which all depend on imports. In this study, a computer application analysis was performed using a finite element method as a preliminary study. In the major developments related to the objective of this study, the air brake system produced by car makers represents a different in the installation point of an air tank according to the type of cars or in the length and direction of its hoses and that leads to cause lots of problems. For solving such problems, the design of the major elements in a swivel type tube coupler was analyzed using a finite element method, and its validity was also verified. In the process that verifies the validity of this study, it was necessary to investigate how much external force affects the desorption of the tube support, which is the most important element in swivel type tube couplers. For achieving the investigation, a pressure test was implemented for the tube support according to the Federal Motor Vehicle Safety Standards(FMVSS). In the results of the pressure test, all samples satisfied the FMVSS. In addition, several tests were implemented by installing the sample of the developed swivel type tube coupler to an actual vehicle. In particular, rotation tests with various angles were applied by welding the swivel type coupler to an air tank through an argon welding process. In the results of the installing test for an actual vehicle, it was verified that the designed structure was determined as a structure that is able to endure the eccentric torque and deformation pressure applied to several directions that are the major problems in such fixed type tube couplers. Therefore, in the comparison of the performance of the developed product with the product of PARKER, it was possible to verify that the localized swivel type tube coupler developed in this study shows more excellent than that of the existing products by PARKER.