• Journal of Applied Biological Chemistry
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• v.61 no.4
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• pp.391-395
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• 2018

There is an increasing concern over arsenic (As) contamination of paddy soil and rice with regard to food safety. This study was conducted to investigate total and inorganic As concentration in one hundred husked and polished rice samples collected at the non-contaminated paddy soil in Korea. Arsenic species in rice samples were extracted using 1% nitric acid ($HNO_3$) with a microwave oven and were measured using high performance liquid chromatography coupled with inductively coupled plasma-mass spectrometry. Mean concentrations of total As in husked rice and polished rice were 0.18 and $0.11mg\;kg^{-1}$, respectively. Also, average inorganic As concentrations in husked rice and polished rice were 0.11 and $0.07mg\;kg^{-1}$, respectively. These levels are lower than the standard guideline value 0.35 and $0.2mg\;kg^{-1}$ for inorganic As in husked and polished rice recommended by Codex Committee on Contaminants in Foods and Ministry of Food and Drug Safety, respectively. The mean of the inorganic As ratio for the total amount of As was 0.65 and 0.67 for husked rice and polished rice, respectively, and the range was from 0.08 to 1.0. For health risk assessment, the average value of cancer risk probability was $9.24{\times}10^{-5}$ and ranged from $2.30{\times}10^{-5}$ to $1.90{\times}10^{-5}$. Therefore, human exposure to As through dietary intake of surveyed rice samples might considered to be a low health risk.

• Journal of Aerospace System Engineering
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• v.15 no.3
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• pp.71-78
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• 2021

Since most functions of modern aircraft are controlled by software, software errors are directly related to aircraft safety. The criterion in Chapter 15 of the MIL-HDBK-516C addresses safe development and verification of military aircraft software. As the U.S. Air Force repeatedly experienced non-compliance with Chapter 15 criterion of the MIL-HDBK-516C, it published an Airworthiness Circular (AC-17-01) as a guide to meeting the criterion. In this paper, Chapter 15 of MIL-HDBK-516C, AC-17-01 and the SW Qualification Guideline (DO-178C) as applied by the Federal Aviation Administration are compared and analyzed. For the analysis, a matching ratio formula between the MIL-HDBK-516C criteria specified in AC-17-01 and the DO-178C specified in MIL-HDBK-516C criteria is defined. The sections that satisfy MIL-HDBK-516C criterion are derived when AC-17-01 or DO-178C matches. Based on the analysis results, the aircraft software development process is established and examples of application of Chapter 15 of MIL-HDBK-516C are addressed.

• Journal of the Korea Society of Computer and Information
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• v.25 no.12
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• pp.155-163
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• 2020

This study developed a system that can collect, manage, and utilize the travel routes of individuals who tested positive for coronavirus disease 2019 (COVID-19) based on the data standardization and quality management principles and presented the analysis data collected from the existing system. Unlike many other countries in the world, Korea demonstrated a rapid response by conducting epidemiological investigations. Further, the local governments have actively shared the travel routes of individuals who tested positive for COVID-19 to facilitate proactive prevention of the infectious disease per the Infectious Disease Control and Prevention Law. However, currently, there is no standard protocol for the local governments to share the information, thus complicating the process of sharing, managing, and utilizing the collected data. Therefore, this study developed a system that can facilitate sharing of the travel routes of individuals who tested positive for COVID-19 by establishing database construction procedures and using the travel route of COVID-19 patients as per the Disaster & Safety Information Sharing Platform and developing a data processing guideline, a data entry system with default templates, and Open API. Although this sharing system was designed to communicate the travel routes of COVID-19 patients, it can also be utilized in case of other infectious diseases. Therefore, it can be used as a response strategy for future outbreaks of infectious diseases.

• The Korean Society of Law and Medicine
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• v.23 no.2
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• pp.119-139
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• 2022

Brain stimulation technology that administers electrical and magnetic stimulation to a brain has shown a significant level of possibility for treating a wide range of various neurological and psychiatric disorders. Depending on its nature, the technology is defined either as invasive or non-invasive, and deep brain stimulation (DBS) is one of the most well-known invasive brain stimulation technologies. Currently categorized as grade 4 medical device in accordance with Guideline On Medical Devices And Their Grades, a Notification of Ministry of Food and Drug Safety (MFDS), the DBS has been used as a stable treatment for several diseases. At the same time, the DBS technology has recently achieved substantial advancement, encouraging active discussions for its use from various perspectives. On the contrary, debates over legal regulation related to the use of DBS has relatively been smaller in numbers. In this context, this article aims to 1) introduce the DBS technology and its safety in setting out the tone; 2) touch upon major legal issues that would potentially rise from its use for four different purposes of treatment, clinical study, areas of non-standard treatment where no other methods are available, and enhancement; and finally 3) highlight disputes concerning common emerging issues observed in the aforementioned four purposes from the viewpoint of legal responsibility and liability of using the DBS, which are benefit-risk assessment, physicians' duty of information, patients' capacity to consent, control for device, and insurance coverage.

• The Journal of the Acoustical Society of Korea
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• v.41 no.5
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• pp.570-588
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• 2022

We scrutinized the acoustic outputs from the 70 shock wave generators of the 15 product models whose technical documents were available, among the 46 ballistic extracorporeal shock wave therapeutic devices of 11 domestic and 6 foreign manufacturers, approved by the Minster of Food & Drug Safety (Rep. Korea). We found that the acoustic Energy Flux Density (EFD), the most popular exposure parameter, was different by up to 563.64 times among shock wave generators at their minimum output settings and by up to 74.62 times at their maximum settings. In the same product model, the EFD was shown to vary depending on shock wave transmitters by up to 81.82 times at its minimum output setting and by up to 46.15 times at its maximum setting. The lowest EFD 0.013 mJ/mm² at the maximum output settings was much lower (2.1 %) than the maximum value 0.62 mJ/mm² at the minimum settings. The Large acoustic output differences (tens to hundreds of times)from the therapeutic devices approved for the same clinical indications imply that their therapeutic efficacy & safety may not be assured. The findings suggest the regulatory authority to revise her guideline to give clearer criteria for clinical approval and equality in performance, and recommend the authority to initiate a post-approval surveillance as well as a test in conformance between the data in technical documents and the real acoustic outputs clinically used.

• The Journal of KAIRB
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• v.4 no.2
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• pp.36-41
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• 2022

Purpose: The purpose of this study is to evaluate how university hospital Institutional Review Boards (IRBs) in Korea classify risk when reviewing clinical trial protocols. Methods: IRB experts (IRB chairman, vice chairman, IRB administrator) in the university hospitals obtaining a Human research protection program (HRPP) or IRB accreditation in Korea were asked to fill out the Google Survey from September 1, 2020 to October 10, 2020. Result: Among the 23 responder hospitals, 8 were accredited by the American Association for Human Research Protection Program (AAHRPP) and 8 were accredited by the HRPP of Ministry of Food and Drug Safety (MFDS). Seven were accredited by Forum for Ethical Review Committees in Asia and the Western Pacific or Korea National Institution for Bioethics Policy. Thirteen of 23 hospitals (56.5%) had 4 levels (less than minimal, low, moderate, high risk), 4 hospitals had 3 levels (less than, slightly over, over than minimal risk), 1 hospital had 5 levels (4 levels plus required data safety monitoring board), and 1 hospital had 2 levels (less than, over than minimal risk) risk classification system. Thirteen of 23 hospitals (56.5%) had difficulty classifying the risk levels of research protocols. Fourteen hospitals (60.9%) responded that different standards among hospitals for risk level determination associated with clinical trials will affect the subject protection. Six hospitals (26.1%) responded that it will not. Three hospitals (13.0%) responded that it will affect the beginning of the clinical trial. To resolve differences in standards between hospitals, 14 hospitals (60.9%) responded that either the Korean Association of IRB or MFDS needs to provide a guideline for risk level determination in clinical trials: 5 hospitals (21.7%) responded education for IRB members and researchers is needed; 3 hospitals (13.0%) responded that difference among institutions needs to be acknowledged; and 1 hospital (4.3%) responded that there needs to be communication among IRB, investigator, and sponsor. Conclusion: After conducting a nationwide survey on how IRB in university hospital determines risk during review of clinical trials, it is reasonable to use 4-level risk classification (less than minimal, low, moderate, high risk); the most utilized method among hospitals. Moreover, personal information and conflict of interest associated with clinical trials have to be considered when reviewing clinical trial protocols.

• Journal of Advanced Navigation Technology
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• v.27 no.4
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• pp.382-390
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• 2023

The Korea market for LUAV (Light Unmanned Aerial Vehicle) weighing less than 150 kg is growing rapidly. As a result, the market for manufacturing and operating LUAV is expanding, and domestic development of parts and finished products is actively taking place. However, the flight control system and onboard software, which are key components of domestic LUAV, are largely dependent on overseas products due to the excessive cost and period required for development. This paper presented a domestic software development and certification procedure using DO-178C, a guideline for aircraft software development, and the Model-based Development method, and conducted a survey of those involved in the development, manufacturing, and certification of LUAV and analyzed the results. In addition, a case study was conducted to apply the software development plan to the helicopter FCC (Flight Control Computer).

• Journal of the Korean Society of Marine Environment & Safety
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• v.29 no.2
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• pp.160-167
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• 2023

An INS is a composite navigation system providing "added value" so defined if work stations provide Multi-Function Displays(MFDs) integrating information and functions for navigational tasks. Even though the minimum requirements for an INS are defined by IMO performance standards, a generic list of the devices and functions that constitute an INS does not exist, so the configuration of the INS is different for each manufacturer, and guidelines based on users' perspectives are also insufficient. This study was conducted to enhance the usability of the INS by analyzing the information required by users according to the ship's operating status and tasks and effectively structuring it in the MFD of the INS. By analyzing INS-related international standards and manufacturers' component equipment lists, mandatory navigation information was selected and card sorting tests were conducted on ship operators with experience in using MFDs to group the information required for each INS task. The results of the study can serve as a basic guideline for manufacturers to structure information based on users' experience when designing products.

• Journal of the Korea institute for structural maintenance and inspection
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• v.28 no.2
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• pp.1-8
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• 2024

The expansion joint is installed to offset the expansion of the superstructure and must ensure sufficient gap during its service life. In detailed guideline of safety inspection and precise safety diagnosis for bridge, damage due to lack or excessive gap is specified, but there are insufficient standards for determining the abnormal behavior of superstructures. In this study, a data-based maintenance was proposed by continuously monitoring the expansion-gap data of the same expansion joint. A total of 2,756 data were collected from 689 expansion joint, taking into account the effects of season. We have developed a method to evaluate changes in the expansion joint-gap that can analyze the thermal movement through four or more data at the same location, and classified the factors that affect the superstructure behavior and analyze the influence of each factor through deep learning and explainable artificial intelligence(AI). Abnormal behavior of the superstructure was classified into narrowing and functional failure through the expansion joint-gap evaluation graph. The influence factor analysis using deep learning and explainable AI is considered to be reliable because the results can be explained by the existing expansion gap calculation formula and bridge design.

• KSCE Journal of Civil and Environmental Engineering Research
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• v.44 no.4
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• pp.577-585
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• 2024

Infrastructure plays a crucial role in the industrial development and economic growth of a nation. However, recently, domestic infrastructure has been causing not only safety risks due to aging but also social and economic inefficiencies, increasing the need for maintenance. In particular, the deterioration rate of bridges is serious, so application of appropriate repair and rehabilitation methods and estimation of its quantity are required. In this study, frequently applied repair methods for bridges using data from the Facility Integrated Management System (FMS) were identified. the empirical correlation between damage volume and the repair volume was analyzed using Bridge Management System (BMS) data. The result of the analysis showed that the ratio of the repair volume to the damage volume was 1.0. The guideline, on the other hand, suggest 1.5 the ratio of the repair volume to the damage volume. Although the guidelines differently present more conservative figures considering safety, this study is significant in that it presents a practical ratio through data analysis results. This results can be used to develop a model that can calculate the amount of repair and rehabilitation of various facilities in the future.