• 대한의용생체공학회:의공학회지
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• 제40권5호
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• pp.197-205
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• 2019

The existing Extracorporeal membrane oxygenation(ECMO) and Cardiopulmonary bypass system(CPB) have been developed and applied to various devices according to their respective indications. However, due to the complicated configuration and difficult usage method, it causes inconvenience to users and there is a risk of an accident. Therefore, smart all-in-one cardiopulmonary circulation device is being developed recently. The smart all-in-one cardiopulmonary assist device consists of a blood pump for cardiopulmonary bypass, a blood oxidizer for cardiopulmonary bypass, a blood circuit for cardiopulmonary bypass, and an artificial cardiopulmonary device. It is an integrated cardiopulmonary bypass device that can be used for a variety of purposes such as emergency, intraoperative, post-operative intensive care, and long-term cardiopulmonary assist, combined with CPB used in open heart surgery and ECMO used when patient's cardiopulmonary function does not work normally. The smart all-in-one cardiopulmonary assist device does not exist as a standard and international standard applicable to advanced medical devices. Therefore, in this study, we will refer to the International Standard for Blood Components, the International Standard for Blood, the Guideline for Blood Products, and prepare applicable performance and safety guidelines to help quality control of medical devices, and contribute to the improvement of the health of people. The guideline, which is the result of conducted a survey of the method of safety and performance test, is based on the principle of all-in-one cardiopulmonary aiding device, related domestic foreign standards, the status of domestic and foreign patents, related literature, blood pump(ISO 18242), blood oxygenator (ISO 7199), and blood circuit (ISO 15676) for cardiopulmonary bypass.The items on blood safety are as follows: American Society for Testing and Materials ASTM F1841-97R17), and in the 2010 Food and Drug Administration's Safety Assessment Guidelines for Medical Assisted Circulatory Devices. In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers / importers, testing inspectors, academia, etc. the final guideline was established through revision and supplementation process. Therefore, we propose guidelines for evaluating the safety and performance of smart all-in-one cardiopulmonary assist devices in line with growing technology.

• 한국산업보건학회지
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• 제31권4호
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• pp.385-395
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• 2021

Objectives: This study aimed to select items for technical guidelines through the guidelines of the Korean Occupational Safety and Health Agency (KOSHA) for agricultural workplaces. Methods: All 1,308 guidelines provided by KOSHA were reviewed and categorized using a Delphi technique questionnaire on their compatibility and urgency. Results: Among all the KOSHA guidelines, 100 items related to agricultural workplaces were selected. After that, two Delphi questionnaires were conducted and 46 items were finally selected. The average compatibility was calculated as 4.26, and urgency was 2.39. As a result of measuring the content validity of 46 items, six items were identified that were not relevant to agriculture. The final selected items were classified into four categories: Health examination and management, machinery standards, safety and health standard guides, and workplace environment management. Conclusions: The various risk factors at agricultural workplaces should be prevented and managed. It was shown that related technical guidelines or work standard manuals should be prepared. The technical guidelines of KOSHA will be provided as basic categories in the agricultural sector.

• 한국환경농학회지
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• 제38권1호
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• pp.1-9
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• 2019

BACKGROUND: Accurate and simple analytical method determining Fluxametamid residue was necessary in various food matrices. Additionally, fulfilment of the international guideline of Codex (Codex Alimentarius Commission CAC/GL 40) was required for the analytical method. In this study, we developed Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) method to determine the Fluxametamid residue in foods. METHODS AND RESULTS: Fluxametamid was extracted with acetonitrile, partitioned and concentrated with dichloromethane. To remove the interferences, silica SPE cartridge was used before LC-MS/MS (Liquid Chromatography-Tandem Mass Spectrometry) analysis with $C_{18}$ column. Five agricultural commodities (mandarin, potato, soybean, hulled rice, and red pepper) were used as a group representative to verify the method. The liner matrix-matched calibration curves were confirmed with coefficient of determination ($r^2$) greater than 0.99 at calibration range of 0.001-0.25 mg/kg. The limits of detection and quantification were 0.001 and 0.005 mg/kg, respectively. Mean average accuracies were shown to be 82.24-115.27%. The precision was also shown to be less than 10% for all five samples. CONCLUSION: The method investigated in this study was suitable to the Codex guideline for the residue analysis. Thus, this method can be useful for determining the residue in various food matrices as routine analysis.

• 한국안전학회지
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• 제27권2호
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• pp.98-104
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• 2012

Current [Guideline for Installation and Management of Sidewalks and Safety Facilities on Roads] suggests that the types of curbs should be Barrier curb ($85^{\circ}$). Although Barrier curbs ($90^{\circ}$) were not specified in the guideline. The curbs installed on the roads currently are Barrier curbs ($90^{\circ}$) which are not specified in the installation standard. Therefore, it is critical to prepare for the installation standard of curbs by researching types of curbs and driving safety. This research have assessed the driving safety throughout Full Scale Crash Test according to type of curbs (Barrier curbs ($85^{\circ}$) and Barrier curbs ($90^{\circ}$)). Barrier curbs ($90^{\circ}$) showed higher figure in Theoretical head Impact Velocity, Post-impact Head Deceleration, Vehicle Damage when Crash, Passenger's Wounds Severity, and every other items than Barrier curbs ($85^{\circ}$). Barrier curbs ($85^{\circ}$) were found to have better Occupant Safety Index. Analysis of Behavior Using Full-Scale Crash Test showed difference depending on the Impact Condition between Barrier curbs ($85^{\circ}$) and Barrier curbs ($90^{\circ}$). Generally, Barrier curbs ($85^{\circ}$) were superior than Barrier curbs ($90^{\circ}$) in terms of protecting the passengers and vehicle damages. When an impact angle increases, Acceleration of Vehicle, Variations of Speed, and Contact Relationship between Wheels and Curbs, two types of curb showed similarity. However, if an impact of an angle decreases, Barrier Curbs ($85^{\circ}$) showed excellence in Driving Safety such as Acceleration of Vehicle, Variations of Speed, and Contact Relationship between Wheels and Curbs.

• 한국토양비료학회지
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• 제49권6호
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• pp.651-654
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• 2016

A number of accidents relating to highly toxic hydrogen fluoride (HF) or hydrofluoric acid (HA) release have occurred over fast few decades in Korea. Thus, this study was conducted to investigate the fluoride (F) concentrations in paddy soil and brown rice from 2 different areas where the soils were exposed to HF and HA. In the first case, the HF leakage accident that occurred in 2012 affected the surrounding soils and crops and consequently, crops (rice) affected by HF were unavailable for forage even though F did not accumulate in the soil. For example, at the time of accident, F concentrations in brown rice samples were $33.0-1,395mg\;kg^{-1}$, while F concentrations in soil samples were $155-295mg\;kg^{-1}$ which were less than the Korean standard guideline values of $400mg\;kg^{-1}$. However, after a year, F concentrations in brown rice were observed below the detection limit ($1mg\;kg^{-1}$), although F concentrations in soils were similar with those in 2012. Also, large amounts of wastewater discharges containing HA occurred in 2013 and some agricultural soils exceeded the Korean standard guideline values for F ($400mg\;kg^{-1}$), but soil-plant F transfer was not observed. In conclusion, it was observed that soil to plant transfer of F is unlikely although HF and HA as gas or liquid form can cause direct damage to plants.

• Journal of Acupuncture Research
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• 제27권1호
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• pp.75-86
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• 2010

Objectives : We developed and proposed a guideline for safety and performance assessment of electric moxibustion apparatus (class II medical device). Methods : We drafted the guideline for safety and performance assessment of electric moxibustion apparatus by referring the existing standards, guidelines and measurement data from commercially available products. Temperature characteristics such as maximum temperature and ramp time, and physical characteristics such as weight, noise and diameter were measured. User friendliness was also evaluated for commercial devices. Results : This guideline only can be applied to the electric moxibustion apparatus where moxa is being heated by electricity for medical proposes. Maximum temperature of higher than $50^{\circ}C$ can be achieved mostly. Ramp rate of temperature seems to be reliable. Control of temperature is needed to be improved. Moxa and its derivative products seem to be regulated for reliable temperature performance for clinical application. Requirements for design and development of electric moxibustion apparatus are suggested : temperature indicator, temperature control and its accuracy, safety measure, surge protection, user friendliness and instruction for use (IFU). Design recommendation of the reduction of noise level and energy loss are suggested for better products. Conclusions : We proposed a guideline for safety and performance assessment of electric moxibustion apparatus to improve the quality of relating products and aid their commercialization by aiming higher industrial competitiveness of the medical device sectors in Korea. Discussion with related institutes such as industry, academy and government is further required. Public hearings also need to be held prior to the establishment of a final guideline and standard.

• 해양환경안전학회지
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• 제28권6호
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• pp.973-991
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• 2022

전 세계적으로 해상을 마주하고 있는 여러 국가들은 기존의 전력 생산방식의 단점을 극복하고 해상풍력 개발을 통한 친환경에너지자원을 활용하고 있다. 해상은 넓은 해역에 대규모 풍력단지를 개발할 수 있는 장점이 있으나 해양구조물의 설치로 인해 선박의 안전운항이 위협받고 있다. 이에 따라, 선박 통항로와 해상풍력단지 간 상호 미치는 영향에 대해 분석하여 선박이 안전하게 운항할 수 있도록 PIANC에서는 표준 Guideline을 제시하였다. 그럼에도 불구하고, 표준 Guideline은 모든상황에서 동일한 이격거리를 산정하였다. 따라서 본 연구에서는 선회성능, 조우상태, 환경외력, 해상밀집도, 해상풍력발전기, 항로형태 등을 요소로 반영한 선박 통항로와 해상풍력단지 간 최적의 이격거리 산정 모델을 개발하였다. 개발된 모델 검증을 위한 시뮬레이션 결과, 운항 준비상태에 따른 입지 특성별 선회성능 크기는 산정 모델에서 제시한 크기와 유사하였다.

• 인터넷정보학회논문지
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• 제20권3호
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• pp.69-75
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• 2019

The safety and performance of medical device software is managed through life-cycle processes, which represent the entire process of research and development (R&D). The life-cycle process of medical device software is represented by an international standard called IEC 62304, ISO/IEC 12207. In order to license the product, the manufacturer must have document artifacts that comply with the IEC 62304 standard. However, these standards only describe the content of the activity and do not provide a method or procedure for documentation. Therefore, this paper suggests R&D documentation guidelines that assist medical device software developers to have R&D documents conforming to the standards. For this purpose, this study identifies the requirements related to documentation among the requirements existing in the standard and extracts them in the form of guidelines showing only the core information of the requirements. In addition, through the Web framework implemented based on this research, the developer can evaluate whether the technical documents are written in accordance with the R&D document guidelines. Medical device software manufacturers can efficiently produce high-quality research and development documents through R&D documentation guidelines, and they can have standards-compliantresearch and development documentation required for licensing procedures.

• 한국정보과학회논문지:소프트웨어및응용
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• 제35권12호
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• pp.731-740
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• 2008

철도 제어 시스템은 대표적인 안전철수 시스템이다. 국제 규격의 컴퓨터 기반의 철도 제어 시스템을 개발하기 위해서 정형 기법을 이용한 요구사항 명세와 검증이 요구된다. 본 논문에서는 정형 기법을 사용하여 요구사항 명세를 작성하는 지침서(guideline)을 개발하고, 컴퓨터 기반의 열차 제어 장치 시스템에 대한 실제 적용 사례를 제시한다. 정형 명세를 위해 상태차트(statechart)와 Z를 사용하고, 정형 명세의 일치성(consistency)과 완전성(completeness)을 검증한다.

• 대한안전경영과학회지
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• 제11권2호
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• pp.33-40
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• 2009

The Railroad Safety Act was implemented in 2005 due to the increased concerns regarding railroad safety since the Daegu subway fire in 2003. In line with this, the Act became a standard to build the total railroad safety systems which has been overlooked compared to the quantitative growth of the railroad business. The minister of the ministry of Land, Transportation and Maritime Affairs lays down the Act for railroad Companies to conduct emergency programs in response to the emergency occurring on the railroad such as fire, explosion, derailment, etc. By enacting the Safety Act, the nation's construction of the contingency management system for railroad emergency increased", and it made the railroad company prepare the Emergency SOP by establishing 'The guideline on the Establishment of the railroad Emergency Plan' in order to support the efficiency of the Act. In line with this, I would like to analyze a matter of system development and the main function of the "railroad Emergency Training Program" for activation improvement of standardized operation procedure developed through the 'Total capitalize Safety Technology development'.