• Journal of Internet Computing and Services
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• v.20 no.3
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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.

• Fire Science and Engineering
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• v.29 no.4
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• pp.81-88
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• 2015

A low-cost device using the light-extinction method was developed to measure the optical smoke density in various fire experiments in the present study. The relative measurement accuracy of low-cost device was evaluated through the comparison of optical density measured by a high-cost standard device consisting of He-Ne laser, photo detector and various optical components. The low-cost device was composed of laser module, photocell and acrylic board. From the experiments using a smoke generator can be easily adjusted the smoke concentration, it was found that the low-cost device could measure the smoke density within the range of ${\pm}10%$, compared to the standard device. In addition, the reliability of low-cost device was also confirmed in the experiment using a polyethylene flame. Finally, it is expected that the low-cost device developed with real-time measurement and simple installation for measuring the smoke density will be used instead of the high-cost standard device.

• Journal of Korean Society for Quality Management
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• v.50 no.3
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• pp.503-515
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• 2022

Purpose: As ISO 13485 was revised in 2016, the domestic GMP (Good Manufacturing Practice) system was also revised and implemented in 2019. However, there are many problems in the domestic medical device industry because most of the small and medium-sized enterprises lack human and material resources. Accordingly, this study was conducted to provide education programs for domestic medical device companies to induce information provision and improve the company's quality management ability. Methods: First, analyze existing education. Second, based on the revised GMP system, a survey paper was produced to investigate difficulties and problems experienced by companies. Third, a two-week survey was conducted on domestic medical device manufacturers, and a total of 77 companies responded to this survey. Fourth, educational program development was conducted based on the results of the survey. Results and Conclusion: The developed education program consists of a total of five sessions. In this study, the educational program developed by grasping the needs of the company through a survey consists of a total of five sessions. The first session consisted of theoretical education and the second to fifth sessions of practical education. Through the education program developed in this study, it is expected to contribute to the overall development of medical device quality by establishing a domestic medical device manufacturing environment that secures the safety and performance of domestic medical device companies.

• Proceedings of the Korean Institute of Electrical and Electronic Material Engineers Conference
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• 2009.06a
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• pp.385-386
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• 2009

This paper deals with assessment of equipotential bonding and electrical continuity in Buinding by investigation on the spot at construction site. The assessment was carried out for continuity of steelwork in reinforced concrete structure, bonding conductor, protective conductor. A new grounding system based on international standards includes unity grounding system, structure grounding utilizing steel reinforced concrete, equipotential bonding, use of surge protective device.

• Journal of the Korean Society of Safety
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• v.29 no.2
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• pp.7-11
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• 2014

The electric shock victims were predominantly male, and more than half of the victims were found in companies with less than five employees in terms of the scale of company, and also more than half of victims had less than one month of experience for work experience. Considering the category of industry, more than half of the victims were engaged in construction, and considering the subcategory of industries, more than 60% of electric shock victims were found in building and other construction works. This study intended to conduct an in-depth analysis on the cause of electric shock accidents to provide basic data for policy proposing taking into considering the characteristics such as the electric shock path, low voltage, grounding and protection of workers. Also this study conducted an in-depth analysis of electric shock accidents for the past eleven years taking into account the necessity of a long-term plan.

• Proceedings of the KAIS Fall Conference
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• 2006.05a
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• pp.244-247
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• 2006

본 논문에서는 누전차단기에 대한 고조파 영향을 규명하기 위해 고조파 합성장치를 이용하여 누전차단기 동작특성을 시험하였다. 시험결과 3차 고조파가 기본파에 합성되었을 때 기본파보다 작은 값의 누설전류에서 누전차단기가 동작되어 오동작 될 수 있는 가능성이 있었고 기본파에 더해진 고조파 차수가 증가할 수 록 누전차단기 동작전류는 증가하였다. 따라서 사무용 빌딩 등과 같이 3차 고조파가 존재하는 장소에서는 누전차단기가 오동작 될 수 있으므로 사용에 주의가 필요한 것으로 나타났다.

• Journal of Korean Society of Industrial and Systems Engineering
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• v.22 no.51
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• pp.63-72
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• 1999

Many firms have applied flexible manufacturing systems as a means of increasing productivity, profitability, and quality. Therefore, the purpose of this paper is to develop the more efficient justification model through an analytical scoring model with the quantitative factors, flexibility factors, and safety factors under uncertainty. In this paper, the three factors for properly comparing and evaluating of flexible manufacturing systems are presented. Especially, this paper has emphasized the flexibility and safety factor; the one consists of organization assessment, process treatment function, products and products quantity, useful life assesment, and software function, the other presents risk assesment, Y2K problem, safety device analysis, total productive management system, safety management. Finally, a normalized scoring model by the new flexibility and safety factors can be used in real fields for flexible manufacturing systems project selection under uncertainty.

• International Journal of Safety
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• v.8 no.2
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• pp.1-4
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• 2009

Various falling prevention systems with vertical guided rail have been supplied in order to prevent falling accidents and acquire the long life and cost down for the maintenance. Almost the imported system is composed of a guided rail and the comfort components. It has the mechanism that cannot be dismounted from the guided rail at the accident site. Thus, the aim of this study is to develop a falling prevent system that has a direct dismounting function, which can release easily from the falling accident point. This system has a high durability and robust. And the cost efficiency of the system and safety for workers also are improved remarkably. From the results, we showed the proposed new falling system is sufficiently safety and satisfies the KOSHA regulation through the numerical stress analysis. Also it is expected as the useful and effective safety device for workers.

• Journal of the Korean Society of Safety
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• v.22 no.6
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• pp.1-6
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• 2007

A Recently elevator accidents were occurred and increased due to carelessness of user and violent behavior. The accident of door detachment in elevator platform by electronic motor scooter show a example of safety concerns and insensibility for safety awareness. In this report, we review the cause of accident of door detachment in elevator platform by electronic motor scooter, and show some suggestions of preventing from the safety concerns about this case.

• Journal of the Korean Society of Safety
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• v.27 no.5
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• pp.30-34
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• 2012

A safety helmet is a personal protective equipment to protect the head from falling and flying objects. A safety helmet has the maximum delivered impact force as shock absorption performance, the lower delivered impact force the better performance, which was not a controlled variety during manufacturing safety helmet. Accordingly there were some difficulties in establishing the standard for improved performance as there was not a clear controllable impact force for improved performance. In this study the shock absorption performance was intended to be found as coefficient of restitution related to impulse. As a research method, a coefficient of restitution during the absorption of shock was calculated using the impulse transferred to pharynx utilizing the safety helmet shock absorption performance testing device based on the theory of momentum and impulse. The estimated impulsive force curve was derived assuming that shock was not absorbed using the measured data. The sample was selected as tested goods of ABS material for safety certification available mainly in the market. As a result of study, the maximum delivered impact force of safety helmet made by a domestic safety certified a company was 735 N, and its coefficient of restitution proved to be 0.64. The smaller coefficient of restitution is, the lower maximum delivered impact force and the higher shock absorption performance. The coefficient of restitution can be used as a performance index of safety helmet.