• 대한의용생체공학회:의공학회지
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• 제44권6호
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• pp.428-442
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• 2023

In this study, we have a goal to develop usability evaluation guidelines for heuristic-based artificial intelligence-based Software as a Medical Device (SaMD) in the medical field. We conducted a gap analysis between medical hardware (H/W) and non-medical software (S/W) based on ten heuristic principles. Through severity assessments, we identified 69 evaluation domains and 112 evaluation criteria aligned with the ten heuristic principles. Subsequently, we categorized each evaluation domain into five types, including user safety, data integrity, regulatory compliance, patient therapeutic effectiveness, and user convenience. We proposed usability evaluation guidelines that apply the newly derived heuristic-based Software as a Medical Device (SaMD) evaluation factors to the risk management process. In the discussion, we also have proposed the potential applications of the research findings and directions for future research. We have emphasized the importance of the judicious application of AI technology in the medical field and the evaluation of usability evaluation and offered valuable guidelines for various stakeholders, including medical device manufacturers, healthcare professionals, and regulatory authorities.

• Toxicological Research
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• 제19권2호
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• pp.83-90
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• 2003

Since histopathological examination was known to be the most sensitive evaluation for testicular toxicity, regulatory authorities have been published the guidelines on practical testicular assay approach. Those guidelines specified details of evaluation including fixation, embedding, stain-ing, histological examination and also seminiferous tubular staging methods. However, there have been confusing understanding among toxicologists and even pathologists on staging theory and its application on industrial testicular toxicity. Guidelines did not intend to conduct quantitative assay with staging but recommended the use of knowledge of staging. To count each tubular stage with statistical analysis is known to be time consuming and labor burdening work but the significance of toxicity has little value. It also has been pointed out that the application of staging theory for longer-term toxicity considered to be lacking of rationale. It could be recommended that qualitative assay with aware-ness of germ cell loss is more efficient method rather than quantitative counting of each tubular stage. Therefore it would be required that comprehensive understanding of testicular toxicity evaluation and the use of testicular staging method.

• 한국경영과학회지
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• 제37권3호
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• pp.79-94
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• 2012

According to the higher dependence of contemporary firms on data digitalization and the information technology, the role and importance of Information Security Management (ISM) is getting higher. Thus, there is a need to arrange proper procedure and a series of device within the organization in order to reduce diverse security risks, which take place from the inside and the outside of firm. In other words, prior examination for reinforcing recognition of ISM, and of a systematic performance method in the refined form is important. This study investigate the key variables influencing the ISM. Thus, this study suggests firm environmental factors that include four exogenous variables, market volatility, task interdependence, perceived benefits, and coordination mechanism affecting awareness of ISM. In addition, it proposes a concept of the ISM process with awareness, development, and performance, and examines the moderating effects of regulatory influence. The research model was tested by using Structural Equation Modeling, via SmartPLS 2.0 analysis on a sample collected from 186 employees in various industries. The research results provide the evidence that supports the tested hypotheses except significance of coordination mechanism. The implications of the findings suggest a new theoretical framework of the ISM and offers important solutions for the practical application guidelines.

• Nuclear Engineering and Technology
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• 제49권3호
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• pp.517-524
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• 2017

Cyber security is an important issue in the field of nuclear engineering because nuclear facilities use digital equipment and digital systems that can lead to serious hazards in the event of an accident. Regulatory agencies worldwide have announced guidelines for cyber security related to nuclear issues, including U.S. NRC Regulatory Guide 5.71. It is important to evaluate cyber security risk in accordance with these regulatory guides. In this study, we propose a cyber security risk evaluation model for nuclear instrumentation and control systems using a Bayesian network and event trees. As it is difficult to perform penetration tests on the systems, the evaluation model can inform research on cyber threats to cyber security systems for nuclear facilities through the use of prior and posterior information and backpropagation calculations. Furthermore, we suggest a methodology for the application of analytical results from the Bayesian network model to an event tree model, which is a probabilistic safety assessment method. The proposed method will provide insight into safety and cyber security risks.

• 방사성폐기물학회지
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• 제19권1호
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• pp.141-160
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• 2021

Unit 1 of the Kori Nuclear Power Plant (NPP) and Unit 1 of the Wolsong NPP are being prepared for decommissioning; their decommissioning is expected to generate large amounts of intermediate-level, low-level, and very low level Waste. Mixed waste containing both radioactive and hazardous substances is expected to be produced. Nevertheless, laws and regulations, such as the Korean Nuclear Safety Act and Waste Management Act, do not define clear regulatory guidelines for mixed waste. However, the United States has strictly enforced regulations on mixed waste, focusing on the human health and environmental effects of its hazardous components. The U.S. Nuclear Regulatory Commission and the U.S. Department of Energy regulate the radioactive components of mixed waste under the Atomic Energy Act. The U.S. Environmental Protection Agency regulates the hazardous waste component of mixed waste under the Resource Conservation and Recovery Act. In this study, the laws, regulations, and authorities pertaining to mixed waste in the United States are reviewed. Through comparison and analysis with waste management laws and regulations in Korea, a treatment direction for mixed waste is suggested. Such a treatment for mixed waste will increase the efficiency of managing mixed waste when decommissioning NPPs in the near future.

• Environmental Analysis Health and Toxicology
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• 제17권4호
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• pp.273-284
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• 2002

At present, the health risks associated with the natural radionuclides of ground water have become a concern as potential social problems. However, there are no regulatory actions or control strategies for such risks. Therefore, we have investigated and discussed the risks and associated management strategies for radionuclides in other countries. US EPA has proposed MCL (300 pCi/L) and AMCL (4,000 pCi/L) for radon, and 30 ppb for uranium, 15 pCi/L for gross-alpha and 5 pCi/L for radium as final MCLs. Also, Canada, WHO and European countries have their inherent management levels. Finally, we suggested several criteria for setting guidelines in our countries including exposure related criteria such as geological distribution, occurrence, exposure probability distribution, exposure population and multimedia exposure assessment, acceptable risk, and cost -benefit analysis. The national-scale exposure and risk assessment, and economic analysis should be conducted for producing and aggregating the representative information on these criteria.

• 항공우주정책ㆍ법학회지
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• 제20권1호
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• pp.255-272
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• 2005

본 논문은 민간항공 운송 여객기의 사용을 중심으로 국가공역의 효율적이고도 경제적인 활용을 위한 국제민간항공운송사회의 노력과 공역의 설계, 관리 및 규제요인을 고찰하고 선진항공국가의 공역관리정책과 운영 관리 설태를 분석하였으며, 국내의 특수목적 공역활용을 전제로, 기능적인 공역봉쇄개념의 도입을 통한 군. 빈 공역사용자 집단의 화합과 형평성 보장을 통해, 국가공역체계의 운영을 활성화하기 위한 정책방향을 제시하였다.

• 해양환경안전학회지
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• 제27권3호
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• pp.421-428
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• 2021

Identifying which international maritime legal instruments are mandatory or recommendatory is complicated task even for maritime regulatory bodies. Although International Maritime Organization (IMO) had tried to ease the complexity by adopting guidelines on uniform wordings for making reference to other instruments in IMO parent conventions, there has still been some confusion identifying the mandatory status of IMO instruments. The aim of this study was to map out a step-based guideline to resolve the complexity of the mandatory status of IMO instruments to the maximum extent possible. This study reviewed the history of IMO rule-making process to find the root cause of the problem, then analyzed the approaches of regulatory enforcement bodies to check the practices. In conclusion, readers are directed to find such information as to legal status of IMO instruments and an improvement is proposed to enhance the transparency of information sharing for maritime industry to make better informed decisions.

• 한국BIM학회 논문집
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• 제6권3호
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• pp.1-14
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• 2016

The usage of Building Information Modelling (BIM) in building projects has enabled improvement in project planning, implementation and collaboration process amongst various stakeholders within architecture, engineering and construction (AEC) industry. However, variations exist in the current practices of BIM implementation and coordination process in the industry. These variations result in inconsistent degree of BIM use across the construction industry. This inconsistency gives rise to several managerial and technological challenges such as data interoperability issues and purposeful integration and exchange of information within the BIM components. In order to tackle the issue, it is essential to analyse the different BIM approaches employed by the industry practitioners. BIM guidelines serve as a critical link between the BIM model, and its subsequent execution. They therefore provide the best reflection of BIM application and processes. This research paper aims to address the variations existing in BIM practices across the construction industry. It includes an extensive study of 21 existing, publicly available BIM-based guidelines in order to establish an understanding of the present state of practice and deduce issues and concerns related to them. All guidelines analysed in this paper are first categorised based on authorship and the release date for efficient comparison. The points of similarity and difference between them are thereby realized and outlined. In addition, the transition of project implementation process from traditional methods to BIM technology is also explained. The existence of inconsistencies in the BIM guidelines reviewed in this paper reflects the need of a BIM 'Code Compliance Check'. The Code Compliance Check will serve as a regulatory project guideline that will further improve the potential of BIM by incorporating a consistent BIM modelling methodology for the entire construction industry.

• 한국건축시공학회:학술대회논문집
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• 한국건축시공학회 2018년도 추계 학술논문 발표대회
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• pp.140-141
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• 2018

Protective coatings at nuclear power plants should be designed to withstand exposure to ambient conditions during normal operation or design-basis accidents. However, there was a change in the perception of the protective coating to the revision of the Regulatory Guidelines by the NRC in July 2000. In other words, maintenance guidelines have been strengthened in order to minimize the clogging of the cooling water system due to the substances in the containment building. Therefore, KHNP, the contractor and operator of the nuclear power plant, plans to develop the coating system for nuclear power plants in accordance with the regulation, and plans to develop its own coating expert.