• The Korean Journal of Health Service Management
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• 제7권3호
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• pp.203-212
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• 2013

Medical devices separated by a committee of the International Electrotechnical Commission IEC TC (Technical Committee) 62 medical electrical equipment being promoted by the International standards. Actually, a lot of standards were existed, but many national and international standards for medical devices were lacking in practical standards that can be applied to their development. Most international standards were focused in electrical and mechanical safety of medical devices. Therefore, there were few practical standards which contain essential performance evaluation. Although medical device regulations do not enforce a fixed lifecycle model, activities are presented in a sequential manner, thus hinting at a waterfall process. Meanwhile, for a decade or more, software teams have benefitted from agile development methods. Several medical device manufacturers have adopted agile practices while keeping development in compliance with regulations, but conflicts arise and decisions have to be taken in favor of agility or formality. However, if there are new practical standards of medical devices, it must be possible to promote the medical devices industry in their nation. To do this, there is a need to develop a new standard could apply to the international market through the analysis of the medical device related technology. Consequently, new standards such as NP (New proposal) or NWIP (New Work Item Proposal) should be developed through international standardization of medical device technology.

• Korean Journal of Acupuncture
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• 제40권4호
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• pp.135-140
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• 2023

Objectives : Moxibustion-related standards have been established by organizations such as the International Organization for Standardization (ISO) and the Korean Standards Association (KSA), among others. Methods : We summarized moxibustion-related standards that have been published by ISO and KSA. Results : Technical Committees 249 (ISO/TC 249), which was established in 2009, has been established moxibustion devices standards in working group (WG) 4. International standards have been established for moxibustion devices, smokeless moxibustion devices, moxa floss quality, and electric heating moxibustion equipment. Work on international standards for infrared moxibustion-like instruments and moxibustion device terminology is currently in progress. Conclusions : Korea has taken a central role establishing international standards for a wide range of moxibustion devices, supported by fundamental research data in this field. To continue its influence in establishing these international standards, further studies providing the basis for moxibustion device standardization are required.

• Journal of radiological science and technology
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• 제39권2호
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• pp.263-271
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• 2016

The market size of the bone absorptiometric X-ray system and the number of its approval by Ministry of Food and Drug Safety (MFDS) has annually increased, with a trend of increasing aging population and osteoporosis patients. For approval of manufactured or imported medical devices in Republic of Korea, it is required to submit its technical document. Therefore, it is need to develop the technical document guideline for the bone absorptiometric X-ray system for manufacturers, importers and reviewers. First of all, the technical documents which were already approved were examined and analyzed through MFDS approval administration system. Second, safety and performance test standards and methods that match international standards were drawn after conducting survey of the market status and the technology development trend for it, with examination and analysis of applicable domestic and overseas standards. Third, by operating industry-research-government cooperation, the guideline draft on writing technical document for the bone absorptiometric X-ray system was discussed, collecting their opinion. As a result, it is suitable to international and domestic condition, includes test evaluation methods and offer various information with appropriate examples to civil petitioner, when they write the technical documents.

• Journal of the Korean Data and Information Science Society
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• 제22권1호
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• pp.125-136
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• 2011

Ground-level ozone, an air pollutant that is monitored by the Environmental Protection Agency (EPA), damages human health by irritating the respiratory system, reducing lung function, damaging lung cells, and aggravating asthma and other chronic conditions. In March 2008, the EPA strengthened ozone standards by lowering acceptable limits from 84 parts per billion to 75 parts per billion. Here epidemiologic data is used to study the effects of ozone regulation on human health and assessed how various regulatory standards for ozone may affect nonaccidental mortality, including respiratory-related deaths during ozone season. The assessment uses statistical methods based on hierarchical Bayesian models to predict the potential effects of the different regulatory standards. It also analyzes the variability of the results and ho they are impacted by different modeling assumptions. We focused on the technical an statistical approach to assessing relationship between new ozone regulations and mortality while other researches have detailed the relationship between ozone and human mortality. We shows a statistical correlation between ozone regulations and mortality, with lower limits of acceptable ozone linked to a decrease in deaths, and projects that mortality is expected to decrease by reducing ozone regulatory standards.

• Proceedings of the Korean Institute of IIIuminating and Electrical Installation Engineers Conference
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• 한국조명전기설비학회 2007년도 춘계학술대회 논문집
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• pp.200-202
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• 2007

In recent years, equipment and network standards have been increasing in both number and complexity. Two standards that will soon be introduced to KOREA are the HV standards for assessing distorting and fluctuating loads, IEC 61000-3-6. Utility engineers, being under increasing time constraints, are turning more and more to software to quickly solve problems. This paper describes the methodology used to implement the above standards in Microsoft Excel in order to assist utility engineers to readily apply these standards in practical situations.

• International journal of advanced smart convergence
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• 제10권3호
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• pp.59-65
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• 2021

In this paper, we propose the AI certification standardization activities for systematic research and planning for the standardization of trustworthy artificial intelligence (AI). The activities will be in two-fold. In the stage 1, we investigate the scope and possibility of standardization through AI reliability technology research targeting international standards organizations. And we establish the AI reliability technology standard and AI reliability verification for the feasibility of the AI reliability technology/certification standards. In the stage 2, based on the standard technical specifications established in the previous stage, we establish AI reliability certification program for verification of products, systems and services. Along with the establishment of the AI reliability certification system, a global InterOp (Interoperability test) event, an AI reliability certification international standard meetings and seminars are to be held for the spread of AI reliability certification. Finally, TAIPP (Trustworthy AI Partnership Project) will be established through the participation of relevant standards organizations and industries to overall maintain and develop standards and certification programs to ensure the governance of AI reliability certification standards.

• Journal of Korean Society for Quality Management
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• 제40권3호
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• pp.295-305
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• 2012

Purpose: This study identified the standardization activities from the early stage of acquisition to disposal during the materiel life cycle and proposed the improvement of standardization process. Methods: Through improvement of duplicated deliberation for the revision of military specification, unification of technical change proposal reception organization, and resolution between the conflicting parts of laws and regulations, simplifying the standardization procedure and strengthening linkages between the civilian standards were gained. Results: We have redefined the concept of the standards and standardization in the field of defense and proposed the standards-driven documentary standards as a measurement standards and reference standards to expand the activities. Conclusion: Through a standardization survey, we came to conclusion that we need to change the concept of standardization in the field of national defense from making the specification to using the means of efficient management of military resources.

• 한국지형공간정보학회:학술대회논문집
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• 한국지형공간정보학회 2002년도 춘계학술대회 논문집
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• pp.119-129
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• 2002

The information system fields of spatial applications have rapidly grown during the last decade in Korea. Spatial data has been produced for a variety of systems without common standards until national GIS Committee defined the data exchange formats among spatial databases in the middle of 1990's. It aimed at promoting data sharing between the different systems in similar application fields. However, a considerable number of databases built prior to the introduction of the standards are not yet standard compliant but still play the roles of the main producers/consumers in the data collection field such as early developed huge AM/FM systems maintained by governmental organizations. The strong autonomy of these databases keeps their own data models, formats and descriptions from being standardized, which leads the sharing to a more difficult stage. Sharing is another way of data acquisition with least efforts and time away from direct collection. A data clearinghouse is the core module which directs users to the relevant data resources. The contents of datasets should be described with predefined metadata standards for precise indexing. Moreover, a number of technical problems have to be resolved for the common use of data between heterogeneous spatial database systems. However, the technical issues can be covered by the present information technologies. The difficulties persist in the political/institutional issues. Institutional issues are derived from the diverse sources such as political background, governmental policies, related laws and/or regulations. The paper will firstly make an analysis of current situation in terms of Korean policies, laws and regulations, secondly abstract the institutional issues from the situation analysis, lastly present guidelines for promoting spatial data sharing in Korea.

• The Journal of Korean Institute of Electromagnetic Engineering and Science
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• 제26권6호
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• pp.581-588
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• 2015

In this paper, we researched that setting standard for RSC(Radar Cross Section) of naval surface ship could be determined and considered in various ways on ship's survivability, technical building feasibility, operation and so on. This study presented fundamental capacity on anti-ship missile, radar, flight and so no and the procedure to set of target/standards for RSC. The RCS standards is good at setting low as low as to improve survivability aspect, but because we should consider effect, technical limit, cost etc, this paper analyzed necessary elements to set standard than to suggest specific number and suggested procedure to set standars according to suggest the boundary of RCS.

• Wind and Structures
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• 제37권2호
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• pp.133-151
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• 2023

This paper first provides a wide overview about the design codes and standards covering the use of Computational Wind Engineering / Computational Fluid Dynamics (CWE/CFD) for wind-sensitive structures and built environment. Second, the paper sets out the basic assumptions and underlying concepts of the new Annex T "Simulations by Computational Fluid Dynamics (CFD/CWE)" of the revised version "Guide for the assessment of wind actions and effects on structures" issued by the Advisory Committee on Technical Recommendations for Constructions of the Italian National Research Council in February 2019 and drafted by the members of the Special Interest Group on Computational Wind Engineering of the Italian Association for Wind Engineering (ANIV-CWE). The same group is currently advising UNI CT021/SC1 in supporting the drafting of the new Annex K - "Derivation of design parameters from wind tunnel tests and numerical simulations" of the revised Eurocode 1: Actions on structures - Part 1-4: General actions - Wind actions. Finally, the paper outlines the subjects most open to development at the technical and applicative level.