• 보건의료산업학회지
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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.

• 대한방사선기술학회지:방사선기술과학
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• 제39권2호
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• pp.263-271
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• 2016

최근 인구 고령화에 따른 골다공증 환자의 증가 및 의료기기 시장의 성장으로 인해 엑스선골밀도측정기 시장이 커지고 있으며, 이에 따른 의료기기 허가 심사건수가 증가하고 있다. 의료기기 기술문서는 의료기기의 허가 심사 시 가장 기본이 되는 문서로 필수 제출 첨부자료 중 하나이다. 기술문서는 의료기기 관련 법령 및 고시에 그 근거를 두고 있으며, 의료기기 전반적인 항목을 기술해야하는 만큼 작성자의 전문성이 필요한 항목이다. 하지만 최근 부정확한 작성의 증가로 인한 심사자들의 업무부담이 증가되고 있어 민원 처리 효율이 저하되고 있다. 특히 엑스선골밀도측정기의 경우 식품의약품안전처 기준규격이 없어, 의료기기 제조/수입업체 등에서 시험항목을 설정하는 데 많은 어려움을 겪고 있다. 따라서 본 연구에서는 개선된 제도가 반영된, 엑스선골밀도측정기 기술문서 작성 가이드라인 개발을 위해 첫째, 개선된 제도 운영에 대한 조사, 품목별 의료기기의 제도 적용에 따른 문서 작성 방법 검토, 기 허가된 품목에 대한 허가 및 기술문서 검토를 완료하였다. 둘째, 품목별 시장현황 조사, 적용 가능한 국내 외 규격을 조사 분석하여 품목별 국제조화된 안전성 및 성능평가 시험기준 및 방법을 도출하였다. 마지막으로, 산 연 관 전문가협의체 논의를 거쳐 기술문서 작성 가이드라인(안)을 최종 도출하였다.

• 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.

• 한국조명전기설비학회:학술대회논문집
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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.

• 품질경영학회지
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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.

• 한국전자파학회논문지
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• 제26권6호
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• pp.581-588
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• 2015

본 논문에서는 함정의 RCS(Radar Cross Section) 기준치 설정은 함정의 생존성, 기술적 건조 가능성, 운용성 등 여러가지 측면이 고려되어 결정될 수 있다. 본 연구는 수상함의 RCS 기준치 및 설계 목표치를 설정하기 위하여 수상함에 위협이 되는 대함유도탄, 연안레이다, 항공기 등의 기본 성능을 조사하고, 조사결과를 토대로 현재의 국내 기술수준에서 가능한 RCS 목표치/기준치 설정을 위한 절차를 제시하였다. RCS 기준은 가급적 낮게 설정하는 것이 생존성 측면에서 좋겠지만, 함정의 고유 기능에 대한 영향, 기술적인 한계, 비용 등을 감안하지 않을 수 없기 때문에, 이 연구에서는 구체적인 숫자의 제시보다는 기준에 필요한 요소를 분석하고, 생존성을 보장할 수 있는 RCS 범위를 제시함으로써 기준치 설정 절차를 제시하였다.

• 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.