• 대한의용생체공학회:의공학회지
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• 제44권3호
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• pp.204-210
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• 2023

This study focuses on analyzing medical device standards and regulatory requirements in the medical device industry, based on the Medical Device Act in Korea. The objective of this analysis is to determine whether the domestic standards for medical devices in Korea align with international and regional standards. Furthermore, it aims to identify the current application of domestic standards in ensuring the safety and essential performance of medical devices. The analysis revealed that out of a total of 281 domestic standards, 127 standards reference international standards. In terms of the application of domestic standards to specific items, there were 473 types of instruments/machines, 30 types of medical supplies, and 45 types of dental materials. However, the level of compliance with international standards among the domestic medical device standards was only 21%. Upon detailed analysis, general and collateral standards accounted for 24%, while particular standards accounted for 19%. This indicates a significant deviation from the latest international standards. On the other hand, the level of compliance with international standards was analyzed to be 60% for particular standards and 72% for general and collateral standards in Korean industrial standards (KS). Considering these results, the disparities between domestic standards and international standards underscore the need for discussions on domestic medical device regulation and standardization. In conclusion, this study emphasizes the significance of maintaining up-to-date medical device standards and ensuring their alignment with international standards to ensure the safety and quality of medical devices. The findings highlight the necessity for further efforts to strengthen the domestic standardization system in order to promote the development of safe and high-quality medical devices.

• 한국조명전기설비학회:학술대회논문집
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• 한국조명전기설비학회 2003년도 학술대회논문집
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• pp.93-95
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• 2003

Owing to WTO/TBT, Many countries are trying to accord their own various national codes and standards with international standards. Also Korean electric power code is being made consistent with the new standards which include the international standards. The new code will affect the many aspects of building construction. In order to cope with the change of the electric power code, this paper analyzed the trend of the international standard(IEC 60364, IEC 61024) and we think this study will help engineers to understand the international electrical standards.

• 한국건설관리학회논문집
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• 제2권4호
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• pp.107-116
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• 2001

국가간 무역거래가 활발해 지면서 통일된 국제규격의 중요성이 강조되고 있다. 이에 따라 세계무역기구(World Trade Organization, WTO)와 APEC(Asia-Pacific Economic Cooperation)에서는 각국의 무역에서 기술장벽에 관한 협정(Agreement on Technical Barriers to Trade, TBT협정)과 무역투자위원회(CTI)회의를 통해 점진적으로 국가표준을 국제표준에 부합시키도록 결의하였다. 또한, ISO(International Organization for Standardization)에서도 ISO/IEC Guide 21을 작성하여 국제규격을 국가규격으로 채택하도록 지침을 마련하였다. 이러한 대외 환경의 변화에 따라 국내에서도 건설시장 개방에 따른 건설분야의 표준 정비와 함께 국제규격과의 부합화에 대한 대비가 필요하게 되었다. 따라서 본 연구는 한국산업규격의 토건부문(KS F)규격 중 콘크리트 시료채취와 시험방법에 대한 규격을 ISO/IEC Guide 21과 통상산업부 부합화 지침서를 기준으로 대응규격인 ISO건설 분야 규격의 구성체계와 내용에 대해서 상호 대비하고, 이에 따른 문제점 도출 및 대안을 제시함으로써 국내 건설분야 표준규격의 부합화 방향을 설정하고자 한다.

• International Journal of Advanced Culture Technology
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• 제2권1호
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• pp.20-24
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• 2014

As the standards organization under ISO responsible for the development of all international financial services standards, ISO/TC 68 plays a key role in the development and adoption of new technologies in the banking, brokerage and insurance industries. In this paper many of its current work projects are introduced for developing ecommerce standards. We need to discuss the recommendations on XML conversion with ISO and other international standard organizations. Each country try to adopt the international standards even though domestic technical standards and barriers. To solve this problem of interworking between these standards, harmonization activities are nedded. For development and distribution of electronic documents to be conformed to international standards, it is enough to have the role of international activities continue to supply part of the domestic industry and the trends in participation and international standard.Our principal focus is on facilitating national and international trade, through the simplification and harmonization of processes, procedures and information flows, and so contributing to the growth of global commerce.

• 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.

• 한국재난정보학회 논문집
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• 제11권2호
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• pp.287-296
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• 2015

본 연구에서는 국제표준화기구에서 제정 관리하고 있는 국제표준 중 재난관리 관련 국제표준, 특히 ISO/TC 292(Security-안전) 분과의 국제표준을 조사하여 재난관리 관련 국제표준 동향을 살펴보고, 각 국제표준과 관련된 국내 법 제도를 살펴보았다. 재난관리기관으로서 국민안전처(구 소방방재청)은 재난관리 관련 국제표준 제정 시 국내 적용하기 위한 방안을 지속적으로 마련하고 있다. 재난관리 관련 국제표준이 지속적으로 제정됨에 따라 재난관리기관은 국제표준을 도입하기 위한 방안을 모색하여 국제사회에 발맞춰 나갈 필요가 있다.

• 무역학회지
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• 제44권4호
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• pp.87-100
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• 2019

A country's participation in international technical standards development directly relates to its trade competitiveness. Many countries adopt international standards or influence their development process through the ISO/IEC. This study applies the ABCD Model to assess such activities through a constructed ITS index, not only in terms of 'level' of contribution but also in terms of 'process' participation that can give important implications related to the future potential influence of countries in standards development. Having examined seven countries, Korea showed the lowest score implying the need to enhance its performance in both 'international standards adoption' and 'internationalization of domestic standards'. Korea needs to more actively participate in currently on-going standards development processes, establish more offices that improve accuracy in the development, and consider participating in additional committees where domestic interests may potentially be at stake. Although KATS has improved greatly in regards to its relevant activities and database construction, a more active and specific plan must be made to allow its efforts to successfully influence Korea in international standards development. Confronted with strong challenges from directly competing countries in trade like China and Japan that showed better ITS scores, there is a need for Korea to step up its research and participation in this field.

• 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.

• 한국신재생에너지학회:학술대회논문집
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• 한국신재생에너지학회 2005년도 춘계학술대회
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• pp.142-146
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• 2005

Standards are increasing of importance for photovoltaics. The rapid growth of production is one reason for this but standards are equally important in ensuring the quality and reliability of installed PV systems. which have a propound impact on acceptance of the technology in the expanding marketplace. Korea government (Korean Agency for Technology and Standards. KATS)make and implement a five year plans for promotion of international standardization of this field from 2004. Through these works and harmonization of PV Korea standards with international standards(international electrotechnical commission. IEC). KATS leads the technology innovations and eventually increases the international Competitiveness. Strategic collaboration with other countries is also strengthened through Korea's participation in IECEE(IEC system for conformity and certification of electrical equipment) on standards and conformity assessment. One of the major goals of the Plan is to facilitate trade between Korea and its trading partners by emphasizing harmonization of its national conformity assessment system with international norms

• 산업경영시스템학회지
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• 제32권2호
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• pp.94-103
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• 2009

In relation to a certification system recently, it is coming out complains about make a rule of thumb certification, problems of after-service and duplication with government certifications. Also there is confusion in operating certification system to lack of properly rule to international standard. These impose a heavy burden on company in terms of times and costs and enhance competitiveness. Nevertheless, the survey was not built yet for the status and problems of the cooperation group standards certification System. So, this study purposes that research on the actual condition and development of operational guide for cooperation group standards certification system. In addition it ultimately improve the certification system for reliability and international competitive power. For more detail on this study, it would be considered conformity assessment, domestic/international conformity assessment and certification criteria. Also comparing survey result on the actual condition with international standards, develop operational guidelines to meet international standards.