• Journal of Biomedical Engineering Research
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• v.44 no.3
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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.

• Proceedings of the Korean Institute of IIIuminating and Electrical Installation Engineers Conference
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• 2003.11a
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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.

• Korean Journal of Construction Engineering and Management
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• v.2 no.4 s.8
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• pp.107-116
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• 2001

As the international trade has been increased, unified worldwide standards are getting more important and necessary. At the TBT(Agreement on Technical Barrier to Trade) of WTO(World Trade Organization) and the CTI meeting of APEC(Asia-Pacific Economic Cooperation), they made an agreement with applying International Standards to National Standards gradually. In addition, ISO (International Organization for Standardization) established the ISO/IEC Guide 21, a guideline for applying International Standards to National Standards. In these environment, Korean Industrial Standards has to be prepared for it. This paper introduce the comparison between Korean Industrial Standards and ISO Standards about the standards of sampling and testing the fresh concrete, based on ISO/IEC Guide 21 by ISO and the Applying guideline by Korean Agency for Technology and Standards, and then discuss the problem about applying them. The overall objective is to establish the applying guideline on construction fields, which is civil and building engineering part(KS F) of Korean Industrial Standards.

• International Journal of Advanced Culture Technology
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• v.2 no.1
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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.

• The Korean Journal of Health Service Management
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• v.7 no.3
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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.

• Journal of the Society of Disaster Information
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• v.11 no.2
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• pp.287-296
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• 2015

In this study, international standards in disaster management and the management of the relevant International Standards Organizations(ISO), in particular ISO / TC 292 (Security- Safety) research subcommittee to look at international standards of relevant international standards for disaster management trends, each international domestic law related to the standard were researched. National Disaster Management Authority as a Ministry of Public Safety and Security (formerly the National Emergency Management Agency) has continued to prepare a plan for applying national disaster management relevant to the international standards. As the disaster management international standard continues to be established, disaster management agencies need to continue to keep pace with the international community to find ways to introduce international standards.

• Korea Trade Review
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• v.44 no.4
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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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• v.40 no.4
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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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• 2005.06a
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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

• Journal of Korean Society of Industrial and Systems Engineering
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• v.32 no.2
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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.