• 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.

• 한국신뢰성학회지:신뢰성응용연구
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• 제5권2호
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• pp.209-219
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• 2005

The required standards for environmental tests for communication and electronic equipment used currently are not standards into which the Korean climate and use environment are taken into consideration. But the most used environmental testing standards of the U.S. army(MIL-STD-810) has been used without taking into consideration the Korean domestic situation and conditions by simply translating the US standards. Adherence to these standards may increase in the manufacturing costs according to excessively strict standards. Therefore, this paper will propose a new environmental test standards for temperature.

• 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.

• 한국자기학회:학술대회 개요집
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• 한국자기학회 2008년도 Asian Magnetics Conference
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• pp.245.1-245.1
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• 2008

• 대한안전경영과학회지
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• 제11권2호
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• pp.167-178
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• 2009

De facto standards can be divided into the U.S. group standards' and 'forum and the consortium standard. mainly applies to high-tech industry forums, and a consortium standard of the industry given the nature of the standard are frequently revised, the country Due to the introduction of standard time. Economic loss to consider when in reality, the introduction of national standards of the United States is limited to the desirable standard, and the fact the actual award of standards, national standards, or if you want to introduce standard, each of depending on the type of attitude and strategy for standards by category, based on the characteristics of each body strategy and are needed. Through this study on utilization of de facto standards for national standards, it is researched that major de facto standards bodies status and domestic industrial fields which need utilization of de facto standards for national standards. Through overseas Case, effective usage of de facto standards will be obtained.

• 대한한의학회지
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• 제27권3호
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• pp.222-226
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• 2006

Objective: The aim of this study was to introduce newly developed cooperation group standards of acupuncture needles for single use and to make a contribution to the future development of Korean Industrial Standards (KS) of acupuncture needles for single use. Results and Conclusion: Quality assurance and quality control with high safety profile is one of the most critical issues in medical device manufacturing. Up to now, proper attention has not been paid to this issue with respect to acupuncture needles for single use and their related devices. We, therefore, organized a committee to make guidelines to produce an acupuncture needle with high quality and safety. In the committee, we reviewed the topic from an historical viewpoint, and investigated the current situation of the standardization of acupuncture needles in other developed countries. Finally, we developed the cooperation group standards in advance of development of KS on the acupuncture needles for single use. The standards are composed of 12 sections describing: Scope, Normative references, Definitions, Materials, Configuration, Appearance and Cleanliness, Quality, Sterilization and Safety, Processing of Surface and Coating Material, Test, Packaging, and Labeling. We hope that the standards would be useful guidelines to produce high quality acupuncture needles and play an important role in the development of KS in the future.

• 한국지반공학회:학술대회논문집
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• 한국지반공학회 2008년도 추계 학술발표회
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• pp.247-258
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• 2008

Environmental standards for beneficial uses of dredged materials are proposed. Even though chemical analysis of ocean sediments are carried out frequently, their analyses results were not interrelated with the effects of biological lives due to a shortage of biological data. These facts have resulted in difficulty to develope Korean's standards of recycling dredged materials. This paper first searched existing current foreign standards, analyzed local contaminated ocean sediment data, identified their main chemical components of contaminants, and then compared with clean-up standards of sediments consisting of lower and higher levels. From these analysis, new environmental standards considering Korean domestic circumstances are proposed. It is judged that new standards are appropriate to both Korean national sedimental environments and economically recycling aspects because environmental standard levels proposed are higher than background levels of sediments in Korean and foreign standards.

• 기술표준
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• 통권49호
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• pp.112-113
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• 2006

• 기술표준
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• 통권49호
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• pp.123-126
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• 2006

• 기술표준
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• 통권49호
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• pp.78-87
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• 2006