• Title/Summary/Keyword: Domestic standards

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A Study on the Analysis and Improvement of Medical Device Standards in Korea (국내 의료기기 표준 분석 및 개선에 관한 연구)

  • Yong Wan Kang;Kyung Ah Kim
    • 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.

A Study on the Present States & Problems of Domestic Standards for Lightweight Aggregate Concrete (국내 경량골재콘크리트 관련 규격의 현황 및 문제점 분석 연구)

  • Kim, Sang-Heon;Park, Dae-Oh;Ji, Suk-Won;Yoo, Taek-Dong;Choi, Soo-Kyung;Seo, Chee-Ho
    • Proceedings of the Korea Concrete Institute Conference
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    • 2006.11a
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    • pp.405-408
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    • 2006
  • In this study it compares a Japanese standards which is most similar contents with domestic standards related with the light weight aggregate concrete and derives the fundamental data from the results so that it will be able to refer at maintenance of standards or specifications in future. The case of domestic is the actual more insufficient condition which is described in the standards and the specifications than Japanese standards. For the production of he domestic light weight concrete the development of general standards and construction guides and control of water content ratio of the light weight aggregates become accomplished rightly in quality of construction site.

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The Optimal Solid Print Density Setting Method for Sheetfed Offset Printing (오프셋 매엽 인쇄의 최적 민인쇄 농도 설정 방법)

  • Seo, Suck-Jin;Kang, Sang-Hoon
    • Journal of the Korean Graphic Arts Communication Society
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    • v.27 no.1
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    • pp.15-27
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    • 2009
  • Since domestic offset print quality control depends on the experience of persons in charge rather than objective data, the standards from the data are needed for the well-organized quality management of high-quality prints. Based on the ISO standards, now the standard specifications, such as GRACoL 7, SWOP 11, SNAP, G7 in America, and EURO Color, ECI, BVDM in Europe, and Japan Color 2001, Japan Color 2004 in Japan, are employed. There exists KS for domestic standards. However, since it has been directly imported from ISO Standards, there are discrepancies in printing materials and media. Although the quality management of commercial prints has been focused and studied. For this circumstance, standards are needed for the production of prints to meet international standards. This paper aims to find out suitable ways to approach domestic printing standards using densitometric method and colorimetric method. Printing experiments on this study were performed with domestic process color inks(Cyan, Magenta, Yellow, Black) and domestic coated papers, under the same conditions as the actual commercial printing processes. In densitometric method, how to set up the optimal solid print density was studied through three tests such as the ways to match solid print density and print contrast to GRACoL standards respectively, and the way to get the highest contrast. In colorimetric method, how to get solid print density with the minimum color difference between the $CIEL^*a^*b^*$ color specification values in GRACoL standards and the measured color specification values in prints, was studied.

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Food Ingestion Standards for Nuclear Emergency Exposure Situations

  • Keum, Dong-Kwon;Jeong, Hyojoon;Jun, In;Lim, Kwang-Muk;Choi, Yong-Ho;Hwang, Won-Tae
    • Journal of Radiation Protection and Research
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    • v.42 no.3
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    • pp.166-175
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    • 2017
  • Background: This study presents food ingestion standards for radioactivity that can be applied in nuclear emergency exposure situations, and discusses the validity of the current domestic standards. Materials and Methods: This study derived food ingestion standards for radiocesium and radioiodine using domestic food intake rates and intervention levels, which serve as a basis for determining the necessity of public protective actions, and then compared them with the existing guidelines. Operational intervention levels were also derived using domestic food intake rates, and were compared with those of the International Atomic Energy Agency. Results and Discussion: The derived activity concentrations for food ingestion standards of radiocesium for infants were higher than those in the Act on Physical Protection and Radiological Emergency (APPRE) for all food categories, while for adults, the derived activity concentrations for drinking water and milk appeared to be slightly lower. The derived activity concentrations for vegetables, fruits, and grains were greater than those in the guidelines of the APPRE, while the derived activity concentrations for meat and seafood were similar to those in the APPRE. The derived activity concentrations for radioiodine were greater than both domestic and global standards. The calculated operational intervention levels (OILs) based on domestic food intake rates were greater than the IAEA's default OIL6 values for most radionuclides, except for a few ${\alpha}$-radionuclides. Conclusion: The current domestic guidelines turned out to be conservative overall, compared to the present results that were calculated using domestic food intake rates. It is recommended that the domestic guidelines should be revised and complemented transparently through an in-depth review by stakeholders on a solid scientific basis.

A Comparative Analysis of Domestic and Foreign Standards to Improve the Performance of Zone Smoke Control System (거실 제연설비 성능 개선을 위한 국내·외 기준 비교 분석에 관한 연구)

  • Huh, Ye-Rim;Kim, Yoon-Seong;Kim, Hye-won;Jin, Seung-Hyeon;Kwon, Young-Jin
    • Proceedings of the Korean Institute of Building Construction Conference
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    • 2022.04a
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    • pp.83-84
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    • 2022
  • In Korea, smoke control measures through NFSC 501 are proposed to reduce human casualties caused by smoke in the event of a fire. However, as a result of investigating and analyzing domestic and foreign standards, it was found that domestic regulations do not set fire source, but simply set smoke emissions by floor area or height of smoke boundary. Foreign regulations set fire source. Therefore, it is judged that it is necessary to review whether the current domestic regulations can be applied in the event of an actual building fire. So, this paper aims to identify the differences in domestic and foreign standards through investigation and analysis of related standards for fire zone smoke control system in each country and use them as basic data to improve the performance of zone smoke control system.

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A Study on The Color Reproduction Properties of Domestic Newspaper Prints (국내 신문 인쇄의 색재현 특성에 대한 평가)

  • Park, Han-Areum;Kang, Sang-Hoon
    • Proceedings of the Korean Printing Society Conference
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    • 2007.11a
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    • pp.29-43
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    • 2007
  • Web offset newspaper prints is the most widely used printing process in domestic printing industry, but there are no industry-wide specifications for press control to assure consistent quality across newspaper printing plants. As newspaper printing becomes more of a commodity and less of an art, it is necessary to develop the print quality specification standard suitable for Korea web offset newspaper printing field. There are a few commonly employed printing standards such as, SNAP(Specification for Non-Heatset Publication) of the US, IFRA(INCA-FIEJ Research Association), J-color (Japan printing machinery association). And there exists KS for domestic standards, however, since it has been directly imported from ISO standards, there are discrepancies in printing materials and media. This paper aims to examine the color reproduction quality of domestic web offset newspaper prints by comparing with foreign standards. Printing experiments on this study have been performed at one of the domestic newspaper printing companies. The color reproduction properties of the web offset newspaper prints are measured by means of densitometry and colorimetry. These measures are evaluated comapratively with the international standards by means of analyzing, the major factors that determine the color reproduction quality of web offset newspapar prints.

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A Study on The Color Reproduction Properties of Domestic Newspaper Prints (국내 신문 인쇄의 색재현 특성에 관한 연구)

  • Park, Han-A-Reum;Kang, Sang-Hoon
    • Journal of the Korean Graphic Arts Communication Society
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    • v.25 no.1
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    • pp.27-41
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    • 2007
  • Web offset newspaper prints is the most widely used printing process in domestic printing industry, but there are no industry-wide specifications for press control to assure consistent quality across newspaper printing plants. As newspaper printing becomes more of a commodity and less of an art, it is necessary to develop the print quality specification standard suitable for Korea web offset newspaper printing field. There are a few commonly employed printing standards such as, SNAP (Specification for Non-Heatset Publication) of the US, IFRA(INCA-FIEJ Research Association), J-color (Japan printing machinery association). And there exists KS for domestic standards, however, since it has been directly imported from ISO standards, there are discrepancies in printing materials and media. This paper aims to examine the color reproduction quality of domestic web offset newspaper prints by comparing with foreign standards. Printing experiments on this study have been performed at one of the domestic newspaper printing companies. The color reproduction properties of the web offset newspaper prints are measured by means of densitometry and colorimetry. These measures are evaluated comapratively with the international standards by means of analyzing, the major factors that determine the color reproduction quality of web offset newspaper prints.

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Comparative Analysis of International and Domestic Safety Assessment Criteria for the Powered-Scooter and the Electric-Wheelchair (전동휠체어 및 의료용스쿠터의 국내·외 안전성 평가기준 비교 분석 연구)

  • Jun, Sung Chul;Seo, Jeong Hee;Lim, Hee Chul;Lee, Chang Hyung;Shin, Young Il;Jung, Duk Young
    • 재활복지
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    • v.16 no.3
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    • pp.421-437
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    • 2012
  • The goal of this study is to provide the basic information for improvement of domestic standards on the powered scooter and the electric wheelchair considering using environments in the nation. The international standards and domestic standards have been analyzed and compared, in order to propose improved domestic standards. Based on the research, the items and standards for general and functional recommendations, electric features, and other suggestions have been reexamined so that the improvements on test item and standards have been identified, corrected, and summarized including max. speed, brake system, lights and so on. We have been preparing the reference data for the improvement of standards on the powered scooter and the electric wheelchair through the comparison & analysis on the international and domestic standards.

A Study on Improvement of Domestic Airport Service for Rescue and Fire Fighting (국내 공항 구조 및 소방 업무 개선방안 연구)

  • Han, Jae-Hyun;Chung, Ki-Yeon
    • Journal of the Korean Society for Aviation and Aeronautics
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    • v.16 no.4
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    • pp.69-74
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    • 2008
  • Aircraft fires due to accident at an airport may be under a special situation. An outstanding characteristic of aircraft fires is their tendency to reach lethal intensity within a very short time. In domestic aviation act, there are regulations related to services coping with the aircraft accidents within an airport. To cope aircraft fires, it is necessary to define clearly the regulations and standards about the services and related activities of rescue and fire fighting, and to keep the regulations and standards. The study has been performed on the basis of International Civil Aviation Organization (ICAO) Airport Services Manual of rescue and fire fighting. The objective of study is to suggest improvement methods for standards applicable to actual service practices of rescue and fire fighting by analyzing through the comparison of domestic and international regulations and standards.

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A Study on the Improvement of Domestic Smoke Control Standards through Analysis the Standards about Air Leakage Rate of Domestic and Abroad (국내·외 누설률에 관한 기준 분석을 통한 국내 연기제어 기준 개선에 관한 연구)

  • Kim, Hye-Won;Han, Ji-Woo;Lee, Byeong-Heun;Jin, Seung-Hyeon;Kwon, Young-Jin
    • Proceedings of the Korean Institute of Building Construction Conference
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    • 2018.11a
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    • pp.61-62
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    • 2018
  • On this Study, it conducts the Standards investigation about air leakage of Buildings for performance improvement of Smoke control in Fire. In domestic standards, it is incomplete the Criteria standards of air leakage. Therefore it is considered that won't limit the smoke spread due to stack effect. But in the case of the United States, it conducts the Hot smoke air-Leakage test and it consider that can prevent the Smoke Spread in Compartment.

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