• 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 Vacuum Society Conference
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• 1996.02a
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• pp.178-178
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• 1996

• Proceedings of the Korean Vacuum Society Conference
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• 1999.02a
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• pp.98-98
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• 1999

• Bulletin of the Korean Chemical Society
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• v.29 no.7
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• pp.1391-1394
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• 2008

Polymer materials are very difficult to decompose for the purpose of chemical analysis. Nondestructive analysis without pretreatment provides a suitable solution that will overcome this obstacle. In this study, CRM candidate samples that contained toxic elements such as As, Cd, Cr and Zn in a polypropylene (PP) were analyzed using instrumental neutron activation analysis (INAA). The analytical results were obtained from ten samples selected by random sampling at two different concentration levels (low and high). Particular attention was paid to reducing analytical errors and evaluating the associated uncertainty.

• Proceedings of the Korean Geotechical Society Conference
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• 2008.10a
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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.

• Journal of the Korean Society for information Management
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• v.40 no.4
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• pp.351-373
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• 2023

This study aimed to analyze and collect research trends of archival management standards in Korea. For this purpose, keywords from the titles, author keywords, and abstracts of papers related to records management standards were statistically analyzed to investigate the major keywords with high-frequency. Network analysis with high frequency keywords was also conducted to identify the subject areas of research in archival management standards. The analysis period is from 2000 to the present, and a total of 212 papers were collected from domestic academic paper search sites such as RISS and ScienceON. As a result of the analysis, from 2000 to 2010, OAIS for archive design, digital record preservation with OAIS, and analysis on ISO standards were mainly conducted in research areas. From 2011 until now, records management certification and ISAD(G)'s conversion to RiC emerged as new research areas. This study will be expected to be basic data to understand research trends in records management standards in Korea and to be a reference for research on records management standards studies.

• Proceedings of the Korean Vacuum Society Conference
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• 1995.06a
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• pp.153-153
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• 1995

• Journal of Korea Technology Innovation Society
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• v.4 no.2
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• pp.172-181
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• 2001

This is a paper to understand the economic effects of the measurement standards by translog cost function. The data, as of the end of 1998, are from a survey of 514 firms in Korean industry. The analysis is compared to that of 1992 data analysis to check the trend. There are a little differences on the estimated coefficients, but there is no basic difference on trend of economic effects. The Investment on measurement standards have been contributed positively on the major managerial indicators such as productivity, profit, and so on.

• Proceedings of the Korea Society for Energy Engineering kosee Conference
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• 1996.04a
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• pp.144-150
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• 1996

The Energy Efficiency Standards and Labelling Act, as amended by the Rational Energy Utilization Act, provides energy efficiency standards and labellings for six equipment categories(viz, refrigerators, air-conditioners, fluorescent lamps and ballasts, incandescent lamps, cars) authorizes the Ministry of Trade. Industry and Energy (MOTIE) to prescribe amended or new energy efficiency standards and labelling standards. This study was initiated by the KIER(Korea Institute of Energy Research) in 1992. KIER's assessment of the appliance energy efficiency standards is designed to evaluate their statistical and engineering analysis according to Korean Industrial Standards(KS). And to make didtinction between the poor efficiency and good efficiency models. 5 grades are classified depending on their tested energy efficiency. This year, based on our analysis, MOTIE mandated updated standards for refrigerators, air-conditioners, Incandescent lamps, and fluorescent lamps.

• Bulletin of the Korean Chemical Society
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• v.26 no.3
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• pp.440-446
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• 2005

A method is described for the determination of dibutyltin (DBT) in sediment by isotope dilution using liquid chromatography inductively-coupled plasma/mass spectrometry (LC-ICP/MS). To achieve the highest accuracy and precision, special attentions are paid in optimization and evaluation of overall processes of the analysis including extraction of analytes, characterization of the standards used for calibration and LC-ICP/MS conditions. An approach for characterization of natural abundance DBT standard has been developed by combining inductively-coupled plasma/optical emission spectrometry (ICP/OES) and LC-ICP/MS for the total Sn assay and the analysis of Sn species present as impurities, respectively. An excellent LC condition for separation of organotin species was found, which is suitable for simultaneous DBT and tributyltin (TBT) analysis as well as impurity analysis of DBT standards. Microwave extraction condition was also optimized for high efficiency while preventing species transformation. The present method determines the amount contents of DBT in sediments with expanded uncertainty of less than 5% and its result shows high degree of equivalence with reference values of an international inter-comparison and a certified reference material (CRM) within stated uncertainties.