• Journal of Society of Preventive Korean Medicine
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• v.28 no.1
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• pp.31-42
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• 2024

Objective : In order to understand the changes in domestic approval regulations applicable to traditional Korean medical device companies, this article will explain the major amendments 「Regulation on Medical Device Approval Report Review, etc.」 from 2005 to the present on a year-by-year basis, and provide a counter plan to the recent changes in approval regulations. Methods : We analysed the changes in approval regulatory amendments related to the traditional Korean medical devices from 2005 to the present. Results : The Ministry of Food and Drug Safety is continuously improving medical device approval regulations to ensure the global competitiveness of domestic medical devices and contribute to the improvement of public health. Recent major approval regulatory amendments include the establishment of a review system for software medical devices and digital therapeutics, the recognition of real world evidence materials, the introduction of a biological evaluation of medical devices within a risk management process and a medical device approval licence renewal system. Conclusions : It is expected that the range of medical devices available to Korean medicine doctors will continue to expand in the future through the provision of non-face-to-face medical services and the development of advanced and new medical devices, as well as wearable medical devices and digital therapeutics. In order to increase the market entry potential of traditional Korean medical devices that incorporate advanced technologies such as digital technology and AI-based diagnosis and prediction technology, it is urgent that the government provide significant support to traditional Korean medical device companies to improve approval regulatory compliance.

• Analytical Science and Technology
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• v.33 no.6
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• pp.262-273
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• 2020

A fluorine content analysis method for krill oils, which is a representative oil formulation in foods, was developed in compliance with the Korea Food and Drug Ministry's "Guidelines for Validation of Testing Methods Related to Food". Using this method for krill oils, the presence of impurities was evaluated via combustion-ion chromatography (C-IC). A review of published technical data on fluorine in krill oils showed that while the traditional wet potentiometric method was typically used, it was not reliable. Moreover, there was no food testing/analysis laboratory in Korea to perform a fluorine test analysis on such an oil matrix. Therefore, we identified halogen (fluorine) tests, developed to national and international standards, and developed a test method suitable for krill oils by selecting a C-IC method that is sufficiently applicable to the oil matrix. Based on the characteristics of the oil matrix, the optimal test method was established through various experiments by reviewing the concerns related to loss and interference in the preparation and introduction of samples. The fluorine content test was carried out on 11 krill oil products that were purchased online. Most products (with the exception of only one) were found to contain less than the reporting limit obtained by the test method. Furthermore, after additional testing, a high fluorine content of approximately 2,000 ~ 3,000 mg/kg was detected on the krill surface, although the concentration varied depending on the area of the krill. A comparison with samples from two ISO/IEC 17025 testing laboratories confirmed that there was no significant difference in the statistical analysis results obtained by ANOVA among the three laboratories. A testing guide for fluorine content analysis was completed.

• Journal of Korean Academy of Nursing
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• v.20 no.3
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• pp.300-306
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• 1990

Colorectal cancer is second only to lung cancer as a cause of death due to cancer in the united States. Studies have shown that fecal occult blood(FOB) tests are effective in detecting colorectal cancer in its early stages. To motivate worksite FOB testing, a randomized controlled trial was conducted. Employees 40 years or older from three federal agencies in Washington State were randomized to a control group(n＝139) which received a letter stating the availability of the FOB test at the worksite clinic or to an intervention group(n＝139) which received the letter about facts on colorectal cancer and a Colorectal Cancer Risk Appraisal. The Colorectal Cancer Risk Appraisal included a feedback on an individual's risk of developing colorectal cancer compared to his / her peers in terms of ‘normal’, ‘moderate’, or ‘high’ risk status. After 3 months, a follow-up questionnaire was sent to all participants to measure the effectiveness of the intervention. In the analysis of the three major outcomes, two possible confounding factors(dietary fat and family history of colorectal cancer) were controlled by logistic regression. Based on a review of the worksite clinic records, the Intervention group had 4.3% higher compliance rate with the FOB test during the follow-up period compared to the control group(p＝.10). The largest effect of the intervention was on the employees' intention to get a FOB test within the next year(62.6% in the intervention group vs. 36.2% in the control group, OR＝3.18, p＜.001). In the final Multivariate logistic model, the employees who were more likely to intend to get a FOB test within the next year were in the intervention group ; were at ‘moderate’ or ‘high’ risk of colorectal cancer ; knew more about the availability of the FOB test at the worksite clinic ; and had a FOB test during the last three years.

• Journal of KIISE:Software and Applications
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• v.32 no.8
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• pp.704-716
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• 2005

Assembling new software systems from Prepared components is an attractive alternative to traditional software development method to reduce development cost and schedule dramatically. However, if separately developed components are tested, integrated and verified with unreasonable effort and high cost, it would not be an effective way to software development. Components are not distributed in the shape of white-box source code so that should be hard to validate and test in new application environment. For solving this problem, built-in tester components are suggested to check the contract-compliance of their server components. If components have various and complex function, built-in tester should be heavy and unflexible to test in composition of components. This paper suggests enhancing automated wrapper technique which substitutes with built-in tester components and shows the usability of the wrapper by design and implementation. Component testing in this way reduces the cost and effort associated with preparation of component testing and makes the various test experiments in components assembly.

• Journal of the Korean BIBLIA Society for library and Information Science
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• v.26 no.4
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• pp.283-304
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• 2015

The purpose of this study was to identify Web accessibility issues of healthcare websites of the Korean government and public agencies by evaluating these websites' accessibility in accordance with the Korean Web Contents Accessibility Guideline. This study conducted both automated and expert testing to assess the accessibility of a total of 27 health-related websites. The results of the assessment which was conducted in two stages indicated that institutions such as the National Hospital and National Rehabilitation Center demonstrated almost no Web accessibility error. In addition, the Korea Health Insurance Review and Assessment Service, the Ministry of Health and Welfare, the Health Services Agency, the Ministry of Food and Drug Safety, and the Korea Medical Dispute Mediation and Arbitration Agency attained very high web accessibility. However, the results of an expert evaluation highlighted that there were considerable errors in providing appropriate alternative text, which was not found in the automated test, and the color contrast of the text content did not comply with Web accessibility standard. Therefore, these websites did not support web accessibility for the sight-impaired. Furthermore, the present study found that it was difficult to deliver accurate information to users due to errors in the default language display and markup, and also, issues of skipping repeated content, content linearization, and compliance with keyboard use were considered as challenges that might arise for people with sight, cognitive and mobility impairments with respect to Web accessibility. It is the first study that evaluated accessibility of healthcare websites of the Korean government and public agencies based on the Korean Web Contents Accessibility Guideline. The present study made a contribution to research on Web accessibility by conducting expert testing, which provided a more complete assessment that identified the degree and specific issues of accessibility errors when compared to automated testing.

• Journal of Korean Academy of Fundamentals of Nursing
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• v.19 no.1
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• pp.74-86
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• 2012

Purpose: The purpose of this study was to develop a comprehensive self-management program promoting self efficacy for Type 2 diabetic patients. Methods: The study was a methodological research design in which previous related research was reviewed to develop the comprehensive self-management program promoting self efficacy using self efficacy theory. Results: Comprehensive self-management programs promoting self efficacy included the whole range of eight self-management domains: diet, exercise, medication, self-testing of blood glucose, complication or foot, stress, time, and general health, and consisted of four sources of self efficacy: enactive mastery experience, vicarious experience, verbal persuasion, and physiological and affective states, as strategies to promote self efficacy. Developmental methods included, in addition to large and small group education, individual education or counseling, and telephone counseling. Conclusion: Further studies are needed in community health centers or hospitals to establish the effects on self-management compliance and glycemic control of the comprehensive self-management program promoting self efficacy.

• Journal of Power System Engineering
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• v.7 no.4
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• pp.55-60
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• 2003

This paper is to investigate the fatigue crack growth of plasma-sprayed coating steels according to heat treatments. The experimental materials are carbon steels(substrate: S45C) with plasma-sprayed coating layers of Ni-4.5%Al and $TiO_2$. The fatigue test is conducted on compact tension specimen by a servo-hydraulic fatigue testing machine. The specimens are heat-treated at $400^{\circ}C\;and\;800^{\circ}C$, respectively. Loading condition is a constant amplitude sinusoidal wave with a frequency of 10Hz and a load ratio of 0.1. The fatigue crack growth length is automatically measured by a compliance method. In the case of non-heat treated specimens, the fatigue crack growth rates of both substrate and coating specimen are almost same. The crack growth rates of substrates and coating steels by heat treatment are larger than those of the non-heat treated one, because the ductile property increase by heat treatment. In ${\Delta}K<18MPa{\cdot}m^{1/2}$, the crack growth rates of the heat-treated specimens are slightly taster than non-heat treated one. But the both heated and non-heated one are almost same in ${\Delta}K>18MPa{\cdot}m^{1/2}$.

• Journal of Power System Engineering
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• v.15 no.1
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• pp.39-44
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• 2011

This study was to investigate the effects of stress ratio and anisotropy on Fatigue Crack Propagation(FCP) behavior of rolled magnesium alloy AZ31B. The experimental materials were a Mg-Al-Zn magnesium alloy. The FCP test was conducted on compact tension specimen by a servo-hydraulic fatigue testing machine in air at room temperature. Compact tension specimens were prepared from the extruded parallel and vertical rolling direction. The test condition was frequency of 10Hz and sinusoidal load stress ratios are 0.1 and 0.7. The FCP rates was automatically measured by a compliance method. In the case of the FCP of AZ31B, the FCP of both direction of LT and TL by anisotropy of specimens are almost same value. In lower stress ratio, the FCP of the LT, TL specimens are increased in lower ${\Delta}K$ region but higher ${\Delta}K$ regions are almost same value. Finally, the result of observed the surface crack, it expressed the quasi-cleavage fracture in lower ${\Delta}K$ region and straight mark on the aspect of the facet in high ${\Delta}K$ region.

• The Journal of the Korea institute of electronic communication sciences
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• v.9 no.7
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• pp.819-825
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• 2014

The diurnal range of temperature in korea is increasing. We know that the environment has deteriorated through report about railway damage and economic loss caused by climate. In these conditions, Monitoring device for railway must operate to support the operations and maintenance. Therefore, In this paper, COM-based monitoring device implemented using Industrial-Extended electronic components and made, We tested compliance about temperature environment of actual railway. We verified through testing about cold and dry heat of monitoring device. Used components in this product will be able to utilize the development of the railway industry of electronics.

• Journal of Nutrition and Health
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• v.28 no.10
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• pp.1015-1021
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• 1995

This study was conducted to evaluate changes in nutritional knowledge, attitudes, behavior intention and behavior in a sample of 27 insulin dependent diabetic students participating in diabetics' camp. Nutritional knowledge related to diabetes, attitudes toward diabetes treatment and behavior intention about dietary changes were tested before and after nutrition education. Six months after nutrition education, an open ended questionnaire about their actual behavior changes was mailed to all participants and 17 of them responded. Pre-and post-testing showed that nutrition education was effective in significant changes in knowledge and in promoting positive attitudes and behavior intention. Increases of knowledge were consistently the same regardless of sex, level of education, regularity of diet, and duration of disease. Compared to male students, female students showed more positive change in knowledge, attitudes and behavior intention. It also appeared that middle school students showed more positive improvement in knowledge, attitudes and behavior than elementary and high school students. A follow-up test showed that their actual behavior changes were not squared with their behavior intention. They pointed out difficulties in having proper amount of meals and snack and the conflict with school time schedule as the major reason for discordance. These findings suggest that nutrition education for diabetics can be effective to improve their knowledge, attitudes and behavior intention and understanding about barriers to behavior change is important for better compliance to the disease.