• Proceedings of the Korean Institute of Navigation and Port Research Conference
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• 2015.10a
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• pp.9-10
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• 2015

e-navigation is a Strategy developed by the IMO. It aims to implement the strategy in 2018. To this end, e-navigation Software Quality Assurance and Human-Centred Design Guidelines has been developing for the implementation and development of e-Navigation. The IMO MSC approved this guideline as a MSC circular in June 2015. In this paper, international standards of software quality assurance and human-centred design has been surveyed and analyzed in terms of usability testing for the practical application of this guideline. The result is planning to be reflected in the practical application guidance for the development of e-navigation equipment hardware-software combination.

• Toxicological Research
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• v.1 no.1
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• pp.31-41
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• 1985

The Japanese Good Laboratory Practice (GLP) Standard on Drugs was finalized as a guideline and implemented in April, 1983. This standard is intended to ensure the quality and integrity of the data from nonclinical toxicity studies submitted to the Ministry of Health and Welfare in support of applications for approval to manufacture or import new drugs or to be used in the reevaluation of previously approved drugs. The standard includes a guideline for organizational matters, personnel, facility, equipment, testing operation, documentation and conduct of studies. Principles and influences of implementation of Japanese GLP will be discussed briefly in comparison with foreign GLPs.

• Journal of the Korean Society for Railway
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• v.11 no.4
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• pp.378-383
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• 2008

In December 2006, the Ministry of Environment Republic of Korea established the guideline which is "Indoor Air Quality Management Guidelines in Public Transportation." as control items, $CO_2$ (carbon dioxide) and PM10 (particle matter) are classified two categories, that is, Level 1 (non-rush hour), Level 2 (rush hour). Therefore, the quality of air in train and subway should be controlled in accordance with the guideline. We took a measure the air freshness inside train twice at Line 4 (Tangogae-Oido), in Sep. 2007 and at Line 1 (Dongincheon-Yongsan) in Nov. 2007, respectively and, also expected the emitted $CO_2$ concentration by using a property of matter such as EMU (Electric Multiple Unit) design reviewing specification and air. According to the measured values, the concentration of PM10 was 44, 57, 45% and the concentration of $CO_2$ was 39, 36, 44% respectively, all measured values are within the guideline and also, as a result we found the expected value and measured value are similar.

• The Journal of Korean Medicine
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• v.43 no.3
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• pp.150-163
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• 2022

Objectives: This research aimed to develop a guideline for evaluating safety and performance of electronic warm-acupuncture apparatus. With the development of medical devices like electronic warm-acupuncture apparatus with improved performance, convenience and safety measures compared to traditional warm-acupuncture needling, safety and performance guideline is a necessity. Methods: By referring to existing standards and guidelines of other electronic devices for Korean medicine with heating function, guideline for safety and performance assessment of electronic warm-acupuncture apparatus was drafted Results: The guideline, presents explanation for adequate temperature and settings of the apparatus, and safety measurements providing against thermal runaway situations along with guidelines for the manual. Guideline for detailed test method for the performance of the apparatus such as accuracy of temperature increase and the timer, and safety unit was also provided. The test items and suggested test methods for the requirements of biological, electrical and electromagnetic safety were referred to Korean approval documents of ministry of Food and Drug Safety. Conclusion: We proposed the relevant items to verify performance and safety of warm-acupuncture apparatus to assure patient safety and improve the quality of currently developing devices for application in clinical field.

• Journal of Korean Clinical Nursing Research
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• v.20 no.2
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• pp.147-161
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• 2014

Purpose: This study was aimed to modify and adapt the previously developed, high-quality enteral tube feeding guidelines for the usage in clinical settings in Korea. Methods: Guideline adaptation process was undertaken according to the guideline adaptation manual version 2.0 developed by NECA (Kim, et al., 2011) and the standardized methodology for nursing practice guideline adaptation (Gu, et al. 2012). Results: The modified and adapted enteral tube feeding guidelines were consisted of 11 domains and 95 recommendations. The domains and numbers of recommendations in each domain were: 4 on general issues, 2 on enteral nutrition indication and discontinue, 6 on enteral nutrition device selection, 12 on enteral tube feeding device insertions, 3 on enteral nutrition formular and choices, 16 on enteral tube feeding start and progress, 20 on enteral tube feeding maintenance and management, 15 on monitoring enteral tube feeding administration, 10 on prevention of error, 5 on medication administration, and 2 on documentation and report. There were 16.1% of the recommendations marked as A grade, 17.8% of B grade, and 66.1% of C grade. Conclusion: The adapted enteral tube feeding nursing practice guideline is to be added to the evidence-based practice guidelines for fundamentals of nursing practice. The guideline is hoped to be disseminated to nurses nationwide in order to improve the efficiency of enteral tube feeding practice.

• Journal of Korean Clinical Nursing Research
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• v.21 no.1
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• pp.31-42
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• 2015

Purpose: This study was done to develop evidence-based nursing practice guidelines to prevent complications related to indwelling urinary catheterization (IUC) in patients in Korea. Methods: A guideline adaptation process was conducted according to the guideline adaptation manual which consists of three main phases, and 9 modules with a total of 24 steps. Results: The newly developed IUC guideline consisted of an introduction, urinary catheterization, summary of recommendations, recommendations, references, and appendices. There were 110 recommendations in 8 sections including assessment, equipment, catheter insertion, catheter maintenance, catheter change, catheter removal, management of complications, and education/consultation. For the grade of recommendations, there were 6.4% for A, 22.7% for B, 67.3% for C. Conclusion: The IUC guideline was developed based on evidence and therefore it is recommended that this guideline be disseminated and utilized by nurses nationwide to improve the quality of care for patients with IUC and decrease complications related to IUC and that it be revised regularly.

• The Journal of Internal Korean Medicine
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• v.40 no.1
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• pp.89-116
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• 2019

Objective: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer," by analyzing existing guidelines and clinical trials. Methods: Committee for the development of a guideline, consisting of 6 Korean medicine doctors, reviewed guidelines and clinical trials on using herbal medicine for treating liver cancer. The trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparators, outcomes, and trial design. We then compared the results of our analysis with the guidelines to identify issues we must to consider when following the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer." Several guidelines for antitumor agents and clinical trials on herbal medicine were obtained from the Ministry of Food and Drug Safety homepage, etc. The search terms were as follows: "liver neoplasms"; "herbal medicine"; "medicine, Korean traditional"; and "medicine, Chinese Traditional.". Results: Ten articles were obtained from pubmed and Embase. There was no guideline for clinical trials on using herbal medicine for treating liver cancer. All the participants in the reviewed articles had primary liver cancer, and the type of intervention varied (e.g., decoction, patches, and capsules. The comparators included placebos and conventional treatments such as chemotherapy. The outcome assessment methods were tumor response, quality of life, survival, and liver function tests. Adverse events occuring during the trial were also evaluated. Conclusion: Findings were derived by reviewing existing guidelines and comparing them with clinical trials on liver cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer."

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.32 no.4
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• pp.130-140
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• 2019

Objective : The purpose of this study is to examine the treatment of allergic rhinitis introduced in the Chinese guideline, and to find out the direction of evidence-establishment and applicability in developing Korean Medicine clinical practice guideline for allergic rhinitis. Method : We studied Traditional Chinese Medicine treatment of allergic rhinitis introduced in the 2018 Chinese society of allergy guidelines for diagnosis and treatment of allergic rhinitis. The treatment are classified into three categories; herbal medicines, acupuncture and the others. And we compared this guidelines with other guidelines for how they differ in description of the database, evidence of level, and strength of recommendation. Results : Herbal medicines are presented based on syndrome differentiation. The basic acupoints for allergic rhinitis are introduced as follows; Fengchi(GB20), Yingxiang(LI20), Feishu(BL13) and Taiyuan(LU9). And in comparison with other guidelines for allergic rhinitis, the Chinese guideline showed lack of description in the database, evidence of level, and strength of recommendation, though they used evidence-based models. Conclusions : Clinical practice guideline projects are also underway in Korea for benefit expansion and improving quality of medical services. It is important to develop guidelines which should be evidence-based and reflect Korean medical environment.

• Quality Improvement in Health Care
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• v.20 no.1
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• pp.42-57
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• 2014

Objective: The objective of this research was to develop a guideline for more effective use of physical restraint on patients in the intensive care unit and training the nurses on it and applying it on clinical practice to assess its effectiveness. Method: This research analyzed the before and after effect of the development of a guideline for physical restraint by dividing the category into nurse and patient. In the case of nurse, a comparison of knowledge and nursing service regarding the use of physical restraint from before the training on physical restraint guideline(Jan. 2011) and after the training on physical restraint guideline(Dec. 2011) was made. In the case of patient, a comparison of physical restraint usage rate and average usage time, the number of unplanned extubation cases were compared from before the use of physical restraint (Jan.~Apr. 2011) and after the use of physical restraint (Sep.~Dec. 2011) were made. Result: After the training on the physical restraint guideline, the knowledge of the nurse and the nursing practice showed notable improvement by (p<0.000) and (p<0.048) respectively and in patient, physical restraint usage rate and average time of usage decreased by (p<0.001) and (p<0.001) respectively. And despite the decrease in the number of cases in which the physical restraint was used, the number of unplanned extubation cases remained the same. Conclusion: Physical restraint guideline training and guideline usage can be stated to have brought out positive effect in both the nurse and patient. In order to maintain such positive effects, continuous training is necessary and continuous revaluation is necessary, regarding knowledge and nursing practices.

• Proceedings of the Korean Society for Noise and Vibration Engineering Conference
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• 2007.05a
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• pp.909-917
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• 2007

Recently the trend of automobile industry is that IQS evaluation index against a sensitivity quality is increasing. To reduce rattle noise due to speaker sound at low frequencies, it is required the advanced investigation of a package tray panel and a door module panel. This paper optimized the design parameters of package tray panel according to the theoretical background about robust design and suggested the design guideline for resonance avoidance and the reduction of vibrational sensitivity considering the excitation frequency of woofer speaker. In addition, it is suggested the design guideline of a door module panel through the sensitivity analysis in case of the speaker excitation. Finally, the design factor analysis of the quality deviation of a mother-car will make it possible to guarantee the stable characteristics of vehicle vibration in the early stage of vehicle development. These improvements can lead to shortening the time needed to develop better vehicles.