• YAKHAK HOEJI
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• v.57 no.3
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• pp.173-186
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• 2013

To ensure the safe use of pharmaceuticals in the market, US, EU and Japan reached a consensus to adopt ICH harmonised tripartite guideline "E2E Pharmacovigilance Planning" in 2004. Subsequently these regions established and implemented new pharmaceutical safety management systems for patients based on ICH E2E guideline and Risk Evaluation and Mitigation Strategy (REMS) in US or Risk Management Plan (RMP) in EU and Japan. In this study we investigated these new foreign systems and suggested a way to improve Korea's regulatory system for pharmaceutical safety management under Korea Pharmaceutical Law in the view of international harmonization.

• Journal of Korea Ship Safrty Technology Authority
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• s.28
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• pp.36-45
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• 2010

While the vessel become bigger and high speed, navigational passages become narrow due to an enlargement of all sorts of new ports, sea-crossing bridges and anchorages, leading to the high probability of marine accidents. Furthermore, a constant increase in the maritime transportation and the traffic volume on the sea led to a variety of sea traffic environments and it is a trend for the demand for the sea transportation environment to increase steadily. At this point of time, the Ministry of Land, Transport, and Maritime Affairs introduced the Korea Maritime Safety Laws evaluating the degree that The Safety Audit System for maritime transport, which evaluates the degree that all kinds of port facilities installed temporarily or installed into navigational passages, and the installations and repair constructions of S.O.C. facilities affect ships' traffic safety, was introduced through Korea Maritime Safety Laws and went into effect from November 28th, 2009. This study was performed to introduce an outline including the concept and purpose of the Maritime Safety Audit(MSA) system for maritime transport and the technological guidelines for scientific and standardized enforcement, thereby analyzing the system.

• Korean Journal of Community Nutrition
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• v.15 no.6
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• pp.806-819
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• 2010

We investigated the foodservice sanitation status of the childcare centers in Chungnam Asan area to provide the information for sanitation guidelines and checklist in various operation types of childcare centers. Self-completed questionnaires were collected from the directors of 95 centers: national-public 9 (9.5%), corporation 10 (10.5%), private 52 (54.7%), and home care 24 (25.3%) types. The analyzed results are shown in foundation type; the investigated items are about critical hygienic problems and safety recognition level, presence of sanitation guideline, demand of dietian's employment and the role, hygienic management and education level, and the present and future of sanitary facility and equipment. From this study we found that home care center, which had low capacity, was comparatively poor at sanitation status, the use of hygienic standard and guideline, and safety recognition level. In our opinion, the use and application of same sanitation standard to any type and size of center is not appropriate and rational. The reestablishment of the sanitation guideline and checklist considering the conditions of various operation types would be necessary. Also periodic hygienic education by hygenic professionals, continuous parents' attention and cooperation of related government organizations are needed for improvement of foodservice sanitation status of childcare centers.

• Journal of Biomedical Engineering Research
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• v.31 no.2
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• pp.129-133
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• 2010

Intense pulsed light(IPL) is a photo-therapeutic medical device using xenon lamps with optical characteristics of incoherence, defocusing, and polychromatic. IPL has been recognized as a representative medical therapeutic device with growth of domestic skin care market. However, there is no standard regulation manual and guideline to evaluate the safety and performance of IPL. International Electrotechnical Commission(IEC) is being statued "Technical Report IEC TR 60825-16" which is a guidelines for the safe use of intense light source equipment on humans and animals. In this study, a standard Korea Food & Drug Administration (KFDA) regulation for the safety and performance of IPL was suggested by developing minimal evaluation methods for optical parameters of IPL such as output energy density, pulse mode, spot size, wavelength and uniformity of output light. We expect that this study may be a step to statue a standard regulation manual and guideline for IPLs used in domestic.

• Advances in concrete construction
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• v.13 no.2
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• pp.191-198
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• 2022

FIB is introduced as the sole guideline for the design purpose that results in a practical relationship for the torsional capacity of concrete beams strengthened with carbon fiber-reinforced polymer (CFRP). This study applies first-order reliability method to assess the reliability evaluation of the torsional capacity of CFRP-strengthened beams on the basis of FIB guidelines. In terms of steel reinforcement losses, this study applies a corrosion model to investigate the ceaseless deterioration of the existing structure. Hence, the average of reliability indices varies between 2.68 and 2.80, indicating the reliability viewpoint of the design methodologies. The average values are somehow low compared to the target values of reliability (3.0 or 3.5) applied in the calibration stage of the FIB guideline. In this way, the partial safety factors may change in the forthcoming guideline revisions. For this aim, the reliability of strengthening ratio was applied to assess the variation in the average value of the reliability index with different partial safety factors. The performance of parametric study for the factor proved that minimum values of 1.60 and 2.32 are required for target values of reliability (3.0 and 3.5), respectively.

• Land and Housing Review
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• v.11 no.3
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• pp.83-92
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• 2020

In South Korea, problems caused by material deterioration of time-worn concrete structures have been increased recently. Because severe material deterioration could damage the structure's safety, it's important to evaluate the old structure's condition and structural capacity regularly to keep its proper performance. The safety evaluation of concrete structures has been initiated and performed periodically since 1995 according to a guideline in accordance with a law in Korea. The guideline prescribes the evaluation types, intervals and methods of the target structure. A lot of cost and labor have been invested every year to carry out the regular safety evaluation. However, it's not clear that the current manual could inspect the old structure's condition and assess the structural capacity precisely. Thus, the verification study initiated to figure out the Korean safety evaluation manual's practicalness. First, the Korean manual was analyzed and then compared with that of other countries for concrete bridges which are representative concrete structure. After that, the previously written evaluation reports were collected and analyzed to find out how the safety evaluation has been carried out. Based on the study results, the parts requiring verification of the manual were drawn. A research program is in progress in order to verify the parts by performing tests with actual structural members from decommissioned concrete bridges.

• Journal of the Korean Society of Safety
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• v.13 no.2
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• pp.104-108
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• 1998

In order to evaluate the performances of safety valves for low pressure, the popping pressure and flow rate of the natural gas have been investigated. The measured results of the popping pressure show that there is a big scattering depending on the manufacture year of a safety valve. And sample A showed the ideal popping pressure mode compared to other B and C samples. The popping flow rate of the safety valve is proportional to the seat size as the inlet pressure increases. These results may be used as a guideline for a design and diagnosis of the safety valve.

• Journal of the Society of Naval Architects of Korea
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• v.46 no.2
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• pp.179-188
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• 2009

WIG crafts are a high speed vessel with features of dynamic supported craft. These crafts, which are predominantly of light weight and operate any substantially greater speeds than conventional craft such as bulk carrier, tanker, container ship, etc., could not be accommodated under traditional maritime safety instruments. It means that there is the need for risk and safety levels to be assessed on a holistic basis, recognizing that high levels of operator training, comprehensive and thoroughly implemented procedures, high levels of automation and sophisticated software can all make significant contributions to risk reduction. To response this requirement, the Interim Guideline for WIG craft(MSC/Circ.1054) were developed in the view of the configuration of WIG craft, which fall between the maritime and aviation regulatory regimes. This paper reviews a safety assessment process and methodology to be used in the design phase of a new ship. The process and methodology is based on the risk-based approach and is applied to safety assessment in concept development phase of small WIG craft in the 20-person class.

• The Transactions of the Korean Institute of Electrical Engineers B
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• v.53 no.2
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• pp.99-106
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• 2004

Train control system in LRT (Light Rail Transit) is developed as a part of "Light Rail Transit System Development Project". But there was no specific requirement representing the system safety. Because system safety must be ensured before the customization, we applied the system to a officially recognized specific procedure, such as "A Guideline to Ensure the Safety of Train Control System in Korea" that was officially announced by KNR (Korea National Railroad) in 2001. We should draw system safely requirement to guarantee system safety for the first time. In this paper, the hazard identification and analysis to derive the safety requirement on LRT train control system are carried out following the KNR guideline. To analyze hazard, we have to deduce system functions, identify related hazards, derive the effects of the hazards, analyze current risk, define the target risk of the system, and deduce the alternative plans to reduce the effects of the hazards. After the hazard analysis following the upper procedure, 30 hazards are identified and analysed. Especially detailed analysis on train collision that is a main hazard of the train control of system is specially carried out.

• Journal of the Korean Society of Safety
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• v.33 no.5
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• pp.84-91
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• 2018

Despite the government 's efforts to reduce constructional disasters, it has been pointed out that the safety management cost of the Construction Technology Promotion Act does not reflect the actual site. Therefore, it is necessary to study the proper guideline of the safety management cost which can be used as the most fundamental measure to prevent construction accidents. Moreover for the securement of the reasonable safety management costs, it is important to calculate its appropriate rate. Thus, in this study, the appropriate rate of safety management cost was proposed by the construction cost & type based on the 111 execution plans of safety management cost, and the rate is analyzed to be 1/10 of the occupational safety and health management cost. The results of this study will be a guideline in improvement to the proper schedule rating system improvement and in implement of pilot projects.