• Journal of Radiation Protection and Research
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• v.41 no.4
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• pp.368-372
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• 2016

Background: Methodologies for a series of radiological consequence assessments show a distinctive difference according to the design principles of the original nuclear suppliers and their technical standards to be imposed. This is due to the uncertainties of the accidental source term, radionuclide behavior in the environment, and subsequent radiological dose. Both types of PWR and PHWR are operated in Korea. However, technical standards for evaluating atmospheric dispersion have been enacted based on the U.S. NRC's positions regardless of the reactor types. For this reason, it might cause a controversy between the licensor and licensee of a nuclear power plant. Materials and Methods: It was modelled under the framework of the NRC Regulatory Guide 1.145 for light-water reactors, reflecting the features of heavy-water reactors as specified in the Canadian National Standard and the modelling features in MACCS2, such as atmospheric diffusion coefficient, ground deposition, surface roughness, radioactive plume depletion, and exposure from ground deposition. Results and Discussion: An integrated accident consequence assessment code, ACCESS (Accident Consequence Assessment Code for Evaluating Site Suitability), was developed by taking into account the unique regulatory positions for reactor types under the framework of the current Korean technical standards. Field tracer experiments and hand calculations have been carried out for validation and verification of the models. Conclusion: The modelling approaches of ACCESS and its features are introduced, and its applicative results for a hypothetical accidental scenario are comprehensively discussed. In an applicative study, the predicted results by the light-water reactor assessment model were higher than those by other models in terms of total doses.

• International Journal of Stem Cells
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• v.17 no.2
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• pp.102-112
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• 2024

An organoid is a self-organized three-dimensional structure derived from stem cells that mimics the structure, cell composition, and functional characteristics of specific organs and tissues and is used for evaluating the safety and effectiveness of drugs and the toxicity of industrial chemicals. Organoid technology is a new methodology that could replace testing on animals testing and accelerate development of precision and regenerative medicine. However, large variations in production can occur between laboratories with low reproducibility of the production process and no internationally agreed standards for quality evaluation factors at endpoints. To overcome these barriers that hinder the regulatory acceptance and commercialization of organoids, Korea established the Organoid Standards Initiative in September 2023 with various stakeholders, including industry, academia, regulatory agencies, and standard development experts, through public and private partnerships. This developed general guidelines for organoid manufacturing and quality evaluation and for quality evaluation guidelines for organoid-specific manufacturing for the liver, intestines, and heart through extensive evidence analysis and consensus among experts. This report is based on the common standard guideline v1.0, which is a general organoid manufacturing and quality evaluation to promote the practical use of organoids. This guideline does not focus on specific organoids or specific contexts of use but provides guidance to organoid makers and users on materials, procedures, and essential quality assessment methods at end points that are essential for organoid production applicable at the current technology level.

• Asian Journal of Business Environment
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• v.5 no.2
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• pp.23-29
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• 2015

Purpose - This theoretical study develops practical recommendations for implementing a quality management system (QMS) in Kazakh organizations to ensure the effectiveness and safety of products and services. We discuss the improvement of Kazakhstan's quality standards based on the requirements of ISO 9000. Research design, data, and methodology - We provide methods for improving the quality standards system, ranging from research and development to the sale of products. We also propose to establish a special quality systems award to motivate enterprises toward product quality improvement. The study's methodological basis included Kazakhstan's legislative and regulatory Acts, and international and national standards defining QMS requirements for scientists worldwide to develop and implement a QMS for enterprises. Results - Aligning the QMS reduces Kazakh companies' costs for the detection and correction of defects, and the external and internal loss caused by the defects. Effective QMS also reduces management costs. Conclusion - This article can help increase the transparency of organizations for their leaders and (if necessary) the external environment, and improve the accuracy, quality, and timeliness of decision-making.

• International Commerce and Information Review
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• v.11 no.1
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• pp.379-403
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• 2009

The Purpose of this study is to research the problems of trade restriction for an environment protection. Environmental regulation relate to trade are Convention on International Trade in Endangered Species of Wild Fauna & Flora, Montreal Protocol on Substances that Deplete the Ozone Layer, Kyoto Protocol to the UN Framework Convention on Climate Change, Basel Convention on the Control of Transboundary Movements of Hazardous Wastes & Their Disposal, Cartagena Protocol on Biosafty and WTO Agreement. Regulatory action for environmental protection has economics instrument, command & control, liablity, damage compensation, voluntary agreement. In the case of our country, impact of regulatory action for environmental protection is low. Because is recognized position of developing country yet. For in the balance rules of trade and enviroment, First must satisfy WTO's basic principles and principle of quantitative restrictions prohibition, Second, operation of protection action must reasonable and objective standards Third, must satisfy GATT article 20 (b) clause and (g) protestation each essential factor To grow for environment advanced country, we should do i) using of FTA ii) international cooperation strengthening for developing country position iii) construction of environment information network

• Journal of the Korean Society of Safety
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• v.37 no.5
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• pp.74-79
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• 2022

This study analyzes the contents of the second revised Regulatory Guide 1.180 (Revision 2) for electromagnetic compatibility qualification published by the U. S. Nuclear Regulatory Commission by comparing them with those of the previous version. The methods and acceptance criteria of both CE101 and CE102 tests pertaining to conductive emission and RE102 test for radiation emission are observed to have been modified in Revision 2. Furthermore, the revised guide is found to afford flexibility in using alternative methods for electromagnetic interference qualification by allowing the combination of different technical base standards.

• Journal of the Korean Institute of Gas
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• v.25 no.6
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• pp.106-110
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• 2021

The emergence of new hydrogen-related technologies and new businesses has expanded the need to reorganize systems in related fields such as manufacturing liquefied hydrogen (charging), and manufacturing liquefied hydrogen storage tanks and containers, and special applications continue to increase. Accordingly, we intend to establish and implement measures to strengthen safety management to share the status of designation of special hydrogen-related regulatory projects and secure minimum safety.

• Proceedings of the Korean Society for Noise and Vibration Engineering Conference
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• 1997.04a
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• pp.376-387
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• 1997

One of the main objectives of noise control act is to define and ensure application and respect of noise exposure limits. Most European countries have prepared a legal framework for noise limits either by national laws, ordinances or municipal by-laws. This paper presents the current European standards.

• Design & Manufacturing
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• v.14 no.2
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• pp.28-33
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• 2020

Recently, as the income level and quality of life have improved, the desire for a pleasant environment has increased, and a deodorization plan is required through thorough prevention and diffusion of odorous substances in waste treatment facilities recognized as hateful facilities, appropriate collection, and selection of the right prevention facilities. In this study, a waste disposal facility was modeled and computerized analysis for odor and ventilation analysis was conducted. Numerical analysis of the waste treatment facility was performed at the size of the actual plant. CATIA V5 R16 for numerical model generation and ANSYS FLUENT V.13 for general purpose flow analysis were used as analysis tools. The average air-age of the internal was 329 seconds, and the air-flow velocity was 0.384m/s. The odor diffusion analysis inside the underground pump room showed congestion-free air circulation through streamline distribution and air-age distribution. This satisfies the ASHRAE criteria. In addition, the results of diffusion analysis of odorous substances such as ammonia, hydrogen sulfide, methyl mercaptan and dimethyl sulfide were all expected to satisfy the regulatory standards. Particularly in the case of the waste loading area, the air-flow velocity was 0.297m/s, and the result of meeting the regulatory standards with 0.167ppm of ammonia, 0.00548ppm of hydrogen sulfide, 0.003ppm of methyl mercaptan, and 0.003ppm of dimethyl sulfide was found.

• The Korean Journal of Health Service Management
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• v.11 no.4
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• pp.189-202
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• 2017

Objectives : This study aims to present a new classification system using evaluation standards to ensure the safety of transport ventilators used in Korea. Due to the rapid advancement of technology, various types of ventilators have been developed and as the range of application increases, so does demand. With quick access to information and a growing economy, the technology used in Korean hospitals is equivalent to that of other countries; however, regulatory and safety consciousness are still lagging in Korea. Methods : Based on researching overseas cases, reference data and standards for improving the current system in Korea are proposed. Results : According to the review of transport ventilator use in Korea, it was found that concerns about safety is due to the absence of a standardized classification system for evaluating the safety and effectiveness of transport ventilators. Conclusions : In order to improve the safety of patients and the quality of medical care, it is essential to establish guidelines and assessment standards guaranteeing the safety of transport ventilators in Korea. Clear definitions and classifications for devices must precede the application of such standards. In addition, effective evaluation standards should be developed in order to resolve problems and improve upon the current system through continuous validation.

• Journal of Environmental Health Sciences
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• v.47 no.1
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• pp.1-19
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• 2021

Objectives: Phthalates, which are widely used as plasticizers, have been recognized as endocrine disruptors. In the present study, we provided information on the regulation of these chemicals and summarized the information available on their detection and toxicity in children's products and those of their alternatives. Methods: The regulatory frameworks related to phthalates in children's products in Korea, the United States (US), and the European Union (EU) were compared. Data on the detection concentration of 16 phthalates and seven phthalate alternatives that could be used in polyvinyl chloride (PVC) plastic products for children as well as on their toxicity classification and endocrine disruption toxicity were collected from the literature. Results: Korea adopted US and EU chemical standards for six phthalates (DEHP, BBP, DBP, DINP, DIDP, and DNOP), but not others (e.g., DIBP, DPP, DHP, and DCHP). Among the ten phthalates and seven substitutes for which regulatory standards were not determined, DIBP, DHP, DEHA, DIBA, DINA, and DEHT were detected in children's products made from PVC plastic. DIBP and DHP, which have a reproductive toxicity classification of 1B, were frequently detected in PVC toys. The reproductive toxicity, estrogenicity, and anti-androgenic activity of the unregulated phthalates and their alternatives have been reported in diverse in vitro and in vivo assays. Conclusion: The use of unregulated phthalates and their substitutes in children's products is increasing. Further monitoring and toxicological information on phthalate alternatives is required to develop proper management plans.