• KOREAN JOURNAL OF CROP SCIENCE
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• v.47
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• pp.186-199
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• 2002

This is a brief review and discussion for present status and prospects of quality evaluation in medicinal plants as oriental medicine materials (OMM). Quality in medicinal plants could be defined as the combination of origin, external appearance, effectiveness and safety, and be evaluated by plant taxonomic, morphological, physiochemical and biological methods. For high-quality improvement and standardization of OMM, medicinal plants should be produced through using proper species or good variety and standard cultivation method in suitable cultivation area. Standardizing of quality means to meet with minimum qualifying criteria of OMM in the market while improving of quality to be over standard quality of medicinal piano in production. For making new high quality and standardized products, we need to keep standard field plants, standard OMM, standard plant specimen, and standard compounds. Researchers and administration have to study and propose the quality factors and their evaluating techniques and criteria, so high-quality and standardized produce of medicinal plane could be produced and distributed under the control of the relevant regulations, and would be contributed to increasing of national health.

• The Journal of Korean Medical History
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• v.27 no.2
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• pp.11-37
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• 2014

Objectives : The purpose of this study was to analyze and identify the problems of the changes in regulations that are relevant to approval, notification, and review of herbal medicinal preparations and crude drug preparations. Methods : I collected the regulations of approval, notification, and review of medicinal products mostly from official gazettes, analyzed enactment and amendments regarding herbal medicinal preparations and crude drug preparations, and studied it from the view point of Korean medicine field. Results : Regulations in regards to approval, notification, and review of herbal medicinal preparations and crude drug preparations were first established in 1978. Herbal drugs started to be categorized as crude drug preparations in 1981 and the regulatory outlines were completed in 1999. From 2008 to 2012, the regulatory standards that let crude drug preparations be new drugs from natural products were established. Through those procedures, the followings became crude drug preparations: 1) wholly new prescriptions that are not recorded in Korean Medical Classics, 2) prescriptions that are recorded in Korean Medical classics but prepared with new standard, composition and efficacy, 3) prescriptions that are recorded in Korean Medical classics but prepared with new formulation, and 4) herbal drugs. In case of herbal medicinal preparations, however, only regulations that are related to 1) drugs prepared with new compositions that are not recorded in Korean Medical Classics, 2) drugs with same prescription and same formulation, and 3) drugs with new formulation were arranged. Conclusions : Actual circumstances on crude drug-oriented regulations regarding approval, notification and review and future forms of prescription and drug administration in Korean Medical Institutions can be expected due to expansion in range of herbal medicinal preparations and shrink in that of on-site preparations. Reasonable improvement in efficient usage of modernized herbal medicinal preparations in Korean medical institutions and prospective cooperation from related pharmaceutical industry are needed.

• KOREAN JOURNAL OF PACKAGING SCIENCE & TECHNOLOGY
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• v.5 no.2
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• pp.42-58
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• 1999

Packaging materials and articles that are used in food contact applications can transfer constituents in the foodstuffs. This kind of risk of possible health hazards to consumers has been generally recognized for a long time with the consequence of establishing corresponding food regulations in most developed countries. However, the language of these laws, their interpretation, and their level of enforcement vary from country to country. Accordingly, the actual migrating levels from packaging materials can be varied depending on the migration testing methods as prescribed in the national legislation in each countries. Therefore, there are needs of elimination of non-tariff trade barriers raised by sanitary and phytosanitary or technical measures under the Final Act of the UR Agreement. In this connection, the EU and USA are currently in an ongoing process of legislation harmonization to overcome potential barriers to free trade. In general, regulations governing component transfer in the USA are more complicated and comprehensive than similar regulations in Europe. In future, standard migration testing procedures for microwave heat susceptor materials and for the use of fatty food simulant should be established and also harmonized among countries. The objective of this investigation is to compare the current regulations for migration testing for plastic containers and packaging materials in USA, EU and Korea or Japan. For those regulations, Korean standards are required to be kept up with the international standards. By doing this, the related Korean regulation could be amended along with the worldwide progress for harmonization.

• Proceedings of the Korea Institute of Fire Science and Engineering Conference
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• 2008.04a
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• pp.73-75
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• 2008

Fire engineering design method based on structural performance of buildings has been developed through all of the worlds since the early 1960's. But recently the worlds have been changed rapidly in aspects of global community and mutural free trade circumstances. Therefore the concepts of fire design on structural performance need to harmonize among countries that have their own unique regulations and ISO TC 92 and SC 4 have worked in order to make the united international standard.

• Journal of Aerospace System Engineering
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• v.9 no.2
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• pp.63-71
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• 2015

An aircraft engine is considered as the most important element among aircraft systems. Thus type certificate is required for an aircraft engine to ensure its safety under appropriate airworthiness standard. U.S. FAR Part 33 or European CS-E is widely adopted as an airworthiness standard for aircraft engines, and other representative countries of the world established own airworthiness standards under their regulations. In this paper, we compared differences of the requirements between FAR Part 33 and CS-E, and proposed the rulemaking items to harmonize Korean Airworthiness Standard for Aircraft Engines with worldwide standards and to contribute to growth of aviation industry.

• International conference on construction engineering and project management
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• 2015.10a
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• pp.24-25
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• 2015

To realize the global standard of the assembly facility, one of key point is an influence of local characteristic. The global standardized information could be a useful input, especially at the beginning stage of the project. The content should be carefully checked against local requirements, in order to develop an Assembly Facility design to meet local regulations & characteristics. The level of input information required in each step is different depend on regions & countries. At an execution stage of the project, the global standard input needs to be updated as customized final input for the construction. There will be many issues to be clarified and coordinated so that the Assembly facilities meet the final requirements for the production technology. As a result, it is important to understand the timing to use the global standard information and the contents what is needed to adapt to the local characteristics. And close collaboration between production technology team and facility team is always required.

• Journal of Korean Society for Quality Management
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• v.50 no.2
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• pp.199-220
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• 2022

Purpose: The purpose of this study is to analyze the score data released by the Korea Institute of Curriculum and Evaluation to find out the problems with the current scoring system provided by the College Scholastic Ability Test and to suggest improvement measures to solve these problems. Methods: We calculated the descriptive statistics of the standard scores using the frequency distribution table of the standard scores and identified the characteristics of the standard scores by expressing the distribution as a graph. Also, we developed an index to evaluate whether each stanine level was stably assigned and calculated the indexes for each area/subject by using the data on the number of examinees for each level. Results: We found that the relationship of conversion from raw scores to integerized standard scores is different depending on the size of the standard deviation of the raw scores, and identified the problem that the raw score information is not fairly reflected in the calculation of the percentile and level as the two raw scores are converted to one standard score. This problem can be solved by calculating the standard score to a decimal point. Conclusion: In this study, as a way to improve the quality of the scores of the current CSAT, the standard score and percentile decimal notation, the specific regulations of the standard score and stanine level calculation method, and the expansion of the open range of the scores were suggested.

• The Journal of KAIRB
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• v.5 no.1
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• pp.21-32
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• 2023

Purspose: The purpose of this study is to examine the meaning and definition of vulnerable subjects in clinical trials in light of domestic and international regulations and guidelines, to analyze the contents of standard operation procedures (SOPs) among advanced general hospitals in Korea that conduct clinical trials, and to examine deliberation procedures for operation plans. Methods: The study examined how vulnerable research subjects were defined and described in related regulations and the classification of vulnerable research subjects presented in the IRB/HRPP SOPs of 18 clinical trial institutions, including 11 AAHRPP-accreditated general hospitals in Korea, as well as the operation of the IRB deliberation. Results: Among all domestic and international regulations and guidelines, only the The Council for International Organization of Medical Sciences (CIOMS) guidelines explain why vulnerability is related to judgments on the severity of physical, psychological, and social harm, why individuals are vulnerable, and for what reasons. However, the classification of vulnerable subjects by institutions differed from the classification by the International Conference on Harmonization-Good Clinical Practice (ICH-GCP). A total of the 16 institutions classified children and minors as vulnerable research subjects. 14 institutions classified subjects who cannot consent freely were classified as vulnerable subjects. 15 institutions classified sujects who can be affected by the organizational hierarchy were classified as vulnerable subjects. Subjects in emergency situations were regarded as vulnerable research subjects in 8 of institutions, while people in wards, patients with incurable diseases, and the economically poor including the unemployed were categorized as vulnerable research subjects in 7, 4, and 4 of institutions, respectively. Additionally, some research subjects were not classified as vulnerable by ICH-GCP but were classified as vulnerable by domestic institutions 15 of the institutions classified pregnant women and fetuses as vulnerable, 11 classified the elderly as vulnerable, and 6 classified foreigners as vulnerable. Conclution: The regulations and institutional SOPs classify subjects differently, which may affect subject protection. There is a need to improve IRBs' classifications of vulnerable research subjects. It is also necessary to establish the standards according to the differences in deliberation processes. Further, it is recommended to maintain a consistent review of validity, assessment of risk/benefit, and a review using checklists and spokeperson. The review of IRB is to be carried out in a manner that respects human dignity by taking into account the physical, psychological, and social conditions of the subjects.

• The Transactions of The Korean Institute of Electrical Engineers
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• v.65 no.9
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• pp.1618-1625
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• 2016

Electric motor systems account for more than half of all electric systems and the amount of energy consumption of those is almost 70 percent of total energy consumption of electric motor systems in industry. As electric motor systems are very responsible for global electricity savings and environment protection. Many international organizations are supporting standards and policy development processes to improve the efficiency of electric motor systems. Many standards are being developed at technical committee of IEC that has been required in order to support the implementation of efficiency regulations. High efficiency standards and levels for electric motor systems are slowly being introduced and compulsory in many countries. Therefore understanding the international efficiency evaluation standards and the regulation of electric motor systems of each country is important. This paper presents the current status and trends of international evaluation standards and regulations about the efficiency of electric motor systems.

• The Journal of Korea Robotics Society
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• v.14 no.4
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• pp.333-339
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• 2019

Cobots are industrial robots with greatly enhanced safety functions that enable them to work in the same space with workers without protector. Cobots are regulated by the Industrial Safety and Health Act and must be certified according to the manufacturing stage, installation stage and usage stage. The ISO 10218-2 standard applied in the installation phase is difficult to apply in the field. Therefore, it is necessary to develop a risk assessment method based on ISO 12100 standard. This paper proposes a new methodology that combines 'JSA' and 'What-if', which reflects the human error and the lack of known risk factors. Accordingly, a new risk assessment template was proposed and the effectiveness of the developed new template was examined. The current cobot safety regulations need to be unified with safety inspections scheme, and robot safety experts and infrastructures need to be expanded and Robot safety regulations should be unified to 'Robot Act'. Based on this research, risk assessment methods suitable for the field need to be developed additionally, and robot safety regulation needs to be transformed to promote the industry.