• Journal of Korean Society for Quality Management
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• v.31 no.3
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• pp.19-36
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• 2003

The manager of manufacturing industry just not to have known what to do related to the law of product liability(PL) that was put into operation in July 1, 2002. The law of PL is a public law about defective product, which was established in order to compensate consumer's damages of property and body caused by product, to make sound society by the safety products and to take international competitiveness. But the existing civil law has been having clause that compensation to be taken is limited. The law of PL is resolving this limitations and is characterized by the easy relief from damages of defective product. The decision in the case of Green-man has been a precedent since the court sentenced the manufacturer to liability. The law of PL has been in force in 27 countries, including all of the EU countries, Japan, Philippines and China. It has been shown that the corporations which meet the Global Standard, could survive in global competition. The economic effects by the law of PL are the increase of consumers relief production cost by the lawsuits. This paper will recommend more biref method that is able to cover PSMS by use of QMS. It will make domestic corporation improve in the plan, manufacture and sale of products to meet the Global Standard.

• 한국벤처창업학회:학술대회논문집
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• 2008.11a
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• pp.285-334
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• 2008

The manager of manufacturing industry just not to have known to do related to the law of Product Liability that was put into operation in July 2002. The law of PL is a public law about defective product, which was established in order to compensate consumer's damages of property and body caused by product, to make sound society by the safety products and to take international competitiveness. The economic effects by the law of Product Liability are the increase of consumers relief production cost by the lawsuits. Product liability as a process has developed significantly in the United Kingdom and the United States of America. The rapid introduction of product liability has recently been a prevalent phenomenon, as global changes arising from rapid development in science and the economy have resulted in a highly interconnected world economy. This thesis was established, based on current literature and business consulting cases in the position of companies, and is one of the operating subjects in a system for legal responsibility in manufactured products. However, there are limitations in the fact that research theories are only able to present a theoretical model and directions. In this context, managers and personnel of multiple companies cannot adequately respond to the recently enforced Product Liability Act. The major findings are summarized as Product Liability Management Activity are positively Correlation of Enterprise Value.

• The Journal of the Institute of Internet, Broadcasting and Communication
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• v.13 no.2
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• pp.217-223
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• 2013

Population aging is a shift in the distribution of a country's population towards older ages. This is usually reflected in an increase in the population's mean and median ages, a decline in the proportion of the population composed of children, and a rise in the proportion of the population that is elderly. Population ageing is widespread across the world. Barrier-free or Design for All concept consists of modifying buildings or facilities so that they can be used by people who are disabled or have physical impairments. Design for All criteria are aimed at ensuring that everyone can participate in the Information society. Safety-related products being easy to adapt according to different needs, or using standardized interfaces that can be accessed simply by using assistive technology. To this end, policy makers and service providers, especially in the ubiquitous technologies, produce new technologies, products, services and applications for pedestrians.

• Journal of Korean Society of Occupational and Environmental Hygiene
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• v.27 no.4
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• pp.423-432
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• 2017

Objectives: This study was conducted to evaluate asbestos handling history of workers at automobile manufacturing plants in Korea. Methods: National regulations on asbestos and Korea Occupational Safety and Health Agency(KOSHA) database on the information of asbestos containing products were reviewed. We investigated asbestos related materials from one automobile manufacturing plant. Material safety data sheets(MSDS) collected in 2010, work environment monitoring results reported from 2000 to 2013, trade union reports and asbestos survey reports were reviewed. We also interviewed workers with long career and did walk-through survey. Results: The Ministry of Labor in Korea has permitted asbestos manufacturing since 1990. In 1997, the use of crocidolite and amosite asbestos were banned. In 2007, the Korean government announced a total ban on the manufacturing, importation and use of all kinds of asbestos, which took full effect in 2009. A total of 174 asbestos products information from KOSHA database was analyzed. Extruded cement panel for building, special brake for crane farm machinery, gasket, joint sheet and thermal insulator were produced until 2007. From automobile manufacturing plant survey, we confirmed that asbestos containing materials(ACM) such as gasket, heating induction materials have been used until 2011. Asbestos containing building materials(ACBM) such as bamlites, slate and ceiling tex were reported at 122 asbestos dismantling projects in 2014. Conclusion: Although the use of all kinds of asbestos were banned from 2009, ACMs and ACBMs installed before 2009 were still found at automobile manufacturing plant until 2011 and 2014 respectively. In particular, asbestos slates should be managed because most of slates had not been removed until 2014.

• Asia-Pacific Journal of Business Venturing and Entrepreneurship
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• v.3 no.3
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• pp.17-65
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• 2008

The manager of manufacturing industry just not to have known to do related to the law of Product Liability that was put into operation in July 2002. The law of PL is a public law about defective product, which was established in order to compensate consumer's damages of property and body caused by product, to make sound society by the safety products and to take international competitiveness. The economic effects by the law of Product Liability are the increase of consumers relief production cost by the lawsuits. Product liability as a process has developed significantly in the United Kingdom and the United States of America. The rapid introduction of product liability has recently been a prevalent phenomenon, as global changes arising from rapid development in science and the economy have resulted in a highly interconnected world economy. This thesis was established, based on current literature and business consulting cases in the position of companies, and is one of the operating subjects in a system for legal responsibility in manufactured products. However, there are limitations in the fact that research theories are only able to present a theoretical model and directions. In this context, managers and personnel of multiple companies cannot adequately respond to the recently enforced Product Liability Act. The major findings are summarized as Product Liability Management Activity are positively Correlation of Enterprise Value.

• Journal of Veterinary Science
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• v.22 no.1
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• pp.5.1-5.16
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• 2021

Background: Arctic-like (AL) lineages of rabies viruses (RABVs) remains endemic in some Arctic and Asia countries. However, their evolutionary dynamics are largely unappreciated. Objectives: We attempted to estimate the evolutionary history, geographic origin and spread of the Arctic-related RABVs. Methods: Full length or partial sequences of the N and G genes were used to infer the evolutionary aspects of AL RABVs by Bayesian evolutionary analysis. Results: The most recent common ancestor (tMRCA) of the current Arctic and AL RABVs emerged in the 1830s and evolved independently after diversification. Population demographic analysis indicated that the viruses experienced gradual growth followed by a sudden decrease in its population size from the mid-1980s to approximately 2000. Genetic flow patterns among the regions reveal a high geographic correlation in AL RABVs transmission. Discrete phylogeography suggests that the geographic origin of the AL RABVs was in east Russia in approximately the 1830s. The ancestral AL RABV then diversified and immigrated to the countries in Northeast Asia, while the viruses in South Asia were dispersed to the neighboring regions from India. The N and G genes of RABVs in both clades sustained high levels of purifying selection, and the positive selection sites were mainly found on the C-terminus of the G gene. Conclusions: The current AL RABVs circulating in South and North Asia evolved and dispersed independently.

• Journal of Korean Neurosurgical Society
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• v.65 no.5
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• pp.730-740
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• 2022

Objective : Although several commercialized bone cements are used during percutaneous vertebroplasty (PVP) for patients with osteoporotic vertebral compression fracture (OVCF), there are no reports using domestic products from South Korea. In this study, we investigated the safety and efficacy of Spinofill^® (Injecta Inc., Gunpo, Korea), a new polymethyl methacrylate product. Methods : A prospective, single-center, and single-arm clinical trial of 30 participants who underwent PVP using Spinofill^® for painful thoracolumbar OVCF was performed with 6-months follow-up. Clinical and surgical outcomes included the Visual analog scale (VAS), Korean-Oswestry disability index (K-ODI), and Odom's criteria, complication rate, and recurrence rate. Radiological outcomes were evaluated by measuring the findings of postoperative computed tomography and simple radiograph. Results : The pain of VAS (from 8.95±1.05 to 4.65±2.06, p<0.001) and the life quality based on K-ODI (from 33.95±5.84 to 25.65±4.79, p<0.001) improved significantly, and successful patient satisfaction were achieved in 20 patients (66.7%) 1 day after surgery. These immediate improvements were maintained or more improved during the follow-up. There was no surgery- or product-related complications, but OVCF recurred in two patients (6.7%). Favorable cement interdigitation was reported in 24 patients (80.0%), and extra-vertebral cement leakage was reported in 13 patients (43.0%). The mean vertebral height ratio (from 60.49%±21.97% to 80.07%±13.16%, p<0.001) and segmental kyphotic angle (from 11.46°±8.50° to 7.79°±6.08°, p=0.002) improved one day after surgery. However, these short-term radiological findings somewhat regressed at the end. Conclusion : The overall outcomes of PVP using Spinofill^® were as favorable as those of other conventionally used products.

• Journal of Acupuncture Research
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• v.26 no.6
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• pp.101-110
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• 2009

Objectives : We developed and proposed a guideline for safety and performance assessment of electric cupping apparatus(Class 2 medical device). Methods : We drafted the guideline for safety and performance assessment of electric cupping apparatus by referring the existing standards and guideline, based on online questionnaire for Korean medical doctors and measurement data from commercially available products. Physical dimension of cups and inner vacuum pressure were acquired for the measurement in order to achieve the purposes. Results : This guideline only can be applied to electric cupping apparatus for enhancing blood circulation by employing negative pressure generated by electricity. Seven items of appearance and label, operation test of pump, variation test of input electricity, vacuum level test, vacuum sustain test, cup-size dependent test, noise level test are suggested for evaluation subjects and methods required for electric cupping devices. Requirements for the design and development of electric cupping devices are suggested: vacuum level indicator, vacuum generation rate, pressure control, valve detachment stability, cup comparability, safety measure, surge protection, user friendliness, instruction for use (IFU). Conclusions : We proposed a guideline for safety and performance assessment of electric cupping apparatus to improve the quality of relating products and aid the commercialization of them, by aiming higher industrial competitiveness of the medical device sectors in Korea. Discussion with related institutes such as industry, academy and government is further required. Public hearings also need to be held prior to the establishment of a final guideline and standard.

• Journal of The Korean Society of Clinical Toxicology
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• v.3 no.2
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• pp.71-78
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• 2005

Purpose: The morbidity of pesticides are largely related with accidental ingestion in human. The four principal ideals of clarity, completeness, conformity and consistency of label are important to make a correct usage and prevent unnecessary health risk. The aim of this study is to evaluate the appropriateness of pesticides labelling practice in Korea. Methods: The photographic label images of pesticide products were gathered through visiting thirteen manufacturers that produce pesticide products in Korea. We scored labelling practice by guidelines of Food and Agriculture Organization of the United Nations in 1995. Results: From August 2005 to November 2005, we gathered 1,296 label images of pesticide and $58.3{\%}$ (755/1,296) of images were scored by check lists for reviewing label content. The average score of four check list categories was $71.9{\pm}2.2$. Each categorical score were $91.7{\pm}0.9$ for the information appearing on the label, $31.3{\pm}0.0$ for safety precaution, $77.7{\pm}2.0$ for instructions for use, $87.0{\pm}8.7$ for general configurations. In safety precaution, the sentence of keeping locked up the product and two mandatory safety pictograms were missed in all label images. In general configurations category, there was score difference in product package types between bottle and bag container ($85.1{\pm}9.0$ vs. $90.3{\pm}7.2$, p < 0.01). Conclusion: Although there was no comparable previous data, the score of safety precaution was lowest than other categories because the two mandatory safety pictograms and locked up warning sentence were missed. In general configurations, the colour contrast was more inappropriate in the labels on bottle than bag container.

• Journal of Biomedical Engineering Research
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• v.40 no.5
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• pp.197-205
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• 2019

The existing Extracorporeal membrane oxygenation(ECMO) and Cardiopulmonary bypass system(CPB) have been developed and applied to various devices according to their respective indications. However, due to the complicated configuration and difficult usage method, it causes inconvenience to users and there is a risk of an accident. Therefore, smart all-in-one cardiopulmonary circulation device is being developed recently. The smart all-in-one cardiopulmonary assist device consists of a blood pump for cardiopulmonary bypass, a blood oxidizer for cardiopulmonary bypass, a blood circuit for cardiopulmonary bypass, and an artificial cardiopulmonary device. It is an integrated cardiopulmonary bypass device that can be used for a variety of purposes such as emergency, intraoperative, post-operative intensive care, and long-term cardiopulmonary assist, combined with CPB used in open heart surgery and ECMO used when patient's cardiopulmonary function does not work normally. The smart all-in-one cardiopulmonary assist device does not exist as a standard and international standard applicable to advanced medical devices. Therefore, in this study, we will refer to the International Standard for Blood Components, the International Standard for Blood, the Guideline for Blood Products, and prepare applicable performance and safety guidelines to help quality control of medical devices, and contribute to the improvement of the health of people. The guideline, which is the result of conducted a survey of the method of safety and performance test, is based on the principle of all-in-one cardiopulmonary aiding device, related domestic foreign standards, the status of domestic and foreign patents, related literature, blood pump(ISO 18242), blood oxygenator (ISO 7199), and blood circuit (ISO 15676) for cardiopulmonary bypass.The items on blood safety are as follows: American Society for Testing and Materials ASTM F1841-97R17), and in the 2010 Food and Drug Administration's Safety Assessment Guidelines for Medical Assisted Circulatory Devices. In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers / importers, testing inspectors, academia, etc. the final guideline was established through revision and supplementation process. Therefore, we propose guidelines for evaluating the safety and performance of smart all-in-one cardiopulmonary assist devices in line with growing technology.