• Title/Summary/Keyword: Plant certification

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Performance assessment and improvement plan of the regulatory management system of veterinary medical devices in Korea (국내 동물용 의료기기 관리실태 평가 및 개선방안 연구)

  • An, Hyo-Jin;Yoon, Hyang-Jin;Kim, Chung-Hyun;Wee, Sung-Hwan;Moon, Jin-San
    • Korean Journal of Veterinary Research
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    • v.55 no.2
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    • pp.97-103
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    • 2015
  • In this study, the Korean veterinary medical devices management system was evaluated relative to systems in the USA, EU, and Japan. Veterinary medical devices are regulated in Korea based on the Medical Appliance Act of 1997. This was initially supervised by the Ministry of Agriculture, Food and Rural Affairs and Korea Animal Health Products Association, and subsequently by the Animal and Plant Quarantine Agency (QIA) in 2000. These devices were classified approximately 1,400 categories as instruments, supplies, artificial insemination apparatus, and other categories. Each of these devices was assigned to four regulatory grades by the QIA in 2007. The ranking system for veterinary medical devices was implemented in 2014 with 820 products from 162 companies registered by that year. However, in vitro diagnostic devices (IVDDs) for animals were managed as medical devices and biological medicine. In vitro diagnostic reagents for treating infection diseases are not subjected to either a classification or grading system. Veterinary medical devices are currently exempt from good manufacturing practices (GMP) and device tracking requirements. Due to gradual growth of the domestic veterinary medical devices market since 2008, regulation of these devices should be improved with re-examination of IVDDs and GMP certification for the effective operating system.

Detection of Apple Scar Skin Viroid by Reverse Transcription Recombinase Polymerase Amplification Assay

  • Kim, Na-Kyeong;Lee, Hyo-Jeong;Ryu, Tae-Ho;Cho, In-Sook;Ju, Ho-Jong;Jeong, Rae-Dong
    • Research in Plant Disease
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    • v.27 no.2
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    • pp.79-83
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    • 2021
  • The aim of the present study was to develop a sensitive and specific detection method for the rapid detection of apple scar skin viroid (ASSVd) in apple leaves. The resulting reverse transcription recombinase polymerase amplification (RT-RPA) assay can be completed in 10 min at 42℃, is 10 times more sensitive than conventional reverse transcription polymerase chain reaction, and can specifically amplify ASSVd without any cross-reactivity with other common apple viruses, including apple stem grooving virus, apple stem pitting virus, and apple chlorotic leaf spot virus. The reliability of the RT-RPA assay was assessed, and the findings suggested that it can be successfully utilized to detect ASSVd in field-collected samples. The RT-RPA assay developed in the present study provides a potentially valuable means for improving the detection of ASSVd in viroid-free certification programs, especially in resource-limited conditions.

Detection and Quantification of Apple Stem Grooving Virus in Micropropagated Apple Plantlets Using Reverse-Transcription Droplet Digital PCR

  • Kim, Sung-Woong;Lee, Hyo-Jeong;Cho, Kang Hee;Jeong, Rae-Dong
    • The Plant Pathology Journal
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    • v.38 no.4
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    • pp.417-422
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    • 2022
  • Apple stem grooving virus (ASGV) is a destructive viral pathogen of pome fruit trees that causes significant losses to fruit production worldwide. Obtaining ASGV-free propagation materials is essential to reduce economic losses, and accurate and sensitive detection methods to screen ASGV-free plantlets during in vitro propagation are urgently necessary. In this study, ASGV was sensitively and accurately quantified from in vitro propagated apple plantlets using a reverse transcription droplet digital polymerase chain reaction (RT-ddPCR) assay. The optimized RT-ddPCR assay was specific to other apple viruses, and was at least 10-times more sensitive than RT-real-time quantitative PCR assay. Furthermore, the optimized RT-ddPCR assay was validated for the detection and quantification of ASGV using micropropagated apple plantlet samples. This RT-ddPCR assay can be utilized for the accurate quantitative detection of ASGV infection in ASGV-free certification programs, and can thus contribute to the production of ASGV-free apple trees.

A Reliable Reverse Transcription Loop-Mediated Isothermal Amplification Assay for Detecting Apple stem grooving virus in Pear

  • Lee, Hyo-Jeong;Jeong, Rae-Dong
    • Research in Plant Disease
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    • v.28 no.2
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    • pp.92-97
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    • 2022
  • Apple stem grooving virus (ASGV) is a high-risk viral pathogen that infects many types of fruit trees, especially pear and apple, and causes serious economic losses across the globe. Thus, rapid and reliable detection assay is needed to identify ASGV infection and prevent its spread. A reliable reverse transcription loop-mediated isothermal amplification (RT-LAMP) was developed, optimize, and evaluated for the coding region of coat protein of ASGV in pear leaf. The developed RT-LAMP facilitated the simple screening of ASGV using visible fluorescence and electrophoresis. The optimized reaction conditions for the RT-LAMP were 63℃ for 50 min, and the results showed high specificity and 100-fold greater sensitivity than the reverse transcription polymerase chain reaction. In addition, the reliability of the RT-LAMP was validated using field-collected pear leaves. Furthermore, the potential application of paper-based RNA isolation, combined with RT-LAMP, was also evaluated for detecting ASGV from field-collected samples. These assays could be widely applied to ASGV detection in field conditions and to virus-free certification programs.

Review of Regulatory Management System on Side Effects for Veterinary Medical Devices in Korea (국내 동물용의료기기 부작용 관리시스템에 대한 고찰)

  • Kang, Kyoung-Mook;Park, Hee-Myung;Lee, Chang-Min;Kang, Min-Hee;Suh, Tae-Young;Kang, Hwan-Goo;Moon, Jin-San
    • Journal of Veterinary Clinics
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    • v.35 no.1
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    • pp.1-6
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    • 2018
  • This study reviewed the regulatory safety management system for prevention of side effects of veterinary medical devices in Korea based on data obtained through analyses of those medical devices. In order to ensure the safety of medical devices, Ministry of Food and Drug Safety has established the management system include licensing, test inspection (134 designated clinical trial agencies) and post management. In addition, it was introduce the good manufacture practice (GMP) certification system and device tracking requirements. In contrast, it is necessary to establish regulations for side effects report and awareness on veterinary medical devices in Korea. The center for veterinary medicine of FDA in the United States has been operated side effects reporting system of veterinary medical devices from user, manufactures and distributor. Due to increase the use of various kinds of veterinary medical devices for animals, it should be required to improve regulation related to the licensing procedures, GMP system, and the side effects reporting system in our country.

An Economical Analysis on Fuel Switching Model of Coal Power Plant using Herbaceous Biomass (초본계 바이오매스 활용 석탄발전소 연료전환 모형 경제성분석 연구)

  • Um, Byung Hwan;Kang, Chan Ho
    • Journal of The Korean Society of Agricultural Engineers
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    • v.61 no.3
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    • pp.89-99
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    • 2019
  • The project to utilize kenaf as thermal power plant fuel has a positive effect on the unused energy utilization, greenhouse gas reduction, and farm income. However, it is analyzed that it is difficult to secure economical efficiency because the fuel cost of kenaf is higher than that of power by thermal power plant and Renewable Energy Certification (REC). The project of power generation using kenaf is meet the government's major policies, while government support is essential for securing economical efficiency. As a result of the sensitivity analysis on the ratio of the government subsidies, to secure economical efficiency, the power generation prices using kenaf through the direct financial support of the government indicate that 47% and 76% of kenaf fuel cost are supported by government in case of the Saemangeum reclamation and Gangneung-si, respectively. In the case of the government indirect policy support, if kenaf is included as a renewable energy source of Renewable Energy Portfolio Standard and REC is granted, the economic efficiency of Saemangeum reclamation and Gangneung-si is obtained when REC secured at 1.05 or more and 2.43 or more, respectively. The results of this study are meaningful in that the direct and indirect effects of the government on the development of the herbaceous energy crop, kenaf, were evaluated economically. These results are to suggest the need for demonstration study, but economics analyze and evaluate are necessary based on operational data through the demonstration phase in the future.

A Study on the Necessity of Korean Standard and Code of Safety for Diving System (잠수 시스템의 국내 표준 및 안전 기준 제정 필요성에 관한 연구)

  • Park, Jong-Yeob;Kang, Sin-Young
    • Journal of Advanced Marine Engineering and Technology
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    • v.35 no.6
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    • pp.856-860
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    • 2011
  • The standard and code of safety for diving systems include requirements in the area of diving plant, personnel qualification, diving medicine and operation. In this study the necessity of Korean standard and code of safety for diving system is suggested through the review and comparison of the diving system regulations of domestic as well as foreign governments and other private organizations. Furthermore, by reviewing the status of oversea's diving organizations the proposition was made which can lead the commercial diving sector to international cooperation.

A small power plant in each household (가정의 작은 발전소 연료전지)

  • Sin, Tae-Seob
    • Journal of the Korean Professional Engineers Association
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    • v.44 no.3
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    • pp.25-29
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    • 2011
  • The fuel cell, a renewable energy facility, hasn t come into wide use to the public. However, the usefulness of it is so high through Supply Business called Green Home, general auxiliary Supply Business, obligation to supply renewable energy for public organizations, Building Certification System and compulsory quota of using renewable energy to power generating businesses, etc. Intial installation was supported by government and a local autonomous entities in case of home fuel cell. Cost-benefits of installing it in home are approximately from $1,000 to $2,500. As Korea applies a progressive tax scheme in home electricity, energy costs are associated with electricity consumption. We should contemplate ways to make effective use of additional waste heat because technology of fuel cell is kind of a cogeneration.

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The Development of Safety Relief Valve for Nuclear Service. (원자력 등급용 안전방출밸브 개발)

  • Kim, Chil-Sung;Kim, Kang-Tae;Kim, Ji-Heon;Jang, Ki-Jong;Hong, Kee-Seong
    • Proceedings of the KSME Conference
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    • 2003.04a
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    • pp.629-636
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    • 2003
  • The purpose of this study is localization of safety relief valves for Nuclear Service through technical development with overall design, fabrication, inspection, capacity certification test and functional qualification test of safety relief valves in accordance with ASME Section III and KEPIC Code. Safety relief valve is the important equipment used to protect the pressure vessel, the steam generator and the other pressure facility from overpressure by discharging the operating medium when the pressure of system is reaching the design pressure of the system. But we're depending on technology of the other country up to the present time. Because we don‘ have our own technologies, we have been spent the great time and money on installing and repairing safety relief valve at nuclear power plant. Therefore we have to achieve the development of safety relief valves for Nuclear Service with our own technologies.

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Developing the requirements of "National Important Facilities" according to the certification criteria of (ISO) (국제표준화기구(ISO)의 인증기준에 준하는 「국가중요시설」의 요구사항 개발)

  • Yim, Heon-Wook
    • Convergence Security Journal
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    • v.17 no.3
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    • pp.65-71
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    • 2017
  • "National important facilities" refers to facilities that have a great influence on national security and people's live s if enemy occupation, destruction, or functional paralysis is imposed by the Ministry of Defense Directive. In view of the case of nuclear plant hacking and the attack on the government building "National important facilities" could be the target of anti-social crimes. In the meantime, the "National important facilities" check is limited to the facilit y survey. so The purpose of this study is to develop generalized requirements. Therefore, comparing the requiremen ts of ISO 9001:2015 and ISO 27001:2013. There are only 8 differences(operating) out of 1-10. And the rest are used in common. In addition, we confirmed that the results of comparing the cases of domestic and foreign CPTED are within the "Six Principles". In Chapter 8, the principle of application of CPTED was inserted and the certification re quirements of the "National important facilities" management system were derived.