• Title/Summary/Keyword: technical guideline

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Case study for technical evaluation and check list to decision of optimized TBM (최적 TBM 장비 발주를 위한 선정 기준 및 체크리스트 사례 검토)

  • Kim, Ki-Hwan;Kim, Hyouk;Kim, Seong-Cheol;Kang, Si-On
    • Journal of Korean Tunnelling and Underground Space Association
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    • v.23 no.6
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    • pp.385-392
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    • 2021
  • When ordering a slurry shield TBM to be used for power cable tunneling, the client organizes an evaluation committee composed of experts, suggest the criteria and evaluation method for technical specifications for supplier selection, and based on the manufacturer's technical proposal were attempted to evaluate and select. It is expected to be referred to as a guideline for future projects to using Shield TBM as one of the methods of verifying performance and quality in advance and securing economic feasibility in the shield TBM tunneling in the recent increasing trend.

The Development for guideline of raw matrials on technical document of Medical Device (의료기기 허가.기술문서 원자재 작성 가이드라인 개발)

  • Park, Ki-Jung;Ryu, Gyu-Ha;Lee, Sung-Hee;Lee, Chang-Hyung;Jung, Jin-Baek;Lee, Jae-Keun;Hur, Chan-Hoi;Kim, Hyung-Bum;Choi, Min-Yong;Kim, Yong-Woo;Hwang, Sang-Yeon;Jung, Jae-Hoon;Koo, Ja-Jung;Hong, Hye-Kyung;Lim, Kyung-Taek;Kang, Se-Ku;Kwak, Young-Ji
    • Journal of Biomedical Engineering Research
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    • v.31 no.6
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    • pp.434-437
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    • 2010
  • For approval of medical devices manufactured or imported, submission of technical documents as well as the application form is required. The manufacturer (or importer) should properly identify the raw materials the applied product is made of and the manufacturing processes the product undergoes before it is shipped in the application form. In the technical documents, scientific data to evaluate the efficacy, safety, and quality of the applied product that has been described in the application form should be provided. Therefore, identifying the raw materials that were used for the parts of the applied product and describing the physical and chemical characteristics of the raw materials are quite important and essential in ensuring the efficacy, safety, and quality of the applied product. To describe the physical and chemical characteristics of the raw materials correctively, the applicant is required to have broad knowledge in the scientific fields such as chemical, polymer, metal, and ceramic science and engineering. But most of the applicant are not experts in these fields, so that the description in the application form often includes wrong and improper descriptions. Thus, we developed a guideline which explains the raw materials for medical devices, show the their examples. The purpose of this description guideline is to help the applicant properly completing the "Raw materials or constituents and their volumes" part in the application form.

Pediatric Cardiothoracic CT Guideline Provided by the Asian Society of Cardiovascular Imaging Congenital Heart Disease Study Group: Part 2. Contemporary Clinical Applications

  • Hyun Woo Goo;Suvipaporn Siripornpitak;Shyh-Jye Chen;Oktavia Lilyasari;Yu-Min Zhong;Haifa Abdul Latiff;Eriko Maeda;Young Jin Kim;I-Chen Tsai;Dong Man Seo
    • Korean Journal of Radiology
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    • v.22 no.8
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    • pp.1397-1415
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    • 2021
  • The use of pediatric cardiothoracic CT for congenital heart disease (CHD) was traditionally limited to the morphologic evaluation of the extracardiac thoracic vessels, lungs, and airways. Currently, the applications of CT have increased, owing to technological advancements in hardware and software as well as several dose-reduction measures. In the previously published part 1 of the guideline by the Asian Society of Cardiovascular Imaging Congenital Heart Disease Study Group, we reviewed the prerequisite technical knowledge for clinical applications in a user-friendly and vendor-specific manner. Herein, we present the second part of our guideline on contemporary clinical applications of pediatric cardiothoracic CT for CHD based on the consensus of experts from the Asian Society of Cardiovascular Imaging CHD Study Group. This guideline describes up-to-date clinical applications effectively in a systematic fashion.

Consideration for Confirmity Assessment of Eco-friendly Public Transportation System based on the Wireless Power Transfer Technology (무선 전력전달 방식 친환경 대중교통 시스템의 적합성 평가에 대한 고찰)

  • Shin, Jung-Jin;Kim, Gi-Hyun;Lee, Kang-Hee;Kim, Han-Su
    • The Transactions of The Korean Institute of Electrical Engineers
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    • v.61 no.10
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    • pp.1524-1528
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    • 2012
  • According to the Article 4(Confirmity Assessment)of the Electrotechnical Regulation, Confirmity Assessment for the Electrotechnical Regulation decides confirmity of Electrotechnical Regulation; whether to satisfy performances and requirements(determined from Electrotechnical Regulation). It evaluates technical requirements, new technology and standards. However, it does not evaluate technical content stated from Electrotechnical Regulation & Conformity Criteria. From Confirmity Assessment, the technology will be decided whether to fulfill performances and technical requirements. Which is predetermined by contents related to Electrotechnical Regulation. Test standards and test conditions will be overlooked to determine its performances and technical requirements for safety. This paper will show that, studies have been done to determine the guideline for Confirmity Assessment, which is evaluated from performances and technical requirements associated with Confirmity Assessment of electrical installation for new technology of wireless power transfer.

Perspectives on Adopting the Guideline for Multi-regional Clinical Trials in Korea: A Multi-stakeholder Survey (한국의 다지역 임상시험 가이드라인 적용에 대한 인식: 다중 이해관계자 설문조사)

  • Sohn, Minji;Song, Yun-Kyoung;Jeon, Ah Young;Oh, Jung Mi;Kim, In-Wha
    • Korean Journal of Clinical Pharmacy
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    • v.29 no.4
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    • pp.267-277
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    • 2019
  • Backgrounds: With the globalization of drug development, multi-regional clinical trials (MRCTs) have emerged to facilitate rapid availability of medicines to patients worldwide. The present study aimed to has explored attitudes and perceptions towards adopting the Korean MRCT guideline. Methods: An online survey, consisting of 16 questions, classified into two subjects, was administered to stakeholders in Korea. Most quantitative components were measured using the Likert scales. A content analysis of the qualitative components was carried out to identify the keywords in open-ended responses. Results: A total of 94 survey responses were analyzed: 51 participants from pharmaceutical companies, 11 from clinical research organizations, and 21 from clinical trial centers. The content of the guideline was rated as appropriate for clarity, acceptability, and applicability (96.8, 96.8, and 93.6%, respectively). The local environmental impact of the systemic/political, academic/technical, and industrial/economical aspects of the guideline was rated as appropriate at 95.7, 97.9, and 91.5%, respectively. The suggested adoption period was 1~2 years (40, 42.6%). The concept and individuals' domestic circumstances were the key problems affecting the clarity, applicability, and local environmental impact of the guideline. Conclusion: The Korean MRCT guideline was well-developed. Their overall impact on the local environmental impact of MRCTs in Korea was expected to be beneficial, but methods are needed to minimize the negative impacts. The findings of this study can inform the priorities for the future adoption of the guideline in Korea.

Validation and Verification Process for the Computerized Procedure System in Nuclear Power Plant Control Room (전자식 절차서 시스템의 원전제어적합성 확인 및 검증절차)

  • Cha, Woo-Chang
    • Journal of the Korean Society of Systems Engineering
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    • v.5 no.1
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    • pp.33-41
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    • 2009
  • The analog or partly digital typed interface of main control room in nuclear power plant (NPP) is gradually being replaced to the totally digitalized interface suitable for the digital environment. SKN 3,4 Nuclear Power Plant is currently developed in such a way to employ advanced displays and controls such as computerized procedure system(CPS), large display panel(LDP), and Soft control. According to the developed design process, the main control room (MCR) of the SKN3,4 was aesthetically designed based on a design concept of the health and sustainability and technically evaluated with human factors guidelines, which somehow lack of the confidence on the evaluation for the rapidly changing digital environment. The suitable review guideline for the digitalized interface and the environment was developed such as the guideline for CPS with information displays on VDU. For the guideline development, tremendous guidelines and technical papers related to evaluation issues of digital environment has been collected, analyzed and transformed to electric database forms and then built on database management system, called Design Review Supporting System to retrieve the appropriate issues for the practical usage of evaluators-in-field.

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The Japan Health Physics Society Guideline on Dose Monitoring for the Lens of the Eye

  • Yokoyama, Sumi;Tsujimura, Norio;Hashimoto, Makoto;Yoshitomi, Hiroshi;Kato, Masahiro;Kurosawa, Tadahiro;Tatsuzaki, Hideo;Sekiguchi, Hiroshi;Koguchi, Yasuhiro;Ono, Koji;Akiyoshi, Masahumi;Kunugita, Naoki;Natsuhori, Masahiro;Natsume, Yoshinori;Nabatame, Kuniaki;Kawashima, Tsunenori;Takagi, Shunji;Ohno, Kazuko;Iwai, Satoshi
    • Journal of Radiation Protection and Research
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    • v.47 no.1
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    • pp.1-7
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    • 2022
  • Background: In Japan, new regulations that revise the dose limit for the lens of the eye (hereafter the lens), operational quantities, and measurement positions for the lens dose were enforced in April 2021. Based on the international safety standards, national guidelines, the results of the Radiation Safety Research Promotion Fund of the Nuclear Regulation Authority, and other studies, the Working Group of Radiation Protection Standardization Committee, the Japan Health Physics Society (JHPS) developed a guideline for radiation dose monitoring for the lens. Materials and Methods: The Working Group of the JHPS discussed the criteria of non-uniform exposure and the management criteria set not to exceed the dose limit for the lens. Results and Discussion: In July 2020, the JHPS guideline was published. The guideline consists of three parts: main text, explanations, and 26 examples. In the questions, the corresponding answers were prepared, and specific examples were provided to enable similar cases to be addressed. Conclusion: With the development of the guideline on radiation dose monitoring of the lens, radiation managers and workers will be able to smoothly comply with revised regulations and optimize radiation protection.

The Improvement on the Empirical Formula of Stormwater Captured Ratio for Water Quality Volume Based Non-Point Pollutants Water Quality Control Basins (WQV 기반 비점오염저감시설의 강우유출수 처리비 경험공식의 개선)

  • Choi, Daegyu;Park, Moo Jong;Park, Bae Kyung;Kim, Sangdan
    • Journal of Korean Society on Water Environment
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    • v.30 no.1
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    • pp.87-94
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    • 2014
  • According to the technical guideline of water pollutant load management, the rainfall captured ratio which can be estimated by the empirical formula is an important element to estimate reduction loads of non-point pollutants water quality control basin. In this study, the rainfall captured ratio is altered to stormwater captured ratio considering its meaning in the technical guideline of water pollutant load management, and the new empircal formula of stormwater captured ratio is suggested. In order to do this, we calculate stormwater captured ratio by using the hourly rainfall data of seven urban weather stations (Busan, Daegu, Daejeon, Gangreung, Seoul, Gwangju, and Jeju) for 43 years. The regression coefficients of the existed empirical formula cannot reflect the catchment properties at all, because they are fixed values regardless of regions. However the empirical formula of stormwater captured ratio has flexible regression coefficients by runoff coefficient(C), so it is allowed to consider the characteristics of runoff in catchment. It is expected that reduction loads of storage based water quality control basin can be more reasonably estimated than before.