• Title/Summary/Keyword: compliance center

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Preliminary Evaluation of Handling Qualities of a SAR(Search & Rescue) Helicopter Simulator Based on ADS-33 Requirements (ADS-33 평가기준에 따른 소방헬기 비행시뮬레이터의 비행조종성 예비평가)

  • Yoon, Sugjoon;Kim, Donghyun;Seong, Eunhye;Park, Taejun;Hwang, Hoyon;Ahn, Jon;Lee, Junghoon
    • Journal of the Korean Society for Aeronautical & Space Sciences
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    • v.44 no.9
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    • pp.796-805
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    • 2016
  • As a part of the first stage in the helicopter flight simulator development, this study numerically evaluates handling qualities of the dynamics model. The flight dynamics model was generated using public information for AS365 N2, the target aircraft of the simulator. The flight simulator is under development as a pilot training and research tool for firefighting missions. The assessment of the model intends to validate general characteristics and suitability before the model is enhanced with flight test data. The evaluation is based on the ADS-33E-PRF(Aeroautical Design Standard Performance Specification Handling Qualities Requirement) criteria, with consideration of category of the aircraft, missions, and environment. The numerical operations follow required or recommended procedures of flight test for compliance demonstration. Evaluation results are evaluated according to the rating specified in maneuverability ADS-33E-PRF. Results have identified to provide a satisfactory platform for flight dynamic model in the general helicopter simulator generated based on the RotorLibFDM, and can be used as a base for basic training and research.

Analysis of Indicated Points and Main Factors Affecting the Quality of Clinical Research for the Development of Internal Audit Tools (자체점검 도구 개발을 위한 지적사항 및 임상연구의 품질에 작용하는 요인 분석)

  • Hye Yun Jang;Jung-Hee Jang;Yoon Jin Lee
    • The Journal of KAIRB
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    • v.5 no.1
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    • pp.14-20
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    • 2023
  • Purpose: To obtain fundamental data on selection tools for an internal audit and develop a new guideline. We scored the indicated points from the internal audit, identified the research progress and problems that occurred, and confirmed the validity of the risk factors involved. Methods: Of the 63 internal audits conducted by Keimyung University Dongsan Hospital from 2014 to 2021, we analyzed 55 clinical trials with an inspection checklist. We excluded 8 that failed to transfer data and refused to comply with the internal audit. The statistical summary of the collected data was verified and interpreted by using frequency analysis and a chi-square test. Result: Of total 55 cases included in the internal audit, sponsor-initiated trial (SIT) was 63.6% (vs. investigator-initiated trial [IIT]), clinical trial for investigational drug was 71.0% (vs. nonclinical or clinical trial for investigational device), domestic multicenter trial was 60.0% (vs. single center or multinational multicenter trial), and trial requisition for MFDS approval was 69.1% (vs. exception for MFDS approval). The 10 areas of the clinical trial inspection checklist (reports, protection of subjects, compliance with protocols, records, management of investigational drug and/or device, delegation of duties, qualification of investigators, management of specimen, contract-agreement and approval of protocols, and preservation of recorded documents) were weighted between 2 to 5 points. The average of the total points was 16.09±13.2 and 20 clinical trials were above the average. As a result of comparing the average of the total points weighted by year, the highest score was in 2020. The 4 factors that play significant roles in determining the internal quality were (1) principal subjects that initiated the clinical trials (p=0.049), (2) type (p=0.003), (3) phase of clinical trials (p=0.024), and (4) number of registered subjects reported at the time of continuing deliberation (p=0.019). Of the 10 areas of the clinical trial inspection checklist, 'record' was the most inappropriate and insufficient. We found more indicated points; the quality of performance declined in IIT, nonclinical trials, and other clinical trials that were not in phase I1-IV4, and the study of more than 30 registered subjects at the time of continuing review. Conclusion: If an institution has an internal audit selection tool that reflects the aforementioned risk factors, it will be possible to effectively manage high-risk studies; thereby, contributing to an efficient internal audit and improving the quality of clinical trials.

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Development of the Regulatory Impact Analysis Framework for the Convergence Industry: Case Study on Regulatory Issues by Emerging Industry (융합산업 규제영향분석 프레임워크 개발: 신산업 분야별 규제이슈 사례 연구)

  • Song, Hye-Lim;Seo, Bong-Goon;Cho, Sung-Min
    • Journal of Intelligence and Information Systems
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    • v.27 no.3
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    • pp.199-230
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    • 2021
  • Innovative new products and services are being launched through the convergence between heterogeneous industries, and social interest and investment in convergence industries such as AI, big data-based future cars, and robots are continuously increasing. However, in the process of commercialization of convergence new products and services, there are many cases where they do not conform to the existing regulatory and legal system, which causes many difficulties in companies launching their products and services into the market. In response to these industrial changes, the current government is promoting the improvement of existing regulatory mechanisms applied to the relevant industry along with the expansion of investment in new industries. This study, in these convergence industry trends, aimed to analysis the existing regulatory system that is an obstacle to market entry of innovative new products and services in order to preemptively predict regulatory issues that will arise in emerging industries. In addition, it was intended to establish a regulatory impact analysis system to evaluate adequacy and prepare improvement measures. The flow of this study is divided into three parts. In the first part, previous studies on regulatory impact analysis and evaluation systems are investigated. This was used as basic data for the development direction of the regulatory impact framework, indicators and items. In the second regulatory impact analysis framework development part, indicators and items are developed based on the previously investigated data, and these are applied to each stage of the framework. In the last part, a case study was presented to solve the regulatory issues faced by actual companies by applying the developed regulatory impact analysis framework. The case study included the autonomous/electric vehicle industry and the Internet of Things (IoT) industry, because it is one of the emerging industries that the Korean government is most interested in recently, and is judged to be most relevant to the realization of an intelligent information society. Specifically, the regulatory impact analysis framework proposed in this study consists of a total of five steps. The first step is to identify the industrial size of the target products and services, related policies, and regulatory issues. In the second stage, regulatory issues are discovered through review of regulatory improvement items for each stage of commercialization (planning, production, commercialization). In the next step, factors related to regulatory compliance costs are derived and costs incurred for existing regulatory compliance are calculated. In the fourth stage, an alternative is prepared by gathering opinions of the relevant industry and experts in the field, and the necessity, validity, and adequacy of the alternative are reviewed. Finally, in the final stage, the adopted alternatives are formulated so that they can be applied to the legislation, and the alternatives are reviewed by legal experts. The implications of this study are summarized as follows. From a theoretical point of view, it is meaningful in that it clearly presents a series of procedures for regulatory impact analysis as a framework. Although previous studies mainly discussed the importance and necessity of regulatory impact analysis, this study presented a systematic framework in consideration of the various factors required for regulatory impact analysis suggested by prior studies. From a practical point of view, this study has significance in that it was applied to actual regulatory issues based on the regulatory impact analysis framework proposed above. The results of this study show that proposals related to regulatory issues were submitted to government departments and finally the current law was revised, suggesting that the framework proposed in this study can be an effective way to resolve regulatory issues. It is expected that the regulatory impact analysis framework proposed in this study will be a meaningful guideline for technology policy researchers and policy makers in the future.

Postoperative Adjuvant MVP Chemotherapy and Radiotherapy for Non-Small Cell Lung Cancer (비소세포성폐암의 수술후 MVP복합화학요법과 방사선병용치료 결과)

  • Kim, Jong-Hoon;Choi, Eun-Kyung;Chang, Hyesook;Kim, Sang-Wee;Suh, Chul-won;Lee, Kyoo-Hyung;Lee, Jung, Shin;Kim, Sang-Hee;Kim, Woo-Sung;Kim, Dong-Soon;Kim, Won-Dong;Park, Seung-Il;Sohn, Kwang-Hyun
    • Radiation Oncology Journal
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    • v.13 no.2
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    • pp.149-156
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    • 1995
  • Purpose : Since February 1991 a Prospective study for non-small cell lung cancer patients who underwent radical resection and had a risk factor of positive resection margin or regional lymph node metastasis has been conducted to evaluate the effect of MVP chemotherapy and radiotherapy on the pattern of failure, disease free and overall survival. and tolerance of combined treatment. Materials and Methods: Twenty nine patients were registered to this study until Sep. 1993; of these 26 received planned therapy Within 3 weeks after radical resection, two cycles of MVP(Mitomycin C $6mg/m^2,$ Vinblastin $6mg/m^2,$ Cisplatin $60mg/m^2$) chemotherapy was given with 4 weeks intervals. Radiotherapy (5040cGy tumor bed dose and 900cGy boost to high risk area) was started 3 to 4 weeks after chemotherapy. Results: One and two year overall survival rates were $76.5\%\;and\;58.6\%$ respectively. Locoregional failure developed in 6 patients$(23.1\%)$ and distant failure in 9 patients$(34.6\%)$ Number of involved lymph nodes, resection margin positivity showed some correlation with failure pattern but T-stage and N-stage showed no statistical significance. The group of patients who received chemotherapy within 2 weeks postoperatively and radiotherapy within 70 days showed lower incidence of distant metastasis. Postoperative combined therapy were well tolerated without definite increase of complication rate, and compliance rate in this study was $90\%$. Conclusion: 1) MVP chemotherapy showed no effect on locoregional recurrence, but appeared to decrease the distant metastasis rate and 2) combined treatments were well tolerated in all patients. 3) The group of patients who received chemotherapy within 2 weeks postoperatively and radiotherapy within 70days showed lower incidence of distant metastasis. 4) Addition of chemotherapy to radiotherapy failed to increase the overall or disease free survival.

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A Study for Investigating of Predictors of Compliance for Preventive Health Behavior. -centered on early detection of cervical cancer- (예방적 건강행위 이행의 예측인자 발견을 위한 연구-자궁암 조기발견을 중심으로-)

  • 이종경
    • Journal of Korean Academy of Nursing
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    • v.12 no.1
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    • pp.25-38
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    • 1982
  • As technological civilization and medical science has developed, standards of living have imp-roved and human life expectancy has been extended. But the incidence and mortality rate of cancer have been gradually increasing due to the pollution of the environment. Even though cancer is still a great threat to human beings, the etiology and appropriate cure forcancerhavenotyetbeendiscovered. The early detection and treatment of cancer is urgently needed. This study concentrates on the health behavior of woman regarding the papanicolau smear for early detection of cervical cancer. It was done in order to provide a direction for scientific health education materials by investigating predictors of preventive health behavior. The subjects for this study were made up of 54 woman, who comply with preventive health practices(compliant) who attended the Cervical Cancer Center of Y University Hospital in order to have tests for early detection of cervical cancer and 54 woman who did not comply with preventive health practices (noncompliant) selected from 100 housewives of I apartment, Kang Nam Ku, Seoul. The study method used, was a questionnaire for the compliance group and an interview for the noncompliance group. The period for data collection was from October 13th to October 24th. 1981. Analysis of the data was done using percentages, T-test, Pearson Correlation and Stepwise Multiple Regression. The results of study were as follows: 1. The hypotheses tested were based on the health belief model; 1) The first hypothesis,“The compliant may have more knowledge of the cervical cancer than the noncompliant”was rejected(T=-1.86, p>.05) 2) The second hypothesis,“The compliant may have a higher severity of cervical cancer than the noncompliant”was accepted (T=5.41, p<.001) 3) The third hypothesis, “The compliant may have a higher susceptability to cervical cancer than the noncompliant”was accepted(T=3.51, p<.01). 4) The fourth hypothesis,“The compliant may have more beneHt than cost'from the cervical cancer tests than the noncompliant" was accepted(T=7.46, p<.001). 5) The fifth hypothesis,“The compliant may have more health concern than the noncompliant”. was accepted(T=3.39, p<.01). These results show that severity, susceptability, benefit(over cost) and health concern influence the preventive health behavior in this Study. 2. In the correlation among variables, it was found that the knowledge of cervical cancer and the benefit(over cost) of preventive health behavior were negatively correlated(r=-2.75, p<.01), Severity of cervical cancer and benefit (over cost) of preventive health behavior were positively correlated(r=.280, p<.01), severity and susceptability of cervical cancer were positively correlated(r= .238, p<.01), benefit(over cost) and health concern were positively correlated(r= .299, p<.01). The benefit(over cost) may be raised by increasing the severity and health concern. Therefore the compliance rate of woman may be raised through health education by increasing the benefit(over cost) of the individual. 3. The Stepwise Multiple Regression between health behavior and predictors. 1) The factor“Benefit(over cost)”could account for preventive health behavior in 34.4% of the sample(F=55.6204 P<.01). 2) When the factor“Severity”is added to this, it accounts for 44.3% of preventive health behavior(F=41.679, p<.01). 3) When the factor“Susceptability”is also included, it accounts for 46.7% of preventive health behavior(F=30.373, p<.01). 4) When the factor “Health concern”is included, it accounts for 48.1% of preventive health behavior(F=23859, p<.05). This means that other factors appear to influence preventive health behavior, since the combination of variables explains only 48.1% of the Preventive health behavior. Therefore further study to investigate the predictors of preventive health behavior is necessary.

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Is Radiotherapy Necessary for Stage 1 Testicular Seminoma? (제1병기 성인 고환 정상피종에 대한 임상적 고찰 및 치료결과 분석)

  • Lee, Jung-Ae;Park, Won;Lim, Do-Hoon;Ahn, Yong-Chan;Huh, Seung-Jae;Yu, Jeong-Il;Choi, Han-Yong;Lee, Hyun-Moo;Cho, Eun-Yoon
    • Radiation Oncology Journal
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    • v.27 no.2
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    • pp.49-54
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    • 2009
  • Purpose: To report on the clinical outcome of patients with stage I testicular seminoma by postoperative radiotherapy (PORT) or surveillance after radical inguinal orchiectomy. Materials and Methods: This study is a retrospective review of 32 stage I pure seminoma patients treated between 1996 and 2005 at the Samsung Medical Center. Twenty two of the patients were treated by PORT, which was directed at the paraaortic lymphatics with a median dose of 25.2 Gy in 14 fractions for 3 weeks. The 10 remaining patients were managed by surveillance. The median follow-up period was 96 months with a range of 24 to 155 months. Results: Clinically, most patients presented with a testicular mass or discomfort. Two of the patients had a history of undescended testes. Pathologically, 23 of the patients had intratubular germ cell neoplasia with seminoma. Both recurrence-free survival (RFS) and overall survival (OS) rates of patients treated by PORT were 100%. In the control group, 1 of the 10 patients suffered a para-aortic lymph node relapse. The RFS and OS rates of the surveillance group were 88.9% and 100%, respectively. Conclusion: No difference in survival was observed between the two groups. Moreover, symptom recurrence was only observed in 1 patient in the control group. The use of PORT may reduce the risk of relapse. With the availability of effective diagnostic and salvage modalities, surveillance monitoring may be considered for patients in good compliance.

Estimate and Environmental Assessment of Greenhouse Gas(GHG) Emissions and Sludge Emissions in Wastewater Treatment Processes for Climate Change (기후변화를 고려한 하수처리공법별 온실가스 및 슬러지 배출량 산정 및 환경성 평가)

  • Oh, Tae-Seok;Kim, Min-Jeong;Lim, Jung-Jin;Kim, Yong-Su;Yoo, Chang-Kyoo
    • Korean Chemical Engineering Research
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    • v.49 no.2
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    • pp.187-194
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    • 2011
  • In compliance with an international law about the ocean dumping of the sludge, the proper sewage treatment process which occurs from the wastewater treatment process has been becoming problem. Generally the sewage and the sludge are controlled from anaerobic condition when the sewage is treated and land filled, where the methane$(CH_{4})$ and the nitrous oxide $(N_{2}O)$ from this process are discharged. Because these gases have been known as one of the responsible gases for global warming, the wastewater treatment process is become known as emission sources of green house gases(GHG). This study is to suggest a new approach of estimate and environmental assessment of greenhouse gas emissions and sludge emissions from wastewater treatment processes. It was carried out by calculating the total amounts of GHG emitted from biological wastewater treatment process and the amount of the sludgegenerated from the processes. Four major biological wastewater treatment processes which are Anaerobic/Anoxic/Oxidation$(A_{2}O)$, Bardenpho, Virginia Initiative Plant(VIP), University of Cape Town(UCT)are used and GPS-X software is used to model four processes. Based on the modeling result of four processes, the amounts of GHG emissions and the sludge produced from each process are calculated by Intergovernmental Panel on Climate Change(IPCC) 2006 guideline report. GHG emissions for water as well as sludge treatment processes are calculated for environmental assessment has been done on the scenario of various sludge treatments, such as composting, incineration and reclamation and each scenario is compared by using a unified index of the economic and environmental assessment. It was found that Bardenpho process among these processes shows a best process that can emit minimum amount of GHG with lowest impact on environment and composting emits the minimum amount of GHG for sludge treatment.

The Changes of Physiologic Parameters with Time in Steroid treated-Late Acute Respiratory Distress Syndrome Patients (스테로이드를 투여한 후기 급성호흡곤란증후군 환자에서 시간경과에 따른 생리학적 지표의 변화)

  • Jeon, Ik Soo;Suh, Gee Young;Koh, Won-Jung;Pyun, Yu Jang;Kang, Eun Hae;Ham, Hyoung Suk;Oui, Misook;Chung, Man Pyo;Kim, Hojoong;Kwon, O Jung
    • Tuberculosis and Respiratory Diseases
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    • v.54 no.4
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    • pp.429-438
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    • 2003
  • Background : The mortality from acute respiratory distress syndrome(ARDS) is >40-50%. Although some prospective trials have failed to demonstrate a survival benefit of steroids in the early stages of ARDS, there are some reports showing some success with steroids in the later stages. This study observed the changes in the physiologic parameters with time in late ARDS patients who were treated with steroids. Methods : The medical charts of 28 intensive care unit patients(male:female=24:4; mean age 64 years), who had been diagnosed with refractory late ARDS ($PaO_2/FIO_2$ <200) and were treated with corticosteroids from December 1999 to July 2002, were retrospectively reviewed. The patients were divided into two groups: the weaned group(n=14), which included the patients who had been successfully weaned from a ventilator after corticosteroid therapy, and the failed group(n=14), which included the patients who had failed weaning. The physiologic parameters included the $PaO_2/FIO_2$ ratio, the positive end-expiratory pressure(PEEP) level, the $PaCO_2$, compliance, the sequential organ failure assessment(SOFA) score, the acute physiologic and the chronic health evaluation(APACHE) II score, and the Murray Lung Injury Score(LIS) in the two groups were compared from the day of mechanical ventilation(Dmv) to 7 days after the corticosteroid therapy. Results : There was no significant difference in the clinical characteristics and the physiologic parameters between the two groups prior to the corticosteroid therapy except for the SOFA score at Dmv(weaned group : $6.6{\pm}2.5$ vs failed group : $8.8{\pm}2.9$, p=0.047). However, within 7 days after corticosteroid therapy, there was significant improvement in the $PaO_2/FIO_2$ ratio, the PEEP level, the $PaCO_2$, the SOFA score, the APACHE II score, and the LIS of the weaned group compared to the failed group. Conclusions : During corticosteroid therapy in late ARDS, the continuation of corticosteroid therapy should be determined carefully in patients who do not show improvement in their physiologic parameters by day 7.

A study on the management of drawings of Metropolitan Rapid Transit (도시철도 도면 관리에 관한 연구 -서울시 도시철도공사를 중심으로-)

  • Kim, Miyon
    • The Korean Journal of Archival Studies
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    • no.11
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    • pp.181-214
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    • 2005
  • Metropolitan rapid transit system plays an essential role in the public transportation system of any large city, and its managing agency is usually charged with the responsibility of storing and managing the design drawings of the system. The drawings are important and historically valuable documents that must be kept permanently because they contain comprehensive data that is used to manage and maintain the system. However, no study has been performed in Korea on how well agencies are preserving and managing these records. Seoul Metropolitan Rapid Transit Corporation(SMRT) is the managing agency established by the city of Seoul to operate subway lines 5, 6, 7, and 8 more efficiently to serve its citizens. By the Act on Records Management in Public Institutions(ARMPI), SMRT should establish a records center to manage its records. Furthermore, all drawings produced by SMRT and other third party entities should be in compliance with the Act. However, SMRT, as a form of local public corporation, can establish a records center by its own way. Accordingly, the National Archives & Records Service(NARS) has very little control over SMRT. Therefore, the purpose of this study is to research and analyze the present state of storage and management of the drawings of metropolitan rapid transit in SMRT and is to find a desirable method of preservation and management for drawings of metropolitan rapid transit. In the process of the study, it was found that a records center is being considered to manage only general official documents and not to manage the drawings as required by ARMPI. SMRT does not have a records center, and the environment of management on the drawings is very poor. Although there is a plan to develop a new management system for the drawings, it will be non-compliant of ARMPI. What's happening at SMRT does not reflect the state of all other cities' metropolitan rapid transit records management systems, but the state of creation of records center of local public corporation is the almost same state as SMRT. There should be continuous education and many studies conducted in order to manage the drawings of metropolitan rapid transit efficiently by records management system. This study proposes a records center based on both professional records centers and union records centers. Although metropolitan rapid transit is constructed and managed by each local public corporation, the overall characteristics and processes of metropolitan rapid transit projects are similar in nature. In consideration of huge quantity, complexity and specialty of drawings produced and used during construction and operation of metropolitan rapid transit, and overlap of each local public corporation's effort and cost of the storage and management of the drawings, they need to be managed in a professional and united way. As an example of professional records center, there is the National Personnel Records Center(NPRC) in St. Louis, Missouri. NPRC is one of the National Archives and Records Administration's largest operations and a central repository of personnel-related records on former and present federal employees and the military. It provides extensive information to government agencies, military veterans, former federal employees, family members, as well as researchers and historians. As an example of union records center, there is the Chinese Union Dangansil. It was established by several institutions and organizations, so united management of records can be performed and human efforts and facilities can be saved. We should establish a professional and united records center which manages drawings of metropolitan rapid transit and provides service to researchers and the public as well as members of the related institutions. This study can be an impetus to improve interest on management of not only drawings of metropolitan rapid transit but also drawings of various public facilities.

Topology Design Optimization and Experimental Validation of Heat Conduction Problems (열전도 문제에 관한 위상 최적설계의 실험적 검증)

  • Cha, Song-Hyun;Kim, Hyun-Seok;Cho, Seonho
    • Journal of the Computational Structural Engineering Institute of Korea
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    • v.28 no.1
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    • pp.9-18
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    • 2015
  • In this paper, we verify the optimal topology design for heat conduction problems in steady stated which is obtained numerically using the adjoint design sensitivity analysis(DSA) method. In adjoint variable method(AVM), the already factorized system matrix is utilized to obtain the adjoint solution so that its computation cost is trivial for the sensitivity. For the topology optimization, the design variables are parameterized into normalized bulk material densities. The objective function and constraint are the thermal compliance of the structure and the allowable volume, respectively. For the experimental validation of the optimal topology design, we compare the results with those that have identical volume but designed intuitively using a thermal imaging camera. To manufacture the optimal design, we apply a simple numerical method to convert it into point cloud data and perform CAD modeling using commercial reverse engineering software. Based on the CAD model, we manufacture the optimal topology design by CNC.