• Title/Summary/Keyword: life safety codes

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A Study on the Countermeasures Taken By the Korean Healthcare and Life Sciences Industry Regarding U.S. Import Refusals: Focus on the Analysis of FDA Violation Codes (한국 바이오헬스 산업의 미국 수입거부 대응 방안 연구 : FDA 위반코드 분석을 중심으로)

  • Yu-Han Lee;Hag-Min Kim
    • Korea Trade Review
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    • v.48 no.3
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    • pp.131-150
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    • 2023
  • The purpose of this study was to find a countermeasure to the U.S. import refusals for the Korean healthcare and life sciences industry. To this end, an analysis of trends during the pandemic was conducted using the KITA Border Rejection Database, which includes information on items and types of import refusals. The reason for rejection was also analyzed according to the FDA violation codes. The degree of countermeasure for import refusals was identified by measuring the unit rejection rate (URR). The results of the analysis showed that the major U.S. import refusals for the Korean healthcare and life sciences industry had expanded from contact lenses to COVID-19 diagnostic kits and drugs after the pandemic broke out. The major reasons for import refusals were non-compliance with the Predicate Device and Drugs Act and non-approval by the FDA for products and facilities. On the other hand, the unit rejection rate (URR) of major items in the Korean healthcare and life sciences industry was measured higher than the industry average. The results therefore showed a low level of response to U.S. import refusals. The results of the analysis of reasons for import refusals by item according to FDA violation codes were as follows. First of all, the main violation for contact lenses and COVID-19 diagnostic kits corresponded to misbranding. This was often due to the fact that Korean companies did not provide the relevant notices and information required by the FDA. Many cases also failed to demonstrate a substantial equivalency compared to predicate devices already on the market. On the other hand, applications for new unapproved drugs were not accepted as they had yet to pass relevant regulations that would prove their safety and efficacy. In conclusion, import refusals for the Korean healthcare and life sciences industry were found to be closely related to technical barriers to trade (TBT).

Breast Conserving Therapy and Quality of Life in Thai Females: a Mixed Methods Study

  • Peerawong, Thanarpan;Phenwan, Tharin;Supanitwatthana, Sojirat;Mahattanobon, Somrit;Kongkamol, Chanon
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.6
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    • pp.2917-2921
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    • 2016
  • Background: To explore factors that influence quality of life (QOL) in patients receiving breast conserving therapy (BCT). Materials and Methods: In this sequential mixed methods study, 118 women from Songklanagarind Hospital were included. We used participants' characteristics, Body Image Scale (BIS), and Functional Assessment of Cancer Therapy with the Breast Cancer Subscale (FACT-B) for analysis. The BIS transformed into presence of body image disturbance (BID). Factors that influenced QOL were determined by stepwise multiple linear regression. Forty-one participants were selected for qualitative analysis. Our female researcher performed the semi-structured interviews with questions based on the symbolic interaction theory. Final codes were analysed using thematic analysis along with investigator triangulation methods. Results: Ninety percent had early stage breast cancer with post-completed BCT, for an average of 2.7 years. The median BIS score and FACT-B score were 2 (IQR=10) and 130 (IQR=39). In the regression analysis, an age of more than 50 years and BID were significant factors. As for the value of conserved breasts, two themes emerged: a conserved breast is an essential part of a participant's life and also the representation of her womanhood; the importance of a breast is related to age. Conclusions: Body image influenced QOL in post BCT participants. The conserved breasts also lead to positive and better impact on their body image as an essential part of their life.

Analysis of Detection Ability Impact of Clang Static Analysis Tool by Source Code Obfuscation Technique (소스 코드 난독화 기법에 의한 Clang 정적 분석 도구의 성능 영향 분석)

  • Jin, Hongjoo;Park, Moon Chan;Lee, Dong Hoon
    • Journal of the Korea Institute of Information Security & Cryptology
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    • v.28 no.3
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    • pp.605-615
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    • 2018
  • Due to the rapid growth of the Internet of Things market, the use of the C/C++ language, which is the most widely used language in embedded systems, is also increasing. To improve the quality of code in the C/C++ language and reduce development costs, it is better to use static analysis, a software verification technique that can be performed in the first half of the software development life cycle. Many programs use static analysis to verify software safety and many static analysis tools are being used and studied. In this paper, we use Clang static analysis tool to check security weakness detection performance of verified test code. In addition, we compared the static analysis results of the test codes applied with the source obfuscation techniques, layout obfuscation, data obfuscation, and control flow obfuscation techniques, and the static analysis results of the original test codes, Analyze the detection ability impact of the Clang static analysis tool.

Damage assessment of buildings after 24 January 2020 Elazığ-Sivrice earthquake

  • Nemutlu, Omer Faruk;Balun, Bilal;Sari, Ali
    • Earthquakes and Structures
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    • v.20 no.3
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    • pp.325-335
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    • 2021
  • The majority of Turkey's geography is at risk of earthquakes. Within the borders of Turkey, including the two major active faults contain the North-Eastern and Eastern Anatolia, earthquake, threatening the safety of life and property. On January 24, 2020, an earthquake of magnitude 6.8 occurred at 8:55 p.m. local time. According to the data obtained from the stations in the region, peak ground acceleration in the east-west direction was measured as 0.292 g from the 2308 coded station in Sivrice. It is thought that the earthquake with a magnitude of Mw 6.8 was developed on the Sivrice-Puturge segment of the Eastern Anatolian Fault, which is a left lateral strike slip fault, and the tear developed in an area of 50-55 km. Aftershocks ranging from 0.8 to 5.1 Mw occurred following the main shock on the Eastern Anatolian Fault. The earthquake caused severe structural damages in Elazığ and neighboring provinces. As a result of the field investigations carried out in this study, significant damage levels were observed in the buildings since it did not meet the criteria in the earthquake codes. Within the study's scope, the structural damage cases in reinforced concrete and masonry structures were investigated. Many structural deficiencies and mistakes such as non-ductile details, poor concrete quality, short columns, strong beams-weak columns mechanism, large and heavy overhangs, masonry building damages and inadequate reinforcement arrangements were observed. Requirements of seismic codes are discussed and compared with observed earthquake damage.

A Study on the Reduction of Stress Concentration for the Breech System (잠금장치의 응력집중 저감에 관한 연구)

  • 이영신;류충현;송근영;김인우;이규섭;차기업
    • Journal of the Korea Institute of Military Science and Technology
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    • v.4 no.1
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    • pp.246-254
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    • 2001
  • The breech system can be considered as a pressure vessel with an internal plug under high explosive pressure. The system consists of a breech block(internal plug) whose front surface subjects to pressure, and a breech ring(pressure vessel). There is the geometric discontinuity around roots of connection parts and then stress concentration is introduced due to pressure, where contact effect may be ignored because contact plane between two equipments is parallel ideally, Generally high stress concentration phenomena shorten the life cycle of the mechanical system. It is well known that shock load is much more harmful on safety of the system than static load. In this present paper, several geometric design variables which may affect stress condition on the system are chosen and the parametric study on the design variables is carried using commercial FEM codes. Finally, the obtained results in the single lug breech system are applied to design the 3 lugs breech system. The 3 lugs breech system can reduce the maximum stress level.

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Examination of Seismic Design for High-Rise Steel Frames Under Huge Earthquake Using Element Bi-linear Time-History Analysis (부재별 탄소성 이력해석을 이용한 거대 지진에서의 고층 강구조 건물 내진 설계 검정)

  • Kim, Moon-Jeong
    • Journal of the Korean Society for Advanced Composite Structures
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    • v.2 no.4
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    • pp.28-34
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    • 2011
  • Because strong urban earthquakes must produce huge losses of both life and property, examinations about the effect of huge earthquakes for tall buildings are very required. The goal of this report is examining model safety and compare the behavior of 2-D tall models under huge seismic loads. This report examines high-rise models designed KBC2009 codes using 1) seismic loads regulated by KBC2009 and 2) amplified seismic loads assumed to strong earthquakes. And observing for more realistic behavior of tall buildings under huge earthquakes, this report takes two analysis methods - response spectrum analysis and non-linear time history analysis considering P-delta effect.

Shear stress indicator to predict seismic performance of residential RC buildings

  • Tekeli, Hamide;Dilmac, Hakan;Demir, Fuat;Gencoglu, Mustafa;Guler, Kadir
    • Computers and Concrete
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    • v.19 no.3
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    • pp.283-291
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    • 2017
  • A large number of residential buildings in regions subjected to severe earthquakes do not have enough load carrying capacity. The most of them have been constructed without receiving any structural engineering attention. It is practically almost impossible to perform detailed experimental evaluation and analytical analysis for each building to determine their seismic vulnerability, because of time and cost constraints. This fact points to a need for a simple evaluation method that focuses on selection of buildings which do not have the life safety performance level by adopting the main requirements given in the seismic codes. This paper deals with seismic assessment of existing reinforced concrete residential buildings and contains an alternative simplified procedure for seismic evaluation of buildings. Accuracy of the proposed procedure is examined by taking into account existing 250 buildings. When the results of the proposed procedure are compared with those of the detailed analyses, it can be seen that the results are quite compatible. It is seen that the accuracy of the proposed procedure is about 80% according to the detailed analysis results of existing buildings. This accuracy percentage indicates that the proposed procedure in this paper can be easily applied to existing buildings to predict their seismic performance level as a first approach before implementing the detailed and complex analyses.

The effect of finite element modeling assumptions on collapse capacity of an RC frame building

  • Ghaemian, Saeed;Muderrisoglu, Ziya;Yazgan, Ufuk
    • Earthquakes and Structures
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    • v.18 no.5
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    • pp.555-565
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    • 2020
  • The main objective of seismic codes is to prevent structural collapse and ensure life safety. Collapse probability of a structure is usually assessed by making a series of analytical model assumptions. This paper investigates the effect of finite element modeling (FEM) assumptions on the estimated collapse capacity of a reinforced concrete (RC) frame building and points out the modeling limitations. Widely used element formulations and hysteresis models are considered in the analysis. A full-scale, three-story RC frame building was utilized as the experimental model. Alternative finite element models are established by adopting a range of different modeling strategies. Using each model, the collapse capacity of the structure is evaluated via Incremental Dynamic Analysis (IDA). Results indicate that the analytically estimated collapse capacities are significantly sensitive to the utilized modeling approaches. Furthermore, results also show that models that represent stiffness degradation lead to a better correlation between the actual and analytical responses. Results of this study are expected to be useful for in developing proper models for assessing the collapse probability of RC frame structures.

Combining in-plane and out-of-plane behaviour of masonry infills in the seismic analysis of RC buildings

  • Manfredi, V.;Masi, A.
    • Earthquakes and Structures
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    • v.6 no.5
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    • pp.515-537
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    • 2014
  • Current seismic codes (e.g. the NTC08 Italian code and the EC8 European code) adopt a performance-based approach for both the design of new buildings and the assessment of existing ones. Different limit states are considered by verifying structural members as well as non structural elements and facilities which have generally been neglected in practice. The key role of non structural elements on building performance has been shown by recent earthquakes (e.g. L'Aquila 2009) where, due to the extensive damage suffered by infills, partitions and ceilings, a lot of private and public buildings became unusable with consequent significant socio-economic effects. Furthermore, the collapse of infill panels, particularly in the case of out-of-plane failure, represented a serious source of risk to life safety. This paper puts forward an infill model capable of accounting for the effects arising from prior in-plane damage on the out-of-plane capacity of infill panels. It permits an assessment of the seismic performance of existing RC buildings with reference to both structural and non structural elements, as well as of their mutual interaction. The model is applied to a building type with RC framed structure designed only to vertical loads and representative of typical Italian buildings. The influence of infill on building performance and the role of the out-of-plane response on structural response are also discussed.

Data Acquisition System Design of I&C System in Nuclear Power Plant (원자력 발전소 계측제어시스템의 정보취득장치 설계)

  • 조정환;이동희
    • Journal of the Korean Institute of Illuminating and Electrical Installation Engineers
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    • v.17 no.2
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    • pp.102-108
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    • 2003
  • This paper presents a new Data acquisition system that can improve a accuracy and response characteristics by designing a SDAS(Signal Datat Acquisition System). I&C(Instrumentation and Control) system, which it applied for Nuclear Power Plant, affects for safety either directly or indirectly. It should be assessed by the equipment qualification procedure to confirm the functionality during design life before it apply on the nuclear power plant depending on safety classification. This paper proposes data acquisition system that required as an essential measurement equipment in the method and procedure of equipment qualification following of standards and codes of IEEE and Nuclear Regulatory Guide. It provides comparable and experimental studies have been carried out. The presented results from the above investigation show considerably improved accuracy performance in the data acquisition system. This circuit will be able to be used in high performance I&C system.