• Title/Summary/Keyword: Device safety

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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).

Assessment of Environmental Pollution in Korean Stream Sediments by Chemical Analyses and Insect Immune Biomarkers

  • Ryoo, Keon-Sang;Byun, Sang-Hyuk;Hong, Yong-Pyo;Cho, Ki-Jong;Bae, Yeon-Jae;Kim, Yong-Gyun
    • Korean Journal of Environmental Biology
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    • v.26 no.4
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    • pp.330-342
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    • 2008
  • A comprehensive quality survey for PCDDs/PCDFs and coplanar PCBs as well as heavy metals (Cu, Zn, Cd and Pb) in sediments has been investigated in August 2006, Korea. Monitoring was undertaken at five streams representing different surrounding environments throughout Juwang and Gapyeong streams (reference sites), Jungrang stream (dense population site), Ansan stream (mixed small population and industrial site), and Siheung stream (heavy industrial site). The levels of heavy metal in samples were found to be significantly higher in sediment from Siheung stream compared to those of other stream sites. The heavy metal concentrations (dry weight basis) in sediment from Siheung stream were as follows; Cd (3.7 ${\mu}g$/g), Pb (1,295 ${\mu}g$/g), Cu (713.4 ${\mu}g$/g) and Zn (358.1 ${\mu}g$/g). Among 12 coplanar PCBs and 17 PCDDs/PCDFs selected as target compounds in this study, PCB (IUPAC no. 118) and OCDD were the most abundant congeners found in all sediment samples, followed by 1,2,3,4,6,7,8-HpCDD, OCDF and 1,2,3,4,6,7,8HpCDF as well as PCB (IUPAC no. 105). These results were shown to be in the same trend as the sediment samples of other countries. The levels of PCDDs/PCDFs/coplanar PCBs in sediment samples were expressed as concentrations and WHO- TEQ values. The PCDDs/PCDFs/coplanar PCBs concentrations and their WHO-TEQ values in sediment from Siheung stream were remarkably high. The levels detected were 788.16 pg/g and 36.080 pg WHO-TEQ/g dry weight for PCDDs/ PCDFs and 314 pg/g and 0.4189 pg WHO-TEQ/g dry weight for coplanar PCBs, respectively, beyond the safety level of sediment value 20 pg WHO-TEQ/g. Sediment samples of the five streams were also monitored by sensitive biomarkers using insect immune responses: hemocyte-spreading behavior and immune-associated enzyme activities of phospholipase A$_2$ (PLA$_2$) and phenoloxidase. Organic extracts of Siheung and Jungrang sediments significantly interfered with the hemocytespreading behavior, whereas those of Ansan, Gapyeong, and Juwang did not. These organic extracts did not inhibit the PLA$_2$ and phenoloxidase activities. However, phenoloxidase was highly susceptible to exposure to aqueous extracts in all site sediments. In comparison, PLA$_2$ activities of the hemocytes were significantly inhibited only by aqueous extracts of Siheung, Jungrang, and Gapyeong sediments, but not by those of Ansan and Juwang. Despite some disparity between bioand chemical monitoring results, the biomarkers can be recommended as a device warning the contamination of biohazard environmental chemicals because of a fast and inexpensive detection method.

A Design of Fire-Command Synchronous Satellite Pyrotechnic Circuit (점화 명령에 동조된 인공위성 파이로테크닉 회로 설계)

  • Koo, Ja Chun;Ra, Sung Woong
    • Journal of Korea Society of Industrial Information Systems
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    • v.18 no.5
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    • pp.81-92
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    • 2013
  • The satellite includes many release mechanisms such as solar array deployment, antenna deployment, cover to protect contamination in scientific equipment, pyro value of the propulsion subsytem, and bypass device in Li-Ion cell module. A drive the initiators is a critical to the successful mission because the initiators of release mechanism driving by the pyrotechnic circuit is operated in single short. The pyrotechnic circuit has to provide switching network for safety. A typical switching network has defect consisting of high current rating fire switch to handle switching transient current during fire the initiator. The pyrotechnic circuit is required some form of power conditioning to reduce the peak power demanded from the bus if the initiators are to be fired from the main bus. This paper design a pyrotechnic circuit synchronized to the fire-command to activate the fire switch to overcome use high current rating fire switch to handle switching transient current during fire the initiator. The pyrotechnic circuit provides a current limited widow pulse for fire current synchronized to the fire-command to insure that fire switch will only carry the current but never switch it. The current limited widow pulse for fire current can be possible to use low current rating and light mass switch in switching network. The current limit function in the pyrotechnic circuit reduces supply voltage to initiator and provides the effect of power conditioning function to reduce peak bus power. The pyrotechnic circuit to apply satellite development on geostationary orbit is verified the function by test in development model.

Effects of Dermal Cell Combination on the Formation of Basement membrane and Epidermis in Skin Equivalents (진피세포의 조성이 인공피부의 기저막과 표피형성에 미치는 영향)

  • Li, Hai-Lan;Jeong, Hyo-Soon;Kim, Jan-Di;Yun, Hye-Young;Baek, Kwang-Jin;Kwon, Nyoun-Soo;Min, Young-Sil;Park, Kyoung-Chan;Kim, Dong-Seok
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.38 no.3
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    • pp.219-224
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    • 2012
  • European Union prohibited the marketing of cosmetic products containing constituents that have been examined through animal experiments. Thus, non-animal test models are needed to replace animal experiments. The reconstructed skin models are important as a test system for cosmetic, pharmaceutical, and medical device safety testing. In the present study, we tried to develop an optimal skin equivalent model containing basement membrane and epidermis. For this purpose, we used mesenchymal stem cells (MSCs) and/or preadipocytes as well as fibroblasts as the dermal matrix cells. The formation of basement membrane and epidermis was verified by immunohistochemical stains. Among various models, the epidermis was thickest when MSCs were used in the dermal matrix. Furthermore, PCNA and involucrin distribution showed that dermal matrix with MSCs resembled human skin. Therefore, skin equivalents with MSCs could be developed as a non-animal test model to replace animal experiments.

Experimental Evaluation of Prestress Force in Tendons for Prestressed Concrete Girders using Sensors (계측 센서를 활용한 PSC 거더 텐던의 긴장력 측정 실험)

  • Shin, Kyung-Joon;Park, Young-Ung;Lee, Seong-Cheol;Kim, Yun Yong;Lee, Hwan-Woo
    • Journal of the Computational Structural Engineering Institute of Korea
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    • v.28 no.6
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    • pp.715-722
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    • 2015
  • The prestressing force has not been managed after construction nevertheless it is one of the importrant factors that maintain the structural safety of PSC girder bridges. The prestressing force is just measured during construction using jacking device and after that, it can not be managed practically. For this reason, this study investigated the measurements of prestress using embedded sensors that can be available now with an ultimate goal to propose smart prestressed girders that can measure the prestress from the birth to the end of service life. 4 types of sensors were installed on the small prestressed girders, and the applicability and the accuracy of those sensors were tested while the prestress was applied to the girders. The results show that a center-hole type loadcell has a tendency to measure a prestressing force higher than a reference value, especially when it is loaded with an eccentricity. a EM sensor shows several advantages that has a good practical accuracy, that can be installed anyplace along the tendons.

The Improvement Index of Smart Public Services to Advance Information Accessibility for the Elderly (고령자 정보접근성 향상을 위한 스마트 공공서비스 지표)

  • Kim, Mi-Yun;Byun, Sung-Jun
    • Journal of Digital Convergence
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    • v.16 no.5
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    • pp.43-53
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    • 2018
  • Recently, public service for the improvement of quality of life and life support such as safety, aging, disaster, welfare, housing, economy, urban environment, traffic etc are actively developed based on open public data, and the spread of the network and the necessity of everyday life, smartphones are playing a role in providing public services. Currently, the development of science is changing the life expectancy of human beings and changing into social structure in which aged people become bigger due to various social conditions and low fertility and aging problems. However, the elderly who do not have easy access to information are very uncomfortable in dealing with mobile devices with very low accessibility and utilization of public services provided by mobile phones. Therefore, this study recategorizes the condition of the elderly presented in the previous study and identifies the problem through case analysis provided for the elderly. Also, we summarize the hierarchy of the core items of the existing interface design and derive it as an improvement index of the public service design for the improvement of the information accessibility of the elderly, and propose a design method to improve the utilization of the public service provided through the mobile device.

A Research on the Characteristics of EEG Information on Drive Behavior (운전거동에 따른 운전자 뇌파특성에 관한 연구)

  • Oh, Dong-Hun;Namgung, Moon;Park, Hee-Soon
    • The Journal of The Korea Institute of Intelligent Transport Systems
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    • v.14 no.5
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    • pp.23-29
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    • 2015
  • In this study, human is the subject of driving a car, the actual EEG is a biological information in a number of reactions that are displayed while driving the vehicle by using a measuring device, occurs during travel of the road EEG to be collected, number of experiments the collected material on the basis of changes associated with running time, extracts the factors such as changes due to road geometry, and analysis was performed. The required changes in the EEG occurring during traveling experiment analysis alpha (${\alpha}$) waves, beta (${\beta}$) wave, after the primary extraction in the form of gamma (${\gamma}$) faction, the brain wave frequency of the entire period of the experiment change rate extracts, to calculate the change in frequency in response to EEG characteristics by applying the regression model to observe a learning effect in response to an increase in the number of experiments, as a result, depending on the number of experiments, EEG changes due to individual differences. The show, by repeatedly driving a section like this, it was possible to verify that comfortably travels driver accustomed in accordance with the stored road geometry and signal, safety facilities.

Study on Dissolution Condition of Monsanto Catalyst (몬산토 촉매의 용해방법에 관한 연구)

  • Choi, Kwang Soon;Lee, Chang Heon;Pyo, Hyung Yeol;Park, Yang Soon;Joe, Kih Soo;Kim, Won Ho
    • Analytical Science and Technology
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    • v.14 no.4
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    • pp.317-323
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    • 2001
  • Dissolution procedures of Monsanto catalyst which has been used to produce acrylronitrile by ammoxidation of propylene have been studied. Optimum dissolution condition of the catalyst supported on silica was obtained by microwave digestion system with mixed of HCl, HF and $H_2O_2$. When a safety device was activated by increased pressure in microwave vessel, Bi, Fe, Mo, Sb and U were not volatilized even though silica was volatilized as $SiF_4$. Quantification results by this method were $SiO_2$ $50.5{\pm}0.4%$, $Sb_2O_3$ $29.6{\pm}0.6%$, $UO_2$ $10.2{\pm}0.1%$, $Fe_2O_3$ $6.1{\pm}0.1%$, $MoO_3$ $0.73{\pm}0.01%$ and $Bi_2O_3$ $0.49{\pm}0.01%$ by ICP-AES and the relative error was within ${\pm}10%$ except bismuth.

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A Study on Authentication Management and Communication Method using AKI Based Verification System in Smart Home Environment (스마트 홈 환경에서 AKI기반 검증 시스템을 활용한 인증관리 및 통신 기법에 관한 연구)

  • Jin, Byung Wook;Park, Jung Oh;Jun, Moon Seog
    • The Journal of the Institute of Internet, Broadcasting and Communication
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    • v.16 no.6
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    • pp.25-31
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    • 2016
  • With the development of IOT technology and the expansion of ICT services recently, a variety of home network services have been advanced based on wired and wireless high speed telecommunication. Domestic and global companies have been studying on the innovative technology for the users using IOT based technology and the environment for the smart home services has been gradually developed. The users live their lives with more convenience due to the expansions and developments of smart phones. However, the threatening on the security of the smart home network had occurred by various attacks with the connection to the smart environment telecommunication, lack of applications on low powered and light weight telecommunication, and the problems of security guideline. In addition, the solutions are required for the new and variant attacking cases such as data forgery and alteration of the device for disguising approach with ill will. In this article, the safe communication protocol was designed using certification management technique based on AKI which supplemented the weakness of PKI, the existing certification system in the smart environment. Utilizing the signature technique based on ECDSA, the efficiency on the communication performance was improved, and the security and the safety were analyzed on the security threat under the smart home environment.

A Study on Improvement of Operation Characteristics and Inspection Method of Standby Power Supply such as Emergency Induction Light using Li-ion Capacitor (리튬이온커패시터를 활용한 비상유도등 예비전원장치의 동작 특성 및 점검방법 개선에 관한 연구)

  • Jung, Jun-Chea
    • Journal of the Society of Disaster Information
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    • v.16 no.2
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    • pp.392-401
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    • 2020
  • Purpose: This study analyzes the operating characteristics of a lithium ion capacitor that can be used as a standby power supply in an emergency, and determines whether the standby power supply is abnormal even by measuring the voltage using a linear proportionality characteristic during charging and discharging. The aim is to provide an experimental basis that can be done. Method: As a method for this study, first, analyze the operation principle and characteristics of the existing backup power supply and lithium ion capacitor, and then measure the voltage of the lithium ion capacitor according to the configuration and system block diagram of the induction lamp used in the experiment. We proceed with the test of the measured value of discharge power for each voltage band to check the amount of power held by the battery and the operation test experiment using induction lamps. Results: Just by checking the charging voltage using the linear proportional characteristics of lithium ion capacitors, it provides a basis for accurately inferring the effective operating time of induction lamp lamps. Conclusion: In the event of a disaster, the lithium ion capacitor is used as a spare power supply for emergency induction lamps to prevent complete discharge of emergency induction lamps, to prevent the problem of performing normal operation of the standby power supply, and to use only a simple voltage measurement to reserve power. It was intended to suggest many uses for evacuation equipment application in the future by making it possible to check whether the device is abnormal.