• 제목/요약/키워드: 510(k)

검색결과 1,196건 처리시간 0.029초

한방의료기기의 미국 시장 진출을 위한 심사제도 소개 (The registration and approval of Oriental Medical devices for the entry into U.S. market)

  • 오지윤;최유나;조수정;정찬영;조현석;이승덕;김갑성;김은정
    • Journal of Acupuncture Research
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    • 제32권4호
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    • pp.91-102
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    • 2015
  • Objectives : The Oriental medical device industry is expected to continue to experience significant growth. It should increase its global market share rather than focusing on the domestic market. Countries around the world self-regulate their domestic market, so this study aims to aid in the development of a particular overseas market by introducing the U.S.(the largest market) medical device registration and approval process. Methods : For an understanding of the US medical device licensing process, we researched the relevant regulatory organization (FDA), the history, definition and classification of medical devices, the approval and 510(k) submission process related to substantial equivalence, IEC 60601-1 Edition 3, usability tests, and so on. Results : Medical devices in the United States are assigned to one of three regulatory classes: Class I, Class II and Class III, based on the level of control necessary to assure the safety and effectiveness of the device. If a company's device is classified as Class II and if it is not exempt, a 510k will be required for marketing. 1) A 510(k) is a premarket submission made to the FDA to demonstrate that the new device to be marketed is "substantially equivalent" to a legally marketed device (predicate device) 2) The IEC 60601-1 Edition 3 preparation process, which contains information related to usability, is expensive and time-consuming but a critical requirement. Conclusions : Although the U.S. market has high barriers to entry, access to this, large overseas market will encourage development of the Oriental medical device industry and commercial value enhancement is expected.

Zr-0.4Sn-1.5Nb-0.2Fe 합금의 인장특성 (Tensile Properties of Zr-0.4Sn-1.5Nb-0.2Fe)

  • 이명호;김준환;최병권;정용환
    • 한국재료학회지
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    • 제14권10호
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    • pp.713-718
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    • 2004
  • To study the dynamic strain aging behavior of Zr-0.4Sn-1.5Nb-0.2Fe sample tube for nuclear fuel cladding in the range of pressurized water reactor (PWR) operation temperature, the tensile tests of the tube specimens, which had been finally heat-treated at $470^{\circ}C\;and\;510^{\circ}C$, had been carried out with the strain rate $1.67{\times}10^{-2}/s\;and\;8.33{\times}10^{-5}/s$ at the various temperatures from room temperature to $500^{\circ}C$. It was observed that the elongation of the specimens got shortened as the temperature increased from $200^{\circ}C\;to\;340^{\circ}C$. The specimens that were finally heat-treated at $470^{\circ}C$ showed a plateau more remarkably on the plot of yield strength-temperature than those heat-treated at $510^{\circ}C$. In the range of $310\sim400^{\circ}C$, the strain rate sensitivity of the specimens finally heat-treated at $510^{\circ}C$ was $30.4\%\sim33.7\%$ lower but the work hardening exponent index of the specimens was a little higher than that without dynamic strain aging effect.

Correction Factors for Outdoor Concentrations of PM2.5 Measured with Portable Real-time Monitors Compared with Gravimetric Methods: Results from South Korea

  • Yun, Dong-Min;Kim, Myeong-Bok;Lee, Jun-Bok;Kim, Bo-Kyeong;Lee, Dong-Jae;Lee, Seon-Yeub;Yu, Sol;Kim, Sung-Roul
    • 한국환경과학회지
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    • 제24권12호
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    • pp.1559-1567
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    • 2015
  • This study investigated the association between $PM_{2.5}$ concentrations obtained with portable real-time monitors and those obtained with gravimetric methods in national urban air-quality monitoring sites in Seoul, South Korea. We used the SidePak AM510 Personal Aerosol Monitor (TSI Inc., 500 Cardigan Road Shoreview, MN) and DustTrak DRX 8533 (TSI Inc., 500 Cardigan Road Shoreview, MN) as portable real-time monitors for measuring $PM_{2.5}$ concentrations and compared these values with those measured with the PMS-103 or SEQ 47/50 models operated by Federal Reference Method (FRM) or the European Committee for Standardization(ECS), respectively, in national urban air-quality monitoring sites in Seoul. Measurements were conducted every other day in the winter and spring seasons of 2014. The estimated daily mean concentrations of $PM_{2.5}$ ranged between 13.4 and $161.9{\mu}g/m^3$ using AM 510 and between 22.0 and $156.0{\mu}g/m^3$ using DustTrak. The Spearman correlation coefficient for $PM_{2.5}$ concentrations between AM 510 and gravimetric results was 0.99, and the correlation between DustTrak and gravimetric results was 0.87. The correction factor suggested was 0.42 and 0.29 for AM 510 and DustTrak, respectively. We found that $PM_{2.5}$ concentrations measured with real-time monitors could overestimate true $PM_{2.5}$ concentrations and therefore the application of a correction factor (0.43) is strongly suggested for quantification when Real-time monitors were operated of $PM_{2.5}$ levels at urban atmospheric environment of South Korea.

A Study on the Acoustic Fault Detection System of Insulators from Their Radiation Noises

  • Park, Kyu-Chil;Yoon, Jong-Rak
    • Journal of information and communication convergence engineering
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    • 제9권5호
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    • pp.510-514
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    • 2011
  • To detect the insulator in the fault state on the electric poles, we first measured radiation sounds from normal state insulators and error state insulators in the anechoic chamber. We processed the signals in frequency domain to find the features with filter bank, narrow band and wide band analysis. So we could found two apparent results from their frequency spectrums - one was 120Hz harmonic components, the other was high average noise level than normal state ones. Then we also introduced a technique for the direction detection of the fault state insulator using the cross correlation from the three dimensional array microphones. To eliminate the noise signal from unexpected directions, we suggested the zero padding technique in cross correlation function. From these, we could conclude that acoustic fault detection techniques are useful of the detection of insulators' faults and the estimation of the direction of the fault state insulators.

동해에서 대기에어로졸이 해색위성자료에 미치는 영향 (Influence of atmospheric aerosol on satellite ocean color data in the East/Japan Sea)

  • 야마다 게이꼬;김상우
    • 해양환경안전학회:학술대회논문집
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    • 해양환경안전학회 2009년도 춘계학술발표회
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    • pp.53-54
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    • 2009
  • The influence of atmospheric aerosol on satellite ocean color data were evaluated using SeaWiFS monthly standard mapped image products. The atmospheric optical thickness (AOT) was increased in spring and summer, and it showed the strong positive correlation with remote sensing reflectance, normalized waterleaving radiance /solar irradiance, at 555 nm (Rrs555) which is a component of the satellite chlorophyll estimation. Such the high AOT and high Rrs555 pixels showed overestimation of satellite chlorophyll in spring, especially in the area which showed large phytoplankton absorption which 1s expressed by low remote sensing reflectance at 443, 490 and 510 nm (Rrs 443, Rrs490 and Rrs510).

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Optical Simulation of Viewing Angle Property of Biaxial Nematic Bent-Core Liquid Crystal

  • Yang, Seungbin;Lee, Ji-Hoon
    • Journal of the Optical Society of Korea
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    • 제20권4호
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    • pp.510-514
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    • 2016
  • The conventional liquid crystal displays (LCDs) have been using optically uniaxial liquid crystal (LC) medium and this often causes a significant image change at oblique viewing angles. We simulated the viewing angle properties of the biaxial nematic (Nb) phase of a bent-core liquid crystal (BLC) and compared the results with the vertically aligned (VA)- and the in-plane switching (IPS)-LCDs. The Nb phase of the BLC showed a smaller transmittance at the dark state as well as a greater contrast ratio at wide viewing angle. The viewing angle property of the Nb-mode without any compensation film was slightly superior to the IPS-mode with the compensation films eliminating the decross of the polarizers at oblique viewing angle.

High-Speed BiCMOS Comparator

  • Jirawath, Parnklang;Wanchana, Thongtungsai
    • 제어로봇시스템학회:학술대회논문집
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    • 제어로봇시스템학회 2000년도 제15차 학술회의논문집
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    • pp.510-510
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    • 2000
  • This paper introduces the design of BiCMOS latched comparator circuit for high-speed system application, which can be used in data conversion, instrumentation, communication system etc. By exploiting the advantage technology of the combination of both the bipolar transistor and the CMOS transistor devices. The comparator circuit includes an input stage that combines MOS sampling with a bipolar regenerative amplifier. The resistive load of conventional current-steering comparator is replaced by a load, which is made by a NMOS transistor. The advantage of design and PSPICE simulation of BiCMOS latched comparator are the circuit will obtain wide bandwidth with lowest power consumption at a single supply voltage. All the characteristics of the proposed BiCMOS latched comparator circuit is carried out by simulation program.

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Recycling of In-site waste soil material to fill a hollow between PHC pile and Earthen wall

  • Jang, Myung-Houn;Choi, Hee-Bok
    • 한국건축시공학회지
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    • 제12권5호
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    • pp.510-517
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    • 2012
  • This study evaluated the recycling potential of in-site waste soil as pile back filling material (PBFM). We performed experiments to check workability, segregation resistance, bond strength, direct shear stress test, and dynamic load test using in-site waste soil in coastal areas. We found that PBFM showed better performance than general cement paste in terms of workability, segregation resistance, and bond strength. On the other hand, the structural performance of PBFM was slightly lower than that of general cement paste due to the skin friction force of pile by Pile Driving Analyzer and direct shear stress. However, because this type of performance degradation in terms of structure can be improved through the use of piles with larger diameter or by changing the type of pile, considering the economics and environment, we considered that recycling of PBFM has sufficient value.

Hot-Pressing Effects on Polymer Electrolyte Membrane Investigated by 2H NMR Spectroscopy

  • Lee, Sang Man;Han, Oc Hee
    • Bulletin of the Korean Chemical Society
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    • 제34권2호
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    • pp.510-514
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    • 2013
  • The structural change of Nafion polymer electrolyte membrane (PEM) induced by hot-pressing, which is one of the representative procedures for preparing membrane-electrode-assembly for low temperature fuel cells, was investigated by $^2H$ nuclear magnetic resonance (NMR) spectroscopy. The hydrophilic channels were asymmetrically flattened and more aligned in the membrane plane than along the hot-pressing direction. The average O-$^2H$ director of $^2H_2O$ in polymer electrolyte membrane was employed to extract the structural information from the $^2H$ NMR peak splitting data. The dependence of $^2H$ NMR data on water contents was systematically analyzed for the first time. The approach presented here can be used to understand the chemicals' behavior in nano-spaces, especially those reshaping and functioning interactively with the chemicals in the wet and/or mixed state.

음식물류 폐기물의 수소 발효 시 linear alkylbenzene sulfonate의 영향 (Effects of Linear Alkylbenzene Sulfonate on Hydrogen Fermentation of Food Waste)

  • 이채영;최재민
    • 한국수소및신에너지학회논문집
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    • 제27권5호
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    • pp.510-516
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    • 2016
  • This study examines the effects of linear alkylbenzene sulfonate on hydrogen fermentation of food waste. The hydrogen production rate was similar with different linear alkylbenzen sulfonate (LAS) concentrations. The maximum hydrogen yield increased with increasing LAS concentration. The highest maximum hydrogen yield was $0.550{\pm}0.005mol$ H2/mol hexose at LAS for 5.52 mg/L. But the maximum hydrogen yield decreased above LAS for 11.05 mg/L. The concentration of acetate in control reactor was increased, but it decreased with increasing LAS concentration in other reactors.