• Journal of Biomedical Engineering Research
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• v.43 no.4
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• pp.199-213
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• 2022

EN ISO 14971:2012 a risk management standard approved and applied as a European standard in 2012, will be adopted and applied as ISO 14971:2019 published in December 2019, ISO/TR 24971(Guidance) published in June 2020 from May 2022. After that, it is applied to IVDD surveillance and IVDR new and conversion, and the manufacturer is already preparing for application or is starting preparation for application. In addition, 98/78/EEC IVDD applied from 1998 will also be applied as REGULATION (EU) 2017/746 IVDR from May 2022. In particular, in IVDR, the requirements for post-marketing investigations such as Post Market Surveillance (PMS), Summary of safety and performance(SSP), Periodic Safety Update Report(PSUR) and Post Market Performance Follow Up(PMPF), which were not required in the existing IVDD, increased, and the contents were also specified. This study focused on ISO14971:2019 among these strengthened and newly applied regulations, and tried to present a detailed analysis and application plan of Post Market Surveillance (PMS) required by 2017/746 IVDR.

• Proceedings of the Korea Information Processing Society Conference
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• 2023.11a
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• pp.662-664
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• 2023

해양 식물플랑크톤의 성장은 유해적인 적조를 유발할 수 있으며, 이는 여러 국가의 생태계에 피해를 주는 상황이다. 적조를 모니터링하는 것은 식물플랑크톤 미생물의 증가를 예방하고 통제하기 위해 중요하다. 그러나 현재의 적조 모니터링 기술은 날씨, 시간 제약 및 실시간 모니터링에 대한 어려움으로 인해 측정 정확도에 영향을 미치는 한계가 있다. 본 연구는 특히 적조 발생을 감지하기 위한 목적으로 개발된 자동 실시간 모니터링 시스템의 성공적인 개발을 보여준다. 개발한 시스템은 음향 반사파 데이터 처리를 통해 합성곱 신경망(Convolutional neural networks, CNN)을 활용하여 식물플랑크톤 농도를 정확하게 구별할 수 있다. 특히, 이 CNN 모델은 음향 신호의 변환된 주파수 스펙트럼과 Cochlodinium polykrikoides (C. polykrikoides)의 농도 간의 상관 관계를 수립하는 데 뛰어난 효과를 나타냈다. 이 CNN 은 C. polykrikoides 를 감지하는 데 0.90 의 정확도를 보여준다. 이러한 모니터링과 CNN 분류의 활용은 실시간 측정의 중요한 잠재력을 보여주며, 추가적인 절차가 필요 없는 자동 모니터링 시스템을 구축할 수 있을 것으로 예상된다.

• Journal of Biomedical Engineering Research
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• v.43 no.1
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• pp.11-18
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• 2022

An electromagnetic generator with variable stimulation parameters is required to conduct basic research on magnetic flux density and frequency for pulsed electromagnetic fields (PEMFs). In this study, we design an electromagnetic generator that can conduct basic research by providing parameters optimized for cell and animal experimental conditions through adjustable stimulation parameters. The magnetic core was selected as a solenoid capable of uniform and stable electromagnetic stimulation. The solenoid was designed in consideration of the experimental mouse and cell culture dish insertion. A voltage and current adjustable power supply for variable magnetic flux density was designed. The system was designed to be adjustable in frequency and pulse width and to enable 3-channel output. The reliability of the system and solenoid was evaluated through magnetic flux density, frequency, and pulse width measurements. The measured magnetic flux density was expressed as an image and qualitatively observed. Based on the acquired image, the stimulation area according to the magnetic flux density decrease rate was extracted. The PEMF frequency and pulse width error rates were presented as mean ± SD, and were confirmed to be 0.0928 ± 0.0934% and 0.529 ± 0.527%, respectively. The magnetic flux density decreased as the distance from the center of the solenoid increased, and decreased sharply from 60 mm or more. The length of the magnetic stimulation area according to the degree of magnetic flux density decrease was obtained through the magnetic flux density image. A PEMF generator and stimulation parameter control system suitable for cell and animal models were designed, and system reliability was evaluated.

• Journal of The Korean Association For Science Education
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• v.35 no.1
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• pp.73-84
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• 2015

In this research, two careers connectable with the contents of the curriculum of fifth to sixth grade elementary school students were selected among other promising future careers in biotechnology and medical engineering fields. 'Design-based promising future career STEAM program' was developed and its validity and effectiveness were verified. Reflecting recent issues, and complying with the STEAM standard (frame) instructional materials were developed through group deliberations for nine months, based on the achievement standards through an analysis of subject curriculum revised in 2009. This was prepared so that students are able to experience biotechnology and medical engineering related careers in a simulational form emphasized with creative design to make them prefer natural sciences and engineering careers and draw their interests and recognition of the relevant careers under the two disciplines. As a result of such application to STEAM Leader School students at the verification stage of the program, the contents and level of the program were verified suitable, receiving favorable reviews. And as a result of applying the developed program on other elementary school students, it was discovered that significant improvements were found in their career consciousness. Through this research, it was suggested that there is a need for a simplification of the curriculum content standards, a provision of 'standard for integration,' development of teachers' ability in reconstituting or organizing the STEAM and proceeding classes, continuous long-term support to see the effects of a policy or a program, and a reinforcement of career education integrated in the curriculum.

• Journal of the Korean Society of Radiology
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• v.8 no.3
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• pp.123-136
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• 2014

In this paper, we study to classify molecular imaging and applications to predict future. Molecular imaging in vivo at the cellular level and the molecular level changes taking place to be imaged, that is molecular cell biology and imaging technology combined with the development of the new field. Molecular imaging is used fluorescence, bioluminescence, SPECT, PET, MRI, Ultrasound and other imaging technologies. That is applied to monitoring of gene therapy, cell tracking and monitoring of cell therapy, antibody imaging, drug development, molecular interaction picture, the near-infrared fluorescence imaging of cancer using fluorescence, bacteria using tumor-targeting imaging, therapeutic early assessment, prediction and therapy. The future of molecular imaging would be developed through fused interdisciplinary research and mutual cooperation, which molecular cell biology, genetics, chemistry, physics, computer science, biomedical engineering, nuclear medicine, radiology, clinical medicine, etc. The advent of molecular imaging will be possible to early diagnosis and personalized treatment of disease in the future.

• Clean Technology
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• v.17 no.1
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• pp.25-30
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• 2011

This study presents a fabrication method of cell-chip using aqueous solution based surface modification. The applications of cell-chip have potential for fundamental study of genetics, cell biology as well as cancer diagnostics and treatment. Conventional methods for fabrication of cell-chip have been limited in economic loss and environmental pollution because of the use of harsh organic solvent, complex process of silicon technology, and expensive equipment. In order to fabricate cell chip, we have proposed simple and eco-friendly process combined polyelectrolyte multilayer coating with microcontact printing. For the proof of concept, the cell chip can be applied to analyze the different expression of cell surface glycans and derivatives between cancer and normal cells. Our proposed method is useful technique for the application of novel cancer diagnostics and basic medical engineering.

• Korean Journal of Materials Research
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• v.29 no.3
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• pp.167-174
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• 2019

To improve the performance of carbon nanofibers as electrode material in electrical double-layer capacitors (EDLCs), we prepare three types of samples with different pore control by electrospinning. The speciments display different surface structures, melting behavior, and electrochemical performance according to the process. Carbon nanofibers with two complex treatment processes show improved performance over the other samples. The mesoporous carbon nanofibers (sample C), which have the optimal conditions, have a high sepecific surface area of $696m^2g^{-1}$, a high average pore diameter of 6.28 nm, and a high mesopore volume ratio of 87.1%. In addition, the electrochemical properties have a high specific capacitance of $110.1F\;g^{-1}$ at a current density of $0.1A\;g^{-1}$ and an excellent cycling stability of 84.8% after 3,000 cycles at a current density of $0.1A\;g^{-1}$. Thus, we explain the improved electrochemical performance by the higher reaction area due to an increased surface area and a faster diffusion path due to the increased volume fraction of the mesopores. Consequently, the mesoporous carbon nanofibers are demonstrated to be a very promising material for use as electrode materials of high-performance EDLCs.

• Korean Journal of Materials Research
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• v.28 no.11
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• pp.640-645
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• 2018

The design of non-precious electrocatalysts with low-cost, good stability, and an improved oxygen reduction reaction(ORR) to replace the platinium-based electrocatalyst is significant for application of fuel cells and metal-air batteries with high energy density. In this study, we synthesize iron-carbide($Fe_3C$) embedded nitrogen(N) doped carbon nanofiber(CNF) as electrocatalysts for ORRs using electrospinning, precursor deposition, and carbonization. To optimize electrochemical performance, we study the three stages according to different amounts of iron precursor. Among them, $Fe_3C$-embedded N doped CNF-1 exhibits the most improved electrochemical performance with a high onset potential of -0.18 V, a high $E_{1/2}$ of -0.29 V, and a nearly four-electron pathway (n = 3.77). In addition, $Fe_3C$-embedded N doped CNF-1 displays exellent long-term stabillity with the lowest ${\Delta}E_{1/2}=8mV$ compared to the other electrocatalysts. The improved electrochemical properties are attributed to synergestic effect of N-doping and well-dispersed iron carbide embedded in CNF. Consequently, $Fe_3C$-embedded N doped CNF is a promising candidate for non-precious electrocatalysts for high-performance ORRs.

• Korean Journal of Materials Research
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• v.29 no.5
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• pp.328-335
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• 2019

Nb-doped $TiO_2$(NTO) coated NiCrAl alloy foam for hydrogen production is prepared using ultrasonic spray pyrolysis deposition(USPD) method. To optimize the size and distribution of NTO particles based on good physical and chemical stability, we synthesize particles by adjusting the weight ratio of the Nb precursor solution(5 wt%, 10 wt% and 15 wt%). The morphological, chemical bonding, and structural properties of the NTO coated NiCrAl alloy foam are investigated by X-ray diffraction(XRD), X-ray photo-electron spectroscopy(XPS), and Field-Emission Scanning Electron Microscopy(FESEM). As a result, the samples of controlled Nb weight ratio exhibit a common diffraction pattern at ${\sim}25.3^{\circ}$, corresponding to the(101) plane, and have chemical bonding(O-Nb=O) at 534 eV. The NTO particles with the optimum weight ratio of N (10 wt%) show a uniform distribution with a size of ~18.2-21.0 nm. In addition, they exhibit the highest corrosion resistance even in the electrochemical stability estimation. As a result, the introduction of NTO coated NiCrAl alloy foam by USPD improves the chemical stability of the NiCrAl alloy foam by protecting the direct electrochemical reaction between the foam and the electrolyte. Thus, the optimized NTO coating can be proposed for excellent protection of NiCrAl alloy foam for hydrocarbon-based steam methane reforming(SMR).

• Korean Journal of Materials Research
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• v.29 no.10
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• pp.623-630
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• 2019

Because of their excellent stability and highly specific surface area, carbon based materials have received attention as electrode materials of electrical double-layer capacitors(EDLCs). Biomass based carbon materials have been studied for electrode materials of EDLCs; these materials have low capacitance and high-rate performance. We fabricated tofu based porous activated carbon by polymer dissolution reaction and KOH activation. The activated porous carbon(APC-15), which has an optimum condition of 15 wt%, has a high specific surface area($1,296.1m^2\;g^{-1}$), an increased average pore diameter(2.3194 nm), and a high mesopore distribution(32.4 %), as well as increased surface functional groups. In addition, APC has a high specific capacitance($195F\;g^{-1}$) at low current density of $0.1A\;g^{-1}$ and excellent specific capacitance($164F\;g^{-1}$) at high current density of $2.0A\;g^{-1}$. Due to the increased specific surface area, volume ratio of mesopores, and surface functional groups, the specific capacitance and high-rate performance increased. Consequently, the tofu based activated porous carbon can be proposed as an electrode material for high-performance EDLCs.