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박기정,유규하,이성희,이창형,정진백,이재근,허찬회,김형범,최민용,김용우,황상연,정재훈,구자중,홍혜경,임경택,강세구,곽지영,Park, Ki-Jung,Ryu, Gyu-Ha,Lee, Sung-Hee,Lee, Chang-Hyung,Jung, Jin-Baek,Lee, Jae-Keun,Hur, Chan-Hoi,Kim, Hyung-Bum,Choi, Min-Yong,Ki 대한의용생체공학회 2010 의공학회지 Vol.31 No.6
For approval of medical devices manufactured or imported, submission of technical documents as well as the application form is required. The manufacturer (or importer) should properly identify the raw materials the applied product is made of and the manufacturing processes the product undergoes before it is shipped in the application form. In the technical documents, scientific data to evaluate the efficacy, safety, and quality of the applied product that has been described in the application form should be provided. Therefore, identifying the raw materials that were used for the parts of the applied product and describing the physical and chemical characteristics of the raw materials are quite important and essential in ensuring the efficacy, safety, and quality of the applied product. To describe the physical and chemical characteristics of the raw materials correctively, the applicant is required to have broad knowledge in the scientific fields such as chemical, polymer, metal, and ceramic science and engineering. But most of the applicant are not experts in these fields, so that the description in the application form often includes wrong and improper descriptions. Thus, we developed a guideline which explains the raw materials for medical devices, show the their examples. The purpose of this description guideline is to help the applicant properly completing the "Raw materials or constituents and their volumes" part in the application form.
박기정,Hui Jin,Renhua Zheng,Sehyun Kim,Seung-Eun Lee,김보형,Sung Vin Yim 대한임상약리학회 2019 Translational and Clinical Pharmacology Vol.27 No.3
This study aimed to investigate the cognition-enhancing effect of Panax ginseng. A randomized, double-blind, placebo-controlled clinical trial was conducted to address the cognition-enhancing effects of Panax ginseng. A total of 90 Korean volunteers with mild cognitive impairment participated in this study. All subjects were allocated randomly into 'Ginseng' group or 'Placebo' group. All subjects were administered 3g of Panax ginseng powder or starch (placebo) for 6 months. The Korean version of the Mini-Mental Status Examination (K-MMSE), Korean version of Instrumental Activities of Daily Living (K-IADL), and Seoul Neuropsychological Screening Battery (SNSB) were used to assess the changes in cognitive function at the end of the 6 month study period. The subjects of the 'Ginseng' group improved significantly on the Rey Complex Figure Test (RCFT) immediate recall (P = 0.0405 and P = 0.0342 in per-protocol (PP) and intention-to-treat (ITT) analysis, respectively) and on the RCFT 20-min delayed recall (P = 0.0396 and P = 0.0355 in PP and ITT analysis, respectively) compared with 'placebo' group throughout the 6 months of Panax ginseng administration. There were no serious adverse events. These results suggest that Panax ginseng has a cognitionenhancing effect.
Nucleate boiling heat transfer in nanofluids with carbon nanotubes up to critical heat fluxes
박기정,강동규,정동수,심상은 대한기계학회 2011 JOURNAL OF MECHANICAL SCIENCE AND TECHNOLOGY Vol.25 No.10
In this study, pool boiling heat transfer coefficients (HTCs) and critical heat fluxes (CHF) are measured on a smooth square flat copper heater in a pool of pure water with and without carbon nanotubes (CNTs) dispersed at 60℃. Tested aqueous nanofluids are prepared using multi-walled CNTs whose volume concentrations are 0.0001, 0.001, 0.01, and 0.05%. For the dispersion of CNTs, DISPERBYK 184 is used in distilled water. Pool boiling HTCs are taken from 10 kW/m² to critical heat flux for all tested fluids. Test results show that the pool boiling HTCs of the nanofluids are lower than those of pure water in entire nucleate boiling regime. On the other hand, critical heat flux is enhanced greatly showing up to 150% increase at the CNT concentration of 0.001% as compared to that of pure water. This is related to the change in surface characteristics by the deposition of CNTs. This deposition makes a thin CNT layer on the surface and the active nucleation sites of the surface are decreased due to this layer. The thin CNT layer acts as the thermal resistance and also decreases the bubble generation rate resulting in a decrease in pool boiling HTCs. The same layer, however, decreases the contact angle on the test surface and extends the nucleate boiling regime to very high heat flux range and reduces the formation of large vapor canopy at near CHF. Thus, a significant increase in CHF results.