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A Study on Development of Guideline on Writing Technical Document for Electrical Medical Devices: Dental X-ray Equipment (치과용엑스선장치의 기술문서 작성을 위한 가이드라인 개발 연구)

  • Lee, Seung-Youl;Kim, Jae-Ryang;Lee, Jun-Ho;Park, Chang-Won
    • Journal of radiological science and technology
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    • v.39 no.4
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    • pp.651-660
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    • 2016
  • Due to recent population aging, the number of check-up for senior citizens has increased steadily. According to this trend, the market size of dental X-ray equipment and the number of approval and review for these devices have simultaneously increased. The technical document of medical device is required for approval and review for medical device, and medical device companies needs to have work comprehension and expertise, as the document needs to include the overall contents such as performances, test criteria, etc.. Yet, since most of domestic manufacturers or importers of medical devices are small businesses, it is difficult for them to recruit professional manpower for approval of medical devices, and submission of inaccurate technical documents has increased. These problems lead to delay of the approval process and to difficulties in quick entering into the market. Especially, the Ministry of Food and Drug safety (MFDS) standards of a dental extra-oral X-ray equipment, a dental intra-oral X-ray equipment, an arm-type computed tomography, and a portable X-ray system have been recently enacted or not. this guideline of dental X-ray equipment adjusting revised standards was developed to help relative companies and reviewers. For this study, first, the methods to write technical document have been reviewed with revised international and domestic regulations and system. Second, the domestic and foreign market status of each item has been surveyed and analyzed. Third, the contents of technical documents already approved by MFDS have been analyzed to select the correct example, test items, criteria, and methods. Finally, the guideline has been developed based on international and domestic regulation, through close review of a consultative body composed of academic, industrial, research institute and government experts.

Identification of Conductive Fractures in Crystalline Recks (유동성 단열 파악을 위한 암반 내 단열특성 규명)

  • 채병곤;최영섭;이대하;김원영;이승구;김중렬
    • Journal of the Korean Society of Groundwater Environment
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    • v.5 no.2
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    • pp.88-100
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    • 1998
  • Since fractures may serve as major conduits of groundwater flow in crystalline rocks, characterization of conductive fractures is especially important for interpretation of flow system. In this study, characterization of fractures to investigate hydraulically conductive fractures in gneisses at an abandoned mine area was performed. The orientation, width, length, movement sense, infilling materials, spacing, aperture, roughness of both joints and faults and intersection and connectivity to other joints were measured on outcrops. In addition, characteristics of subsurface fractures were examined by core logging in five boreholes, of which the orientations were acquired by acoustic televiewer logging from three boreholes. The dominant fracture sets were grouped from outcrops; GSet 1: N50-82$^{\circ}$E/55-90$^{\circ}$SE, GSet 2: N2-8$^{\circ}$E/56-86$^{\circ}$SE, GSet 3: N46-72$^{\circ}$W/60-85$^{\circ}$NE, GSet 4:Nl2-38$^{\circ}$W/15-40$^{\circ}$SW and from subsurface; HSet 1: N50-90$^{\circ}$E/55-90$^{\circ}$SE, HSet 2: N10-30$^{\circ}$E/50-70$^{\circ}$SE, HSet 3: N20-60$^{\circ}$W/50-80$^{\circ}$NE, HSet 4: N10-50$^{\circ}$E/$\leq$40$^{\circ}$NW. Among them, GSet 1, GSet 3 and HSet 1, HSet 3 are the most intensely developed fracture sets in the study area. The mean fracture spacings of HSet 1 are 30-47cm and code 1 fractures, such as faults and open fractures, comprise 21.0-42.9 percent of the whole fractures in each borehole. HSet 3 shows the mean fracture spacings of 55-57cm and the ratio of code 1 fractures is 15.4-26.9 percent. In spite of the mean fracture spacing of 239cm, code 1 fractures of HSet 4 have the highest ratio of 54.5 percent. From the fact that faults or open fractures have high hydraulic conductivity, it can be inferred that the three fracture sets of N55-85$^{\circ}$E/50-80$^{\circ}$SE, N20-60$^{\circ}$W/50-75$^{\circ}$NE and N10-30$^{\circ}$E/$\leq$30$^{\circ}$NW from a fracture system of relatively high conductivity. It is indirectly verified with geophysical loggings and constant injection tests performed in the boreholes.

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Weed Occurrence and Rice Yield as Affected by Environment Friendly Farming Methods (친환경 농법에 따른 논 잡초발생 차이와 벼 수량에 끼치는 영향)

  • Cho, Kwang-Min;Lee, Sang-Bok;Kim, Sun;An, Xue-Hua;Chun, Jae-Chul
    • Korean Journal of Weed Science
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    • v.31 no.3
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    • pp.279-288
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    • 2011
  • To suggest the weed management technique for environment friendly rice cultivation, we investigated occurrence patterns of weeds, the actual condition of weed management, and rice yield at the environment friendly agricultural complex located in Honam and Chungnam regions. The practical performance of weed management was relatively satisfactory in decreasing order of agricultural technique with golden-apple-snail (GAS) > agricultural technique with duck (Duck) > agricultural technique with rice bran (RB) > agricultural technique with soft-shelled turtle (ST). In the rice fields employed by agricultural technique with GAS, the dominant weeds were Echinochloa crus-galli, Ludwigia prostrata, Monochoria vaginalis, Sagittaria trifolia, and Aneilema keisak. However, E. crus-galli, M. vaginalis, L. prostrata, Aeschynomene indica and Bidens frondosa were found as dominant weeds at the fields using the Duck and E. crus-galli, M. vaginalis, L. prostrata, Polyganum hydropiper and Eleocharis kuroguwai at the fields using RB. In comparison of rice yield ($5.2\;MT\;ha^{-1}$) obtained from the conventional cultivation using herbicides, about 93% was reached by Duck, about 91% by GAS, about 92% by RB, and about 78% by ST. When rice qualities obtained from environment friendly rice cultivation were compared with those from the conventional cultivation, the producing rates of perfect kernel, immature kernel, immature opaque kernel, cracked rice, and damaged kernel were lower in the former cultivation, whereas contents of protein, amylose, and fatty acid were similar in the two cultivation methods. The problems found in the environment friendly agriculture were poor plowing and harrowing, carless irrigation management, and geological poor condition as cultivation area with cold water. These have caused severe infestation of weeds, frequent incident of disease and insect pest, and rice lodging. This resulted in reduction of rice yield as high as about 32 to 79% as compared with the conventional cultivation using herbicides.

Factors Affecting the Extraction of Protein from Antarctic Krill (남빙양산(南氷洋産) 크릴단백질(蛋白質)의 추출조건(抽出條件))

  • Lee, Sung-Ki;Kim, Young-Myoung;Min, Byong-Yong
    • Korean Journal of Food Science and Technology
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    • v.17 no.2
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    • pp.65-70
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    • 1985
  • To recover proteins from antarctic krill(Euphausia superba) for the use of food material, some factors affecting the extraction of protein were investigated. The protein solubility profile showed a minimum solubility level(33.2-38.8%) within the range of pH4.0-4.5 and very high solubility levels as 56.8% at pH2.0 and 80.7% at pH11.0. The extraction yield increased as the solvent-to-krill ratios increase in which a ratio of 5:1(volume of solvent/weight of krill) was found to be preferable from the point of handling convenience and extraction yield. The extraction temperatures did not seem to be important variables on extraction of protein. The extraction of krill protein occurred fairly rapidly with little further extraction of protein after 30 minutes. The extraction of protein was slightly decreased at both acidic(pH2.0) and alkaline(pH11.0) conditions with the increasing concentration of sodium chloride. The extractibility of krill protein at strong alkaline condition(pH11.0) was higher than at strong acidic condition(pH2.0) under the same concentration range as 1-6% of sodium chloride. In phosphate treatments, the extraction of protein was slightly influenced by presence of sodium chloride as the concentration range of 3-4% in the aqueous solvent by which maximize the extraction yield as over 80%.

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Studies on a Nematode, Anguillicola crassa Parasitic in the Air Bladder of the Eel (뱀장어 부레에 기생(寄生)하는 선충(線虫), Anguillicola crassa에 관(關)한 연구(硏究))

  • Kim, Young-Gill;Kim, Eul-Bae;Kim, Jong-Yeon;Chun, Seh-Kyu
    • Journal of fish pathology
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    • v.2 no.1
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    • pp.1-18
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    • 1989
  • In Korea, studies on a Nematode, Anguillicola crassa parasitic in the air bladder of eel are not yet reported. This reason led the author to study the parasitic species, state and life history of the A. crassa parasitized in the air bladder of eel in order to take effective control measures against its damage. The size of fully developed eggs was 80 to $92(86.7){\times}62$ to $71(67.4)\;{\mu}m$, larva was 210 to $240(225){\times}18$ to $23(20.6)\;{\mu}m$. The intermediate host of A. crassa was Thermocyclops hyalinus, it was capable for parasitizing the eel after 4 days of invasion and then the size of larva was 360 to $420(390){\times}28$ to $35(31)\;{\mu}m$. Fifty days after eel had ingested the Thermocyclops hyalinus infected with larva of A. crassa, the larvae matured into adult worms in the air bladder of eel. The size of detected adult worms was 7.3 to $31.0(16.5){\times}0.5$ to 2.2(1.2) mm, 4.9 to $13.3(8.3){\times}0.3$ to 0.9(0.4) mm. Investigating the morphology of the worms, they were identified as A. crassa. Monthly the parasitic rate of the worms in the eel was high in June, September and December, but low in January to March. After the investigation on the significance between non-parasitic fish and parasitic fish, it was not significant, therefore it can be considered that there is no effect of infection in the growth of eel. Any abnormality of eels air bladder tissue was not seen by the infection of A. crassa. At 25.0 to $26.7^{\circ}C$ of water temperature the death time of Thermocyclops hyalinus by masoten treatment was 14 hours in 0.5 ppm, 20 hours in 0.4 ppm, 22 hours in 0.3 ppm, 30 hours in 0.2 ppm and 42 hours in 0.1 ppm.

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Chemical Structures and Physiological Activities of Plant Growth Substance, Malformin B's (식물생장조절물질 말포민 B동족체의 화학구조 및 생리활성)

  • Kim, K.W.
    • Korean Journal of Weed Science
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    • v.15 no.1
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    • pp.85-98
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    • 1995
  • Six malformin B's produced by Aspergillus niger van Tiegh. were separated by HPLC. Their structures determined by the methods of amino acid analyses, mass spectrometry, and two-dimensional NMR were revealed as cyclic pentapeptides structurally related to malformin $A_1$. Both the NMR and MS/MS data suggest that the respective structures of separated malformin B's were as follows; cyclo-D-Cys-D-Cys-L-Val-D-Leu-L-allo-Ile for $B_{1a}$, cyclo-D-Cys-D-Cys-L-Val-D-Leu-L-Leu for $B_{1b}$, cyclo-D-Cys-D-Cys-L-Val-D-Val-L-Leu for $B_2$, cyclo-D-Cys-D-Cys-L-Val-D-Ile-L-Leu for $B_3$, cyclo-D-Cys-D-Cys-L-Val-D-Ile-L-Ile for $B_4$, and cyclo-D-Cys-D-Cys-L-Val-D-Val-L-Ile for $B_5$. Among the malformin B's, the structure of $B_{1b}$ was the same as that of malformin $A_3$ or C. All the malformin B's showed physiological activities in the two assay systems using corn(Zea mays L.) roots and mung bean(Phaseolus aureus Roxb.) hypercotyl segments. The malformin B's with molecular weight 529 were more effective for inducing corn root curvature than those with molecular weight 515. The difference in molecular weight of malformin B's, i.e., the retention time on HPLC, results in the polarity change of the whole malformin molecule which affects the revealation of the malformin activities. In addition, the disulfide form of the malformin B's gives the rigidity of the molecule, whereas the combination of the fourth and the fifth amino acid residues provides the optimal three-dimensional configuration to the malformin receptor of plants. Presumably, these two factors are appeared to be essential for the greatest physiological activity of malformin B's. malformin $B_{1a}$ caused the corn root curvature by 90% at a concentration of $0.25{\mu}M$. However, such differential activities with molecular weight of 529 or 515 of malformin B's were not found in the mung bean hypercotyl segment test. Maximum stimulation of mung bean hypercotyl growth was observed at $0.1{\mu}M$ concentration of malformin B's. The growth of the segments treated with $B_5$ was 154% greater than that of the control.

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Physicochemical and Sensory Characteristics of Vanilla Ice Cream Treated by Gamma Irradiation (감마선 조사에 의한 바닐라 아이스크림의 물리화학적 및 관능적 특성 평가)

  • Kim, Hyun-Joo;Han, In-Jun;Choi, Jong-Il;Song, Beom-Seok;Kim, Jae-Hun;Ham, Jun-Sang;Lee, Wan-Gyu;Yook, Hong-Sun;Shin, Mee-Hye;Byun, Myung-Woo;Lee, Ju-Woon
    • Food Science of Animal Resources
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    • v.28 no.1
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    • pp.69-75
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    • 2008
  • This study evaluated the physicochemical and sensory characteristics of vanilla ice cream treated with gamma irradiation. The general composition of the vanilla ice cream used for the study was 45.4-53.3% moisture, 5.5-5.9% fat and 3.9-4.1% protein, and these values did not change following gamma irradiation. The Hunter L, a and b values were slightly decreased following gamma irradiation. The fatty acid composition of the ice cream included caprylic acid, capric acid, lauric acid, myristic acid, palmitic acid and stearic acid, and there was no detectable change following irradiation. There was no significant difference in TBARS (2-thiobarbituric acid reactive substances) values between non-irradiated and irradiated samples at a dose of 3 kGy or less (p<0.05). Sensory evaluation indicated that gamma-irradiated vanilla ice cream did not show any difference in color relative to non-irradiated ice cream. However, gamma irradiation did affect the flavor, taste and overall acceptability of ice cream at doses above 3 kGy. These results indicate that gamma irradiation at 3 kGy is an effective treatment for sustaining the physicochemical characteristics of vanilla ice cream with minimal changes in sensory characteristics, though further studies should be carried out to reduce the deterioration of sensory qualities induced by gamma irradiation.

TGF-$\beta$3 Selectively Induces Mouse IgA and IgG2b isotype (TGF-$\beta$3는 마우스 IgA, IgG2b 항체의 선택적 유도작용)

  • 이은경;박석래;전계택;김평현;이세원;최의열
    • Korean Journal of Microbiology
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    • v.35 no.2
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    • pp.164-168
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    • 1999
  • TGF-$\beta$3 is among five TGF-$\beta$ isolorms and shows 80% sequence identity to TGF-$\beta$I, a prototype of TGF--$\beta$. It has been reported that TGF-$\beta$I, particularly in the presence of IL-2 or L-5, increases the pmduction of IgA and IgG2b isoiypes by LPS-actwated murine B cells. We examined the effect of TGF-P3 on Ig synlhesis by B cells from different lymphoid origins. IgA induction by TGP-$\beta$3 was mardnal in LPS-activated spleen B cell culture, while 1gA production was markedly enhanced in the culture shulated with TGF-$\beta$P3 and L-5. In addition, number of IgA secreting cells was increased by TGF-$\beta$P3. Under the same conditions, TGP-$\beta$3 alone was enough to increase IgG2b production but IgM and 1gGl. Sirmlar patiem of IgA and IgGZb enbancement by TGF-$\beta$3 and L-5 was observed in the cullures of mesenteric lymph node B cells. Thus, overall effect of TGF-$\beta$3 on Ig synthesis was quite similar to that of TGF-$\beta$I. Nonetheless, it remains to be underslood whether TGF-$\beta$3 is an important modulator in B cell differentiation since regulation of TGF-$\beta$3 expression is considered to differ from that of TGF-$\beta$I

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The Effects of Supplemental Levels of Bamboo Vinegar Liquids on Growth Performance, Serum Profile, Carcass Grade, and Meat Quality Characteristics in Finishing Pigs (죽초액 첨가수준이 비육돈의 육생산성, 혈액성상, 도체성적 및 육질특성에 미치는 영향)

  • Kook, K.;Jeong, J.H.;Kim, K.H.
    • Journal of Animal Science and Technology
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    • v.47 no.5
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    • pp.721-730
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    • 2005
  • Effects of levels of Bomboo Vinegar Liquids(BVL) on growth performance, serum profile and meat quality in employing 90 pigs were investigated. Ninety pigs were allocated into 3 groups and fed by dietary levels of BVL 0(control), 2.0 and 4.0% were included in experimental diets of each of the groups. Concentrated diet was supplemented with 2.0 and 4.0% BVL. The results showed that the daily weight gains and the feed conversion increased significantly(p<0.05) in 2.0% BVL and the feed intake increased slightly. The glucose and the cholesterol contents at the serum decreased significantly(p<0.05) in 2.0 and 4.0% BVL. On the other hand the total protein concentration and the blood urea nitrogen(BUN) increased significantly(p<0.05) in 4.0% BVL. The carcass weight increased significantly(p<0.05) in 4.0% BVL, and back fat thickness had decreased significantly(p<0.05) in 2.0 and 4.0% BVL. The carcass grade tended to increase in 2.0 and 4.0% BVL. The total fat content of loin tended to increase in 2.0 and 4.0% BVL while the cholesterol content decreased significantly(p<0.05). The pH had lower slightly in 2.0 and 4.0% BVL, the lightness and the yellowness of the meat color had higher significantly(p<0.05) while the redness decreased. Shear force values had lower significantly(p<0.05) in 2.0 and 4.0% BVL. For the fatty acid composition, the saturated fatty acids decreased significantly(p<0.05) in 2.0 and 4.0% BVL while unsaturated fatty acids(oleic acid and linoleic acid) increased significantly(p<0.05). For the sensory evaluation, 2.0 and 4.0% BVL had a significant(p<0.05) effect of diminishing the odor and improving the appearance. The taste was also significantly(p<0.05) improved. In conclusion the 2.0% BVL had a positive effect on the feeding performance, the carcass grade and the meat quality characteristics therefore 2.0% BVL is the appropriate supplemental levels of BVL for finishing pigs.

he Effects of Supplemental Levels of Bamboo Vinegar on Growth Performance, Serum Profile and Meat Quality in Fattening Hanwoo Cow (죽초액의 첨가수준이 비육 한우암소의 육생산성, 혈액성상 및 육질에 미치는 영향)

  • Kook, K.;Kim, K. H.
    • Journal of Animal Science and Technology
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    • v.45 no.1
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    • pp.57-68
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    • 2003
  • Effects of supplemental levels of Bomboo vinegar(BV) on growth performance, serum profile and meat quality in 15 Korean native Hanwoo cows was investigated. Concentrate diet was supplemented with Bamboo vinegar with 3% and 6% of the diet. Daily weight gain was increased slightly at 3% BV, but it was decreased in 6% BV. Feed intake was decreased(P<0.05) at 6% BV. Glucose concentration of serum profile was decreased(P<0.05) at 3% and 6% BV. Total protein and cholesterol concentrations were increased(P<0.05) at 3% and 6% BV. BUN concentration was increased(P<0.05) at 3% BV. In carcass characteristics the longissimus muscles of all BV treatments showed no significant(P<0.05) effects, but back fat thickness was decreased significantly(P<0.05) in 6% BV. Marbling score was increased significantly(P<0.05) at 3% BV, thus improving the meat quality. Cut meat production was not difference by treatment. Crude fat content of proximate chemical composition in longissimus muscle was increased(P<0.05) in 3% BV. Shear force and cholesterol contents were decreased(P<0.05) in 3% and 6% BV. The 16:0 of fatty acid composition in longissimus was decreased(P<0.05) whereas 18:1 was increased(P<0.05) at 3% and 6% BV. The composition of saturated fatty acids(SFA) was decreased(P< 0.05), whereas unsaturated fatty acids(USFA) was increased(P<0.05) in 3% BV. Odor and appearance of sensory evaluation were not difference by treatment. Taste was improved significantly (P<0.05) in 3% and 6% BV with the peculiar and savory taste of Hanwoo being more emphasized. The results of this experiment indicated that 3% BV improved the marbling score and crude fat content, decreased the shear force and cholesterol contents, increased the USFA composition, and improved the taste of sensory evaluation in Korean native Hanwoo cows.