• 제목/요약/키워드: IS Process

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Features and Trends of IEC Particular Standards for Medical Equipment Related to Diagnostic X-ray Based on IEC 60601-1:2005 Ed. 3.0 (IEC 60601-1: 3판이 적용된 진단용 X선장치 관련 개별규격의 동향 및 특징)

  • Kim, Hyun-Ji;Kim, Jung-Min;Choi, In-Seok;Yoon, Yong-Su;Seo, Deok-Nam;Kim, Jung-Su;Kim, Dae-Young;Park, Sung-Yong
    • Journal of radiological science and technology
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    • 제36권1호
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    • pp.1-10
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    • 2013
  • IEC publications have applied in many countries all over the world such as Europe or Japan and these also have been published as in dustrial standards (KS) and notifications of Korea Food and Drug Administration (KFDA) in Korea. As the general standard of IEC 60601 series for medical electric (ME) equipment was revised as $3^{rd}$ edition in 2005, additional and particular standards have been revised or established newly. Under these circumstances, it is importance for manufacturing and assembling companies or authorized testing companies to understand the trend for revisions of IEC publications. Therefore in this study, the latest version of 3 IEC standards related to medical X-ray equipment : IEC 60601-2-44 for X-ray equipment for computed tomography (CT), IEC 60601-2-45 for mammographic X-ray equipment and IEC 60601-2-54 for X-ray equipment for radiography or radioscopy were covered and analyzed for trends and features accompanied by revision based on IEC 60601-1 $3^{rd}$ Ed. As KFDA notifications in force have referred to the particular standards based on 2nd edition of IEC 60601-1, those revised version of 3 particular standards were compared to KFDA notifications in force. The features of the latest standards applying IEC 60601-1 $3^{rd}$ Ed were shown as following: 1) Requirements for mechanical hazards, especially (motorized) moving parts were emphasized. 2) Indication and recording of patient dose were required. 3) Risk management process was introduced and enabled to monitor potential risks systematically. 4) DR system (digital radiography system) as well as analogue system (film-screen system) was included in the scope. Presently, KFDA will revise the notifications applying the particular standards based on IEC 60601-1 $3^{rd}$ Ed in a few years. Therefore the features of particular standards applying IEC 60601-1 $3^{rd}$ Ed was expected to help manufacturers, assemblers or testing companies of medical electric equipment understand IEC publications or KFDA notifications slated to be published.

Minimally invasive cardiac surgery with the partial mini-sternotomy in children (소아연령군에서의 부분흉골소절개를 통한 최소침투적심장수술)

  • 이정렬;임홍국;성숙환;김용진;노준량;서경필
    • Journal of Chest Surgery
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    • 제31권5호
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    • pp.466-471
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    • 1998
  • Purpose: The safety and efficacy of minimally invasive techniques in congenital heart surgery were tested in this study. Materal and method: Between July 1997 and November 1997, a total of 46 children were underwent minimally invasive cardiac operations at Seoul National University Children's Hospital. Age and body weight of the patients averaged 34.6${\pm}$41.8 (Range: 1∼148) months and 14.5${\pm}$9.9(Range: 3.0∼40.0) kg, respectively. Twenty eight patients were male. Preoperative surgical indications included 15 atrial septal defects, 25 ventricular septal defects, 1 foreign body in aorta, 3 partial atrioventricular septal defects, 1 total anomalous pulmonary venous connection(cardiac type), and 1 tetralogy of Fallot. After creating a small lower midline skin incision starting as down as possible from the sternal notch, a vertical midline sternotomy extended from xyphoid process to the level of the second intercostal space, where one of the T-, J-, I- or inverted C-shaped lower lying mini-sternotomy was completed with a creation of unilateral right or bilateral trap door sternal opening. A conventional direct aortic and bicaval cannulation was routine. Result: A mean length of skin incision was 6.1${\pm}$1.0(range: 4.0∼9.0) cm. A mean distance between the suprasternal notch and the upper most point of the skin incision was 4.0${\pm}$1.1 (range: 2.0∼7.0) cm. Mean cardiopulmonary bypass time, aortic cross-clamp time, and the operation time were 62.9${\pm}$20.0(range: 28∼147), 29.8${\pm}$12.8(range: 11∼79), and 161.1${\pm}$34.5 (range: 100-250) minutes. A mean total amount of postoperative blood transfusion was 71.0${\pm}$68.1 (range: 0∼267) cc. All patients were extubated mean 11.3${\pm}$13.8(range: 1∼73) hours after operation. A mean total amount of analgesics used was 0.8${\pm}$1.8(range: 0∼9) mg of morphine. The mean duration of stay in intensive care unit and hospital stay were 35.0${\pm}$32.2 (range: 10∼194) hours and 6.2${\pm}$2.0(range: 3∼11) days. There were no wound complications and hospital deaths. Conclusion: This short-term experience disclosed that the minimally invasive technique can be feasibly applied in a selected group of congenital heart disease as well as is cosmetically more attractive approach.

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The Effect of Radiation Therapy on hemophilic Athropathy (혈우병성 관절증에 대한 방사선 치료의 역할)

  • Kang Jin Oh;Hong Seong Eon;Kim Sang Gi;Shin Dong Oh
    • Radiation Oncology Journal
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    • 제23권2호
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    • pp.106-110
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    • 2005
  • Purpose : Repetitive bleeding into the joint space is the cause of debilitative hemophilic arthropathy. To interrupt this process, we treated the hemophilic patients suffering from repetitive joint bleeding with radiation therapy. Materials and Methods : From 1997 to 2001, a total of 41 joints from 37 hemophilic arthropathy patients were treated with radiation therapy at Kyung Hee University Hospital. The treated joints were 35 ankles, 3 knees and 3 elbows, respectively. The age of the patients ranged from 4 to 27 years (median age: 11 years). The radiation dose ranged from 900 cGy to 2360 cGy (median dose: 900cGy). The fraction size was 150 cGy, 180 cGy or 200 cGy. The number of bleeding in one year before and after radiotherapy was compared. Results : There was a tendency of frequent bleeding for the Patients younger than 11 (p=0.051) but there was also a tendency for more improvement in this group (p=0.057). The number of joint bleedings was related with joint pain (p=0.012) and joint swelling (p=0.033) but not with the Arbold-Hilgartner stage (p=0.739), cartilage destruction (p=0.718) and synovial hypertrophy (p=0.079). The number of bleeding was reduced in thirty-three cases, and eight cases showed no improvement after radiation therapy. The average number of bleeding in a month was 2.52 before radiotherapy, but this was reduced to 1.4 after radiotherapy (p=0.017). Conclusion : Radiation therapy was effective for the hemophilia patients with repetitive joint bleeding to decrease the bleeding frequency and to prevent hemophilic arthropathy.

Eco-friendly and efficient in situ restoration of the constructed sea stream by bioaugmentation of a microbial consortium (복합미생물 생물증강법을 이용한 인공해수하천의 친환경 효율적 현장 수질정화)

  • Yoo, Jangyeon;Kim, In-Soo;Kim, Soo-Hyeon;Ekpeghere, Kalu I.;Chang, Jae-Soo;Park, Young-In;Koh, Sung-Cheol
    • Korean Journal of Microbiology
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    • 제53권2호
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    • pp.83-96
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    • 2017
  • A constructed sea stream in Yeongdo, Busan, Republic of Korea is mostly static due to the lifted stream bed and tidal characters, and receives domestic wastewater nearby, causing a consistent odor production and water quality degradation. Bioaugmentation of a microbial consortium was proposed as an effective and economical restoration technology to restore the polluted stream. The microbial consortium activated on site was augmented on a periodic basis (7~10 days) into the most polluted site (Site 2) which was chosen considering the pollution level and tidal movement. Physicochemical parameters of water qualities were monitored including pH, temperature, DO, ORP, SS, COD, T-N, and T-P. COD and microbial community analyses of the sediments were also performed. A significant reduction in SS, COD, T-N, and COD (sediment) at Site 2 occurred showing their removal rates 51%, 58% and 27% and 35%, respectively, in 13 months while T-P increased by 47%. In most of the test sites, population densities of sulfate reducing bacterial (SRB) groups (Desulfobacteraceae_uc_s, Desulfobacterales_uc_s, Desulfuromonadaceae_uc_s, Desulfuromonas_g1_uc, and Desulfobacter postgatei) and Anaerolinaeles was observed to generally decrease after the bioaugmentation while those of Gamma-proteobacteria (NOR5-6B_s and NOR5-6A_s), Bacteroidales_uc_s, and Flavobacteriales_uc_s appeared to generally increase. Aerobic microbial communities (Flavobacteriaceae_uc_s) were dominant in St. 4 that showed the highest level of DO and least level of COD. These microbial communities could be used as an indicator organism to monitor the restoration process. The alpha diversity indices (OTUs, Chao1, and Shannon) of microbial communities generally decreased after the augmentation. Fast uniFrac analysis of all the samples of different sites and dates showed that there was a similarity in the microbial community structures regardless of samples as the augmentation advanced in comparison with before- and early bioaugmentation event, indicating occurrence of changing of the indigenous microbial community structures. It was concluded that the bioaugmentation could improve the polluted water quality and simultaneously change the microbial community structures via their niche changes. This in situ remediation technology will contribute to an eco-friendly and economically cleaning up of polluted streams of brine water and freshwater.

Radioprotective Effect of Red Ginseng in Irradiated Mice with ${\gamma}$-ray (생쥐에서 홍삼의 감마선조사에 의한 방어효과)

  • Seung, Ka-Yeon;Lee, Heung-Man;Kim, Jong-Sang;Lee, Jun-Haeng
    • Journal of the Korean Society of Radiology
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    • 제4권1호
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    • pp.31-35
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    • 2010
  • Recently, the incidents of direct or indirect radiation exposure due to increase of use of radiation or radioisotope are on the increase in medical and industrial circles. If cells are irradiated, free radicals are created through biological process, and cells are directly or indirectly damaged. This research intends to explore into the effect of saponin at the level of cell (in vitro) and entity (in vivo), using red ginseng extract "saponin", as radioprotective agent. In the experiment implemented at the level of cell (in vitro), degree of cell activity was measures by adding mouse mesenchymal stem cells "C3H/10T1/2 cells" into red ginseng extract "saponin(0, 0.05, 0.2, and 0.4 g/L)", and then the optimal concentration of saponin influencing cells was calculated, in 24, 48, 72, and 96 hours after gamma irradiation at the optimal concentration of saponin, each cell survival rate was observed through XTT assay. The best time period of cultivation for the optimal activity of C3H/10T1/2 cells was as 48 hours, and the degree of optimal activity was shown at 0.05 g/L. In 48 hours after irradiation of 5 Gy to C3H/10T1/2 cells at 0.05 g/L, the degree of activity of cells increased by 10%. In the experiment implemented at the level of entity (in vivo), red ginseng extract "saponin" at a dose of 100 mg/kg/day was injected into the abdominal cavity of six-week immature mouse for two weeks. Right after the last abdominal injection, total body irradiation of gamma rays was carried out at a dose of 5 Gy and 10 Gy. And after irradiation, the blood sample was taken, and then the number of red corpuscles was counted. In result, the decrement of experimental group treated with red ginseng extract "saponin" was 2.3 times larger than that of control group. In view of the results so far achieved, it was revealed that red ginseng extract "saponin" has a radiation exposure protection effect in the experiment implemented at the level of cell (in vitro). In case of animal experiment, the decrement of number of red corpuscles decreased. Finally, it is necessary to carry out more various researches continuously.

Changes of Visual Acuity and Ophthalmic Symptoms in Female Workers examining Silver Plating Products (은도금제품 검사실 여성근로자들의 시력변화 및 안증상)

  • Ryu, Seung-Ho;Son, Jeong-Il;Lee, Soo-Jin;Song, Jae-Cheol
    • Journal of Preventive Medicine and Public Health
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    • 제30권3호
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    • pp.567-576
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    • 1997
  • To evaluate the effects of reflected glare on eyes, authors assessed the periodic health examination(1991-1996) & self-administered questionnaire data of a semiconductor producing company. The 13 lead frame(LF) department workers have been exposed to high reflected glare in the process for examining the silver plating products. We compared the data of connector(14) and clerical(12) workers as the non-exposed ones. Among LF department workers, 100% felt their visual acuity worsened(connector:81.8%, clerical:85.7%), and 70% had worn the glasses o. contact lenses(connector : 14.3%, clerical :40%) since working at the company. Major ophthalmic symptoms of the LF workers are asthenopia, tearing, decreased visual acuity, congestion and glare. Decrease of visual acuity by Hahn's line change of the LF workers is significantly high during a 5-year follow-up(p<0.05 by simple regression) compared with connector clerical workers.

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A Study on Oxygen Reduction Reaction of PtM Electrocatalysts Synthesized by a Modified Polyol Process (수정된 폴리올 방법을 적용하여 합성한 PtM 촉매들의 산소환원반응성 연구)

  • Yang, Jongwon;Hyun, Kyuwhan;Chu, Cheunho;Kwon, Yongchai
    • Applied Chemistry for Engineering
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    • 제25권1호
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    • pp.78-83
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    • 2014
  • In this research, we evaluated the performance and characteristics of carbon supported PtM (M = Ni and Y) alloy catalysts (PtM/Cs) synthesized by a modified polyol method. With the PtM/Cs employed as a catalyst for the oxygen reduction reaction (ORR) of cathodes in proton exchange membrane fuel cells (PEMFCs), their catalytic and ORR activities and electrical performance were investigated and compared with those of commercial Pt/C. Their particle sizes, particle distributions and electrochemically active surface areas (EAS) were measured by TEM and cyclic voltammetry (CV), while their ORR activity and electrical performance were explored using linear sweeping voltammetries with rotating disk electrodes and rotating ring-disk electrodes as well as PEMFC single cell tests. TEM and CV measurements show that PtM/Cs have the compatible particle size and EAS with Pt/C. When it comes to ORR activity, PtM/C showed the equivalent or better half-wave potential, kinetic current density, transferred electron number per oxygen molecule and $H_2O_2$ production(%) to or than commerical Pt/C. Based on results gained by the three electrode tests, when the PEMFC single cell tests were carried out, the current density measured at 0.6 V and maximum power density of PEMFC single cell adopting PtM/C catalysts were better than those adopting Pt/C catalyst. It is therefore concluded that PtM/C catalysts synthesized by modified polyol can result in the equivalent or better ORR catalytic capability and PEMFC performance to or than commercial Pt/C catalyst.

Quality Characteristics, Carbon Dioxide, and Ethylene Production of Asparagus (Asparagus officinalis L.) Treated with 1-Methylcyclopropene and 2-Chloroethylphosphonic Acid during Storage (아스파라거스에서 1-MCP와 CEPA 처리에 따른 CO2 및 에틸렌 발생과 품질특성)

  • Lee, Jung-Soo
    • Horticultural Science & Technology
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    • 제33권5호
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    • pp.675-686
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    • 2015
  • Asparagus (Asparagus officinalis L.) needs proper post-harvest treatment to prolong its storage life. This study investigated the effect of 1-methylcyclopropene (1-MCP) on the quality and storage life of asparagus. Fresh-harvested asparagus was treated with 1-MCP ($1mg{\cdot}L^{-1}$), CEPA($10mg{\cdot}L^{-1}$), and 1-MCP($1mg{\cdot}L^{-1}$) + CEPA($10mg{\cdot}L^{-1}$) and compared with an untreated control. The carbon dioxide ($CO_2$) production, ethylene production, and morphological characteristics of the preserved asparagus were observed. The flow-system and the static-type measurement methods for ethylene and $CO_2$ production (respiration rate) were used. Weight loss, respiration rate, degree of freshness, and ethylene production were monitored during storage at $7^{\circ}C$. The results further showed that CEPA (2-chloroethylphosphonic acid) treatment had greater effects on $CO_2$ and ethylene production than using the 1-MCP process. The asparagus treated with CEPA or 1-MCP + CEPA had significantly increased the ethylene production rate compared to the control or using only 1-MCP during storage. There were no evident changes in the respiration rate of asparagus under 1-MCP treatment as compared with the control. Using the flow-system, slight differences in the rates of $CO_2$ and ethylene production were noted as compared to using the static type. Findings showed that in using the flow-system, asparagus manifested clearer results as compared with the static type. Weight loss in asparagus was significantly lower in control and 1-MCP treated samples than in those treated with CEPA. Likewise, the $CO_2$ and ethylene production of the CEPA treated samples significantly increased. The 1-MCP treatment reduced the effects of CEPA on weight loss, soluble solids content, and osmolality. The effect was not observed with exogenous ethylene as CEPA treatment had no visible effect as compared to the untreated group. Thus, 1-MCP treatment of asparagus could slightly reduce damage to the quality of asparagus during its distribution where ethylene gas is produced. Therefore, this study suggests that 1-MCP treatment can reduce the damage induced by ethylene gas on asparagus in poor distribution environments.

Microbial Hazard Analysis of Manufacturing Processes for Starch Noodle (당면의 제조공정별 미생물학적 위해요소 분석)

  • Cheon, Jin-Young;Yang, Ji Hye;Kim, Min Jeong;Lee, Su-Mi;Cha, Myeonghwa;Park, Ki-Hwan;Ryu, Kyung
    • Journal of Food Hygiene and Safety
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    • 제27권4호
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    • pp.420-426
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    • 2012
  • The purpose of this study was to identify control points through microbiological hazard analysis in the manufacturing processes of starch noodles. Samples were collected from the ingredients, manufacturing processes, equipment and environment. Microbiological hazard assessments were performed using aerobic plate counts (APC), Enterobacteriaceae (EB), E. coli and five pathogens including B. cereus, E. coli O157:H7, L. monocytogenes, Salmonella spp., and S. aureus. The APC levels in raw materials were from 2.12 to 3.83 log CFU/g. The contamination levels after kneading were 4.31 log CFU/g for APCs and 2.88 log CFU/g for EB counts. APCs decreased to 1.63 log CFU/g and EB were not detected after gelatinization, but their levels slightly increased upon cooling, cutting, ripening, freezing, thawing, and separating. The reuse of cooling and coating water would be a critical source of microbial increase after cooling. After drying, APCs and EB counts decreased to 5.05 log CFU/g and 2.74 log CFU/g, respectively, and the levels were maintained to final products. These results suggest that the cooling process is a critical control point for microbiological safety, and the cooling water should be treated and controlled to prevent cross contamination by pre-requisite program.

Investigation of Microbial Contamination in Oenanthe javanica at Postharvest Environments (미나리(Oenanthe javanica) 수확 후 처리 환경에서의 위생지표세균 및 병원성 미생물 오염도 조사)

  • Kim, Yeon Rok;Lee, Kyoung Ah;Choi, In-Wook;Lee, Young-Ha;Kim, Se-Ri;Kim, Won-Il;Ryu, Song Hee;Lee, Hyo Sub;Ryu, Jae-Gee;Kim, Hwang-Yong
    • Journal of Food Hygiene and Safety
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    • 제29권4호
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    • pp.268-277
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    • 2014
  • This study assessed microbiological hazards at postharvest stage of dropwort farms (A, B, C, D, E, F, G, H, I) located in 4 different areas in Korea. The samples were assessed for sanitary indication bacteria (total aerobic bacteria, coliform, and Escherichia coli) and pathogenic bacteria (Escherichia coli O157:H7, Listeria monocytogenes, Staphylococcus aureus and Bacillus cereus). Total aerobic bacteria and coliform in 9 dropwort farms were detected at the levels of 0~7.00 and 0~4.25 log CFU/g, mL, of $100cm^2$. In particular, microbial contamination in worker's hand showed higher than cultivation environment factors. Escherichia coli was detected in several farms of soil, irrigation water, washing water and worker's hand and also, dropwort in these farms was contaminated with E. coli (positive reaction). In case of pathogenic bacteria, B. cereus was detected at the highest levels in soil. S. aureus was detected qualitatively from only one sample of dropwort washed by water. E. coli O157:H7 and L. monocytogenes were not detected. Although dropwort pass through 2 process (trimming and washing), the microbial contamination was not differ significantly before and after which indicates that current washing system was not effect on reduction of microorganism. From these results, the postharvest environment and workers have been considered as cross-contamination factors. Thus, processing equipments and personal hygiene should be managed to reduce the microbial contamination of dropwort. Accordingly management system such as good agricultural practices (GAP) criteria is needed for the safety of dropwort