• 제목/요약/키워드: 510(k)

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수산 자숙액의 방사선 조사 여부 판별 특성 연구 (Identification of Irradiated Seafood Cooking Drips Using Various Detection Methods)

  • 최종일;김연주;김재훈;이주운
    • 한국식품영양과학회지
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    • 제40권11호
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    • pp.1569-1574
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    • 2011
  • 수산 자숙액의 조사 여부를 판별하기 위해 물리적(PSL, TL) 및 화학적(hydrocarbon 분석) 검지 시험을 진행하였다. 10 kGy까지의 감마선 조사를 적용한 자숙액을 PSL법으로 측정하였을 때, 모든 자숙액에서 260~510의 photon counts를 나타내어 자숙액의 방사선조사 여부의 확인 방법으로서 PSL은 적용 가능성이 낮다고 사료되었다. 수산 자숙액에 TL법을 적용한 결과 톳 및 문어 자숙액의 경우 방사선 조사한 자숙액에서 150~250$^{\circ}C$ 범위에서 특정한 glow curve가 나타났으므로 방사선조사 여부를 확인하는데 적용이 가능할 것이라고 사료된다. 참치 자숙액의 경우 감마선조사에 의해 유래되는 hydrocarbon은 검출되지 않았는데, 이는 참치 가공에서 부산물로 얻어지는 자숙액의 낮은 지방산 함량과 자숙 공정에 따른 상이한 지방산 조성에서 비롯한 것이라고 사료된다.

뇌지주막하 출혈 후 뇌혈관 연축에 대한 동맥내 Papaverine 주입의 치료효과 (Effect of the Intra-arterial Papaverine Infusion on the Symptomatic Cerebral Vasospasm after Aneurysmal Subarachnoid Hemorrhage)

  • 신준재;이재환;신용삼;허승곤;김동익;이규창
    • Journal of Korean Neurosurgical Society
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    • 제30권3호
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    • pp.325-333
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    • 2001
  • Objective : To clarify the benefits and therapeutic effects of intra-arterial papaverine infusion on the symptomatic cerebral vasospasm, we analyzed the results of treatment in 32 patients retrospectively. Methods : A total of 510 patients underwent surgical clipping or endovascular intra-aneurysmal treatment for ruptured intracranial aneurysm between May, 1996 and June, 1999. The delayed ischemic deficit(DID) was developed in 90 of 510 patients. Of these 90 patients, 32 developed symptomatic vasospasm inspite of using modest "3H therapy". The brain CT scan was taken before the intra-arterial infusion of papaverine. The 32 patients underwent 42 intra-arterial papaverine infusion. The symptomatic vasospasm was divided into three groups : deterioration of mental status(Group 1), appearance of a focal neurologic deficit(Group 2), or both(Group 3). We measured Glasgow Coma Scale(GCS), arterial diameters, and cerebral circulation time(CCT) at the time of pre- and postangioplasty. Results : The number of patients in group 1, 2 and 3 were 26, 7, 9 respectively. Eighteen cases showed improvement of GCS more than 2 scores, 16 more than 1, and 8 showed no change of GCS. Average cerebral circulation time(CCT) was decreased ranging from 0.0%-67.5%, and arterial diameters were increased in 21 cases ranging from 1 to 4 folds. Conclusion : Intra-arterial papaverine infusion seemed to have therapeutic effects on symptomatic vasospasm by improving the neurological signs and increasing the arterial diameter. We suggest that intra-arterial papaverine infusion would be an useful adjunctive therapeutic modality in symptomatic vasospasm.

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Self-wastage에 의한 2.25Cr-1Mo Steel 시편의 Re-open 현상 (Reopening Phenomena of the 2.25Cr-1Mo Steel Specimen by Self-wastage)

  • 정경채;권상운;최종현;박진호;황성태
    • 공업화학
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    • 제10권4호
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    • pp.531-536
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    • 1999
  • 누출시험 장치를 이용하여 미량 물 누출 실험을 수행하였다. 2.25Cr-1Mo 시편의 누출경로는 나트륨-물 반응 생성물에 의해 plugging되는 경우가 발생하였으나, 대부분 re-open상태를 나타내었다. 또한 누출 경로가 완전 re-open된 후 나트륨 부위에서 시편의 self-wastage pattern은 온도에 영향을 받지 않음을 알 수 있었으며, 누출경로가 re-open 되면서 나타나는 defected 크기는 대략 5 mm 이내임을 알 수 있었다. 누출 경로가 완전 re-open 되는데 걸리는 시간은나트륨 온도가 높을수록 짧게 나타났으며, 평균적으로 $450^{\circ}C$에서 143분, $475^{\circ}C$의 경우 40.7분, $510^{\circ}C$의 경우 34.7분을 나타내었다.

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의료기기의 결함으로 인한 손해배상책임과 미국 연방법 우선 적용 이론에 관하여 (The Liability for Unsafe Medical Product and The Preemption Clause of Medical Device Act)

  • 김장한
    • 의료법학
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    • 제15권2호
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    • pp.63-89
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    • 2014
  • In 1976, the Dalkon Shield-intrauterine device injured several thousand women in U.S.A. which caused the changes of medical deivce regulation. The Medical Device Regulation Act or Medical Device Amendments of 1976 (MDA) was introduce. As part of the process of regulating medical devices, the MDA divides medical devices into three categories. The class II, and III devices which have moderate harm or more can use the section 510 (k), premarket notification process if the manufacturer can establish that its device is "substantially equivalent" to a device that was marketed before 1976. In 21 U.S.C. ${\S}$ 360k(a), MDA introduced a provision which expressly preempts competing state laws or regulations. After that, the judicial debates had began over the proper interpretation and application of Section 360(k) In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that manufacturer approved by the Food and Drug Administration (FDA)'s pre-market approval process are preempted from liability, even when the devices have defective design or lack of labeling. But the Supreme Court ruled in Medtronic Inc. v. Lora Lohr that the manufactures which use the section 510 (k) process cannot be preempted and in Bausch v. Stryker Corp. that manufactures which violated the CGMP standard are also liable to the damage of patient at the state courts. In 2009, the Supreme Court ruled in Wyeth v. Levine that patients harmed by prescription drugs can claim damages in state courts. This may cause a double standard between prescription drugs and medical devices. FDA Preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding Food and Drug Administration approved products. FDA Preemption has been a highly contentious issue. In general, consumer groups are against it while the FDA and pharmaceutical manufacturers are in favor of it. This issues also influences the theory of product liability of U.S.A. Complete immunity preemption is an issue need to be more declared.

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지르코니아 전해질을 이용한 단실형 고체산화물 연료전지의 전기화학 특성 (The Electrochemical Property of the Single-Chamber Solid Oxide Fuel Cell Based on a Zirconia Electrolyte)

  • 박희정;주종훈;양재교;진연호;이규형
    • 한국전기전자재료학회논문지
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    • 제29권8호
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    • pp.510-515
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    • 2016
  • Single-chamber solid oxide fuel cells (SC-SOFCs) consist of only one gas chamber, in which both the anode and the cathode are exposed to the same fuel-oxidant mixture. Thus, this configuration shows good thermal and mechanical resistance and allows rapid start-up and -down. In this study, the unit cell consisting of $La_{0.8}Sr_{0.2}MnO_3$ (cathode) / $Zr_{0.84}Y_{0.16}O_{2-x}$ (electrolyte) / $Ni-Zr_{0.84}Y_{0.16}O_{2-x}$ (anode) was fabricated and its electrochemical property was investigated as a function of temperature and the volume ratio of fuel and oxidant for SC-SOFCs. Impedance spectra were also investigated in order to figure out the electrical characteristics of the cell. As a result, the cell performance was governed by the polarization resistances of the electrodes. The cell exhibited an acceptable cell-performance of $86mW/cm^2$ at $800^{\circ}C$ and stable performance for 3 hs under 0.7 V.

HPLC를 이용한 대두유 인지질의 분석 (Analyses of Phospholipids in Soybean Oils by HPLC)

  • 윤석후;민병성;여영근;엘에이호라스
    • 한국식품과학회지
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    • 제19권1호
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    • pp.66-68
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    • 1987
  • 헥산으로 추출한 대두유의 탈취유와 클로로포름-메타놀로 추출한 대두원유내에 존재하는 인지질의 정성정량 분석을 고성능 액체크로마토그라피를 사용하여 행하였다. 헥산으로 추출한 대두원유, 탈검유, 정제유, 탈색유 및 탈취유의 인함량은 각각 510, 120, 5, 1.4. 1ppm이었으며 클로로포름-메타놀로 추출한 대두원유의 인함량은 800ppm이었다. 원유내에서 확인된 인지질은 포스파터딜콜린, 포스파티딜에타놀아민, 포스파티딜이노시틀, 포스파티딜세린, 포스파티딜산이었으며, 탈취유에서는 포스파티딜세린과 포스파티딜에타놀아민만이 검출되었다. 이 분석방법을 사용하면 대두유내의 모든 인지질을 30분이내에 개별적으로 분리하고, 0.1ppm수준까지 정량분석할수 있다.

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콩 유용성분 탐색에 관한 연구: 콩 Ferritin의 정제 및 특성 (Investigation of useful components in soybean seeds: Purification and characterization of soybean ferritin)

  • 서경원;오석홍
    • Applied Biological Chemistry
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    • 제41권7호
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    • pp.522-526
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    • 1998
  • 콩 유용성분 탐색의 일환으로 그리고 향후 콩 ferritin 항체 및 유전자 확보를 목표로 발아된 콩으로부터 ferritin을 분리 정제하여 그 몇가지 특성을 조사하였다. 72시간 발아된 콩으로부터 ammonium sulfate 침전(0.55 saturation), DEAE-cellulose, Sephacryl S-300, Bio-Scale Q2 column chromatographies를 통하여 ferritin을 분리하였다. 정제된 콩 ferritin은 SDS-PAGE 분석에서 21 kDa의 크기를 나타냈으며, Sephacry S-300을 통한 겔거르기 chromatography와 non-denaturing 폴리아크릴아마이드 전기영동 분석에서 $510{\sim}560\;kDa$의 크기로 측정 되었다. 또한, immunodiffusion test에서 anti-soybean ferritin antiserum과 상호 반응하였다. 원자흡광광도계와 표준 철 용액을 이용한 정제된 콩 ferritin 중의 철 함유량은 833 mol Fe/mol protein 이었으며, 이는 호박씨로부터 분리한 ferritin보다 31배 더 많은 양의 철 함유량 이었다. 정제된 콩 ferritin중의 철은 horse spleen ferritin 중의 철과 유사하게 iron staining 되었다.

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Li 이차전지용 티타네이트 나노튜브 제조 및 특성평가 (Characterization and preparation titanate nanotubes for Li-ion secondary battery)

  • 오효진;이남희;윤초롱;정상철;김선재
    • 한국전기전자재료학회:학술대회논문집
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    • 한국전기전자재료학회 2007년도 추계학술대회 논문집
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    • pp.510-510
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    • 2007
  • Titanate nanotube(TNT)는 높은 비표면적과 우수한 물리화학적 특성을 가지고 있어 광촉매, 수소 저장재료, 태양전지용 전극재료 등에 적용되고 있다. 또한, 티타네이트 나노튜브는 전자 이동이 원활한 구조적 특징을 가지고 있어 리듐 이차전지용 호스트 재료로서 많은 연구가 진행 중이다. 이에 본 연구에서는 저온균일침전법으로 제조한 루틸상 $TiO_2$ 분말에 Lithium chloride를 1~10wt%를 동시에 첨가한 후 10M의 sodium hydroxide 수용액 내에서 수열합성하여 리튬이 도핑된 티타네이트 나노튜브를 제조하였다. 제조된 분말의 입자형상 및 크기는 전자주사 현미경을 이용하여 관찰하였으며, X-선 회절분석을 이용하여 리튬 첨가에 따른 결정상 변화를 관찰하였다. 또한 리튬이 도핑된 티타네이트 나노튜브의 전기화학적 특성 평가를 위해 양극 활물질 : 도전제 : 바인더를 75 : 20 : 5의 비율로 혼합한 후 coin cell을 제조하였고, potentiostat를 이용하여 용량 측정 및 cycle 특성을 실시하였다. 수열 합성법에 의해 형성된 입자는 직경 10nm, 길이 수 ${\mu}m$로 관찰되었으며, X-선 회절 시험 결과 LiO와 같은 이차상은 발견되지 않았다. 측정된 coin cell의 용량은 240mAh/g을 나타내었으나, 싸이클 특성이 빠르게 저하됨을 확인할 수 있었다.

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Influences of Chronic Shoulder Pain on Muscle Tone Changes in Trunk Muscles

  • Jeon, Hye Mi;Choi, Yoo Rim;Park, Si Eun;An, Ho Jung;Lee, Sang Bin;Choi, Wan Suk;Kim, Nyeon Jun;Kim, Hee Kyoung;Kim, Mi Jung;Kim, Soon Hee
    • 국제물리치료학회지
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    • 제4권1호
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    • pp.510-515
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    • 2013
  • The purpose of this study was to examine the influences of chronic shoulder pain on the muscle tone in trunk muscles. The study's subjects were 40 men and women in their 30 to 50s, which were divided into two groups. A chronic shoulder pain group consisted of 20 subjects who had been diagnosed with chronic shoulder pain by doctors, and a painless group consisted of 20 subjects who had experienced no such pain. An analysis was performed using electromyography on the muscle tone in the rectus abdominalis, external oblique, internal oblique, and erector spinae muscles under the same conditions between the two groups. The analysis results were as follows. The chronic shoulder pain group exhibited an overall high level of trunk muscle tone than the painless group, along with a statistically significant difference in the rectus abdominalis(p<.05). Moreover, the chronic shoulder pain group showed differences in the trunk muscle tone depending on the affected side. The chronic left shoulder pain group yielded higher levels of muscle tone in the right-side trunk muscles. In particular, the group revealed statistically significant differences in the rectus abdominalis and internal oblique(p<.05). The chronic right shoulder pain group exhibited higher levels of muscle tone in the left-side trunk muscles with a statistically significant difference in the internal oblique(p<.05). The above results suggested that chronic shoulder pain influences increases in the muscle tone in the trunk muscles on the opposite side to the affected shoulder.

하동화력발전소 비산재의 입도크기와 미연탄소 함량이 지오폴리머의 압축강도에 미치는 영향 (Effect of Particle Size and Unburned Carbon Content of Fly Ash from Hadong Power Plant on Compressive Strength of Geopolymers)

  • 강남희;전철민;주형태;이수정
    • 한국재료학회지
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    • 제23권9호
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    • pp.510-516
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    • 2013
  • Fly ash is one of the aluminosilicate sources used for the synthesis of geopolymers. The particle size distribution of fly ash and the content of unburned carbon residue are known to affect the compressive strength of geopolymers. In this study, the effects of particle size and unburned carbon content of fly ash on the compressive strength of geopolymers have been studied over a compositional range in geopolymer gels. Unburned carbon was effectively separated in the $-46{\mu}m$ fraction using an air classifier and the fixed carbon content declined from 3.04 wt% to 0.06 wt%. The mean particle size ($d_{50}$) decreased from $22.17{\mu}m$ to $10.79{\mu}m$. Size separation of fly ash by air classification resulted in reduced particle size and carbon residue content with a collateral increase in reactivity with alkali activators. Geopolymers produced from carbon-free ash, which was separated by air classification, developed up to 50 % higher compressive strength compared to geopolymers synthesized from raw ash. It was presumed that porous carbon particles hinder geopolymerization by trapping vitreous spheres in the pores of carbon particles and allowing them to remain intact in spite of alkaline attack. The microstructure of the geopolymers did not vary considerably with compressive strength, but the highest connectivity of the geopolymer gel network was achieved when the Si/Al ratio of the geopolymer gel was 5.0.