• Title/Summary/Keyword: 제작증명

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Development of Korean Version of Heparin-Coated Shunt (헤파린 표면처리된 국산화 혈관우회도관의 개발)

  • Sun, Kyung;Park, Ki-Dong;Baik, Kwang-Je;Lee, Hye-Won;Choi, Jong-Won;Kim, Seung-Chol;Kim, Taik-Jin;Lee, Seung-Yeol;Kim, Kwang-Taek;Kim, Hyoung-Mook;Lee, In-Sung
    • Journal of Chest Surgery
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    • v.32 no.2
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    • pp.97-107
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    • 1999
  • Background: This study was designed to develop a Korean version of the heparin-coated vascular bypass shunt by using a physical dispersing technique. The safety and effectiveness of the thrombo-resistant shunt were tested in experimental animals. Material and Method: A bypass shunt model was constructed on the descending thoracic aorta of 21 adult mongrel dogs(17.5-25 kg). The animals were divided into groups of no-treatment(CONTROL group; n=3), no-treatment with systemic heparinization(HEPARIN group; n=6), Gott heparin shunt (GOTT group; n=6), or Korean heparin shunt(KIST group; n=6). Parameters observed were complete blood cell counts, coagulation profiles, kidney and liver function(BUN/Cr and AST/ ALT), and surface scanning electron microscope(SSEM) findings. Blood was sampled from the aortic blood distal to the shunt and was compared before the bypass and at 2 hours after the bypass. Result: There were no differences between the groups before the bypass. At bypass 2 hours, platelet level increased in the HEPARIN and GOTT groups(p<0.05), but there were no differences between the groups. Changes in other blood cell counts were insignificant between the groups. Activated clotting time, activated partial thromboplastin time, and thrombin time were prolonged in the HEPARIN group(p<0.05) and differences between the groups were significant(p<0.005). Prothrombin time increased in the GOTT group(p<0.05) without having any differences between the groups. Changes in fibrinogen level were insignificant between the groups. Antithrombin III levels were increased in the HEPARIN and KIST groups(p<0.05), and the inter-group differences were also significant(p<0.05). Protein C level decreased in the HEPARIN group(p<0.05) without having any differences between the groups. BUN levels increased in all groups, especially in the HEPARIN and KIST groups(p<0.05), but there were no differences between the groups. Changes of Cr, AST, and ALT levels were insignificant between the groups. SSEM findings revealed severe aggregation of platelets and other cellular elements in the CONTROL group, and the HEPARIN group showed more adherence of the cellular elements than the GOTT or KIST group. Conclusion: Above results show that the heparin-coated bypass shunts(either GOTT or KIST) can suppress thrombus formation on the surface without inducing bleeding tendencies, while systemic heparinization(HEPARIN) may not be able to block activation of the coagulation system on the surface in contact with foreign materials but increases the bleeding tendencies. We also conclude that the thrombo-resistant effects of the Korean version of heparin shunt(KIST) are similar to those of the commercialized heparin shunt(GOTT).

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A Comparative Study of Domestic and International regulation on Mixed-fleet Flying of Flight crew (운항승무원의 항공기 2개 형식 운항관련 국내외 기준 비교 연구)

  • Lee, Koo-Hee
    • The Korean Journal of Air & Space Law and Policy
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    • v.30 no.2
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    • pp.403-425
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    • 2015
  • The Chicago Convention and Annexes have become the basis of aviation safety regulations for every contracting state. Generally, the State's aviation safety regulations refer to the Standards and Recommended Practices(SARPs) provided in the Annexes of the Chicago Convention. In order to properly reflect international aviation safety regulations, constant studies of the aviation fields are of paramount importance. This Paper is intended to identify the main differences between korean and foreign regulation and suggest a few amendment proposals on Mixed-fleet Flying(at or more two aircraft type operation) of flight crew. Comparing with these regulations, the korean regulations and implementations have some insufficiency points. I suggest some amendment proposals of korean regulations concerning Mixed-fleet Flying that flight crew operate aircraft of different types. Basically an operator shall not assign a pilot-in-command or a co-pilot to operate at the flight controls of a type of airplane during take-off and landing unless that pilot has operated the flight controls during at least three take-offs and landings within the preceding 90 days on the same type of airplane or in a flight simulator. Also, flight crew members are familiarized with the significant differences in equipment and/or procedures between concurrently operated types. An operator shall ensure that piloting technique and the ability to execute emergency procedures is checked in such a way as to demonstrate the pilot's competence on each type or variant of a type of airplane. Proficiency check shall be performed periodically. When an operator schedules flight crew on different types of airplanes with similar characteristics in terms of operating procedures, systems and handling, the State shall decide the requirements for each type of airplane can be combined. In conclusion, it is necessary for flight crew members to remain concurrently qualified to operate multiple types. The operator shall have a program to include, as a minimum, required differences training between types and qualification to maintain currency on each type. If the Operator utilizes flight crew members to concurrently operate aircraft of different types, the operator shall have qualification processes approved or accepted by the State. If applicable, the qualification curriculum as defined in the operator's Advanced Qualification Program could be applied. Flight crew members are familiarized with the significant differences in equipment and/or procedures between concurrently operated types. The difference among different types of airpcrafts decrease and standards for these airpcrafts can be applied increasingly because function and performance have been improved by aircraft manufacture company in accordance to basic aircraft system in terms of developing new aircrafts for flight standard procedure and safety of flight. Also, it becomes more necessary for flight crews to control multi aircraft types due to various aviation business and activation of leisure business. Nevertheless, in terms of flight crew training and qualification program, there are no regulations in Korea to be applied to new aircraft types differently in accordance with different levels. In addition, it has no choice different programs based on different levels because there are not provisions to restrict or limit and specific standards to operate at or more than two aircraft types for flight safety. Therefore the aviation authority introduce Flight Standardization and/or Operational Evaluation Board in order to analysis differences among aircraft types. In addition to that, the aviation authority should also improve standard flight evaluation and qualification system among different aircraft types for flight crews to apply reasonable training and qualification efficiently. For all the issue mentioned above, I have studied the ICAO SARPs and some state's regulation concerning operating aircraft of different types(Mixed-fleet flying), and suggested some proposals on the different aircraft type operation as an example of comprehensive problem solving. I hope that this paper is 1) to help understanding about the international issue, 2) to help the improvement of korean aviation regulations, 3) to help compliance with international standards and to contribute to the promotion of aviation safety, in addition.