• Air Cleaning Technology
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• v.29 no.2
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• pp.34-43
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• 2016

• Air Cleaning Technology
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• v.29 no.2
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• pp.11-20
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• 2016

• Proceedings of the SAREK Conference
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• 2009.06a
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• pp.887-892
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• 2009

Biosafety research facilities require to verified about the facility and experimental environment, especially for level-3 and level-4 of biosafety research facilities verification is very important. In this paper, introduce verified procedures and present the methods and the results through a verified case of the biosafety level-3 research facilities.

• Proceedings of the SAREK Conference
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• 2009.06a
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• pp.881-886
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• 2009

Bio safety level-3 laboratory is the research facility with concerns for the BL-3 contamination, at the same time the safety of it is guarantied. Based on comfortable environmental maintenance of the research laboratory, building, machinery, electricity, and controls are facilitated to keep airtightness(minus pressure) of each room in case of not only access and operation, but even emergency.

• Proceedings of the SAREK Conference
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• 2009.06a
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• pp.745-750
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• 2009

In Korea, since the implementation of the GMO Law, the intrest of biosafety level 3(BL3) lab. is increasing. In this study, using CONTAM which is applying multizone modelling, the multizone simulation for design verification of BL3 lab. was performed. In BL3 lab., because required air change rate is greater than general estimated air-conditioning load and it is difficult to maintain room pressure difference efficiently, to maintain pressure difference between laboratory rooms is important through sealing condition of doors and proper airflow control of laboratory rooms. In this study, about BL3 lab.(M. tuberculosis research lab.), the multizone simulation for four kind of biohazard scenarios was performed in the case of unexpected spread of contaminants in the laboratory room, anteroom, corridor and inside of BSC. Multizone simulation results show that these approach methods are used as a tool for the design and verification of BL3 lab.

• Korean Journal of Air-Conditioning and Refrigeration Engineering
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• v.21 no.12
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• pp.671-677
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• 2009

In Korea, since the implementation of the LMO Law, the interest of biosafety level 3(BL3) lab. is increasing. In this study, using CONTAM which is applying multizone modelling, the multizone simulation for design verification of BL3 lab. is performed. In BL3 lab., because required air change rate is greater than general estimated air-conditioning load and it is difficult to maintain room pressure difference efficiently, to maintain pressure difference between laboratory rooms is important through sealing condition of doors and proper airflow control of laboratory rooms. In this study, about BL3 lab,(M. tuberculosis research lab.), the multizone simulation for four kind of biohazard scenarios is carried out in the case of unexpected spread of contaminants in the laboratory room, anteroom, corridor and inside of BSC. Multizone simulation results show that these approach methods are used as a tool for the design and verification of BL3 lab.

• Proceedings of the SAREK Conference
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• 2009.06a
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• pp.874-879
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• 2009

• Proceedings of the Korean Institute of Surface Engineering Conference
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• 2018.06a
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• pp.22-22
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• 2018

의료기기는 사용목적과 사용 시 인체에 미치는 잠재적 위해성의 정도에 따라 4개의 등급으로 분류하며, 두 가지 이상의 등급에 해당되는 제품의 경우에는 가장 높은 등급으로 분류하게 된다. 의료기기 품목허가를 위해서는 기술문서를 작성하여야 하며, 이를 위해서는 기술문서 심사를 신청하는 절차를 이해하여야 한다. 의료기기 기술문서란 의료기기의 성능과 안전성 등 품질에 관한 자료로서 해당 품목의 원자재, 구조, 사용목적, 사용방법, 작용원리, 사용 시 주의사항, 시험규격 등이 포함되는 문서를 말하며, '의료기기 허가 신청서'와 '첨부자료(임상시험자료 포함)'로 구성되어 있다. 의료기기 품목허가 시 제출되는 기술문서를 통하여 해당 의료기기의 안전성 및 성능이 충분히 입증되어야 하며, 인체 삽입되는 표면처리 임플란트를 포함한 인체 접촉 의료기기의 안전성의 경우 '의료기기의 생물학적 안전에 관한 공통 기준규격'에 따라 평가 후 제조 수입품목 허가를 진행해야 한다. 또한 성능의 경우는 해당 규격 또는 자사의 기준 및 시험방법에 따른 성능에 관한 자료, 물리 화학적 특성에 관한 자료를 통하여 평가되어야 하며, 기허가 인증된 제품에 한 번도 사용되지 않은 원재료 또는 적용부위 및 적용방법이 달라 안전성 및 유효성 확인이 필요한 경우 임상시험에 관한 자료가 요구될 수 있다. 본 발표에서는 이러한 인체 삽입용 표면처리 임플란트의 전반적인 인허가 절차에 대해서 안내하고자 한다.

• Korean Journal of Air-Conditioning and Refrigeration Engineering
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• v.22 no.11
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• pp.745-750
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• 2010

Since the implementation of the LMO Law in Korea, the importance of the design qualification of BSL3 lab. is emphasizing. In this study, multizone simulation for three kind of biohazard scenarios using CONTAM is performed for design qualification of BSL3 lab. Also, in the case of unexpected spread of contaminants such as Influenza A virus(H1N1) in BL3 zone, the design qualification is carried out for diffusion and decontamination of contaminants according to differential pressure of BSL3 anteroom and door area of BSL3 lab. Also, in this study, appropriateness of laboratory room differential pressure and air flow rate to maintain pressure difference between laboratory rooms, and energy consumption due to air change rate variation according to door area in BL3 lab. Simulation results show that these approach methods are used as a tool for the design and verification of BL3 lab.

• Journal of The Korea Institute of Healthcare Architecture
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• v.17 no.1
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• pp.23-32
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• 2011

Recently, with the advent of high risk infectious agent such as the Ebola virus, SARS, special research facilities dealing with such dangerous pathogenic are drawing attention gradually. Especially, this kind of facilities can be called BL4(Biosafety Level 4) facility. At the moment, Korean government is going to construct BL4 institute in order to handle efficiently such kind of pathogen. However, there are no proper design guidelines for BL4 facility. This paper proposes circulation system of BL4 facility on the basis of analysis of existing BL4 guidelines of Canada, and Korean BL3 facilities. The outcomes of this study are as follows. At first, functional areas of BL4 facilities have been divided into three categories according to the hazard level ; dangerous area, transitional area, and ordinary area. Secondly, circulation system of BL4 facility has been explored as a form of diagram according to the circulating subjects. These include human, laboratory animals, hazardous pathogen, equipments and cloth. This study has some limitations in that it lacks empirical evidences and concrete SOPs(Standard Operating Procedure). Despite of some weaknesses, it is expected to give some preliminary guidelines for the design of circulation system in BL4 facilities.