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조승관(S. K. Cho),조은정(E. J. Cho),김한성(H. S. Kim) 한국정밀공학회 2004 한국정밀공학회 학술발표대회 논문집 Vol.2004 No.10월
In clinical use, coronary stents keep coronary arteries open after expansion with a balloon catheter and prevent the expanded artery from collapsing. Coronary stents are positioned in artery by catheter with a balloon along a guide wire to the lesion site. Flexibility is one of important ability for delivery. In this paper, Palmaz-Schatz stent and Tenax complete stent were selected because these are the most representative of tubular stents. Finite element analyses for the stent system were performed using ABAQUS/Standard code. The present study estimated the flexibility of coronary stents due to loading directions. Moreover the present paper suggests a numerical method to test the flexibility of stents. In conclusion this paper shows how the finite element analysis can be effectively organized in the stent development.
의료용 표시기의 안전성 및 성능 평가를 위한 시험 항목 및 시험방법(안)연구
김영균,조승관,이태우,여창민,정병조,권영미,차지훈,허찬희,박기정,김동섭,김한성,Kim, Y.G.,Cho, S.K.,Lee, T.W.,Yeo, C.M.,Jung, B.J.,Kwon, Y.M.,Cha, J.H.,Hur, C.H.,Park, K.J.,Kim, D.S.,Kim, H.S. 대한의용생체공학회 2011 의공학회지 Vol.32 No.2
Tattooing is a performance for decorative and cosmetic marking by placing permanent ink into the skin. As the cultural meaning of tattoo in Korea is changing, the tattoo machines are widely spread n permanent cosmetic market. Though the use of the tattoo machine was increased, the evaluation standards of tattoo machine were not existed. Korea Food and Drug Association regulated the electrical and mechanical safety standards which were founded on the IEC 601-1 second edition. Also they regulated he biological safety standards which were derived from the ISO 10993 series, however, these general valuations of common medical device were insufficient for evaluating tattoo machine. We developed the standards of tattoo machine for safety and performance evaluation for tattoo machine by preliminary hazard analysis in ISO 14971. The evaluation criteria of tattoo machines are focused on the mechanical invasion. We suggested the additional evaluation items of the needle speed, length, vibration with general valuation criteria of common medical device. We anticipate that this research may be a primary stage to figure a standard regulation and evaluation for tattoo machine.