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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.