Journal of Biomedical Engineering Research (대한의용생체공학회:의공학회지)

The Korean Society of Medical and Biological Engineering (대한의용생체공학회)
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Development of Standards of Tattoo Machine for Safety and Performance Evaluation

의료용 표시기의 안전성 및 성능 평가를 위한 시험 항목 및 시험방법(안)연구

  • Kim, Y.G. (Department of Biomedical Engineering, Yonsei University) ;
  • Cho, S.K. (Department of Biomedical Engineering, Yonsei University) ;
  • Lee, T.W. (Department of Biomedical Engineering, Yonsei University) ;
  • Yeo, C.M. (Department of Biomedical Engineering, Yonsei University) ;
  • Jung, B.J. (Department of Biomedical Engineering, Yonsei University) ;
  • Kwon, Y.M. (National Institute of Food and Drug Safety Evaluation Pharmaceuticals & Medical devices Research Department Fusion Technology Medical Devices Team) ;
  • Cha, J.H. (National Institute of Food and Drug Safety Evaluation Pharmaceuticals & Medical devices Research Department Fusion Technology Medical Devices Team) ;
  • Hur, C.H. (National Institute of Food and Drug Safety Evaluation Pharmaceuticals & Medical devices Research Department Fusion Technology Medical Devices Team) ;
  • Park, K.J. (National Institute of Food and Drug Safety Evaluation Pharmaceuticals & Medical devices Research Department Fusion Technology Medical Devices Team) ;
  • Kim, D.S. (National Institute of Food and Drug Safety Evaluation Pharmaceuticals & Medical devices Research Department Fusion Technology Medical Devices Team) ;
  • Kim, H.S. (Department of Biomedical Engineering, Yonsei University)
  • 김영균 (연세대학교 보건과학대학 의공학과) ;
  • 조승관 (연세대학교 보건과학대학 의공학과) ;
  • 이태우 (연세대학교 보건과학대학 의공학과) ;
  • 여창민 (연세대학교 보건과학대학 의공학과) ;
  • 정병조 (연세대학교 보건과학대학 의공학과) ;
  • 권영미 (식품의약품안전평가원 융합기기팀) ;
  • 차지훈 (식품의약품안전평가원 융합기기팀) ;
  • 허찬희 (식품의약품안전평가원 융합기기팀) ;
  • 박기정 (식품의약품안전평가원 융합기기팀) ;
  • 김동섭 (식품의약품안전평가원 융합기기팀) ;
  • 김한성 (연세대학교 보건과학대학 의공학과)
  • Received : 2010.12.16
  • Accepted : 2011.04.07
  • Published : 2011.04.30
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Abstract

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.

Keywords

References

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