Journal of Biomedical Engineering Research (대한의용생체공학회:의공학회지)

The Korean Society of Medical and Biological Engineering (대한의용생체공학회)
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Study for Mechanical and Physicochemcial Properties of Silicone Gel Filled Mammary Implants

실리콘겔 인공유방의 기계적 및 물리화학적 특성에 대한 연구

  • Baek, H. (Medical Device team, Medical Device Assessment Headquarter, Korea Testing & Research institute) ;
  • Jang, D.H. (Medical Device team, Medical Device Assessment Headquarter, Korea Testing & Research institute) ;
  • Song, J.M. (Medical Device team, Medical Device Assessment Headquarter, Korea Testing & Research institute) ;
  • Lee, S.Y. (Medical Device team, Medical Device Assessment Headquarter, Korea Testing & Research institute) ;
  • Seo, M.Y. (Medical Device team, Medical Device Assessment Headquarter, Korea Testing & Research institute) ;
  • Park, G.J. (Medical Device team, Medical Device Assessment Headquarter, Korea Testing & Research institute) ;
  • Maeng, E.H. (Medical Device team, Medical Device Assessment Headquarter, Korea Testing & Research institute)
  • 백홍 (한국화학융합시험연구원 의료기기본부 의료용품팀) ;
  • 장동혁 (한국화학융합시험연구원 의료기기본부 의료용품팀) ;
  • 송정민 (한국화학융합시험연구원 의료기기본부 의료용품팀) ;
  • 이승영 (한국화학융합시험연구원 의료기기본부 의료용품팀) ;
  • 서무엽 (한국화학융합시험연구원 의료기기본부 의료용품팀) ;
  • 박길종 (한국화학융합시험연구원 의료기기본부 의료용품팀) ;
  • 맹은호 (한국화학융합시험연구원 의료기기본부 의료용품팀)
  • Received : 2012.05.10
  • Accepted : 2012.06.21
  • Published : 2012.06.30
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Abstract

The purpose of this study is to develop the guideline of the physicochemical and mechanical properties evaluation for silicone gel filled breast implants. First of all, the use and development status for silicone gel filled breast implants were investigated, and then, standard and criteria about performance evaluation established by the international organizations such as ASTM, FDA guidance and ISO were examined. To evaluate the mechanical properties, data research and testing for breaking strength, elongation, tensile set, joint intensity, silicone gel cohesion, weight loss from heating, static rupture resistance, impact resistance test, fatigue test, and gel bleed were performed. On the other hand, to evaluate the physicochemical properties, volatile matter, extent of cross linking, heavy metals, and extractable were analyzed. In this study, results for general function, mechanical properties and physicochemical properties were examined and reviewed for the accordance with international standard, and objective and standardized guideline was provided.

Keywords

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