Journal of Biomedical Engineering Research (대한의용생체공학회:의공학회지)

The Korean Society of Medical and Biological Engineering (대한의용생체공학회)
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A Study on the Safety and Performance Test Guideline of Low Intensity Therapeutic Ultrasound Device

저강도 초음파 치료기기의 안전성 및 성능평가 가이드라인 수립을 위한 연구

  • Kim, Ju-Young (Department of Biomedical Engineering, Inje University) ;
  • Kim, Jae-Young (Department of Biomedical Engineering, Inje University) ;
  • Noh, Si-Cheol (Department of Radiological Science, International University of Korea) ;
  • Choi, Heung-Ho (Department of Biomedical Engineering, Inje University)
  • Received : 2015.08.05
  • Accepted : 2015.10.16
  • Published : 2015.10.31
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Abstract

In this study, we suggested the performance and safety testing guideline for low intensity pulsed ultrasound (LIPUS) represented by the ultrasound fracture treatment device and cartilage treatment device and low intensity focused ultrasound (LIFU) represented by ultrasonic face lifting device. For these study, the international standards and management regulations of Korea, Japan and United State were analyzed. And the usefulness and applicability were evaluated by testing with commercial equipment and reflecting the views of the industry and experts. As a result of this study, the safety and performance test guidelines for low intensity therapeutic ultrasound device were proposed by presenting the 10 items for LIPUS and 12 items for LIFU. The suggested guidelines are considered a high utilization in the domestic testing and approval authorities. And they are also thought to be useful to new technology development.

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References

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