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학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
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연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
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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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참고문헌 (20)
참고문헌 신청
/ 1050 / Performance standards for ultrasonic therapy products / FDA CFR 21:1050.10
/ 1998 / Ultrasonics, Surgical systems, Measurement and declaration of the basic output characteristics / IEC 61847
/ 2009 / Medical electrical equipment, Part 2-5, Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment / IEC 60601-2-5
/ 2010 / Requirements for measurement standards for high intensity therapeutic ultrasound (HITU) devices / IEC/TR 62649
/ 2012 / Medical electrical equipment, Part 1, General requirements for basic safety and essential performance / IEC 60601-1
/ 1998 / Ultrasonics, Surgical systems, Measurement and declaration of the basic output characteristics / IEC 61847
/ 2009 / Medical electrical equipment, Part 2-5, Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment / IEC 60601-2-5
/ 2010 / Requirements for measurement standards for high intensity therapeutic ultrasound (HITU) devices / IEC/TR 62649
/ 2012 / Medical electrical equipment, Part 1, General requirements for basic safety and essential performance / IEC 60601-1
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