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A Study on the Safety and Performance Test Guideline of Low Intensity Therapeutic Ultrasound Device
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저강도 초음파 치료기기의 안전성 및 성능평가 가이드라인 수립을 위한 연구

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Type
Academic journal
Author
Journal
The Korea Society Of Medical & Biological Engineering 의공학회지 의공학회지 제36권 제5호 KCI Accredited Journals
Published
2015.1
Pages
162 - 168 (7page)

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A Study on the Safety and Performance Test Guideline of Low Intensity Therapeutic Ultrasound Device
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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.
#Low Intensity Pulsed Ultrasound #Low Intensity Focused Ultrasound #Therapeutic Ultrasound #Safety and Performance Test

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References (20)

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/ 1050 / Performance standards for ultrasonic therapy products / FDA CFR 21:1050.10 google schola / 1998 / Ultrasonics, Surgical systems, Measurement and declaration of the basic output characteristics / IEC 61847 google schola / 2009 / Medical electrical equipment, Part 2-5, Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment / IEC 60601-2-5 google schola / 2010 / Requirements for measurement standards for high intensity therapeutic ultrasound (HITU) devices / IEC/TR 62649 google schola / 2012 / Medical electrical equipment, Part 1, General requirements for basic safety and essential performance / IEC 60601-1 google schola

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