Advanced SearchSearch Tips
A Study on the Safety and Performance Test Guideline of Low Intensity Therapeutic Ultrasound Device
facebook(new window)  Pirnt(new window) E-mail(new window) Excel Download
 Title & Authors
A Study on the Safety and Performance Test Guideline of Low Intensity Therapeutic Ultrasound Device
Kim, Ju-Young; Kim, Jae-Young; Noh, Si-Cheol; Choi, Heung-Ho;
  PDF(new window)
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;
 Cited by
Paul A Artho, Jason G Thyne, Barry P Warring, et. al., "A Calibration Study of Therapeutic Ultrasound Units", Physical Therapy, vol. 82, no. 3, pp. 257-263, 2002.

J. Y. Chapelon, M. Ribault, F. Vernier, et. al., "Treatment of localised prostate cancer with transrectal high intensity focused ultrasound", Eur J Ultrasound, vol. 9, pp. 31-38, 1999. crossref(new window)

W. Matthew White, Inder Raj S. Makin, Peter G. Barthe, et al., "Selective Creation of Thermal Injury Zones in the Superficial Musculoaponeurotic System Using Intense Ultrasound Therapy", American Medical Association, vol. 9, pp. 22-29, 2007.

Dieter Gebauer, Edgar Mayr, Ernst Orthner, et al., "Low- Intensity pulsed ultrasound : Effects on nonunions", Ultrasound in Med. & Biol., vol. 31, pp. 1391-1402, 2005. crossref(new window)

S.M. Hong, S.M. Han, E.O. Han, et. al., "The Effect of Low Intensity Ultrasound on Osteoblast Activation", J. Boimed. Eng. Res., vol. 25, no. 3, pp. 201-206, 2004.

Chak Hei Fung, Wing Hoi Cheung, Neill M. Pounder, et al., "Effects of different therapeutic ultrasound intensities on fracture healing in rat", Ultrasound in Med. & Biol., vol. 38, pp. 745-752, 2012. crossref(new window)

C.Y. Ko, D.H. Seo, H.S. Kim, et. al., "Suppression of Osteoporotic bone loss on the site to which low Intensity Ultrasound is Irradiated - In vivo test on BMD and Morphological Characteristics", J. Boimed. Eng. Res., vol. 30, no. 1, pp. 49-55, 2009.

Murad Alam, Lucile E. White, Nicolle Martin et al., "Ultrasound tightening of facial and neck skin : A rater-blinded prospective cohort study", J Am Acad Dermatol, vol. 62, pp. 262-269, 2010. crossref(new window)

Adam Shaw, Gail ter Haar, NPL Report DQL-AC 015: Requirements for Measurement Standards in High Intensity Focused Ultrasound(HIFU) Fields, Middlesex, National Physical Laboratory Press, 2007, pp. 7-8.

Food and Drug Administration, "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use. Federal Register", 2011.

FDA CFR 21:1050.10, "Performance standards for ultrasonic therapy products", 2013.

KFDA Draft guidance, "Guideline for High Intensity Focused Ultrasound device evaluation", 2009.

ISO 14971, "The requirements for application of a risk management system for medical devices", 2012.

IEC 60601-1, "Medical electrical equipment, Part 1, General requirements for basic safety and essential performance", 2012.

IEC 60601-2-5, "Medical electrical equipment, Part 2-5, Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment", 2009.

IEC 61689, "Ultrasonics, Physiotherapy systems, Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz", 2013.

IEC/TR 62649, "Requirements for measurement standards for high intensity therapeutic ultrasound (HITU) devices", 2010.

IEC 61847, "Ultrasonics, Surgical systems, Measurement and declaration of the basic output characteristics", 1998.

Kenji Takegami, Yukio Kaneko, Toshiaki Watanabe, et al., "Polyacrylamide gel containing egg white as new model for irradiation experiments using focused ultrasound", Ultrasound in Med. & Biol., vol. 30, pp. 1419-1422, 2004. crossref(new window)

J.Y. Kim, H.D. Jung, J.H. Min, et. al., "The Analysis of thermal denature characteristic on tissue by using Egg-white TMM phantom", in proc. 48th Conference Korean Society of Medical & Biological Engineering, Seoul, Korea, May. 2013, pp. 278-281.