5MHz 초과 초음파자극기에 대한 IEC 61689 규격 적용의 유효성에 관한 연구 = A Study on Effectiveness of Application of the IEC 61689 Standard to Ultrasonic Physiotherapy Systems with Frequency Range over 5MHz

다국어 초록 (Multilingual Abstract)

Ultrasonic physiotherapy systems should comply with IEC 60601-2-5(particular requirements for safety of ultrasonic physiotherapy equipment) standard for safety of patients and clinical performances. One of the most important parameters in the standard is the effective radiating area ($A_{ER}$). It has to be measured in accordance with IEC 61689 (field specifications and methods of measurement in the frequency range 0.5MHz to 5MHz). Typical ultrasonic physiotherapy system works in the frequency range 1MHz ~ 3MHz to comply with the IEC 61689. However, ultrasonic physiotherapy system using frequencies over 5MHz is out of the IEC 61689's scope. That is, even if such ultrasonic physiotherapy systems are developed by demands of the market, there is no standard to apply. It is the motivation for this study. Whereas there are other parameters to be considered, this study focuses on the effective radiating area and shows effectiveness of applying IEC 61689 in measuring effective radiating area of ultrasonic physiotherapy systems using frequency range over 5MHz by comparing the results of computer simulation and experiment. Results of this study shows that applying the IEC 61689 standard to ultrasonic physiotherapy system using frequency range over 5MHz is possible.

참고문헌 (Reference)

1 "Regulations for classification of medical devices, No. 2014-110"

2 "Particular requirements for the safety of ultrasonic physiotherapy equipment"

3 Andrè V. Alvarenga, "Metrological aspects on therapeutic ultrasound parameters: effective radiating area and non-uniformity ration" 3 : 643-649, 2010

4 Mario-Ibrahin Gutièrrez, "Methods for Characterization of Physiotherapy Ultrasonic Transducers"

5 "IEC 61161 Radiation force balances and performance requirements"

6 Rinaldo Guirro, "Evaluation of the acoustic intensity of new ultrasound therapy equipment" 39 : 553-557, 2002

7 Raejoon Park, "Electrical Treatment" Hyunmoonsa 434-, 2009