|
KMID : 1142220180130020113
|
|
Regulatory Research on Food, Drug & Cosmetic
2018 Volume.13 No. 2 p.113 ~ p.124
|
|
|
A Study on Developing a New Evaluation Method and a Testing Guideline for Extracorporeal Shockwave Using Cavitation Visualization
|
|
Lee Chong-Ju
Kim Jae-Young
Choi Sung-Hye
Kim Mi-Jeong
|
|
|
Abstract
|
|
|
|
This study will develop new guidelines for evaluating new performance evaluation items of external shock appliances that address absenteeism and tardiness and musculoskeletal disorders. Extra-temperature shock devices have a non-invasive therapeutic device that affects each patient’s inter-processing disorder that affects each other’s intra-processor abnormalities, shorter than other procedures, resulting in shorter utilization rates. However, due to strong shock waves, the impact of the shock wave of the shock wave is altered to determine the location of the shock waves, and there is no obvious way to identify the performance of the product. Currently, the methods of assessing the performance of the external shock instrument are measured using a hydrogen-phones in accordance with IEC 61846:1998, but using hydrophone is highly accurate, with a lot of error factors and a dependence on technicians. Therefore, the implementation of the right quality control and precision management is necessary, and the performance evaluation method for consideration of the technical and economic aspects should be developed. In this study, the Commission developed efficient performance evaluation techniques by visualizing the effectiveness of one of the key therapies induced by an external shock to stimulate the affected area. To analyze the accurate performance evaluation of an external shock instrument, the testing methods of the key performance assessment items listed in IEC 61846:1998 were investigated and analyzed, and the test items and methods applied for the permit were analyzed. The Method for evaluating the effectiveness of an external impulse performance assessment using the cavitation phenomenon of this study will save time and cost simultaneously while retaining equivalent accuracy with existing performance assessment techniques. It is also expected to provide a detailed description of the vendor's ability to test the performance and quality of the device by testing the test methods for the testing of an external impulse device
|
|
|
KEYWORD
|
|
|
Extracorporeal shockwave, Cavitation, Evaluation, Test Method
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|
|