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Development of a Guideline for Performance Evaluation of External Hand-Held Ultrasonic Probe
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 Title & Authors
Development of a Guideline for Performance Evaluation of External Hand-Held Ultrasonic Probe
Kim, San; Hwang, Yoonsu; Son, Dae-Woong; Yoon, Soonjong; Lee, Jaewon; Kim, Hyeogju;
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 Abstract
The electrical medical device market have been expanded since the public interest in healthy living that has deepened together with the global health trend of the aging population. The external hand-held ultrasonic probe is a frequently approved medical device and it is commonly used in the clinical field. However, there is no obvious standard or a guideline in Korea on regarding evaluation of performance of such external hand-held ultrasonic probe for approval and quality management. In this study, local and foreign reference standards were reviewed to propose performance test standards and methods after conducting characteristic of probe, market, and permission status. In addition, such proposed test items were validated to develop a draft guideline that is internationally harmonized for performance evaluation. This study is expected not only improve the quality and performance of the external hand-held ultrasonic probe but also contribute to securing consistency of permission and evaluation works for approval.
 Keywords
external hand-held ultrasonic probe;medical electrical equipment;standard;safety and performance evaluation;
 Language
Korean
 Cited by
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