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KMID : 1142220160110010073
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Regulatory Research on Food, Drug & Cosmetic
2016 Volume.11 No. 1 p.73 ~ p.83
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A Study on Development of Guideline to establish Safety and Performance Evaluation for Portable Ultrasound Diagnostic Device
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Lee Chong-Ju
Koo Yoon-Jeong
Kang Min-Jae
Hong Seung-Hwa
Park Chang-Won
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Abstract
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The ultrasound diagnostic device is widely used in diagnosis of diseases as it is more convenient to acquire images and it is also free from harmful energy such as radiation. Medical paradigm have shifted from treatmentcentered approach in past to prevention-centered approach recently due to improvement of the standard of living. Therefore, traditional ultrasound diagnostic devices have been becoming downsizing and weight lightening to be using as point-of care treatment or home healthcare. And, the research and development of the portable ultrasound diagnostic device with mobility and portability have increased. The portable ultrasound diagnostic device add some functions that wireless communication technology which can transmit and receive images using Wi-Fi, Bluetooth and other technologies like downsizing its parts, etc, and displaying images on a smart-phone or tablet PC. Since the portable ultrasound diagnostic device is applied with the new technologies, the need has arisen for the development of safety and performance evaluation items for the device. In this research, the test items to evaluate the safety of the device were developed into three items including basic safety for medical electrical equipment, electromagnetic safety, and other safety. Since domestic standards for performance of ultrasound diagnostic device disaccord with IEC 60601-1:2005 Ed.3, this research proposed test items harmonized with international standards by applying revised IEC 60601-2-37:2007 which is international standards for ultrasound diagnostic device. This research developed guideline for safety and performance evaluation of portable ultrasound diagnostic device and is expected to support the approval and review process of portable ultrasound diagnostic device by providing differences from traditional ultrasound diagnostic devices. In addition, this research
contributes to promoting national health and strengthening the industrial competitiveness of domestic medical devices by verifying the quality of devices applied with new technologies.
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KEYWORD
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Portable Ultrasound diagnostic device, Safety, Performance, Guideline
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