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KMID : 1142220140090010033
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Regulatory Research on Food, Drug & Cosmetic
2014 Volume.9 No. 1 p.33 ~ p.43
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A Study on Development of a Guideline for Performance Evaluation of Automatic Sphygmomanometer
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Cho Eun-Jeong
Yeon Hong-Won
Kim Hyeog-Ju
Kang Shin-Jung
Lee Jae-Won
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Abstract
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As the average age is increasing and the dietary life is becoming westernized recently, the adult diseases, such as cardiovascular disease, diabetes, etc., are increasing. Of all the diseases, hypertension, which is a cardiovascular disease, shows the highest frequency of occurrence because it is the biggest risk factor of coronary artery disease, cerebrovascular disease.1) As shown above, blood pressure is a basic bio-signal which can predict the health status
and it is used in the health management. The method measuring blood pressure with stethoscope and mercury sphygmomanometer by healthcare provider at hospital was changed to the self-measurement method at home through the development of automated electronic sphygmomanometer. Proper health management through the blood pressure will be available with the accurate blood pressure measurement by having an automated electronic sphygmomanometer with consistent performance above the certain standard. Hereupon, detailed performance evaluation technology will be developed to evaluate the performance of automated electronic sphygmomanometer in this study. For this, we have researched and analyzed the characteristics of automated electronic sphygmomanometer and the domestic and international standard; furthermore, we have developed a guideline needed for the evaluation on performance of automated electronic sphygmomanometers by additionally reviewing the testing method for testing criteria which was set up when the automated electronic sphygmomanometer was licensed. For the testing method of developed performance evaluation guideline, we tried to verify the application of testing method at the time of quality control in order to increase the credibility by testing the automated electronic sphygmomanometer directly. We expect the protection of national health and trengthening of competitiveness in domestic medical device industry through the production of automated electronic sphygmomanometers with consistent quality through this guideline.
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KEYWORD
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Automated electronic Sphygmomanometer, Performance, Testing method
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