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KMID : 1142220160110020159
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Regulatory Research on Food, Drug & Cosmetic
2016 Volume.11 No. 2 p.159 ~ p.171
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A Study on Development of Standard Operating Procedure for Analytical Performance Evaluation of Self-Monitoring Blood Glucose Test System
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Lee Seung-Ro
Jung Y.-A.
Lee Chang-Hyung
Yoo Si-Hyung
Park Chang-Won
Hong Seung-Hwa
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Abstract
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Self-Monitoring Blood Glucose test system is a medical device crucial for diabetes management, including dietary control and insulin dosage control, and there has been a worldwide emphasis on strengthening the standard for its performance evaluation on its accuracy. On May 15, 2013, the International Organization for Standardization have published the amendment of ISO 15197:2013 which strengthened the evaluation standard. The Ministry of Food and Drug Safety (MFDS) is currently preparing the amendment of the domestic medical device standard specification incorporating the amended international standard specification. However, according to the manufacturers of personal blood glucose monitoring system, medical device testing agencies, and related researchers, they found it difficult to utilize the new standard specification due to ambiguous explanation on the test items. The MFDS developed a standard test guideline of an internationally harmonized personal blood glucose monitoring system through scientific verification before the amendment of standard specification incorporating the amendment of ISO 15197:2013. The guideline established the foundation for efficient performance evaluation by manufacturers and testing agencies. The standard test guideline developed in this study is expected to be used by medical device manufacturers of personal blood glucose monitoring system, medical device testing agencies and related researchers as an evaluation guidance. Thus it is expected to contribute to strengthening international competitiveness of Korean medical devices.
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KEYWORD
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Self-Monitoring Blood Glucose test system, ISO 15197, Medical device standard specification, Standard operating procedure
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