온,습도 시험을 통한 자가 혈당 측정 센서의 안정성 평가 = Stability Test of Self-Monitoring Blood Glucose Sensors based on Temperature and Humidity

다국어 초록 (Multilingual Abstract)

A self-monitoring blood glucose sensor is a kind of in vitro diagnostic medical devices which converts electrical signal to glucose. Performance and stability testing are conducted primarily to evaluate glucose sensors. Stability testing determines shelf-life of glucose sensors, which is mainly performed accelerated testing. Previous stability testing has been done only using temperature condition. In this study, we add humidity condition in order to reduce testing time. As a result, in the case of glucose sensors of manufacturer A, we can show accelerating temperature and humidity was degradated faster than accelerating temperature only. On the other hand, however, glucose sensors of manufacturer B degradated rapidly in temperature condition. We found that degradation pattern changes, depending on the type of glucose sensors` enzyme and intermediate.

참고문헌 (Reference)

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13 NCCLS EP25-A, "Evaluation of Stability of In Vitro Diagnostic Reagents" Approved guideline 2009

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