개인용 혈당측정기의 신뢰성 보증시험 개발

The value of blood sugar is measured by a personal blood glucose meter which consists of two parts: a glucose strip and a blood glucose meter. A personal blood glucose meter makes use of electric media which are composed of glucose oxidase and electron. This study is to propose a method of reliability demonstration test derived from field data analysis and FMEA(Failure Mode and Effect Analysis). Detailed Conditions for reliability demonstration test are selected from the comparison of various failure mechanisms. The most dominant failure mechanism is wear-out which is caused by strip insertion/extraction. The testing device that can reproduce the failure mechanism of strip insertion/extraction is made to conduct reliability demonstration test. Using the testing device, it is confirmed that target lifetime of selected devices is more than 2 years.