GB/T 19634-2005 Translated English of Chinese Standard. (GBT 19634-2005, GB/T19634-2005, GBT19634-2005): In vitro diagnostic test systems - General technical requirement for blood-glucose monitoring systems for self-testinghttps://www.chinesestandard.net, 19 juli 2015 - 24 sidor This Standard specifies the terms and definitions, requirements, test methods, labels and instructions for use, packaging, transportation, and storage for blood-glucose monitoring systems for self-testing. This Standard is applicable to the blood-glucose monitoring systems for self-testing intended for in vitro monitoring the glucose concentration in capillary whole blood and/or venous whole blood (normally including portable glucose meters, disposable test strips, and control materials). |
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according to formula accuracy of blood-glucose anticoagulant recommended batches of blood-glucose blood or control blood-glucose monitoring systems blood-glucose test strips CALCULATE batch-batch difference calibration capillary blood-samples COLLECT venous blood-samples comply with specifications control material diagnostic medical device different batches fresh anticoagulant venous GB/T glucose concentration 5.5mmol/L glucose concentration range glucose measurements glucose meters glycolysis information provided labels and instructions languages are optional lay persons Measurement repeatability measurement results Medical electrical equipment meter and blood-glucose Note obtain samples packed cell volume partial pressure PERFORM the test performance characteristics plasma portion Precision Quality control range reagent Recovery rate reference analysis meter repeatability of blood-glucose requirements for blood-glucose samples with glucose standard measurement procedure standard substance Storage strips and control strips shall comply Symbols System accuracy systems for self-testing terms and definitions test for blood-glucose Test method test result obtained value of test vitro diagnostic medical vitro monitoring whole blood