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-testing

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).