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GB/T 19634-2005 English PDF (GBT19634-2005)

GB/T 19634-2005 English PDF (GBT19634-2005)

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GB/T 19634-2005: [Including 2006XG1] 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).

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