This standard specifies the requirements, test methods, marking, labeling, instruction manual, packaging, transportation and storage of glycohemoglobin analyzers. This standard applies to: instruments for measuring the concentration of glycated hemoglobin (HbA1c) in human blood; instruments with glycated hemoglobin (HbA1c) items in the testing items, when evaluating the glycated hemoglobin testing module of the instrument. This standard does not apply to instruments that are not used by professionals, non-laboratory instruments for measuring the concentration of glycated hemoglobin (HbA1c) in human blood.
