Update: 03 November, 2023
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.
File format: PDF
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MD5 Checksum: 81837D8E3BA737A84D93B5FD5F6D8134
Publication date: 03 November, 2023
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PDF Link: Glycohemoglobin Analyzer PDF