YY/T 1246-2014 in English

本标准适用于对人类血液中糖化血红蛋白（HbA1c）浓度进行检测的仪器；适用于检测项目中包含糖化血红蛋白（HbA1c）项目的仪器，评价该仪器糖化血红蛋白检测模块。
本标准规定了糖化血红蛋白分析仪的要求、试验方法、标志、标签、使用说明书、包装、运输和贮存等内容。
本标准不适用于非专业人员使用、非实验室使用的对人类血液中糖化血红蛋白（HbA1c）浓度进行检测的仪器。

Scope

This standard specifies the requirements, test methods, signs, labels, instructions for use, packaging, transportation and storage of glycosylated hemoglobin analyzers (hereinafter referred to as analyzers). This standard is applicable to:
　——Instruments that detect the concentration of glycated hemoglobin (HbAlc) in human blood;
　——Instruments that include glycated hemoglobin (HbAlc) in the test items, when evaluating the glycated hemoglobin detection module of the instrument. This standard does not apply to instruments used by non-professionals and non-laboratories to detect the concentration of glycated hemoglobin (HbAlc) in human blood.