1.范围1。1本标准规定了本标准第3.3条中定义的便携式全血葡萄糖监测系统（以下简称血糖监测系统）的要求，该系统用于帮助确定个人血糖浓度，以便进行糖尿病管理。1.1.1排除在范围之外的检查本标准不涉及新生儿低血糖症的葡萄糖筛查和/或监测，以及血糖浓度低于2的个体的葡萄糖检测。 5 mmol/L或大于19 mmol/L。

1. Scope1.1This Standard specifies requirements for portable whole blood glucose monitor systems, as defined in Clause 3.3 of this Standard, hereinafter referred to as blood glucose monitor system(s), used to aid in the determination of an individual's blood glucose concentration for the purpose of diabetes management.1.1.1Aspects excluded from scopeThis Standard does not address glucose screening and/or monitoring of neonates for hypoglycemia, and glucose testing for individuals with a blood glucose concentration less than 2.5 mmol/L or greater than 19 mmol/L.