ISO 15197:2013规定了测量毛细血管血液样本中葡萄糖浓度的体外葡萄糖监测系统、特定设计验证程序和预期用户性能验证的要求。这些系统旨在由非专业人员进行自我测量，以管理糖尿病。 ISO 15197:2013适用于此类系统的制造商以及负责评估这些系统性能的其他组织（如监管机构和合格评定机构）。

ISO 15197:2013 specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users. These systems are intended for self-measurement by lay persons for management of diabetes mellitus. ISO 15197:2013 is applicable to manufacturers of such systems and those other organizations (e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems.