标准摘要
[中文适用范围]： 本国际标准规定了测量毛细血管血样中葡萄糖浓度的体外血糖监测系统、特定设计验证程序以及预期用户性能验证的要求。 这些系统旨在供非专业人士自我测量以管理糖尿病。 [外文原描述]： 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.
英文名称In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus