ISO 15197:2003 试管试验系统-糖尿病自我试验血液葡萄糖监测系统

标准编号：ISO 15197:2003

中文名称：试管试验系统-糖尿病自我试验血液葡萄糖监测系统

英文名称：In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

发布日期：2003-05

标准范围

ISO 15197:2003规定了测量毛细血管血液样品中葡萄糖浓度的体外葡萄糖监测系统的要求以及预期用户验证和确认性能的程序。这些系统旨在供糖尿病管理的外行人进行自我测试。ISO 15197:2003适用于此类系统的制造商和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 15197:2003没有对可能影响这些系统性能的所有可能因素进行全面评估；不涉及用于诊断糖尿病的葡萄糖浓度测量；不涉及糖尿病管理的医学方面；不适用于结果按顺序排列的测量程序（例如目视、半定量测试方法）。

ISO 15197:2003 specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples and procedures for the verification and the validation of performance by the intended users. These systems are intended for self-testing by laypersons for management of diabetes mellitus.ISO 15197:2003 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.ISO 15197:2003 does not provide a comprehensive evaluation of all possible factors that could affect the performance of these systems; does not pertain to glucose concentration measurement for the purpose of diagnosing diabetes mellitus; does not address the medical aspects of diabetes mellitus management; does not apply to measurement procedures with results on an ordinal scale (e.g. visual, semiquantitative test methods).

标准预览图