ISO 15197-2013 体外诊断试验系统.糖尿病症管理中自测用血糖监测系统的要求

标准号：ISO 15197-2013
中文标准名称：体外诊断试验系统.糖尿病症管理中自测用血糖监测系统的要求
英文标准名称：In vitro diagnostic test systems.Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
标准类型：C39
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C39
国际标准分类号：11.100.10
引用标准：ISO 13485;ISO 14971;ISO 17511;ISO 18113-1;ISO 18113-4;ISO 18113-5;ISO 23640;IEC 60068-2-64;IEC 61010-1;IEC 61010-2-101;IEC 61326-1;IEC 61326-2-6;IEC 62366;EN 13612
适用范围：This International Standard 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.