BS EN ISO 15197:2015规定了测量 毛细血管血液样本中的葡萄糖浓度，用于特定设计验证程序和 预期用户对性能的验证。这些系统用于自我测量 由非专业人士管理糖尿病。本国际标准适用于此类系统的制造商和其他组织 （如监管机构和合格评定机构）负责评估 这些系统的性能。本国际标准并未对可能影响产品性能的所有可能因素进行全面评估 这些系统涉及用于诊断糖尿病的葡萄糖浓度测量，涉及糖尿病管理的医学方面，适用于按顺序测量值的测量程序（例如，视觉， 半定量测量程序）或连续血糖监测系统， 适用于医疗应用中使用的血糖仪，而非用于患者的自我检测 糖尿病的管理交叉参考:ISO 13485ISO 14971ISO 17511ISO 18113-1ISO 18113-4ISO 18113-5ISO 23640IEC 60068-2-64IEC 61010-1IEC 61010-2-101IEC 61326-1IEC 61326-2-6IEC 62366EN 13612EN ISO 13485:2012EN ISO 14971:2012EN ISO 17511: 2003EN ISO 18113-1:2011EN ISO 18113-4:2011EN ISO 18113-5:2011EN ISO 23640:2014EN 60068-2-64:2008EN 61010-1:2010EN 61010-2-101:2002EN 61326-1:2013EN 61326-2-6:2013EN 62366:2008EN 13612:200298/79/ECISO/IEC指南99:2007ISO 5725-2ISO 5725-3购买本文件时可提供的所有现行修订内容。

BS EN ISO 15197:2015 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.This International Standard 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.This International Standard does not:provide a comprehensive evaluation of all possible factors that could affect the performance of these systems,pertain to glucose concentration measurement for the purpose of diagnosing diabetes mellitus,address the medical aspects of diabetes mellitus management,apply to measurement procedures with measured values on an ordinal scale (e.g. visual, semiquantitative measurement procedures), or to continuous glucose monitoring systems, apply to glucose meters intended for use in medical applications other than self-testing for the management of diabetes mellitusCross References:ISO 13485ISO 14971ISO 17511ISO 18113-1ISO 18113-4ISO 18113-5ISO 23640IEC 60068-2-64IEC 61010-1IEC 61010-2-101IEC 61326-1IEC 61326-2-6IEC 62366EN 13612EN ISO 13485:2012EN ISO 14971:2012EN ISO 17511:2003EN ISO 18113-1:2011EN ISO 18113-4:2011EN ISO 18113-5:2011EN ISO 23640:2014EN 60068-2-64:2008EN 61010-1:2010EN 61010-2-101:2002EN 61326-1:2013EN 61326-2-6:2013EN 62366:2008EN 13612:200298/79/ECISO/IEC Guide 99:2007ISO 5725-1ISO 5725-2ISO 5725-3All current amendments available at time of purchase are included with the purchase of this document.