标准号：ISO 15197-2003
实施状态：作废
中文名称：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
被替代标准：ISO 15197-2013
代替标准：ISO/FDIS 15197-2003
采用标准：DIN EN ISO 15197-2004,IDT;BS EN ISO 15197-2003,IDT;GB/T 19634-2005,NEQ;EN ISO 15197-2003,IDT;EN ISO 15197/AC-2005,IDT;NF S92-026-2004,IDT;CAN/CSA-ISO 15197-05-2005,IDT;SN EN ISO 15197-2003,IDT;SN EN ISO 15197/AC-2005,IDT;OENORM EN ISO 15197-2003,IDT;OENORM EN ISO 15197-2005,IDT;PN-EN ISO 15197-2004,IDT;PN-EN ISO 15197-2010,IDT;PN-EN ISO 15197/AC-2006,IDT;UNE-EN ISO 15197-2004,IDT;GOST R ISO 15197-2009,IDT
起草单位：ISO/TC 212
标准简介：This International Standard 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.
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, or
— apply to measurement procedures with results on an ordinal scale (e.g. visual, semiquantitative test methods).
文件格式：PDF
文件大小：854.24KB
文件页数：40
（以上信息更新时间为：2019-11-23）
ISO 15197-2003 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.pdf
(854.24 KB)
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