In Vitro Diagnostic Test Systems - Requirements for Blood-glucose Monitoring Systems for Self-testing in Managing Diabetes Mellitus
出版:CSA Group
专家解读视频
基本信息
标准编号: CSA ISO 15197:2005 (R2010)
发布时间:2010/7/29 0:00:00
标准类别:Standard
出版单位:CSA Group
标准页数:43
标准简介
Defines 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.
标准备注
Supersedes CSA Z316.4. (02/2005)
本标准替代的旧标准
等同采用的国际标准
ISO 15197:2003 - Identical


