ISO 15197-2013 标准详情
- 标准号:ISO 15197-2013
- 中文标题:体外诊断试验系统 糖尿病管理用血糖自测监测系统的要求
- 英文标题:In vitro diagnostic test systems -- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
- 标准类别:国际标准化组织ISO
- 发布日期:2013-05-14
ISO 15197:2013 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. The
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