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BS EN ISO 15197:2015现行

In Vitro Diagnostic Test Systems - Requirements For Blood-Glucose Monitoring Systems For Self-Testing In Managing Diabetes Mellitus

出版:British Standards Institution

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基本信息
标准编号: BS EN ISO 15197:2015
发布时间:2015/6/30 0:00:00
标准类别:Standard
出版单位:British Standards Institution
标准页数:60
标准简介

Describes 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.

标准备注

Supersedes 00/560160 DC (06/2003) Supersedes 11/30208525 DC. (06/2015)