DS DS/EN ISO 15197/AC
DS DSEN SO 15197AC 2005-MAY-23 n vtro dagnostc test systems - Requrements for blood-glucose montorng systems for self-testng n managng dabetes melltus
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This standard specifies procedures 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.