Abstract
System accuracy evaluation of the systems for selfmonitoring of blood glucose GL50 evo and GL 44 following DIN EN ISO 15197:2015 – A comparison of accuracy in hypo (<70 mg/dL)- and hyper glycemic (≥180 mg/dL) glucose ranges
Highlights
System accuracy evaluation of the systems for selfmonitoring of blood glucose GL50 evo and GL 44 following DIN EN ISO 15197:2015 – A comparison of accuracy in hypo (
ISO 15197:2015, [2] for which mandatory compliance is recommended for selfmonitoring blood glucose (SMBG) systems by 2015, [3] has tighter accuracy requirements than ISO 15197:2003, [4] and outlines current minimum accuracy standards necessary in Europe for Conformite Europeene (CE) marking
A postmarketing evaluation of the CE-marked GL50 evo and GL44 systems were performed in accordance with ISO 15197:2015 protocols and requirements
Summary
System accuracy evaluation of the systems for selfmonitoring of blood glucose GL50 evo and GL 44 following DIN EN ISO 15197:2015 – A comparison of accuracy in hypo (
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