This study aimed to investigate if 27 CE-labeled BG monitoring
systems from 18 different manufacturers meet the requirements
defined in the standard DIN EN ISO 15197. The
evaluation was performed in a laboratory by trained medical
personnel under controlled conditions. The test procedures,
protocols, and statistical analyses of the results were as described
in DIN EN ISO 15197. Sixteen of the 27 BG monitoring
systems fulfilled the minimum accuracy requirements of the
standard, i.e., they had 95% of their individual BG results
within 15mg=dL of the reference method at BG concentrations