DIN EN ISO 15197:2013-11

This standard is the result of the revision of DIN EN ISO 15197:2004. At international level, the work had been done by ISO/TC 212 and CEN/TC 140. At national level, the responsible committee is NA 063-03-11 AA "Patientennahe Sofortdiagnostik (POCT)" ("Point-of-care-testing (POCT)"). Blood-glucose monitoring systems are in vitro diagnostic medical devices used predominantly by individuals affected by diabetes mellitus. Diabetes mellitus is caused by a deficiency in insulin secretion or by insulin resistance leading to abnormally high concentrations of glucose in the blood, which may result in acute and chronic health complications. When used properly, a glucose monitoring system allows the user to monitor and take action to control the concentration of glucose present in the blood. This International Standard is intended for blood-glucose monitoring systems used by lay persons. The primary objectives are to establish requirements that result in acceptable performance and to specify procedures for demonstrating conformance to this International Standard. Requirements that are unique to self-monitoring devices for blood-glucose are addressed in this standard. The revised performance criteria in this edition are the result of improvements in technology since publication of the previous edition. This standard 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. These systems are intended for self-measurement by lay persons for management of diabetes mellitus. The document is applicable to manufacturers of such systems and those other organizations (for example regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems.