DIN EN ISO 15197:2013-09

This standard is the product of the revision of DIN EN ISO 15197:2004. The work has been performed internationally in ISO/TC 212 and CEN/TC 140. Nationally, NA 063-03-11 AA "Patientennahe Sofortdiagnostik (POCT)" "Point-of-Care-Testing (POCT)" is responsible for the work. Blood-glucose monitoring systems are in vitro diagnostic medical devices used predominantly by individuals affected by diabetes mellitus. Diabetic 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 compilations. 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 inacceptable performance and to specify procedures for demonstrating conformance to this International Standard. This standard deals with requirements that are only applicable for glucose monitoring systems for personal use. The revisions contained in this document are the result of improvements in performance achieved since the publication of the previous version. 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 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 instance regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems.