DIN EN ISO 15197:2015-12

Requirements that are unique to self-monitoring devices for blood-glucose, are addressed in this Standard. The revisions in this standard are the result of performance improvements 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 and procedures for the verification and the validation of performance by the intended users. These systems are intended for self-measurement by lay persons for management of diabetes mellitus. This document is applicable to manufacturers of such systems and those other organizations (e. g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems.