In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

ISO 15197:2003 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-testing by laypersons for management of diabetes mellitus.

ISO 15197:2003 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.

ISO 15197:2003 does not provide a comprehensive evaluation of all possible factors that could affect the performance of these systems; does not pertain to glucose concentration measurement for the purpose of diagnosing diabetes mellitus; does not address the medical aspects of diabetes mellitus management; does not apply to measurement procedures with results on an ordinal scale (e.g. visual, semiquantitative test methods).