This International Standard specifies requirements for in vitro glucose measurement systems for measuring glucose concentrations in capillary blood samples for specific design verification procedures and for validation of performance by the intended users. These systems are intended for self-measurement by laypeople to manage diabetes mellitus. This International Standard applies to the manufacturers of such systems and to those other organizations (e.g. regulatory authorities and conformity assessment institutions) responsible for assessing the performance of these systems. This International Standard does not provide a comprehensive assessment of all possible factors that may affect the performance of these systems; does not apply to glucose concentration measurement for diagnosing diabetes mellitus; does not address the medical aspects of managing diabetes mellitus; does not apply to measurement methods in which the measured values are presented on an ordinal scale (e.g. visual, semi-quantitative measurement methods) or to continuous glucose measurement systems; does not apply to blood glucose meters in medical applications that are not intended for use in self-monitoring for the management of diabetes mellitus.
EN ISO 15197:2013 history
2015EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
2013EN ISO 15197:2013 In vitro diagnostic test systems - Requirements for bloodglucose monitoring systems for self-testing in managing diabetes mellitus
2003EN ISO 15197:2003 In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus ISO 15197:2003