EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
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 monitoring systems; does not apply to blood glucose meters in medical applications that are not intended for self-monitoring use for the management of diabetes mellitus.
EN ISO 15197:2015 Referenced Document
EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broad-band random and guidance
IEC 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
IEC 61010-2-101:2015 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
IEC 61326-1:2012 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
IEC 61326-2-6:2012 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 14971:2007 Medical devices - Application of risk management to medical devices
ISO 17511:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
ISO 18113-1:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
EN ISO 15197:2015 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