BS EN ISO 15197:2015 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 the intended users. These systems are intended for self-measurement by lay persons for management of diabetes mellitus.

This International Standard 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.

This International Standard does not:

• provide a comprehensive evaluation of all possible factors that could affect the performance of these systems,
• pertain to glucose concentration measurement for the purpose of diagnosing diabetes mellitus,
• address the medical aspects of diabetes mellitus management,
• apply to measurement procedures with measured values on an ordinal scale (e.g. visual, semiquantitative measurement procedures), or to continuous glucose monitoring systems, apply to glucose meters intended for use in medical applications other than self-testing for the management of diabetes mellitus

Cross References:
ISO 13485
ISO 14971
ISO 17511
ISO 18113-1
ISO 18113-4
ISO 18113-5
ISO 23640
IEC 60068-2-64
IEC 61010-1
IEC 61010-2-101
IEC 61326-1
IEC 61326-2-6
IEC 62366
EN 13612
EN ISO 13485:2012
EN ISO 14971:2012
EN ISO 17511:2003
EN ISO 18113-1:2011
EN ISO 18113-4:2011
EN ISO 18113-5:2011
EN ISO 23640:2014
EN 60068-2-64:2008
EN 61010-1:2010
EN 61010-2-101:2002
EN 61326-1:2013
EN 61326-2-6:2013
EN 62366:2008
EN 13612:2002
98/79/EC
ISO/IEC Guide 99:2007
ISO 5725-1
ISO 5725-2
ISO 5725-3


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