ISO 15197 specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, and procedures for verification and verification of performance by intended users. These systems are intended for layman self-testing for the management of diabetes mellitus.
ISO 15197 is applicable to manufacturers of such systems and to other bodies (eg regulatory authorities and conformity assessment bodies) that have the responsibility to evaluate the performance of these systems.
ISO 15197 does not provide a comprehensive assessment of all possible factors that could affect the performance of these systems; It is not related to the measurement of glucose concentration for the purpose of diagnosing diabetes. It does not address the medical aspects of diabetes mellitus management and does not apply to measurement procedures with results on an ordinal scale.
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