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ISO 15197:2013Published

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

Systèmes d'essais de diagnostic in vitro — Exigences relatives aux systèmes d'autosurveillance de la glycémie destinés à la prise en charge du diabète sucré

A new edition is under development: ISO/CD 15197.

Abstract / scope

ISO 15197:2013 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.

ISO 15197:2013 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.

Life cycle

Replaces

ISO 15197:2003WithdrawnIn vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitusInternational Standard · Published 28 Apr 2003 · ISO/TC 212

Replaced by

ISO/CD 15197Under developmentIn vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitusInternational Standard · ISO/TC 212ISO/NP 15197Deleted (project abandoned)In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitusInternational Standard · ISO/TC 212