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ISO 15197:2013

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

Publication date:   May 14, 2013

General information

90.60 Close of review   Mar 4, 2024

ISO

ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems

International Standard

11.100.10   In vitro diagnostic test systems

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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

PREVIOUSLY

WITHDRAWN
ISO 15197:2003

NOW

PUBLISHED
ISO 15197:2013
90.60 Close of review
Mar 4, 2024

REVISED BY

ABANDON
ISO/NP 15197