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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) EN ISO 15197:2015

Publication date:   Sep 16, 2015

General information

60.60 Standard published   Jun 10, 2015

CEN

CEN/TC 140 In vitro diagnostic medical devices

European Norm

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.

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

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Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 15197:2013

NOW

PUBLISHED
EN ISO 15197:2015
60.60 Standard published
Jun 10, 2015

CORRIGENDA / AMENDMENTS

IN_DEVELOPMENT
EN ISO 15197:2015/prA11

Relations

Adopted from ISO 15197:2013 IDENTICAL