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SSH 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)

Mar 31, 2016

General information

60.60     Mar 31, 2016

DPS

DPS/KT 140

European Norm

11.100.10  

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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 directives

Directives related to this standards.

98/79/EC

In vitro diagnostic medical devices

Harmonized
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Life cycle

PREVIOUSLY

Replaces
SSH EN ISO 15197:2013

NOW

PUBLISHED
SSH EN ISO 15197:2015
60.60 Standard published
Mar 31, 2016

Related project

Adopted from EN ISO 15197:2015

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