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

Current stage: 90.93 Effective date: Oct 24, 2018

Originator: ISO

Owner: ISO/TC 212

Type: International Standard

ICS: 11.100.10

Languages: English French

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Status: Published

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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

Revises
ISO 15197:2003

NOW

PUBLISHED
ISO 15197:2013
90.93 Standard confirmed
Oct 24, 2018

REVISED BY

ABANDON
ISO/NP 15197

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