Standard

ISO 15197:2013

May 2013 Current

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Abstract

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.

Products specifications

Standard from ISO
Published: May 14 2013
Edition: 2
Document type: IS
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.100.10
International TC: ISO/TC 212

Product Relations

Adopted by: NF EN ISO 15197:2015
Adopted by: SN EN ISO 15197:2013
Adopted by: NF EN ISO 15197:2013
Revises: ISO 15197:2003

ISO 15197:2013

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ISO 15197:2013

ISO 15197:2003

Abstract

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ISO 15197:2013

ISO 15197:2003

Abstract

Products specifications

Product Relations

Product life cycle