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

ISO 15197:2013

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

This international standard 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.

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Publication Details

Date of Publication: May 15, 2013

Order Code PDF: ISO15197E

Order Code Print: print not available

Edition: Second

Pages: 46

ISO 15197:2013 Additional Details

 This document 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.

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