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ISO 15197:2013

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
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ISO 15197:2013

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

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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.

SDO ISO: International Organization for Standardization
Document Number ISO 15197
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 212
Publish Date Document Id Type View
Not Available ISO 15197:2013 Revision