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.
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.
This document is available in electronic format only.
Date of Publication: May 15, 2013
Order Code PDF: ISO15197E
Order Code Print: print not available
ISO 15197:2013 Additional Details
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Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems.