International Standard
ISO 15197:2013
In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
Reference number
ISO 15197:2013
Edition 2
International Standard
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ISO 15197:2013
Published (Edition 2, 2013)
This standard was last reviewed and confirmed in 2018. Therefore this version remains current.

ISO 15197:2013

ISO 15197:2013
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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.

General information

  •  : Published
     : 2013-05
    : Close of review [90.60]
  •  : 2
     : 46
  • ISO/TC 212
  • RSS updates

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