Reference number
ISO 15197:2013
© ISO 2024
International Standard
ISO 15197:2013
In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
Edition 2
2013-05
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Published (Edition 2, 2013)
This publication was last reviewed and confirmed in 2018. Therefore this version remains current.

ISO 15197:2013

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Format
CHF 173
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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.

General information

  • Status
     : Published
    Publication date
     : 2013-05
    Stage
    : Close of review [90.60]
  • Edition
     : 2
    Number of pages
     : 46
  • Technical Committee :
    ISO/TC 212
    ICS :
    11.100.10 
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