ISO 15197:2013 Preview

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

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

  • Current status : Published
    Publication date : 2013-05
  • Edition : 2
    Number of pages : 46
  • :
    ISO/TC 212
    Clinical laboratory testing and in vitro diagnostic test systems
  • 11.100.10
    In vitro diagnostic test systems

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