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ISO 15197:2013

Current Date published:

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.

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Related Information

Similar Standards

  • BS EN 13532:2002

    General requirements for in vitro diagnostic medical devices for self-testing

  • BS EN 13612:2002

    Performance evaluation of in vitro diagnostic medical devices

  • BS EN 13641:2002

    Elimination or reduction of risk of infection related to in vitro diagnostic reagents

  • BS EN 13975:2003

    Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects

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Pages: 46

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ISO 15197:2013

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