Approved Work Item
ISO/AWI 15197
In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
Reference number
ISO/AWI 15197
Edition 3
© ISO 2024
Approved Work Item
Under development
A working group has prepared a draft.
Will replace ISO 15197:2013

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
     : Under development
    Stage
    : New project registered in TC/SC work programme [20.00]
  • Edition
     : 3
  • Technical Committee :
    ISO/TC 212
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goals

3
Good Health and Well-being
9
Industry, Innovation and Infrastructure

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