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EN ISO 15197:2015 Standard

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  Keywords:

#measurement #international #management #intended #performance

  Directive

In vitro diagnostic medical devices Directive (98/79/EC)

  Last Official Journal reference

Thursday 15th of April 2021

  Description:

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)

  Purpose

This International Standard 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. This International Standard 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. This International Standard does not: — provide a comprehensive evaluation of all possible factors that could affect the performance of these systems, — pertain to glucose concentration measurement for the purpose of diagnosing diabetes mellitus, — address the medical aspects of diabetes mellitus management, — apply to measurement procedures with measured values on an ordinal scale (e.g. visual, semiquantitative measurement procedures), or to continuous glucose monitoring systems, — apply to glucose meters intended for use in medical applications other than self-testing for the management of diabetes mellitus.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 15197:2013"

Anyway is still possible use the "EN ISO 15197:2013" until July 31st, 2016

  Related Standards

EN ISO 20776-1:2006

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EN 13612:2002/AC:2002

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EN 14136:2004

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Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

EN 14254:2004

In vitro diagnostic medical devices Directive (98/79/EC)

In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

EN 14820:2004

In vitro diagnostic medical devices Directive (98/79/EC)

Single-use containers for human venous blood specimen collection

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