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DIN EN ISO 15197

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

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Organization: DIN
Publication Date: 1 December 2015
Status: active
Page Count: 56
ICS Code (In vitro diagnostic test systems): 11.100.10
scope:

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

Document History

DIN EN ISO 15197
December 1, 2015
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
This International Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures...
November 1, 2013
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
This International Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures...
September 1, 2013
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013), German version EN ISO 15197:2013
This International Standard specifies requirement for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures...
May 1, 2004
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003); German version EN ISO 15197:2003, text German and English
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References

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