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This standard was last reviewed and confirmed in 2018. Therefore this version remains current.
Abstract Preview
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
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Status : PublishedPublication date : 2013-05
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Edition : 2Number of pages : 46
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- ICS :
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In vitro diagnostic test systems
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Life cycle
A standard is reviewed every 5 years
Revisions / Corrigenda
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Previously
ISO 15197:2003
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Now confirmed
ISO 15197:2013
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