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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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More accurate self-testing results for diabetes patients with new ISO standard
Diabetes patients will benefit from the latest version of an ISOstandard for self-testing glucose monitoring systems. The standard requiresthat manufacturers of these systems provide even greater accuracy.
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