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  • BSI
    BS EN ISO 15197:2015 - TC Tracked Changes. In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
    Edition: 2020
    $736.46
    / user per year

Description of BS EN ISO 15197:2015 - TC 2020

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.

Standard NumberBS EN ISO 15197:2015 - TC
TitleTracked Changes. In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
StatusUnder Review
Publication Date2020-02-25
DescriptorsGlucose, Blood, Measurement, Clinical investigation instruments
ICS11.100.10 In vitro diagnostic test systems, 11.040.55 Diagnostic equipment
CommitteeCH/212
ISBN978 0 539 09157 1
PublisherBSI
Pages0

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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