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In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

ISO 15197:2013

In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

This International Standard specifies procedures for the determination of performance criteria for quantitative in vitro blood glucose monitoring systems for management of diabetes mellitus. 

This document is available in electronic format only.

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Details

Date of Publication: May 15, 2013

Order Code PDF: ISO15197E

Order Code Print: print not available

Edition: Second

Pages: 46

ISO 15197:2013 Additional Details

Membership discounts cannot be applied to ISO documents because they are not published by CLSI. CLSI is able to offer ISO Technical Committee 212 approved and draft standards through an agreement with the American National Standards Institute.

Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems.

ISO 15197:2013 Abstract

ISO 15197: In Vitro Diagnostic Test Systems — Requirements for Blood-Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus This International Standard specifies procedures for the determination of performance criteria for quantitative in vitro blood glucose monitoring systems for management of diabetes mellitus. Organization: ISO Date of Publication: 05/15/2013 Edition: Second Edition Pages: 54