DIN EN ISO 15197:2015 Edition

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

Published By	Publication Date	Number of Pages
DIN	2015-12	56

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Categories: 11.100.10 - In vitro diagnostic test systems, DIN

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Description

Requirements that are unique to self-monitoring devices for blood-glucose, are addressed in this Standard. The revisions in this standard are the result of performance improvements achieved since the publication of the previous version. This Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples and procedures for the verification and the validation of performance by the intended users. These systems are intended for self-measurement by lay persons for management of diabetes mellitus. This document 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.

Additional information

Published Code	DIN
Published By	Deutsches Institut für Normung
Publication Date	2015-12
Pages Count	56
Language	Germany
Descriptors	Blood counts, CE marking, Checks, Definitions, Diabetes, Diagnosis, Diagnosis (medical), Efficiency, Evaluations, Glucose, Human medicine, In vitro, Information supplied by the manufacturer, Instructions for use, In-vitro diagnostic, Laboratory medicine, Marking, Measuring instruments, Measuring systems, Medical equipment, Medical sciences, Medical technology, Performance, Product information, Products documentation, Reliability, Safety, Self-testing, Specification (approval), Sugar content, Testing, Power, Output capacity
File Size	2.6 MB
ICS Codes	11.100.10 - In vitro diagnostic test systems

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DIN EN ISO 15197:2015 Edition

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