ČSN EN ISO 15197 ed. 3 (857019)

Systémy diagnostických zkoušek in vitro - Požadavky na systémy monitorování glykémie pro sebetestování pacientů s diabetes mellitus

ČSN EN ISO 15197 ed. 3 Systémy diagnostických zkoušek in vitro - Požadavky na systémy monitorování glykémie pro sebetestování pacientů s diabetes mellitus
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Anotace obsahu normy

This International Standard 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.
This International Standard 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.
This International Standard does not:
- provide a comprehensive evaluation of all possible factors that could affect the performance of these systems,
- pertain to glucose concentration measurement for the purpose of diagnosing diabetes mellitus,
- address the medical aspects of diabetes mellitus management,
- apply to measurement procedures with measured values on an ordinal scale (e.g. visual, semiquantitative measurement procedures), or to continuous glucose monitoring systems,
- apply to glucose meters intended for use in medical applications other than self-testing for the management of diabetes mellitus

Označení ČSN EN ISO 15197 ed. 3 (857019)
Katalogové číslo 98792
Cena 570 Kč570
Datum schválení 1. 2. 2016
Datum účinnosti 1. 3. 2016
Jazyk angličtina (obsahuje pouze anglický originál)
Počet stran 64 stran formátu A4
EAN kód 8590963987927
Tato norma nahradila ČSN EN ISO 15197 ed. 2 (857019) z prosince 2013
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