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ISO 18113-3 FRENCH

Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 3: Instruments de diagnostic in vitro à usage professionnel

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Organization: ISO
Publication Date: 15 December 2009
Status: active
Page Count: 16
ICS Code (In vitro diagnostic test systems): 11.100.10

Document History

ISO 18113-3 FRENCH
December 15, 2009
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 3: Instruments de diagnostic in vitro à usage professionnel
A description is not available for this item.

References

This document references:
EN 591 - Instructions for Use for In Vitro Diagnostic Instruments for Professional Use
Published by CEN on March 1, 2001
A description is not available for this item.
This document references:
EN 980 - Symbols for use in the labelling of medical devices
Published by CEN on May 1, 2008
This European Standard specifies symbols for use in the information supplied by the manufacturer with medical devices. The requirements of this European Standard are not intended to apply to symbols...
This document references:
IEC 61010-2-101 - Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
Published by IEC on October 1, 2018
Equipment included in scope This part of IEC 61010 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. IVD medical equipment,...
This document references:
ISO 14971 - Medical devices - Application of risk management to medical devices
Published by ISO on December 1, 2019
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process...
This document is referenced by:
DIN EN ISO 18113-2 - In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 2: In-vitro-diagnostische Reagenzien fuer den Gebrauch durch Fachpersonal (ISO 18113-2:2009); Deutsche Fassung EN ISO 18113-2:2011
Published by DIN on January 1, 2013
Der vorliegende Teil von ISO 18113 legt Anforderungen an die Bereitstellung von Informationen durch den Hersteller von Reagenzien für in-vitro-diagnostische Untersuchungen für den Gebrauch durch...
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