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ISO 18113-1 FRENCH

Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 1: Termes, définitions et exigences générales

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Organization: ISO
Publication Date: 15 December 2009
Status: active
Page Count: 58
ICS Code (In vitro diagnostic test systems): 11.100.10

Document History

ISO 18113-1 FRENCH
December 15, 2009
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 1: Termes, définitions et exigences générales
A description is not available for this item.

References

This document references:
EN 13612 - Performance evaluation of in vitro diagnostic medical devices
Published by CEN on March 1, 2002
A description is not available for this item.
This document references:
EN 13640 - Stability Testing of in Vitro Diagnostic Reagents
Published by CEN on March 1, 2002
A description is not available for this item.
This document references:
EN 375 - Information Supplied by the manufacturer with in Vitro Diagnostic Reagents for Professional Use
Published by CEN on January 1, 2001
A description is not available for this item.
This document references:
EN 376 - Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Self-Testing
Published by CEN on February 1, 2002
A description is not available for this item.
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 is referenced by:
SN EN ISO 18113-5 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
Published by SNV on May 1, 2012
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for self-testing. This part of ISO 18113 also applies to apparatus and equipment intended...
This document is referenced by:
CSA ISO 14971 - Medical devices - Application of risk management to medical devices
Published by CSA on January 1, 2007
This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and...
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...
This document is referenced by:
DIN EN ISO 18113-3 - In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 3: Geraete fuer in-vitro-diagnostische Untersuchungen zum Gebrauch durch Fachpersonal (ISO 18113-3:2009); Deutsche Fassung EN ISO 18113-3:2011
Published by DIN on January 1, 2013
Der vorliegende Teil von ISO 18113 legt Anforderungen an die Bereitstellung von Informationen durch den Hersteller von Geräten für in-vitro-diagnostische Untersuchungen zum Gebrauch durch...
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