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CEN - EN 376

In Vitro Diagnostic Systems - Requirements for Labelling of In Vitro Diagnostic Reagents for Self-Testing

inactive
Organization: CEN
Publication Date: 1 May 1992
Status: inactive
Page Count: 10
ICS Code (Biological evaluation of medical devices): 11.100.20

Document History

EN 376
February 1, 2002
Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Self-Testing
A description is not available for this item.
EN 376
May 1, 1992
In Vitro Diagnostic Systems - Requirements for Labelling of In Vitro Diagnostic Reagents for Self-Testing
A description is not available for this item.

References

This document is referenced by:
SN EN 1041 - Information supplied by the manufacturer of medical devices
Published by SNV on October 1, 2013
This European Standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical...
This document is referenced by:
CSA ISO 15197 - In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
Published by CSA on January 1, 2015
This International Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures...
This document is referenced by:
DIN EN ISO 18113-1 - In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 1: Begriffe und allgemeine Anforderungen (ISO 18113-1:2009); Deutsche Fassung EN ISO 18113-1:2011
Published by DIN on January 1, 2013
Dieser Teil von ISO 18113 definiert Konzepte, stellt allgemeine Prinzipien auf und legt wesentliche Anforderungen an die durch den Hersteller von In-vitro-Diagnostika bereitzustellenden Informationen...
This document is referenced by:
DIN EN ISO 18113-4 - In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 4: Reagenzien fuer in-vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO 18113-4:2009); Deutsche Fassung EN ISO 18113-4:2011
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 zur Eigenanwendung fest....
This document is referenced by:
DIN EN ISO 18113-4 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
Published by DIN on January 1, 2013
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing. This part of ISO 18113 also applies to information supplied by the...
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