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Normas DIN – AENOR
DIN EN ISO 18113-4:2013-01

DIN EN ISO 18113-4:2013-01

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009); German version EN ISO 18113-4:2011 / Note: DIN EN ISO 18113-4 (2010-05) remains valid alongside this standard until 2014-10-31.

Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 4: Réactifs de diagnostic in vitro pour auto-tests (ISO 18113-4:2009); Version allemande EN ISO 18113-4:2011 / Attention: DIN EN ISO 18113-4 (2010-05) reste valable avec la présente norme jusqu'à 2014-10-31.

In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 4: Reagenzien für in-vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO 18113-4:2009); Deutsche Fassung EN ISO 18113-4:2011 / Achtung: Daneben gilt DIN EN ISO 18113-4 (2010-05) noch bis 2014-10-31.

Fecha:
2013-01 /Active
Equivalencias internacionales:

EN ISO 18113-4 (2011-10)

ISO 18113-4 (2009-12)

TS EN ISO 18113-4 (2014-11-14)

Relación con otras normas DIN:
Resumen:
This part of DIN EN ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing. Furthermore, this part of DIN EN ISO 18113 applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing. This part of DIN EN ISO 18113 can also be applied to accessories, where appropriate. This part of DIN EN ISO 18113 applies to labels for the outer and immediate container and to the instructions for use.
Keywords:
Apparatus for analysis, Applications, CE marking, Data of the manufacturer, Diagnosis (medical), Diagnostic equipment, Diagnostic systems, Enterprises, In vitro, Information, Instructions for use, Investigations, In-vitro diagnostic, Labelling, Labels, Laboratory medicine, Marking of roads, Medical equipment, Medical sciences, Medical technology, Operational instructions, Reagents, Self-testing, Specification (approval), User information
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