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Normas DIN – AENOR
DIN EN ISO 18113-1:2013-01

DIN EN ISO 18113-1:2013-01

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2011 / Note: DIN EN ISO 18113-1 (2010-05) remains valid alongside this standard until 2014-10-31.

Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 1: Termes, définitions et exigences générales (ISO 18113-1:2009); Version allemande EN ISO 18113-1:2011 / Attention: DIN EN ISO 18113-1 (2010-05) reste valable avec la présente norme jusqu'à 2014-10-31.

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 / Achtung: Daneben gilt DIN EN ISO 18113-1 (2010-05) noch bis 2014-10-31.

Fecha:
2013-01 /Active
Equivalencias internacionales:

EN ISO 18113-1 (2011-10)

ISO 18113-1 (2009-12)

TS EN ISO 18113-1 (2014-11-11)

Relación con otras normas DIN:
Resumen:
This Standard defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.
Keywords:
Apparatus for analysis, Applications, CE marking, Data of the manufacturer, Definitions, Diagnosis (medical), Diagnostic equipment, Diagnostic systems, Enterprises, Experts, In vitro, Information, Information supplied by the manufacturer, Inscription, Instructions for use, Investigations, In-vitro diagnostic, Labelling, Laboratory medicine, Medical equipment, Medical products, Medical sciences, Medical technology, Operational instructions, Product information, Self-testing, Specification (approval), Terminology, User information, Vocabulary
117,29
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