DIN EN ISO 18113-3:2007-02

Clinical laboratory testing and in vitro diagnostic medical systems - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/DIS 18113-3:2006); German version prEN ISO 18113-3:2006

Essais cliniques de laboratoire et systèmes médicaux de diagnostic in vitro - Informations fournies par le fabricant (marquage) - Partie 3: Instruments de diagnostic in vitro à usage professionel (ISO/DIS 18113-3:2006); Version allemande prEN ISO 18113-3:2006

Labormedizinische Untersuchungen und In-vitro-Diagnostika-Systeme - Bereitstellung von Informationen durch den Hersteller (Beschilderung) - Teil 3: Geräte für in-vitro-diagnostische Untersuchungen zum Gebrauch durch Fachpersonal (ISO/DIS 18113-3:2006); Deutsche Fassung prEN ISO 18113-3:2006

Información:

Fecha Anulación:

2010-05 /Withdrawn

ICS:

11.100.10 - In vitro diagnostic test systems

Equivalencias internacionales:

ISO/DIS 18113-3 (2006-11)

prEN ISO 18113-3 (2006-11)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 18113-3:2010-05

Resumen:

This part of DIN EN ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for professional use. Furthermore, this part of DIN EN ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for professional use. This part of DIN EN ISO 18113 can also be applied to accessories, where appropriate.

Keywords:

Apparatus for analysis, Applications, Data of the manufacturer, Diagnosis, Diagnostic equipment, Diagnostic systems, Enterprises, Experts, In vitro, Information, Instructions for use, Instruments, Investigations, In-vitro diagnostic, Labelling, Laboratory medicine, Medical equipment, Medical sciences, Medical technology, Operational instructions, Personnel, Self-testing, Specification (approval), User information

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