DIN EN ISO 18113-4:2007-02

Clinical laboratory testing and in vitro diagnostic medical systems - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2006); German version prEN ISO 18113-4:2006

Essais cliniques de laboratoire et systèmes médicaux de diagnostic in vitro - Informations fournies par le fabricant (marquage) - Partie 4: Réactifs de diagnostic in vitro pour auto-essais (ISO/DIS 18113-4:2006); Version allemande prEN ISO 18113-4:2006

Labormedizinische Untersuchungen und In-vitro-Diagnostika-Systeme - Bereitstellung von Informationen durch den Hersteller (Beschilderung) - Teil 4: Reagenzien für in-vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO/DIS 18113-4:2006); Deutsche Fassung prEN ISO 18113-4:2006

Información:

Fecha Anulación:

2010-05 /Withdrawn

ICS:

11.100.10 - In vitro diagnostic test systems

Equivalencias internacionales:

ISO/DIS 18113-4 (2006-11)

prEN ISO 18113-4 (2006-11)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 18113-4:2010-05

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, 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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