In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing

Informationen über die Norm:

Bezeichnung normen: ČSN EN ISO 18113-4-ed.2
Zeichen: 857027
Katalog-Nummer: 519964
Ausgabedatum normen: 1.11.2024
Zahl der Seiten: 28
Gewicht ca.: 84 g (0.19 Pfund)
Land: Tschechische technische Norm
Kategorie: Technische Normen ČSN

Die Annotation des Normtextes ČSN EN ISO 18113-4-ed.2 (857027):

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing.
This document can also be applicable to accessories.
This document is applicable to the labels for outer and immediate containers and to the instructions for use.
This document does not apply to:
a) IVD instruments or equipment;
b) IVD reagents for professional use