ISO 18113-4:2022

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
Autor: ISO
Código ICS: 11.100.10


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.

Especificaciones de la Norma
Fecha de Publicación 06/10/2022
Título Secundario Dispositifs médicaux de diagnostic in vitro — Informations fournies par le fabricant (étiquetage) — Partie 4: Réactifs de diagnostic in vitro destinés aux autodiagnostics
Páginas Técnicas 11
Idioma Inglés