ISO 18113-5:2022

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
Autor: ISO
Código ICS: 11.100.10
Vigente
$94.010

Alcance

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing.This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing.This document can also be applicable to accessories.This document does not apply to:a) instructions for instrument servicing or repair;b) IVD reagents, including calibrators and control materials for use in control of the reagent;c) IVD instruments 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 5: Instruments de diagnostic in vitro destinés aux autodiagnostics
Páginas Técnicas 10
Idioma Inglés