ISO/DTS 16766

Projet

Projet au stade approbation.

Résumé

This document provides guidance to manufacturers on the minimal considerations for in vitro diagnostic (IVD) medical devices in a public health crisis: - general considerations; - risk reduction; - monitoring the devices’ post-market performance and quality assurance; - implementing a communication system. This document does not supersede the existing traditional regulatory authorization requirements for IVD medical devices available in the marketplace.

Informations générales

État actuel
: Projet

Stade
: Texte final reçu ou FDIS enregistré pour approbation formelle [50.00]
Edition
: 1
Comité technique :
ISO/TC 212

ICS :
11.100.10
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