ISO/TS 16766

Manufacturers’ considerations for in vitro diagnostic medical devices in a public health emergency

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.

OEN:

ISO

Langue:

English

Code(s) de l'ICS:

11.100.10

Statut:

Brouillon

Date de Publication:

1969-12-30

Numéro Standard:

ISO/TS 16766