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.

SDO:

ISO

Language:

English

ICS Codes:

11.100.10

Status:

Draft

Publish date:

1969-12-30

Standard Number:

ISO/TS 16766