ISO/TS 16766

Under publication (Edition 1, 2024)

Final production steps (up to seven weeks).

Abstract

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.

General information

Status
: Under development

Publication date
: 2024-11

Stage
: International Standard under publication [60.00]
Edition
: 1
Technical Committee :
ISO/TC 212

ICS :
11.100.10
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