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  • ISO
    ISO/TS 16766:2024 Manufacturers’ considerations for in vitro diagnostic medical devices in a public health emergency
    Edition: 2024
    $286.57
    / user per year

Content Description

This document provides guidance to manufacturers on the minimum requirements for the lifecycle management of in vitro diagnostic (IVD) medical devices that are developed in preparation for and in response to a public health emergency involving infectious agents requiring immediate availability of authorized IVD devices.

NOTE            This document does not replace existing national (or regional) regulatory pathway requirements for IVD medical devices under non-emergency situations. The regulatory authorization process of emergency use-IVD medical devices is country-specific and it includes:

—                   following a risk management process;

—                   monitoring the device’s post-market performance and quality assurance;

—                   implementing a communication system.



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About ISO

ISO, the International Organization for Standardization, brings global experts together to agree on the best way of doing things – for anything from making a product to managing a process. As one of the oldest non-governmental international organizations, ISO has enabled trade and cooperation between people and companies all over the world since 1946. The International Standards published by ISO serve to make lives easier, safer and better.
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