ISO/TS 16766
Manufacturers’ considerations for in vitro diagnostic medical devices in a public health emergency
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.
This document is available in electronic format only.
Details
Date of Publication: November 1, 2024
Order Code PDF: ISOTS16766Ed1E
Order Code Print: print not available
Edition: First
Pages: 13
ISO/TS 16766 Additional Details
Membership discounts cannot be applied to ISO documents because they are not published by CLSI. CLSI is able to offer ISO Technical Committee 212 approved and draft standards through an agreement with the American National Standards Institute.
Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems.