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
  • Edition
     : 1
  • Technical Committee
     : ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
  • ICS
     :
    11.100.10 In vitro diagnostic test systems

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goals

3
Good Health and Well-being
9
Industry, Innovation and Infrastructure
11
Sustainable Cities and Communities

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