ISO/AWI TS 16766
ISO/AWI TS 16766


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 

  •  :  Under development
  •  : 1
  •  : ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
  •  :

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