ISO/CD TS 16766.2
u
ISO/CD TS 16766.2
84816

Status : Under development

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

  •  : Under development
    : CD study initiated [30.20]
  •  : 1
  • ISO/TC 212
    11.100.10 
  • RSS updates

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