ISO/CD TS 16766.2
Manufacturers’considerations for in vitro diagnostic medical devices in a public health crisis
Reference number
ISO/CD TS 16766.2
Edición 1
Committee Draft
ISO/CD TS 16766.2
84816
El comité está revisando un borrador.

Resumen

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.

Informaciones generales

  •  : En desarrollo
    : Cierre del periodo de observaciones [30.60]
  •  : 1
  • ISO/TC 212
    11.100.10 
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