Draft
Technical Specification
ISO/DTS 16766
Manufacturers’ considerations for in vitro diagnostic medical devices in a public health emergency
Reference number
ISO/DTS 16766
Edition 1
Draft Technical Specification
ISO/DTS 16766
84816
This draft is in the approval phase.

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
    : Proof sent to secretariat or FDIS ballot initiated: 8 weeks [50.20]
  •  : 1
     : 13
  • ISO/TC 212
    11.100.10 
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