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.
Status: Under development
Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
- ICS :
This standard contributes to the following Sustainable Development Goals:
ISO/AWI TS 16766Stage: 20.00
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