Draft
Technical SpecificationISO/DTS 16766
Manufacturers’ considerations for in vitro diagnostic medical devices in a public health emergency
Reference number
ISO/DTS 16766
ISO/DTS 16766
Edition 1
© ISO 2024
Draft Technical Specification
Résumé
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.
Informations générales
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État actuel: ProjetStade: Epreuve envoyée au secrétariat ou mise au vote du FDIS: 8 semaines [50.20]
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Edition: 1
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Comité technique :ISO/TC 212ICS :11.100.10
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