Borrador del Comité
ISO/CD 24884
Electronic Instructions for Use for In Vitro Diagnostic Medical Devices (Minimum required information and means of delivery)
Reference number
ISO/CD 24884
ISO/CD 24884
Edition 1
© ISO 2024
Borrador del Comité
Resumen
The proposed new standard provides guidelines on the conditions (means of delivery) and minimum required information which shall be physically delivered, when providing electronic instructions for use (eIFU) for in vitro diagnostic medical devices (IVDs). Not in the scope of this standard: The content of the eIFU as it is covered by ISO 18113-1, -2, -3, -4, -5. This document is applicable to the in vitro diagnostic manufacturers, the developer (investigators), and the users such as medical laboratories. It is also intended to be used by the organizations (e.g. regulatory authorities and conformity assessment bodies), which are responsible for assessing the performance and quality control.
Informaciones generales
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Estado: En desarrolloEtapa: Cierre del periodo de observaciones [30.60]
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Edición: 1
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Comité Técnico :ISO/TC 212
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