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UNI CEI EN ISO 14971:2022

Current
Current

The latest, up-to-date edition.

Medical devices - Application of risk management to medical devices
Published date

04-21-2022

This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices.

Committee
ISO/TC 210
DocumentType
Standard
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Current
Supersedes

Standards Relationship
ISO 14971:2019 Identical
EN ISO 14971:2019 Identical
EN ISO 14971:2019+A11:2021 Identical

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