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ISO/TR 24971:2020

Medical devices — Guidance on the application of ISO 14971

Jun 16, 2020

General information

90.92     Jul 6, 2026

ISO

ISO/TC 210

Technical Report

11.040.01  

English   French  

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Scope

This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019.
The risk management process can be part of a quality management system, for example one that is based on ISO 13485:2016[24], but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to risk management and can be fulfilled by applying ISO 14971:2019. See also the ISO Handbook: ISO 13485:2016 — Medical devices — A practical guide[25].

Life cycle

PREVIOUSLY

WITHDRAWN
ISO/TR 24971:2013

NOW

PUBLISHED
ISO/TR 24971:2020
90.92 Standard to be revised
Jul 6, 2026

REVISED BY

PROJECT
ISO/AWI TS 24971-1

National adoptions

SRPS CEN ISO/TR 24971:2026  
ISS

Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)

60.60   Standard published

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