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ISO TR 24971:2020 ED2

Medical devices - Guidance on the application of ISO 14971

Jun 16, 2020

General information

60.60     Jun 19, 2020

IEC

TC 62/SC 62A

Technical Report

11.040.01  

English  

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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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO TR 24971:2013 ED1

NOW

PUBLISHED
ISO TR 24971:2020 ED2
60.60 Standard published
Jun 19, 2020