Standard

ISO/TR 24971:2020

Jun 2020 Current

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Abstract

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].

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Standard from ISO
Published: June 16 2020
Edition: 2
Document type: TR
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.040.01
International TC: ISO/TC 210

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Adopted by: FD CEN ISO/TR 24971:2020
Adopted by: SNG CEN ISO/TR 24971:2020
Revises: ISO/TR 24971:2013
Joinded work item: IEC/SC62A, 0

ISO/TR 24971:2020

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ISO/TR 24971:2020

ISO/TR 24971:2013

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ISO/TR 24971:2020

ISO/TR 24971:2013

Abstract

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