ISO/TR 24971:2020

Medical devices — Guidance on the application of ISO 14971

Standard Details

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^].

General Information

Status : Published

Standard Type: Main

Document No: ISO/TR 24971:2020

Document Year: 2020

Pages: 87

Edition: 2

Section Volume:
ISO/TC 210. Quality management and corresponding general aspects for medical devices

ICS:
11.040.01 Medical equipment in general

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ISO/TR 24971:2020

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ISO/TR 24971:2013

ISO/TR 24971:2020

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