DS/ISO TR 24971:2020

Medical devices – Guidance on the application of ISO 14971


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 113.75

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.


Number of pages: 96

Published: 2020-06-22

Date of approval: 2020-06-22

International relationships : ISO TR 24971:2020 IDT

ICS: 11.040.01 - Medical equipment in general

Item number: M333733


Committees

Committee

  • IEC/TC 62/SC 62A

Danish committee

DS/S-562

Included in