Standard Technical reports · SIS-ISO/TR 24971:2020

Medical devices - Guidance on the application of ISO 14971

Status: Withdrawn

· Replaced by: SIS-CEN ISO/TR 24971:2020
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Standard Technical reports · SIS-ISO/TR 24971:2020

Medical devices - Guidance on the application of ISO 14971
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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].

Subjects

General (11.040.01) Quality management and corresponding general aspects for medical devices (11.110.10)


Buy this standard

Standard Technical reports · SIS-ISO/TR 24971:2020

Medical devices - Guidance on the application of ISO 14971
Subscribe on standards - Read more Dölj
Price: 1 570 SEK
standard ikon pdf

PDF

Price: 1 570 SEK
standard ikon

Paper

Price: 2 512 SEK
standard ikon pdf + standard ikon

PDF + paper

Show more Show less

Product information

Language: English

Written by: Std Vård

International title:

Article no: STD-80022580

Edition: 2

Approved: 6/17/2020

No of pages: 96

Replaces: SIS-ISO/TR 24971:2014

Replaced by: SIS-CEN ISO/TR 24971:2020