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PD ISO/TR 24971:2020

PD ISO/TR 24971:2020

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Medical devices. Guidance on the application of ISO 14971

Available format(s)

Hardcopy , PDF

Superseded date

22-07-2020

Language(s)

English

Published date

19-06-2020

Publisher

British Standards Institution

This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019.

This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO14971:2019.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 ISO14971:2019. Some requirements in ISO13485:2016 (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 ISO14971:2019. See also the ISO Handbook: ISO13485:2016 — Medical devices — A practical guide[ 25].

Committee
CH/210/4
DocumentType
Standard
ISBN
9780539066142
Pages
96
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO/TR 24971:2020 Identical
CEN ISO/TR 24971:2020 Identical

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Hardcopy - English
PDF - English
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