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SA TR ISO 24971:2020

Current
Current

The latest, up-to-date edition.

Medical devices - Guidance on the application of AS ISO 14971
Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

08-28-2020

Publisher

Standards Australia

Preview

Identically adopts ISO/TR 24971:2020, which provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to AS ISO 14971:2020.

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].

Committee
HE-028
DocumentType
Technical Report
ISBN
978 1 76072 951 6
Pages
89
PublisherName
Standards Australia
Status
Current

Standards Relationship
ISO/TR 24971:2020 Identical

First published as SA TR ISO 24971:2020.

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Hardcopy - English
PDF 1 User - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
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