SA TR ISO 24971:2020
Current
The latest, up-to-date edition.
Medical devices - Guidance on the application of AS ISO 14971
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
English
08-28-2020
Important note : All end users must be registered with an Account prior to user licenses being assigned.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.
| Committee |
HE-028
|
| DocumentType |
Technical Report
|
| ISBN |
978 1 76072 951 6
|
| Pages |
89
|
| PublisherName |
Standards Australia
|
| Status |
Current
|
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].
| Standards | Relationship |
| ISO/TR 24971:2020 | Identical |
First published as SA TR ISO 24971:2020.
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