ISO/TR 24971:2020
Current
The latest, up-to-date edition.
Medical devices Guidance on the application of ISO 14971
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
English, French
16-06-2020
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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].
| DocumentType |
Technical Report
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| Pages |
87
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| ProductNote |
THIS STANDARD ALSO REFERS TO :AAMI TIR 57,IEC 62366-1:2015,IEC TR 62366-2,IEC 62502,IEC 80001-1:2010,ISO/IEC Guide 63:2019,ISO/DIS 10017,ISO Handbook: ISO 13485:2016,ISO 14155,ISO 15189,ISO 15197,,ISO/TR 20416
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| PublisherName |
International Organization for Standardization
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| Status |
Current
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| Supersedes |
| Standards | Relationship |
| PD ISO/TR 24971:2020 | Identical |
| PD ISO/TR 24971 | Identical |
| CEN ISO/TR 24971:2020 | Identical |
| SA TR ISO 24971:2020 | Identical |
| S.R. CEN ISO/TR 24971:2020 | Identical |
| TR T 24971:2020 | Identical |
| CSA ISO/TR 24971:21 | Identical |
| IS/ISO/TR 24971 : 2020 | Identical |
| UNE-CEN ISO/TR 24971:2020 | Identical |
| UNI ISO/TR 24971:2021 | Identical |
| AS ISO 22367:2021 | Medical laboratories - Application of risk management to medical laboratories |
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