I.S. EN ISO 14971:2019/A11:2021
Current
The latest, up-to-date edition.
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Hardcopy , PDF
English
26-12-2021
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
CONTENTS
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for risk management system
5 Risk analysis
6 Risk evaluation
7 Risk control
8 Evaluation of overall residual risk
9 Risk management review
10 Production and post-production activities
Annex A (informative) Rationale for requirements
Annex B (informative) Risk management process for medical devices
Annex C (informative) Fundamental risk concepts
Bibliography
This document specifies terminology, principles and a process for risk management of medical devices,
including software as a medical device and in vitro diagnostic medical devices.
| Committee |
ISO/TC 210
|
| DocumentType |
Standard
|
| Pages |
36
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. THIS STANDARD ALSO REFERS TO IEC/TR 60513.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 14971:2019+A11:2021 | Identical |
| ISO 14971:2019 | Identical |
| EN ISO 14971:2019 | Identical |
| ISO 14155:2020 | Clinical investigation of medical devices for human subjects — Good clinical practice |
| ISO 18113-1:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
| ISO/IEC Guide 63:2019 | Guide to the development and inclusion of aspects of safety in International Standards for medical devices |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| IEC 62366-1:2015 | Medical devices - Part 1: Application of usability engineering to medical devices |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| ISO 20916:2019 | In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice |
| ISO 10993-1:2018 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO/TR 24971:2020 | Medical devices — Guidance on the application of ISO 14971 |
| ISO 31000:2018 | Risk management — Guidelines |
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