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.
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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.
| 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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.