I.S. EN ISO 14971:2019&A11:2021
Current
The latest, up-to-date edition.
Hardcopy , PDF
English
12-26-2021
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.
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
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