I.S. EN IEC 80001-1:2021
Current
The latest, up-to-date edition.
Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
Hardcopy , PDF
English
11-15-2021
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.
FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Principles
5 Framework
6 RISK MANAGEMENT PROCESS
Annex A (informative) IEC 80001-1 requirements mapping table
Annex B (informative) Guidance for accompanying document Information
Bibliography
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