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
15-11-2021
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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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
This document specifies general requirements for ORGANIZATIONS in the application of RISK MANAGEMENT before, during and after the connection of a HEALTH IT SYSTEM within a HEALTH IT INFRASTRUCTURE, by addressing the KEY PROPERTIES of SAFETY, EFFECTIVENESS and SECURITY whilst engaging appropriate stakeholders.
| Committee |
SC 62A
|
| DocumentType |
Standard
|
| ISBN |
978-2-8322-9748-3
|
| Pages |
88
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| IEC 80001-1:2021 | Identical |
| EN IEC 80001-1:2021 | Identical |
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