EN IEC 80001-1:2021
Current
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
Published date
29-10-2021
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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 |
CLC/TC 62
|
| DocumentType |
Standard
|
| PublisherName |
European Committee for Standards - Electrical
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| CEI EN IEC 80001-1:2022 | Identical |
| BS EN IEC 80001-1:2021 | Equivalent |
| IEC 80001-1:2021 | Identical |
| DIN EN IEC 80001-1:2023-02 | Identical |
| DS/EN IEC 80001-1:2021 | Identical |
| SS-EN IEC 80001-1, UTG 2:2023 | Identical |
| I.S. EN IEC 80001-1:2021 | Identical |
| VDE 0756-1:2023-02 | Identical |
| BS EN IEC 80001-1:2021 | Identical |
| UNE-EN IEC 80001-1:2021 | Identical |
| NS-EN 13060:2025 | Sterilizers for medical purposes - Small steam sterilizers - Requirements and testing |
Summarise
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