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 , PDF 3 Users , PDF 5 Users , PDF 9 Users
English - French
21-09-2021
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IEC 80001-1:2021 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.
IEC 80001-1:2021 cancels and replaces the first edition published in 2010. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) structure changed to better align with ISO 31000;
b) establishment of requirements for an ORGANIZATION in the application of RISK MANAGEMENT;
c) communication of the value, intention and purpose of RISK MANAGEMENT through principles that support preservation of the KEY PROPERTIES during the implementation and use of connected HEALTH SOFTWARE and/or HEALTH IT SYSTEMS.
| DocumentType |
Standard
|
| Pages |
75
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DIN EN IEC 80001-1:2023-02 | Identical |
| DS/EN IEC 80001-1:2021 | Identical |
| CEI EN IEC 80001-1:2022 | Identical |
| EN IEC 80001-1:2021 | Identical |
| I.S. EN IEC 80001-1:2021 | Identical |
| SS-EN IEC 80001-1, UTG 2:2023 | Identical |
| ABNT NBR IEC 80001-1:2024 | Identical |
| VDE 0756-1:2023-02 | Identical |
| OVE EN IEC 80001-1:2023 03 01 | Identical |
| UNE-EN IEC 80001-1:2021 | Identical |
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