UNE-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 (Endorsed by Asociación Española de Normalización in December of 2021.)
Hardcopy , PDF
English
01-12-2021
This document specifies a framework of general requirements, guidance, 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 |
CTN 209/SC 62
|
| DocumentType |
Standard
|
| Pages |
45
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| IEC 80001-1:2021 | Identical |
| EN IEC 80001-1:2021 | Identical |
| BS EN IEC 80001-1:2021 | Equivalent |
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