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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

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

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