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EVS-EN IEC 80001-1:2021

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

General information
Valid from 15.11.2021
Base Documents
IEC 80001-1:2021; EN IEC 80001-1:2021
Directives or regulations
None
Standard history
Status
Date
Type
Name
15.11.2021
Main
05.04.2011
Main

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.

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