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EVS-EN 80001-1:2011

Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities

General information
Valid from 05.04.2011
Base Documents
IEC 80001-1:2010; EN 80001-1:2011
Directives or regulations
None
Standard history
Status
Date
Type
Name
Main
prEN IEC 80001-1:2019
05.04.2011
Main
Recognizing that MEDICAL DEVICES are incorporated into IT-NETWORKS to achieve desirable benefits (for example, INTEROPERABILITY), this international standard defines the roles, responsibilities and activities that are necessary for RISK MANAGEMENT of IT-NETWORKS incorporating MEDICAL DEVICES to address SAFETY, EFFECTIVENESS and DATA AND SYSTEM SECURITY (the KEY PROPERTIES). This international standard does not specify acceptable RISK levels.
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