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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 21.09.2021
Directives or regulations
None
Standard history
Status
Date
Type
Name
21.09.2021
Main
27.10.2010
Main
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.
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