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– IEC 60601-1-1 (device combinations)
– IEC 60601-1-2 (electromagnetic compatibility)
– IEC 60601-1-4 (software-controlled functions)
– IEC 60601-1-8 (alarm systems)
15.26
IT networks and cybersecurity
15.26.1
Prerequisites
This chapter is intended for the operating organization and users of the device, and
the IT representatives and device owners of the health-care facility appointed by the
operating organization.
The following information must be noted before connecting the device to a network:
– Accompanying documents of this device
Connecting this device to a network that incorporates other devices or making
subsequent changes to that network can lead to new risks for patients, users, and
third parties. These risks must be identified, analyzed, and assessed before the
device is connected to the network or the network is changed. Appropriate actions
must be taken.
The following provides examples of subsequent changes to the network:
– Changing the network configuration
– Removing devices from the network
– Adding new devices to the network
– Performing upgrades or updates on devices that are connected to the network
Dräger recommends compliance with IEC 80001-1 (Application of risk
management for IT-networks incorporating medical devices) and creation of the
following documents:
– Description of the network of the health-care facility
– Description of the network-based alarm systems
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Instructions for use
Atlan A100 (XL), A300 (XL), A350 (XL) SW 2.1n
Technical data
301
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