safety, installation and commissioning
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IEC 60601-1 classifies networks and data networks as shown in figure 11 according to criteria A, B and C to identify a
statement about the consequences and required response times. Reaction time means for connection of a PEMS to a
network or data network, the time lag between the occurrence of a fault in the network or data network and the occurrence of
patient harm. Table 1 contains potential risks based on severity and response time in case of data loss or alteration of data in
a network or data network.
Severity
Reaction time
Network class
Example
Death or serious injury
Second(s)
A
Infusion (closed loop), lack of control of operation robot
Minute(s)
A
Missing alarm transfer of an intensive care network
Hour(s)
A/B
Wrong therapy data on dialysis machine or ventilator
Medium injury
Second(s)
A
Wrong alarm transfer, lack of control of operation robot
Minute(s)
A/B
Wrong alarm transfer, lack of control of operation robot
Hour(s)
B
Image mutilation, loss of therapy protocol
Light injury
Second(s)
B
Minute(s)
B
Loss of a x-ray image
Hour(s)
B/C
Malfunction of a tele-medic connection
Minor
Second(s)
C
Minute(s)
C
Hour(s)
C
Breakdown of a tele-medic connection
Table 1: Possible risks by severity and reaction time in case of data loss or disturbances of the network or data network
respectively.
Class „C“ network or data network:
All time-critical processes and applications for which a malfunction or interruption would lead to a critical situation for the
patient as in an intensive care network are categorized as class C. Such a network should not be connected to the general
hospital network, because such a connection might create uncontrollable risks. The accessibility of such an isolated (floating)
network has to be very high; interruptions should not occur or only very seldom. For such a network the manufacturer /
deliverer is the only responsible party. He must define the specifications of the network nodes to be used.
Note: In practice such an isolation of networks in hospitals can be realized only with very high technical effort or not at all.
Depending on the manufacturer, the patient monitors in intensive care can also show x-ray images, laboratory data and other
patient related information; this requires a connection of the intensive care network and the general hospital network to
transfer data such as x-ray images form the PACS. In this case the responsibility for such networks is clearly transferred to
the operator.
Class „B“ network or data network:
This category of networks or data networks includes all applications and processes, which are not time-critical and which
handle therapeutic or diagnostic patient data. Such a network may be connected to another network such as a hospital
network via a defined and controllable or safe interface. The standards for such a network are high so that interruptions are
limited.
The specifications of such a network are either defined by the manufacturer or the system administrator who is appointed by
the operator. As class B networks are usually radiological networks, it is difficult to define the responsibility for such a system
when several manufacturers allocate different modules.
