3 IEC EMC Compliance
Per IEC 60601-1-2 Medical Electrical Equipment requires special precautions regarding
Electromagnetic Compatibility (EMC) and must be installed and put into service according to the
EMC information provided in the following tables. Full declaration is stored on-site in the user
manual delivered with the system.
The MR system is designed and tested to the following standards:
Table 2-2: Guidance And Manufacturer’s Declaration – Electromagnetic Emissions
The system is intended for use in the electromagnetic environment specified below. The customer or the user of the system should
assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment – Guidance
RF Emissions CISPR 11 Group 2 The system must emit electromagnetic energy in order to perform its
intended function. Nearby electronic equipment may be affected
RF Emissions CISPR 11 Class A The system is suitable for use in all establishments other than domestic
and those directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes
Table 2-3: Guidance And Manufacturer’s Declaration – Electromagnetic Immunity
The system is intended for use in the electromagnetic environment specified below. The customer or the user of the system should
assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance Level
Electrostatic discharge (ESD) IEC
61000-4-2
±6 kV contact ±6 kV contact
±8 kV air ±8 kV air
Electrical fast transient / burst IEC
61000-4-4
±2 kV for power supply lines ±2 kV for power supply lines
±1 kV for input/output lines ±1 kV for input/output lines
Surge IEC 61000-4-5 ±1 kV line(s) to line(s) ±1 kV differential mode
±2 kV line(s) to earth ±2 kV common mode
Voltage dips, short interruptions and volt‐
age variations on power supply input
lines IEC 61000-4-11
<5 % U
T
(>95 % dip in U
T
) for 5 sec.
<5 % U
T
(>95 % dip in U
T
) for 5 sec.
Power Frequency (50/60Hz) magnetic
field IEC 61000-4-8
3 A/m 3 A/m
Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 3 Vrms
Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2,5 GHz 3 V/m
SIGNA Voyager Pre-Installation
Direction 5680008–1EN, Revision 2
Chapter 2 General System Level 27
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