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Guidance and manufacturer’s declaration-electromagnetic immunity for all equipment and systems.
Immunity test IEC 60601 test level Compliance level
Hearing aids are intended for use in the electromagnetic environment specified below. The customer
or the user of hearing aids should assure that it is used in such an environment.
LEGAL INFORMATION
Electrostatic
discharge
(ESD) IEC
61000-4-2
Contact discharge:
±2 kV, ±4 kV,
±6 kV, ± 8 kV
Air discharge:
±2 kV, ±4 kV,
±8 kV, ±15 kV
Contact discharge:
±2 kV, ±4 kV,
±6 kV, ± 8 kV
Air discharge:
±2 kV, ±4 kV,
±8 kV, ±15 kV
Radiated RF
electromagnetic
fields immunity test
10V/m,80MHz
-2.7GHz 80% AM at 1KHz
RF Band (IEC
60601-1-2:2014+
A1:2020 section 8.10 table 9)
10V/m,80MHz
-2.7GHz 80% AM at 1KHz
RF Band(IEC
60601-1-2:2014+
A1:2020 section 8.10 table 9)
Electrical fast
transient and
burst test
IEC 61000-4-4
AC port:±2 kV
Patient coupling
port：±1 kV
100kHz repetition frequency
N/A
Surge test
IEC 61000-4-5
Line to line: ±500V, ±1kV
Line to ground:
±500V,±1kV,±2 kV
N/A
Power frequency
(50Hz/60Hz)
magnetic field
IEC61000-4-8
30 A/m, 50Hz and 60Hz 30 A/m, 50Hz and 60Hz
2. Guidance and manufacture’s declaration - electromagnetic immunity-for all EQUIPMENT
and SYSTEMS.
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