50
51
Immunity standards EN 60601-1-2
IEC 60601-1-2
EN 61000-4-2
IEC 61000-4-2
EN IEC 61000-4-3
IEC 61000-4-3
EN 61000-4-4
IEC 61000-4-4
EN 61000-4-5
IEC 61000-4-5
EN 61000-4-6
IEC 61000-4-6
EN 61000-4-8
IEC 61000-4-8
EN 61000-4-11
IEC 61000-4-11
IEC 60601-1
ISO 7637-2
23.
Information and explanation of
symbols
xxxx
With the CE symbol, Sonova AG confirms that
this product – including accessories – meets the
requirements of the Medical Devices Regulation MDR
2017/745, Medical Devices Directive 93/42/EEC as well
as the Radio Equipment Directive 2014/53/EU.
The numbers after the CE symbol correspond to the code
of certified institutions that were consulted under the
above-mentioned regulation and directives.
This symbol indicates that the products described in
these user instructions adhere to the requirements for
an applied part of Type B of EN 60601-1. The surface of
the hearing aid is specified as applied part of Type B.
Indicates the medical device manufacturer, as defined in
Medical Devices Regulation (EU) 2017/745.
Indicates the date when the medical device was
manufactured.
Indicates the Authorized representative in the European
Community. The EC REP is also the importer to the
European Union.
This symbol indicates that it is important for the user to
read and take into account the relevant information in
these user guides.
