44
45
Immunity standards
EN 60601-1-2:2015
IEC 60601-1-2:2014
EN 61000-4-2:2009
IEC 61000-4-2:2008
EN 61000-4-3:2006+A1+A2
IEC 61000-4-3:2006+A1+A2
EN 61000-4-4:2012
IEC 61000-4-4:2012
EN 61000-4-5:2014
IEC 61000-4-5:2014
EN 61000-4-6:2014
IEC 61000-4-6:2013
EN 61000-4-8:2010
IEC 61000-4-8:2009
EN 61000-4-11:2004
IEC 61000-4-11:2004
IEC 60601-1 (§ 4.10.2):2005
ISO 7637-2:2011
18. Information and description
of symbols
With the CE symbol, Sonova AG confirms that this
product – including accessories – meets the
requirements of the 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 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 an applied part of Type B.
Indicates the medical device manufacturer, as
defined in EU Directive 93/42/EEC.
Indicates the Authorized representative in the
European Community. The EC REP is also the
importer to the European Union.
