60
61
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
21. Information and description
of symbols
With the CE symbol, Sonova AG confirms
that this product – including accessories –
meets the requirements of the Medical
Devices Regulation (EU) 2017/745 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 and regulations.
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 Medical Device Regulation (EU)
2017/745.
