187692(10) - EN - P280 Mattress Instructions for Use Page 43
Compliance
Electromagnetic Compatibility
Compliance
CE conformity mark
The CE conformity mark applicable to class IIa Medical Devices was applied
to the P280 mattress for the first time in 2011.
Standards
Name
EN 60601-1 (2006) & A1 (2013)
IEC 60601-1: 2005 & A1 (2012),
(Edition 3) +CORR1 + CORR2
EN 60601-1-2: 2015
IEC 60601-1-2: 2014
EN 60601-1-6: 2010
IEC 60601-1-6: 2010
EN 60601-1-8: 2007
IEC 60601-1-8: 2007
EN ISO 14971: 2012
EN ISO 10993-1: 2009 / AC: 2010
EN ISO 10993-5: 2009
EN ISO 10993-10: 2010
EN ISO 15223-1: 2016
EN 1041: 2008