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Accella™ Therapy Mattress Instructions for Use Page 53
Compliance
Compliance
Electromagnetic Compatibility
Compliance
CE conformity mark
The CE conformity mark applicable to class IIa Medical Devices was applied
to the Accella™ Therapy mattress for the first time in 2018.
Standards
Designation
EN 60601-1: 2007 / A1: 2017
IEC 60601-1: 2005 / A1: 2012
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 / A1: 2013
IEC 60601-1-8: 2006 / A1: 2013
EN ISO 14971: 2012
EN ISO 10993-1: 2010
EN ISO 10993-5: 2010
EN ISO 10993-10: 2010
EN ISO 15223-1: 2016
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