i-5
Regulatory Requirements
Classifications
•
Type of protection against electrical shock: Class I
•
Degree of protection against electrical shock (Patient connection): Type BF equipment
•
Degree of protection against harmful ingress of water: Ordinary equipment and all of
applied parts (IPX7, IPX8) except ECG meet ingress protection level according to IEC 60529.
•
Degree of safety of application in the presence of a flammable anesthetic material with
air or with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a
flammable anesthetic mixture with air or with oxygen or nitrous oxide.
•
Mode of operation: Continuous operation
Electromechanical safety standards met
•
MDD 93/42/EEC
•
EN ISO 10993-1:2009 (ISO 10993-1:2009)
•
EN ISO 10993-10:2013 (ISO 10993-10:2010)
•
EN ISO 10993-5:2009 (ISO 10993-5:2009)
•
EN ISO 13485:2016 (ISO 13485:2016)
•
EN ISO 14155:2011+AC:2011 (ISO 14155:2011)
•
EN ISO 14971:2012 (ISO 14971:2007)
•
EN ISO 15223-1:2016 (ISO 15223-1:2016)
•
EN 1041:2008+A1:2013
•
EN 55011:2016+A1:2017 (CISPR 11:2015/AMD1:2016)
•
EN 55032:2015 (CISPR 32:2015)
•
EN 60601-1:2006+A1:2013 (IEC 60601-1:2005/AMD1:2012)
•
EN 60601-1-2:2015 (IEC 60601-1-2:2014)
•
EN 60601-1-6:2010+A1:2015 (IEC 60601-1-6:2010/AMD1:2013)
•
EN 60601-2-37:2008+A11:2011+A1:2015 (IEC 60601-2-37:2007/AMD1:2015)
•
EN 61000-3-2:2014 (IEC 61000-3-2:2018)
•
EN 61000-3-3:2013 (IEC 61000-3-3:2013)
•
EN 61000-4-11:2004 (IEC 61000-4-11:2004)
•
EN 61000-4-2:2009 (IEC 61000-4-2:2008)
•
EN 61000-4-3:2006+A1:2008+A2:2010 (IEC 61000-4-3:2006/AMD2:2010)
•
EN 61000-4-4:2012 (IEC 61000-4-4:2012)
Summary of Contents for X-CUBE 70
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