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COMPLIED STANDARDS LIST
Risk management
EN ISO 14971:2012 / ISO 14971:2007 Medical devices - Applica-
tion of risk management to medical devices
Labeling
EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices.
Symbols to be used with medical device labels, labelling and
information to be supplied. Part 1 : General requirements
User manual
EN 1041:2008 +A1:2013 Information supplied by the manufactur-
er of medical devices
General Requirements
for Safety
EN 60601-1:2006+A1:2013/ IEC 60601-1:2005+A1:2012 Medical
electrical equipment - Part 1: General requirements for basic
safety and essential performance
EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical
equipment - Part 1-11: General requirements for basic safety and
essential performance - Collateral standard: Requirements for
medical electrical equipment and medical electrical systems used
in the home healthcare environment
Electromagnetic
compatibility
EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical
equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral standard: Electromagnetic
disturbances - Requirements and tests
Performance
requirements
EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part
1: Requirements and test methods for non-automated measure-
ment type
EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers -
Part 3: Supplementary requirements for electro-mechanical blood
pressure measuring systems
IEC 80601-2-30:2009+A1:2013 Medical electrical equipment-
Part 2-30: Particular requirements for the basic safety and
essential performance of automated non-invasive sphygmoma-
nometers
Clinical investigation
EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4:
Test procedures to determine the overall system accuracy of
automated non-invasive sphygmomanometers
ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2:
Clinical validation of automated measurement type
Usability
EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013
Medical electrical equipment - Part 1-6: General requirements
for basic safety and essential performance - Collateral standard:
Usability
IEC 62366-1:2015 Medical devices - Part 1: Application of usabil-
ity engineering to medical devices
Software life-cycle
processes
EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015
Medical device software - Software life-cycle processes
ENGLISH
