Complied European Standards List
Risk management
ISO/EN 14971:2012 Medical devices — Application of
risk management to medical devices
Labeling
ISO/EN 15223-1:2012 Medical devices. Symbols to
be used with medical device labels, labelling and
information to be supplied. General requirements
User manual
EN 1041: 2008 Medical equipment manufacturers
to provide information
General Requirements
for Safety
EN 60601-1: 2006+A1:2013 Medical electrical equipment
- Part 1: General requirements for basic safety and
essential performance
IEC/EN 60601-1-11: 2010 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
IEC/EN 80601-2-30:2009 Medical electrical equipment -
Part 2-30: Particular requirements for the basic safety
and essential performance of automated
noninvasive sphygmomanometers
Electromagnetic
compatibility
IEC/EN 60601-1-2:2007 Medical electrical equipment -
Part 1-2: General requirements for basic safety
and essential performance - Collateral
standard:Electromagnetic compatibility -
Requirements and tests
Performance
requirements
EN 1060-1:1995+A2:2009 Non-invasive blood pressure
Part 1: General requirements
EN 1060-3:1997+A2:2009 Non-invasive blood pressure
Part 3: Supplementary requirements for
electromechanical blood pressure measuring system
Clinical investigation
EN 1060-4: 2004 Automatic Blood Pressure Monitor
overall system Interventional accuracy of the testing
process
Usability
IEC/EN 60601-1-6: 2010 Medical electrical equipment --
Part 1-6: General requirements for basic safety and
essential performance - Collateral Standard:
Usability
IEC/EN 62366: 2007 Medical devices - Application of
usability engineering to medical devices
Software life-cycle processes
IEC/EN 62304:2006+AC: 2008 Medical device software
- Software life cycle processes
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