USER GUIDE
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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 sphygmomanometers
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 usability 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
Bio-compatibility
ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within
a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin
sensitization
Unique Device
Identification (UDI)
HIB Supplier Standard (SLS) 2.4 (contains serial number and date of manufacture)
