Medel ELITE Gebrauchsanweisung Seite 71

Performance requirements
Clinical investigation
Usability
Software life-cycle processes
Bio-compatibility
EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1: Requirements and test
methods for non-automated measurement type.
IEC 80601-2-30:2013 Medical electrical equipment- Part 2-30: Particular requirements for the
basic safety and essential performance of automated non-invasive sphygmomanometers
ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of auto-
mated measurement type
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
EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical device software - Software
life-cycle processes
ISO 10993-1:2018 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 cytotox-
icity
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and
skin sensitization
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