GERATHERM Smart GT-1775 Manual page 71

Quality standards
Clinical testing
Usability
Software life
cycle proc-
esses
Biocompati-
bility
EN 1060-4:2004
Non-invasive sphygmomanometers – Part 4:
Test procedures to determine the overall system
accuracy of automated non-invasive sphyg-
momanometers
ISO 81060-2:2013
Non-invasive sphygmomanometers – Part 2:
Clinical investigation of equipment of intermittent
automated type
EN 60601-1-6:2010+A1:2015/IEC 60601-1-
6:2010+A1:2013
Medical electrical devices - Part 1-6:
General requirements for basic safety and es-
sential performance
– Collateral standard: Usability
EN 62366:2008/ IEC 62366-1:2015
Medical devices – Application of usability
to medical devices
EN 62304:2006/AC: 2008 / IEC 62304:2006
Medical devices software – Software lifecycle
processes
ISO 10993-1:2009
Biological evaluation of medical devices – Part 1:
Evaluation and testing within a risk management
system
ISO 10993-5:2009
Biological evaluation of medical devices - Part 5:
Test methods to assess in-vitro cytotoxicity
ISO 10993-10:2010
Biological evaluation of medical devices
- Part 10:
Tests for irritation and skin sensitisation
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