User's Manual

EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test

procedures to determine the overall system accuracy of automated

non-invasive sphygmomanometers

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

Clinical investigation

Usability

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

ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical

validation of automated measurement type