24
Clinical investigation EN 1060-4:2004 Non-invasive sphygmomanometers -
Part 4: Test procedures to determine the overall system
accuracy of automated non-invasive sphygmomanom-
eters
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
EMC Guidance
1) This product needs special precautions regarding EMC and needs
to be installed and put into service according to the EMC information
provided, and this unit can be affected by portable and mobile RF
communications equipment.
2) Do not use a mobile phone or other devices that emit electromag-
netic fields, near the unit. This may result in incorrect operation of
the unit.
3) Caution: This unit has been thoroughly tested and inspected to
assure proper performance and operation!
4) Caution: This machine should not be used adjacent to or stacked
with other equipment and that if adjacent or stacked use is necessary,
this machine should be observed to verify normal operation in the
configuration in which it will be used.
To Next Page
Loading...