18
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 perfor
-
mance - 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 in-
stalled 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 electromagnetic 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.
Table 1
Guidance and manufacturer’s declaration – electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below. The customer or
the user of the device should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The device uses RF energy only for its internal
function. Therefore, its RF emissions are very
low and are not likely to cause any interference in
nearby electronic equipment.
RF emissions
CISPR 11
Class B
The device is suitable for use in all establishments,
other than domestic and those directly connected
to the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies