EN 1060-4:2004 Non-invasive sphygmomanometers
-Part 4: Test procedures to determine the overall
system accuracy of automated non-invasive
sphygmomanometers
ISO 81060-2:2013 Non-invasive sphygmomanometers
-Part 2: Clinical validation of automated measurement type
EN 60601-1-6:2010/IEC 60601-1-6:2010+A1:2013
Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential
performance - Collateral standard: Usability
EN 62366:2008/ IEC 62366-1:2015 Medical devices
-Application of usability engineering to medical devices
EN 62304:2006/AC: 2008 / IEC 62304:2006 Medical
device software - Software life-cycle processes
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
Clinical
investigation
Usability
processes
Bio
-compatibility
Complied Standards List
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 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
RF emissions
CISPR 11
Group 1
Class B
Class A
Complies
Compliance
Harmonic
emissions
IEC 61000-3-2
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
RF emissions
CISPR 11
Emissions test
Electromagnetic environment
- guidance
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.
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.
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.
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EMC GUIDANCE
COMPLIED STANDARDS LIST
