2
1
2
0
Table 3
Band
Maximum
Distance
Compliance
385
0.3
27
Service
Modulation
380-390
1.8
450
430-470
2
0.3
28
710
704-787
745
780
0.2
0.3
9
810
870
930
800-960
2
0.3
28
2
0.3
28
2
0.3
28
0.2
0.3
9
1720
1845
1970
1700-
1990
2450
2400-
2570
5240
5500
5785
5100-
5800
Guidance and manufacturer’s declaration - electromagnetic Immunity
Test
Frequency
(MHz)
Radiated RF
IEC61000-4-3
(Test
specifications
for
ENCLOSURE
PORT
IMMUNITY to
RF wireless
communicati-
ons
equipment)
(MHz)
(m)
IEC
60601-1-2
Test Level
(V/m)
TETRA
400
Pulse
modulation
18 Hz
GMRS 460,
FRS 460
FM ± 5k Hz
deviation
1 kHz sine
LTE Band
13,
17
Pulse
modulation
217 Hz
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation
18 Hz
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1,
3, 4,25;
UMTS
Pulse
modulation
217 Hz
Bluetooth,
WLAN,
802.11
b/g/n, RFID
2450, LTE
Band 7
Pulse
modulation
217 Hz
WLAN
802.11
a/n
Pulse
modulation
217 Hz
level
(V/m)
27
28
9
28
Power
(W)
28
9
28
Risk management
Labeling
User manual
General Requirements
for Safety
Electromagnetic
compatibility
Performance
requirements
Clinical investigation
Usability
Software life-cycle
processes
Bio-compatibility
EN ISO 14971:2012/ISO 14971:2007 Medical devices -
Application of risk management to medical devices
EN ISO 15223-1:2016/ISO 15223-1:2016 Medical devices.
Symbols to be used with medical device labels, labelling and
information to be supplied. Part 1: General requirements
EN 1041:2008 +A1:2013 Information supplied by the manufacturer
of medical devices
EN 60601-1-2:2015/IEC 60601-1-2:2014 Medical electrical
equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral standard: Electromagnetic
disturbances - Requirements and tests
EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part
1: Requirements and test methods for non-automated
measurement type
IEC 80601-2-30:2018 Medical electrical equipment- Part 2-30:
Particular requirements for the basic safety and essential
performance of automated non-invasive sphygmomanometers
EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test
procedures to determine the overall system accuracy of automated
non-invasive sphygmomanometers
ISO 81060-2:2018 Non-invasive sphygmomanometers - Part 2:
Clinical validation of intermittent automated measurement type
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
ISO 10993-1:2018 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 sensiti
s
ation
EN 60601-1:2006+A1:2013/IEC 60601-1:2005+A1:2012 Medical
electrical equipment - Part 1: General requirements for basic safety
and essential performance
EN 60601-1-11:2015/IEC 60601-1-11:2015 Medical electrical
equipment - Part 1-11: General requirements for basic safety and
essential performance - Collateral standard: Requirements for
medical electrical equipment and medical electrical systems used in
the home healthcare environment
Complied Standards List
