Medical

EMC REQUIREMENTS SUMMARY
For Internal Use Only 1 of 30 26/05/2014

EMC
Requirements for
Medical Devices

Prepared By: Victor H. Kee, P.Eng
Ultratech Engineering Labs Inc.

Table of Contents
PUBLISHED DATE DEFINITIONS .............................................................................................................................. 3
PERFORMANCE CRITERIA DEFINITIONS ............................................................................................................... 3
EN 60601-1-2:1993 (1
ST
Edition) Immunity for Medical Electrical Equipment .................................................................. 4
IEC/EN 60601-1-2:2001 (2
nd
Edition) Immunity for Medical Electrical Equipment ............................................................ 5
IEC/EN 60601-1-2:2007 (3
nd
Edition) Immunity for Medical Electrical Equipment ............................................................ 6
IEC 60601-1-2:2014 (4
th
Edition) Immunity for Medical Electrical Equipment ................................................................... 7
Regulatory Impact Analysis .................................................................................................................................................... 26
Sections 15.21 & 15.105 - Information to User ...................................................................................................................... 29
EN 55011 Emissions Group 1 ................................................................................................................................................. 30

Published date Definitions
doa - latest date of announcement of the European standard at national level

dop - latest date by which the EN has to be implemented at national level by publication of an identical national standard
or by endorsement

dow - latest date by which the national standards conflicting with the EN have to be withdrawn

Performance Criteria Definitions
Performance Criteria A for phenomena of a continuous nature:
The apparatus shall continue to operate as intended. No degradation of performance or loss of function is allowed below a
performance level specified by the manufacturer, when the apparatus if used as intended. In some cases the performance
level may be replaced by a permissible loss of performance. If the minimum performance level or the permissible
performance loss is not specified by the manufacturer then either of these may be derived from the product description
and documentation (including leaflets and advertising) and what the user may reasonably expect from the apparatus if
used as intended.
Performance Criteria B for phenomena of a transient nature:
The apparatus shall continue to operate as intended after the test. No degradation of performance or loss of function is
allowed below a performance level specified by the manufacturer, when the apparatus if used as intended. In some cases
the performance level may be replaced by a permissible loss of performance.
During the test, degradation of performance is however allowed. No change of actual operating state or stored data is
allowed.
If the minimum performance level or the permissible performance loss is not specified by the manufacturer then either of
these may be derived from the product description and documentation (including leaflets and advertising) and what the
user may reasonably expect from the apparatus if used as intended.
Performance Criteria C for power supply failure phenomena:
Temporary loss of function is allowed, provided the loss of function is self recoverable or can be restored by the operation
of the controls.
Functions and or information protected by a battery backup shall not be lost.
Performance Criteria D:
The apparatus or sub-system shall continue to operate as intended. No degradation of performance or loss of function is
allowed other than a failure into a safe-mode.
Performance Criteria R for power supply failure phenomena:
The equipment shall withstand the test without damage or other disturbances ( such as the corruption of software or
misoperation of fault protection facilities) and shall operate properly within the specified limits after transient
electromagnetic phenomenon has ceased. (It is not necessary to operate properly while the test condition is present).
The exposure may cause the operation of fuses or other specified devices which have to be replaced or reset before
normal operation is restored.

EN 60601-1-2:1993 (1
ST
Edition) Immunity for Medical Electrical Equipment

Emissions Requirements
Conducted
Emissions
Radiated
Emissions
Harmonic
Emission
Flicker

Class A equipment CISPR 11 CISPR 11 N/A N/A
Class B equipment CISPR 11 CISPR 11 N/A N/A

Immunity Requirements

Description

Severity Required
Performance
Criteria

Standard
Electrostatic Discharge 4kV contact, 8kV air B IEC 801.2
Radiated RF Immunity 3V/m, 26-1000 MHz, 1kHz 80%AM modulation A IEC 801.3
Electrical Fast Transient 1kV on AC (2kV for permanent installed eqpt.),
500V on I/O and DC lines
B IEC 801.4
Surge Withstand 2kV common mode, 1kV differential on AC lines B IEC 801.5
Conducted RF Immunity 3Vrms, 0.15-80 MHz, 1kHz 80% AM modulation
(sel freq. 1, 2, 7.1, 13.56, 21, 27.12 & 68 MHz)
A IEC 801.6
Magnetic Field Immunity 50 Hz, 3A/m A IEC 801.8
Dips
Dropouts
Interrupts
Voltage variations
30% for 10 mS,
100% for 100 mS
>95% for 5 sec
15% from Nominal
B
C
C
C
IEC 801.11

IEC/EN 60601-1-2:2001 (2
nd
(dop) 2002-08-01
(dow) 2004-11-01

Conducted
Emissions
Radiated
Emissions
Harmonic
Emission
Flicker

Class A equipment CISPR 11 CISPR 11 IEC 1000-3-2
(230VAC, 50Hz)
IEC 1000-3-3
(230VAC, 50Hz)
Class B equipment CISPR 11 CISPR 11 IEC 1000-3-2
(230VAC, 50Hz)
IEC 1000-3-3
(230VAC, 50Hz)


Description

Severity Required
Performance
Criteria

Standard
Electrostatic Discharge 6kV contact, 8kV air A IEC 61000-4-2
Radiated RF Immunity 3V/m, 80-2500MHz, 1kHz/2Hz 80%AM modulation

10V/m, 80-2500MHz, 1kHz/2Hz 80%AM modulation
for life support equipment
Dwell Time is 3 seconds for 2Hz modulation
Dwell Time is 1 second for 1kHz modulation
A IEC 61000-4-3
Electrical Fast Transient 2kV on AC and DC 5KHz Repetition
1kV on I/O
A IEC 61000-4-4
Surge Withstand 2kV common mode, 1kV differential on AC lines
(minimum 5 surges at each phase angle)
A IEC 61000-4-5
Conducted RF Immunity 3Vrms, 0.15-80 MHz, 1kHz/2Hz 80% AM modulation

3Vrms, 0.15-80 MHz, 1kHz/2Hz 80% AM modulation

(Calibration required level set to 0-25% of target
voltage)
Patient coupled leads are tested with current clamp
A IEC 61000-4-6
Magnetic Field Immunity 50 and 60 Hz, 3A/m A IEC 61000-4-8
Dips
Dips
Dropouts
Interrupts
Dip to 40% for 5 cycles (100 ms)
Dip to 70% for 25 cycles (500ms)
Dropout to 5% for 10 ms
>95% for 5 sec

*A
*A
*A
C
IEC 61000-4-11
*Applicable to all life support equipment and any equipment with less than 1kVA input power. Equipment with input power
above 1kVA and below 16A/phase need only meet Criteria B.
IEC/EN 60601-1-2:2007 (3
nd
(dop) 2008-02-01
(dow) 2012-06-01

Conducted
Emissions
Radiated
Emissions
Harmonic
Emission
Flicker

(230VAC, 50Hz)
IEC 1000-3-3
(230VAC, 50Hz)
(230VAC, 50Hz)
IEC 1000-3-3
(230VAC, 50Hz)


Description

Severity Required
Performance
Criteria

Standard
Electrostatic Discharge 6kV contact, 8kV air A IEC 61000-4-2
Radiated RF Immunity 3V/m, 80-2500MHz, 1kHz/2Hz 80%AM modulation

10V/m, 80-2500MHz, 1kHz/2Hz 80%AM modulation
Dwell Time is 3 seconds for 2Hz modulation
Dwell Time is 1 second for 1kHz modulation
A IEC 61000-4-3
1kV on I/O
A IEC 61000-4-4
Surge Withstand 2kV common mode, 1kV differential on AC lines
(minimum 5 surges at each phase angle)
A IEC 61000-4-5
Conducted RF Immunity 3Vrms, 0.15-80 MHz, 1kHz/2Hz 80% AM modulation

3Vrms, 0.15-80 MHz, 1kHz/2Hz 80% AM modulation

(Calibration required level set to 0-25% of target
voltage)
Patient coupled leads are tested with current clamp
A IEC 61000-4-6
Magnetic Field Immunity 50 and 60 Hz, 3A/m A IEC 61000-4-8
Dips
Dips
Dropouts
Interrupts
Dip to 40% for 5 cycles (100 ms)
Dip to 70% for 25 cycles (500ms)
Dropout to 5% for 10 ms
>95% for 5 sec

*A
*A
*A
C
IEC 61000-4-11
*Applicable to all life support equipment and any equipment with less than 1kVA input power. Equipment with input power
above 1kVA and below 16A/phase need only meet Criteria B.
IEC 60601-1-2:2014 (4
th
(dop) 2015-01-01
(dow) 2017-04-01
Conducted
Emissions
Radiated
Emissions
Harmonic
Emission
Flicker

(230VAC, 50Hz)
IEC 1000-3-3
(230VAC, 50Hz)
(230VAC, 50Hz)
IEC 1000-3-3
(230VAC, 50Hz)


Description

Severity Required
Performance
Criteria

Standard
Electrostatic Discharge 8kV contact, 15kV air Risk
Assessment
IEC 61000-4-2
Radiated RF Immunity 3V/m, 80-2700MHz, 1kHz 80%AM modulation
Professional Healthcare Facility Environment

10V/m, 80-2700MHz, 1kHz 80%AM modulation
Home Healthcare Environment
Modulation frequencies and dwell times defined by
Risk Assessment and test plan
Risk
Assessment
IEC 61000-4-3
1kV on I/O 100KHz Repetition
(patient coupling ports excluded)
Risk
Assessment
IEC 61000-4-4
Surge Withstand 500V,1kV & 2kV common mode, 500V & 1kV
differential on AC & DC lines (>3m)
2KV common mode on I/O lines (Outdoor cables)
Risk
Assessment
IEC 61000-4-5
Conducted RF Immunity 3Vrms, 0.15-80 MHz, 1kHz 80% AM modulation
6Vrms in ISM bands (I/O cables <3m excluded)
Patient coupled ports tested with current clamp
Modulation frequencies defined by Risk Assessment
Risk
Assessment
IEC 61000-4-6
Magnetic Field Immunity 50 and 60 Hz, 30A/m Risk
Assessment
IEC 61000-4-8
Dips
Dips
Dropouts

Interrupts
Dip to 0% for 1 cycles @ 0phase angle
Dip to 70% for 25/30 cycles @ 0 phase angle
Dropout to 0% for 0.5 cycles @ 0, 45, 90, 135 , 180,
225, 270 & 315 phase angles
100% for 250/300 cycles
Risk
Assessment

IEC 61000-4-11

3
rd
EDITION NOTABLE ITEMS
TESTING REQUIREMENTS EMISSION
ME Equipment and ME Systems are classified as either Class A or Class B and Group 1 or Group 2 as
per CISPR 11 (Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment Electromagnetic
Disturbance Characteristics Limits and Methods of Measurement).
Class A equipment is equipment 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
Class B equipment is equipment suitable for use in all establishments including domestic establishments
and those directly connected to the public low-voltage power supply network that supplies buildings used
for domestic purposes
Warning: Class A equipment is intended for use in an industrial environment. In the
documentation for the user, a statement shall be incl uded drawing attention to the fact that
there may be potential difficulties in ensuring electromagnetic compatibility in other
environments, due to conducted as well as radiated disturbances.

Class B equipment is equipment suitable for use in domestic establishments and in
establishments directly connected to a low voltage power supply network which supplies
buildings used for domestic purposes.
Compliance criteria

EMC Risk Analysis and Test Plan

The risk assessment must identify what effected systems, subsystems and components will cause an effect and whether the
affected part is "critical" to the function of the product. This risk assessment will form the basis for identification of pass/fail.
A test plan drawing up how the equipment is to be setup, monitored and the test points involved is required to be carried out
prior to any EMC tests. The essential function of the equipment must be clearly identified detailing the minimum performance
criteria acceptable for tests of a continuous nature as well as for tests of a transient nature. The test plan will form the envelope
in how the EMC tests are to be performed.

Production firmware/software must be provided for the EMC test portion as it has been shown in the past that software code
can be an EMC threat.

Identification and Marking
Information to User

a) A marking on the outside of the medical device that contains an RF transmitter or that applies RF energy for
diagnosis or treatment;
b) A marking on the outside of the medical device that uses the connector ESD exemption;
c) A marking on the outside of the medical device that must be used in a shielded location;
d) A statement that the medical device needs special precaution regarding EMC;
e) A statement that the medical device can be affected by portable and mobile RF communications equipment;
f) If the ESD exemptions is used:
1) The ESD warning symbol;
2) A warning that pins of the connector should not be touched;
3) An ESD precautionary procedure;
4) A recommendation that all staff be trained in the ESD precautionary procedure;
5) A specification of the minimum contents of the ESD precautionary procedure.
g) If claimed, a warning that type A professional equipment may cause interference;
h) In the technical description:
1) A list of cables, maximum lengths of cables, transducers and other accessories that may affect
compliance;
2) A warning that use of accessories, cables, and transducers other than those specified may result in
increased emissions and decreased immunity;
3) Tables regarding the emissions and immunity of the medical device;
4) A warning that the medical device should not be used adjacent to or stacked with other equipment;
5) A list of the products essential performance;
6) Any justifications for lower immunity levels;
7) A table with safety separation distances for portable and mobile RF transmitters. .

Guidance and Manufacturers Declaration





CISPR11 or EN 55011 Conduced and Radiated Emissions

All medical electrical equipment and/or systems7, must be correctly classified as defined in CISPR 11 as Group 1 or Group 2;
Class A or Class B. This must be done in accordance with CISPR 11, based on the equipments intended use and intended site
of use. The intended use is specified by the manufacturer, not by a testing laboratory.

CCC.3 Division into classes

EQUIPMENT and SYSTEMS predominantly intended for use in domestic environments and connected to the
PUBLIC MAINS NETWORK (e.g. home care EQUIPMENT and EQUIPMENT for doctors offices in residential areas)
should meet the requirements for CISPR 11 Class B.

EQUIPMENT and SYSTEMS that are intended to be connected (e.g. in hospitals) to dedicated supply systems
(normally fed by separation transformers) should meet the requirements for either CISPR 11 Class A or
Class B.

EQUIPMENT and SYSTEMS that are specified for use only in a shielded location may be classified based on
compliance of the system formed by the EQUIPMENT or SYSTEM together with the specified type of shielded
location, i.e. with the assumption that the EQUIPMENT or SYSTEM has been installed in a shielded location
meeting the EQUIPMENT or SYSTEM manufacturers specifications for minimum RF shielding effectiveness
and minimum RF filter attenuation. If classification is made on this basis, 6.8.3.201 c) 2) of this standard
requires a statement of this fact to appear in Table 201, as well as a recommendation to verify the actual
shielding effectiveness and filter attenuation of the shielded location.

Tests on medical equipment shall include all modes of operation including DC operations, AC 120V, AC 230V, AC 120V
with DC Backup, AC 230V with DC backup, Standby mode, Blower On mode, Dialup and communications modeetc.

EN 61000-3-2/3 Harmonics Emissions and Voltage Flicker

Harmonics emissions and voltage flicker is required to be performed.

EN 61000-4-2 Electrostatic Discharge

All ports which may be exposed during normal operation must have detachable cover to protect the interface pins from ESD
damage. If a protective cover is not provided, the port pins become a valid test point for ESD. The other option is to provide
adequate labeling to exempt the port from ESD testing.

EN 61000-4-3 Radiated Immunity

The range is extended to 2500MHz up from 1000MHz.
Modulation frequency is set to 2Hz Amplitude Modulation with 80% depth for Respironics Equipment.
Dwell time at each frequency interval is 3 seconds minimum

EN 61000-4-4 Electrical Fast Transients

For PATIENT coupling points that do not have a conductive contact, the PATIENT
coupling point shall be terminated with the artificial hand and RC element specified
in CISPR 16-1. The metal foil of the artificial hand shall be sized and placed to
simulate the approximate area and location of PATIENT coupling in NORMAL USE. The
metal foil of the artificial hand shall be connected to terminal M of the RC element
and the other terminal of the RC element shall be connected to the ground
reference plane.

For PATIENT coupling points that have conductive contact to the PATIENT, terminal M
of the RC element (see CISPR 16-1) shall be connected directly to the conductive
PATIENT connection, and the other terminal of the RC element shall be connected to
the ground reference plane. If normal operation of the EQUIPMENT or SYSTEM cannot
be verified with terminal M connected to the coupling point, an insulating material
with a maximum thickness of 5 mm may be applied between the metal foil of the
artificial hand (see CISPR 16-1) and the PATIENT coupling point. In this case, the
metal foil of the artificial hand shall be sized and placed to simulate the
approximate area and location of PATIENT coupling in NORMAL USE, and terminal M
of the RC element shall be connected to the metal foil but not to the PATIENT
coupling point. The other terminal of the RC element shall be connected to the
ground reference plane in all cases.

EN 61000-4-5 Surge Withstand

The test methods and equipment specified by IEC 61000-4-5 for the combination wave
test shall apply, with the following modifications:

1) Only power lines and a.c. inputs to a.c.-to-d.c. converters and battery chargers are
tested; however, all EQUIPMENT and SYSTEM cables shall be attached during the test.

2) Five surges at each voltage level and polarity shall be applied to each power line at
each of the following a.c. voltage waveform angles: 0 or 180, 90 and 270.
NOTE While testing at both 0 and 180 is allowed, testing at only one of these two phase angles, in
addition to 90 and 270, is required.

*3) EQUIPMENT and SYSTEMS that do not have a surge protection device in the primary
power circuit may be tested only at 2 kV line(s) to ground and 1 kV line(s) to line(s).
However, in case of dispute, the EQUIPMENT or SYSTEM shall comply at all the IMMUNITY
TEST LEVELS specified in 36.202.5 a).

*4) Class II EQUIPMENT and SYSTEMS without any grounded interconnections are exempt
from line(s) to ground testing.

5) For INTERNALLY POWERED EQUIPMENT and SYSTEMS without the option of a.c. or d.c.
power inputs, this test does not apply.

6) For EQUIPMENT and SYSTEMS that have, for power input, multiple voltage settings or
autoranging voltage capability, the test shall be performed at the minimum and
maximum RATED input voltages. The test may be performed with the EQUIPMENT or
SYSTEM powered at any one of its NOMINAL power frequencies.

7) For EQUIPMENT and SYSTEMS with internal battery backup, it shall be verified that the
EQUIPMENT or SYSTEM continues operation from mains power after the tests specified in
this subclause.

EN 61000-4-6 Conducted RF Immunity

Modulation frequency is set to 2Hz Amplitude Modulation with 80% depth for Medical Equipment related to
biological functions else it is 1kHz, AM with 80% depth..
Dwell time at each frequency interval is 3 seconds minimum

EN 61000-4-8 Magnetic Field Immunity

EN 61000-4-11 Voltage Dips

4
th
EDITION NOTABLE ITEMS

1. Only Voltage dips, short interruptions and voltage variations need to be tested at more than one line voltage.
All other EMC tests to be tested only at one line voltage/frequency. 3rd Edition required max and min line
voltage tests on EFT, Surge, Dips/Dropouts and Magnetic Field Immunity.
2. Both standby and operating modes need to be tested for emissions and the modes for maximum emissions
should be used. For immunity, it is suggested that standby mode be included especially where medical
equipment is in standby mode for long periods of time.
3. The environment the medical equipment is to be operated in dictates the Emissions standard and class to be
used. For portable devices apply CISPR 11 Class B, CISPR 25/ISO 7637-2 and RTCA-DO-160/ISO
7137/EUROCAE ED-14 with harmonics/flicker. Interesting to note that for professional healthcare facility
environment, harmonics/flicker is referred to as a Basic EMC standard although it appears in the Official
Journal as a Product Standard.
4. Specific procedures are provided on when EUT damage as a result of EMC tests occur. If the test is repeated
three times and the equipment still meets basic safety and essential performance, it is deemed to pass that
test. This provides more wiggle room when an ancillary function is affected but the essential performance
remains unaffected.
5. Specific medical environments are now clearly defined as; Emergency Medical Services Environment, Home
Healthcare Environment, Professional Healthcare Facility Environment and Special Environments.
Professional healthcare environment is considered a controlled EM environment. MRI, x-ray and other
medical equipment requiring shielded rooms have special label and user information detailing the use in
special environments. X-ray generators operating in intermittent mode may have the quasi-peak limits
relaxed by 20dB for discontinuous conducted and radiated emissions.
6. ESD Levels for contact discharge has been increased from 6kV to 8kV and air discharge has been increased
from 8kV to 15kV. This is major item change that will have huge consequences as current medical equipment
will be affected by the much higher ESD test levels to be met.
7. Radiated Immunity upper frequency has been extended to 2.7GHz from 2.5GHz. More importantly, all home
healthcare environment equipment must meet 10V/m which will also apply to all portable equipment. The 4th
edition outlines risk assessment to also take into account fields as high as 28V/m when portable wireless
devices are used within 30cm of the medical device. This could mean additional test levels and modulations.

8. Magnetic Field Immunity is increased from 3A/m to 30A/m.
9. Electrical Fast Transient levels stay the same but the newer 100kHz repetition rate is now mandatory over the
5kHz rate allowed before. Patient coupled ports are excluded.
10. Surge levels stay the same but previous lower level surge is now mandated so surge test is carried out at
500V, 1000V for differential mode and 500V, 1000V and 2000V for common mode on AC and DC ports.
Additional 2kV common mode surge has been added for ports providing outdoor I/O cables.

11. Conducted RF immunity levels have been raised to 6Vrms in the ISM & Amateur radio bands and 3Vrms
in non ISM & Amateur radio bands. ISM & Amateur radio bands are;

1.8-2.0 MHz
3.5-4.0 MHz
5.3-5.4 MHz
6.765-6.795 MHz
7.0-7.3 MHz
10.1-10.15 MHz
13.553-13.567 MHz
14.0-14.20MHz
18.07-18.17 MHz
21.0-21.4 MHz
24.89-24.99 MHz
26.957-27.283 MHz
40.66-40.70 MHz
50.0-54.0 MHz

I/O cables shorter than 3m are excluded. Patient coupled cables are tested with current clamp and tubes
with liquids are also tested as patient coupled cables.
12. Medical equipment capable of being powered by vehicles battery must meet the ISO 7637-2 automotive
transient pulses.
13. The artificial hand is required to be applied onto the medical device. The artificial hand is a requirement for
CISPR 11 conducted emissions and according to CISPR 16-1-2, for conducted RF immunity. Under the 4th
edition, the 220pf/510 circuit must be used to terminate patient coupled points that have conductive
contact to the patient.
14. A Test plan with 27 items is now specified to be completed before EMC tests are performed.
15. Patient coupled conducted emissions is recommended to be measured and limited to 24dBuA from 1-30
MHz. This is informative but may be included in the test plan.
16. Performance degradation is now defined in the risk assessment and test plan and guidelines are provided
as example cases in Annex H.

Regulatory Impact Analysis
The 4th edition IEC 60601-1-2:2014 represents a huge step in re-defining the electromagnetic performance for
medical devices and raises the immunity levels required for medical devices to operate safely and within its
essential performance requirements. Many existing medical products will not meet the 4th edition requirements
and a gap analysis will reveal that incrementally, the following minimum additional tests need to be conducted
from the 3rd edition standard;

Electrostatic Discharge 8kV contact, 15kV air
Radiated RF Immunity 3V/m, 2500-2700MHz, 1kHz 80%AM modulation Professional
Healthcare Facility Environment 10V/m, 80-2700MHz, 1kHz 80%AM
modulation Home Healthcare Environment
Modulation frequencies and dwell times defined by Risk Assessment
and test plan
Electrical Fast Transient 2kV on AC and DC, 100KHz Repetition rate 1kV on I/O 100KHz
Repetition rate (patient coupling ports excluded)
Surge Withstand 2KV common mode on I/O lines (Outdoor cables)
Conducted RF Immunity 6Vrms in ISM & Amateur Radio bands (I/O cables < 3m excluded)
Patient coupled ports tested with current clamp
Magnetic Field Immunity 50 and 60 Hz, 30A/m
Dips Dips Dropouts Interrupts Dip to 0% for 1 cycles @ 0phase angle Dip to 70% for 25/30 cycles @
0 phase angle Dropout to 0% for 0.5 cycles @ 0, 45, 90, 135 , 180,
225, 270 & 315 phase angles 100% for 250/300 cycles
Gap Analysis of Test Requirements

A gap analysis of the incrementals will reveal that only the 3rd edition surge tests may be not be required to be re-
tested. This being the case, it may be more expeditious to just test everything to the 4th edition and the latest
requirements than to provide the gap analysis and technical rational linking 3rd edition reports/test plans and risk
analysis.

There is usually a 3 year transition period provided before an adopted standard become mandatory. Manufactures are
advised to start addressing the elevated EMC levels that will impact the current and future medical products as design
changes will probably be required to address any EMC deficiencies detected. New products currently in the pipes may
need to have their design specifications revised to account for the increased EMC immunity the device will be
eventually required to meet.

FCC part 15 Subpart B Emissions

Exemption for Medical Devices

The following devices are subject only to the general conditions of operation in
Secs. 15.5 and 15.29 and are exempt from the specific technical standards and other
requirements contained in this part. The operator of the exempted device shall be
required to stop operating the device upon a finding by the Commission or its
representative that the device is causing harmful interference. Operation shall not
resume until the condition causing the harmful interference has been corrected.
Although not mandatory, it is strongly recommended that the manufacturer of an
exempted device endeavor to have the device meet the specific technical standards in
this part.

(e) Specialized medical digital devices (generally used at the direction of or under
the supervision of a licensed health care practitioner) whether used in a patient's
home or a health care facility. Non-specialized medical devices, i.e., devices
marketed through retail channels for use by the general public, are not exempted.
This exemption also does not apply to digital devices used for record keeping or any
purpose not directly connected with medical treatment.

Conducted Emissions
Frequency (MHz) QP Class A (dBV) AVG Class A (dBV) QP Class B (dBV) AVG Class B (dBV)
0.15 to 0.5 79 66 66 to 56* 56 to 46*
0.5 to 5 73 60 56 46
5 to 30 73 60 60 50
* linearly decreasing with the log of the frequency
Notes.
1. The tighter limit applies at the band edges.
2. Both limits must be met. If the quasi-peak value meets the average limit then the limits are deemed to have been met.
3. The line voltage used must be 120VAC for FCC compliance.
4. The limit applies to any equipment which is connected to the AC mains network regardless of whether there is power
present or if the unit is in battery operation.
Radiated Emission @ 3m
Frequency (MHz) QP Class A Limit (dBV/m) QP Class B Limit (dBV/m)
30 to 88 49.54 40.00
88 to 216 53.98 43.52
216 to 960 56.90 46.02
Above 960 60.00 53.98

30 to 88 39.08 29.54
88 to 216 43.52 33.06
216 to 960 46.44 35.56
Above 960 49.54 43.52

Notes.
1. The preferred distance for Class B is 3 meters. The preferred distance for Class A is 10 meters.
3. The measurement resolution bandwidth is 120kHz. For 30-1000MHz and 1MHz above 1GHz.
4. Above 1GHz, an average detector is used.
FCC Labeling Requirements for Computing Devices

Sections 15.21 & 15.105 - Information to User
The users manual or instruction manual for an intentional or unintentional radiator shall caution the user that changes or
modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the
equipment.

(a) For a Class B digital device or peripheral, the instructions furnished the user shall include the following or similar
statement, placed in a prominent location in the text of the manual.

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this
device may not cause harmful interference and (2) this device must accept any interference received, including
interference that may cause undesired operation.

NOTE: This equipment has been tested and found to comply with the limits for a Class B digital devices, pursuant
to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful
interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy
and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a particular installation. If
this equipment does cause harmful interference to radio or television reception, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the interference by one of more of the
following measures:

Reorient or relocate the receiving antenna
Increase the separation between the equipment and receiver
Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
Consult the dealer or an experienced radio/TV technician for help.

Warning: Changes or modifications not expressly approved by <manufacturer> could void the users
authority to operate the equipment.

EN 55011 Emissions Group 1

Conducted Emissions
Frequency (MHz) QP Class A (dBV) AVG Class A (dBV) QP Class B (dBV) AVG Class B (dBV)
0.15 to 0.5 79 66 66 to 56* 56 to 46*
0.5 to 5 73 60 56 46
5 to 30 73 60 60 50
* linearly decreasing with the log of the frequency
Notes
6. Both limits must be met. If the quasi-peak value meets the average limit then the limits are deemed to have been met.
7. The line voltage used must be 230VAC for European compliance.
8. The limit applies to any equipment which is connected to the AC mains network regardless of whether there is power
present or if the unit is in battery operation.
30 to 230 50 40.5
230 to 1000 57 47.5

30 to 230 39.5 30
230 to 1000 46.5 37

30 to 230 30 20.5
230 to 1000 37 27.5
Notes.
2. The preferred distance for Class A is 30 meters and for Class B is 10 meters.

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EMC REQUIREMENTS SUMMARY

For Internal Use Only 1 of 30 26/05/2014

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