IEC 61326-2-6:2020

Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment

IEC 61326-2-6:2020 specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT, taking into account the particularities and specific aspects of this electrical equipment and their electromagnetic environment.

Matériel électrique de mesure, de commande et de laboratoire - Exigences relatives à la CEM - Partie 2-6: Exigences particulières - Matériel médical de diagnostic in vitro (IVD)

L'IEC 61326-2-6:2020 spécifie les exigences minimales pour l’immunité et les émissions relatives à la compatibilité électromagnétique des MATERIELS MEDICAUX DE DIAGNOSTIC IN VITRO (IVD – in vitro diagnostic), en prenant en compte les particularités et aspects spéc ifiques de ces matériels et de leur environnement électromagnétique.

General Information

• Status: Published
• Publication Date: 27-Oct-2020
• ICS: 17.220.20 - Measurement of electrical and magnetic quantities
• ICS: 25.040.40 - Industrial process measurement and control
• ICS: 33.100.20 - Immunity
• Technical Committee: SC 65A - System aspects
• Drafting Committee: WG 4 - TC 65/SC 65A/WG 4
• Current Stage: PPUB - Publication issued
• Start Date: 28-Oct-2020
• Completion Date: 27-Nov-2020

Relations

• Revises: IEC 61326-2-6:2012 - Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
• Effective Date: 05-Sep-2023
• Revised: IEC 61326-2-6:2025 - Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical electrical equipment
• Effective Date: 05-Sep-2023

Overview

IEC 61326-2-6:2020 - Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment - specifies minimum electromagnetic compatibility (EMC) immunity and emissions requirements tailored to IVD devices. It is a Part 2 supplement to IEC 61326-1:2020, taking into account the particularities of laboratory and diagnostic equipment and the electromagnetic environments in which they operate (professional healthcare facilities and home healthcare).

Key facts:

• Edition: 3.0 (2020)
• Scope: minimum immunity and emissions requirements for IVD medical equipment
• Works in conjunction with IEC 61326-1:2020 and references ISO 14971 for risk management

Key Topics and Technical Requirements

• EMC test plan: configuration of the Equipment Under Test (EUT), operational conditions, and definition of functional performance during testing.
• Immunity requirements: defined tests and conditions to assess IVD equipment resistance to radiated and conducted disturbances, including separate tables for devices intended for professional healthcare facility environments and home healthcare environments.
• Emission requirements: guidance on limiting electromagnetic emissions so IVD equipment does not interfere with other systems.
• Performance criteria: classification of acceptable behavior under disturbance (e.g., maintain essential performance and basic safety).
• Test results and reporting: requirements for documenting test procedures, outcomes and interpretations in the test report.
• Instructions for use: EMC-related information that manufacturers should include in user documentation.
• Annexes: includes requirements for portable test & measurement equipment (Annex A) and an informative guide for EMC analysis and assessment (Annex B).
• Tables 101–103: specify immunity test requirements for different intended use environments.

Practical Applications - Who Uses This Standard

• IVD device manufacturers - design and verification of EMC performance during product development.
• Compliance and regulatory teams - evidence for safety and essential performance in regulatory submissions.
• Test laboratories and certification bodies - test planning, execution and reporting for EMC conformity.
• Design engineers and system integrators - guidance to reduce risk from electromagnetic disturbances and to meet mandatory EMC criteria.
• Quality and risk managers - integration with ISO 14971-based risk assessments to ensure basic safety and essential performance under EMC disturbances.

Related Standards

• IEC 61326-1:2020 - General EMC requirements for measurement, control and laboratory equipment (use in conjunction with Part 2-6).
• ISO 14971:2019 - Medical device risk management (referenced for risk-based approach to EMC impacts).

This standard is essential for ensuring that in vitro diagnostic (IVD) medical equipment achieves reliable EMC compliance, preserves essential performance, and protects basic safety across diverse healthcare environments.

Standards Content (Sample)

IEC 61326-2-6 ®
Edition 3.0 2020-10
REDLINE VERSION
INTERNATIONAL
STANDARD
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inside
Electrical equipment for measurement, control and laboratory use –
EMC requirements –
Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment

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IEC 61326-2-6 ®
Edition 3.0 2020-10
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Electrical equipment for measurement, control and laboratory use –

EMC requirements –
Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 17.220.20; 25.040.40; 33.100.20 ISBN 978-2-8322-9014-9

– 2 – IEC 61326-2-6:2020 RLV © IEC 2020
CONTENTS
FOREWORD . 3
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 General . 8
5 EMC test plan . 8
5.1 General . 8
5.2 Configuration of EUT during testing . 8
5.3 Operation conditions of EUT during testing . 8
5.4 Specification of FUNCTIONAL PERFORMANCE . 9
5.5 Test description . 9
6 Immunity requirements . 9
6.1 Conditions during the tests. 9
6.2 Immunity test requirements . 9
6.3 Random aspects . 10
6.4 Performance criteria . 13
7 Emission requirements . 14
8 Test results and test report . 14
9 Instructions for use . 14
Annex A (normative) Immunity test requirements for PORTABLE TEST AND MEASUREMENT
EQUIPMENT powered by battery or from the circuit being measured . 16
Annex B (informative) Guide for analysis and assessment for electromagnetic
compatibility. 17
Bibliography . 18

Table 101 – Immunity requirements for IVD medical equipment .
Table 101 – Immunity test requirements for equipment intended to be used in
PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT . 11
Table 102 – Immunity test requirements for equipment intended to be used in a HOME
HEALTHCARE ENVIRONMENT . 12
Table 103 – Immunity test requirements for equipment intended to be used in a HOME
HEALTHCARE ENVIRONMENT . 13

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
ELECTRICAL EQUIPMENT FOR MEASUREMENT,
CONTROL AND LABORATORY USE –
EMC REQUIREMENTS –
Part 2-6: Particular requirements –
In vitro diagnostic (IVD) medical equipment

FOREWORD
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– 4 – IEC 61326-2-6:2020 RLV © IEC 2020
International Standard IEC 61326-2-6 has been prepared by subcommittee 65A: System
aspects, of IEC technical committee 65: Industrial-process measurement, control and
automation.
This third edition cancels and replaces the second published in 2012. This edition constitutes
a technical revision.
This edition includes the following significant technical change with respect to the previous
edition:
– update of the document with respect to IEC 61326-1:2020.
The text of this International Standard is based on the following documents:
FDIS Report on voting
65A/979/FDIS 65A/990/RVD
Full information on the voting for the approval of this International Standard can be found in
the report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document the following print types are used:
– Terms used throughout this document which have been defined in Clause 3 of this
document and of IEC 61326-1:2020: SMALL CAPITALS.
This part of IEC 61326 is to be used in conjunction with IEC 61326-1:2020 and follows the
same numbering of clauses, subclauses, tables and figures.
When a particular subclause of IEC 61326-1 is not mentioned in this part, that subclause
applies as far as is reasonable. When this standard states “addition”, “modification” or
“replacement”, the relevant text in IEC 61326-1 is to be adapted accordingly.
NOTE The following numbering system is used:
– subclauses, tables and figures that are numbered starting from 101 are additional to those in
IEC 61326-1;
– unless notes are in a new subclause or involve notes in IEC 61326-1, they are numbered starting from 101
including those in a replaced clause or subclause;
– additional annexes are lettered AA, BB, etc.
A list of all parts of the IEC 61326 series, under the general title Electrical equipment for
measurement, control and laboratory use – EMC requirements, can be found on the IEC
website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
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• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
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colour printer.
– 6 – IEC 61326-2-6:2020 RLV © IEC 2020
ELECTRICAL EQUIPMENT FOR MEASUREMENT,
CONTROL AND LABORATORY USE –
EMC REQUIREMENTS –
Part 2-6: Particular requirements –
In vitro diagnostic (IVD) medical equipment

1 Scope
In addition to the scope of IEC 61326-1, this part of IEC 61326 specifies minimum
requirements for immunity and emissions regarding electromagnetic compatibility for IN VITRO
DIAGNOSTIC (IVD) MEDICAL EQUIPMENT, taking into account the particularities and specific
aspects of this electrical equipment and their electromagnetic environment.
2 Normative references
Clause 2 of IEC 61326-1:20122020 applies, except as follows:
Addition:
IEC 61326-1:20122020, Electrical equipment for measurement, control and laboratory use –
EMC requirements – Part 1: General requirements
ISO 14971:20072019, Medical devices – Application of risk management to medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 61326-1 apply,
except as follows.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
Addition:
3.101
in vitro diagnostic medical equipment
instruments and apparatus intended for use in the diagnosis of disease or other conditions,
including a determination of the state of health, in order to cure, mitigate, treat, or prevent
disease
Note 1 to entry: Such instruments or apparatus are intended for use in the collection, preparation, and
examination of specimens taken from the human body without direct or wired patient connection with the device.
Note 2 to entry: IVD: In vitro diagnostic.
3.102
professional healthcare facility environment
environment where professional healthcare is administered

Note 1 to entry: Locations include hospitals, diagnostic laboratories, blood banks, blood donation centres,
physician offices, intensive care units, surgical centres, emergency rooms, surgery rooms, clinics, patient rooms,
dental offices, limited care facilities, nursing homes, drugstore with trained operator, and first aid rooms.
Note 2 to entry: Most environments and locations in the PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT are
considered to have a CONTROLLED ELECTROMAGNETIC ENVIRONMENT with regard to fixed electromagnetic sources.
However, mobile communication devices are widely used by healthcare professionals in providing efficient patient
care. For this reason, it is more difficult to control the environment for proximity electromagnetic disturbances.
Examples of electromagnetic sources that might be used adjacent to IVD MEDICAL EQUIPMENT are:
– high frequency surgical equipment;
– radio frequency identification (RFID) systems;
– wireless local area networks (WLAN);
– handheld mobile radios (e.g. TETRA, two-way radio);
– paging systems;
– other wireless devices (including consumer devices).
Note 3 to entry: It is assumed that IVD MEDICAL EQUIPMENT is not directly connected to the public mains network.
Note 4 to entry: IVD MEDICAL EQUIPMENT should have a suitable level of immunity to ensure the safe and effective
performance of the device in its intended use environment. IVD MEDICAL EQUIPMENT that might be used in
ambulances, or any ground vehicle or aircraft can require a higher level of immunity than the PROFESSIONAL
HEALTHCARE FACILITY ENVIRONMENT.
3.103
home healthcare environment
environment other than a PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT with a much more
diverse electromagnetic environment with electromagnetic disturbances that may be more
uncontrolled and less well-characterized in terms of amplitude and probability of occurrence
Note 1 to entry: Except in transportation or while operating under battery power, IVD MEDICAL EQUIPMENT is
usually connected to the public mains network.
Note 2 to entry: The characteristics of this environment justify higher immunity test levels for basic safety and
ESSENTIAL PERFORMANCE. Locations include the home, and any public place such as shops and libraries, offices,
transport stations and airports, etc. Examples of electromagnetic sources that might be used near IVD MEDICAL
EQUIPMENT in these environments or otherwise expose the IVD MEDICAL EQUIPMENT to intense electromagnetic
disturbances are:
– small mains frequency transformers (50 Hz and 60 Hz), e.g. in a clock radio on a bedside table;
– mains disturbances;
– mobile phones (often several);
– fixed radio broadcast stations;
– TV transmitting equipment;
– amateur Radio Equipment;
– mobile radio transmitters (e.g. taxi, police).
3.104
analyte
constituent of a sample with a measurable property
EXAMPLES In “mass of protein in 24-hour urine”, “protein” is the ANALYTE and “mass” is the property. In
“concentration of glucose in plasma”, “glucose” is the ANALYTE and “concentration” is the property. In both cases,
the full phrase designates the measurand measured property.
[SOURCE: ISO 18113-1:2009, 3.3, modified – property has been added after measurand]
3.105
basic safety
freedom from unacceptable risk to the operator directly caused by physical hazards when IVD
MEDICAL EQUIPMENT is used under normal condition and single fault condition

– 8 – IEC 61326-2-6:2020 RLV © IEC 2020
3.106
essential performance
performance of a clinical function, other than that related to BASIC SAFETY, where loss or
degradation beyond the limits specified in the user documentation results in an unacceptable
risk
Note 1 to entry: ESSENTIAL PERFORMANCE is most easily understood by considering whether its absence or
degradation would result in an unacceptable risk.
3.2 Abbreviations
Subclause 3.2 of IEC 61326-1:2020 applies.
4 General
Clause 4 of IEC 61326-1:20122020 applies, except as follows:.
Addition:
4.101 Electromagnetic environment of IVD medical equipment
Similar to conventional medical electrical equipment, in-vitro diagnostic medical equipment is
used in a wide variety of electromagnetic environments. IVD devices shall function properly
and safely in home environments, as well as in typical healthcare environments (hospitals,
clinics, doctor’s offices). This means that the device shall have a minimum level of immunity
appropriate for these areas.
Devices intended for use in other environments, such as in ambulances, aircraft, cars or
helicopters, can require a higher level of immunity to ensure the safe and effective
performance of the device.
5 EMC test plan
5.1 General
Subclause 5.1 of IEC 61326-1:20122020 applies.
5.2 Configuration of EUT during testing
Subclause 5.2 of IEC 61326-1:20122020 applies.
5.3 Operation conditions of EUT during testing
Subclause 5.3 of IEC 61326-1:20122020 applies, except as follows:
Addition:
5.3.101 Operational conditions
The device shall be set to conditions specified by the manufacturer.
When different input power modes are available (e.g. battery, a.c. options), the manufacturer
shall specify these mode(s) of operation, which cover(s) the most severe condition in
accordance with the product risk analysis.
The device shall be set to conditions specified in the user documentation in accordance with
the intended use.
For each mode of operation, the power option (e.g. battery, AC or DC supply) which
represents the most severe condition shall be specified in accordance with the product risk
analysis.
5.4 Specification of FUNCTIONAL PERFORMANCE
Subclause 5.4 of IEC 61326-1:20122020 applies.
5.5 Test description
Subclause 5.5 of IEC 61326-1:20122020 applies.
6 Immunity requirements
6.1 Conditions during the tests
Subclause 6.1 of IEC 61326-1:20122020 is replaced as follows.
6.101 Conditions during the tests
The configuration and modes of operation during the tests shall be precisely noted in the test
report.
PORTS in accordance with Table 101 or Table 102 of this
Tests shall be applied to the relevant
document, as applicable.
The tests shall be conducted in accordance with the basic standards. The tests shall be
carried out one at a time in accordance with the basic standards. If additional methods are
required, the method and rationale shall be documented in the test report.
6.2 Immunity test requirements
Subclause 6.2 of IEC 61326-1:20122020 and its title are replaced as follows.
6.2 Risk assessment and consideration of EMC immunity requirements
Powerful electromagnetic emission sources can lead to malfunctions in nearby medical
equipment under certain circumstances. Different types of medical electrical equipment have
different levels of risk with a malfunction. IVD MEDICAL EQUIPMENT however is not intended to
keep alive or resuscitate patients, so a malfunction would not directly cause the death or
serious injury of a patient. Such a malfunction in IVD MEDICAL electrical EQUIPMENT can result
in an incorrect reading, which can in turn lead to a wrong therapeutic decision (misdiagnosis).
For some ANALYTES and in some circumstances, an incorrect result could result in serious
harm to the patient. In the case of larger IVD electrical MEDICAL EQUIPMENT, electromagnetic
disturbances can also cause malfunctions that pose a direct threat to the operator, for
example through unexpected mechanical movements.
The manufacturer shall perform a risk analysis and assessment according to ISO 14971 for
guidance in assessing risk associated with direct hazards as well as
ISO 14971:2007, Annex H for guidelines for assessing the risk to patients from incorrect IVD
test results.
The manufacturer shall perform risk management according to ISO 14971 for guidance in
assessing risk associated with direct hazards.
NOTE As a rule, results from IVD MEDICAL EQUIPMENT are checked for plausibility by medical personnel or
followed-up by decisions of a healthcare professional. IVD MEDICAL EQUIPMENT for self-testing by lay users is
always provided with advice on action to be taken in case of indeterminate results. The users are urged to contact
their medical practitioner first before making any decision of medical relevance.

– 10 – IEC 61326-2-6:2020 RLV © IEC 2020
Risks associated with the use of IVD medical equipment are similar to risks associated with
non-life-supporting medical equipment. Therefore the immunity test requirements given in
following Table 101 are similar to the requirements for non-life-supporting medical equipment.
Table 101 – Immunity requirements for IVD medical equipment
EMC Basic
Port Phenomenon Test value
Standard
Electrostatic 2 kV and 4 kV contact discharge
IEC 61000-4-2
discharge (ESD) 2 kV, 4 kV and 8 kV air discharge
3 V/m (80 MHz to 1 GHz)
Enclosure Electromagnetic field IEC 61000-4-3 3 V/m (1,4 GHz to 2 GHz)
1 V/m (2,0 GHz to 2,7 GHz)
Power frequency
IEC 61000-4-8 3 A/m, (50 Hz, 60 Hz)
a
magnetic field
0 % during 1 cycle
d d
Voltage dip IEC 61000-4-11 40 % during 5/6 cycles
d
70 % during 25/30 cycles
AC power
d
Short interruptions IEC 61000-4-11 Less than 5 % during 250/300 cycles

(including protective
Burst IEC 61000-4-4 1 kV (5/50 ns, 5 kHz)
earth)
e f
Surge IEC 61000-4-5 1 kV / 2 kV
Conducted RF IEC 61000-4-6 3 V (150 kHz to 80 MHz)
b,c
Burst IEC 61000-4-4 1 kV (5/50 ns, 5 kHz)
DC power
e f
Surge IEC 61000-4-5 1 kV / 2 kV
(including protective
earth)
Conducted RF IEC 61000-4-6 3 V (150 kHz to 80 MHz)
Burst IEC 61000-4-4 0,5 kV (5/50 ns, 5 kHz)
b
I/O signal/control Surge IEC 61000-4-5 None
Conducted RF IEC 61000-4-6 3 V (150 kHz to 80 MHz)
Burst IEC 61000-4-4 1 kV (5/50 ns, 5 kHz)
I/O signal/control
connected directly Surge IEC 61000-4-5 None
to mains supply
Conducted RF IEC 61000-4-6 3 V (150 kHz to 80 MHz)
a
Test applied to only potentially magnetically sensitive equipment. CRT display interference is allowed above 1
A/m.
b
Only in case of lines > 3 m.
c
DC connections between parts of equipment/system which are not connected to a DC distribution network are
treated as I/O signal/control ports.
d
For example: “5/6 cycles" means "5 cycles for 50 Hz test" or "6 cycles for 60 Hz test”
e
Line to line.
f
Line to earth (ground).
Performance criteria shall be determined in relation to the electromagnetic phenomena by
taking into account EUT operating modes that can affect data results and EUT operating
modes that can affect sample processing and user interface. Applicable immunity phenomena
from Table 101 shall be applied for each EUT operating mode.
The EUT may show performance criteria A, B or C as a result of the application of the test,
but shall not impair the performance characteristics necessary to maintain the residual risk
within acceptable limits. Refer to ISO 14971 for guidelines for evaluation of residual risk
acceptability.
The performance criteria shall be reported in the test report.

For equipment intended to be used in a PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT, the
immunity requirements of Table 101 shall be applied.
In addition, depending on the outcome of the risk assessment of the electromagnetic
environment, consideration shall be given to include the immunity test requirements
of Table 102 and Table 103.
The risk assessment shall include point-of-care testing equipment or other equipment used
close to patients, who might have home use electronics such as mobile phones even in the
professional environment.
Table 101 – Immunity test requirements for equipment intended
to be used in PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT
Perform
PORT Phenomenon Basic standard Test value ance
criterion
ENCLOSURE Electrostatic discharge IEC 61000-4-2 ± 4 kV contact B
± 2 kV, ± 4 kV, ± 8 kV air B
Electromagnetic field IEC 61000-4-3 3 V/m (80 MHz to 6 GHz) A
Power frequency IEC 61000-4-8 3 A/m (50 Hz, 60 Hz) A
magnetic field
AC power Burst IEC 61000-4-4 ± 1 kV (5 kHz or 100 kHz) B
(including protective
Surge IEC 61000-4-5 ± 0,5 kV line-to-line B
earth)
± 1 kV line-to-ground B
Conducted RF IEC 61000-4-6 3 V (150 kHz to 80 MHz) A
Voltage dip IEC 61000-4-11 0 % during 0,5 cycles B
0 % during 1 cycle B
a
70 % during 25/30 cycles C
a
Short interruptions IEC 61000-4-11 0 % during 250/300 cycles C
b, c
DC power Burst IEC 61000-4-4 ± 1 kV (5 kHz or 100 kHz) B
(including protective
Surge IEC 61000-4-5 ± 0,5 kV line-to-line B
earth) ± 1 kV line-to-ground B
Conducted RF IEC 61000-4-6 3 V (150 kHz to 80 MHz) A
c
b
I/O signal/control  Burst IEC 61000-4-4 ± 0,5 kV (5 kHz or 100 kHz) B

e
Surge IEC 61000-4-5 ± 1 kV line-to-ground B
(including functional
earth)
b
Conducted RF IEC 61000-4-6 3 V (150 kHz to 80 MHz) A
c
b
I/O signal/control Burst IEC 61000-4-4 ± 1 kV (5 kHz or 100 kHz) B

d
Surge IEC 61000-4-5 ± 0,5 kV line-to-line B
connected directly
± 1 kV line-to-ground B
to mains supply
b
Conducted RF IEC 61000-4-6 3 V (150 kHz to 80 MHz) A
a
For example, “25/30 cycles" means "25 cycles for 50 Hz test" or "30 cycles for 60 Hz test”.
b
Only in the case of lines > 3 m.
c
DC POWER PORTS intended to be connected to a low voltage DC supply (≤ 60 V), where secondary circuits
(isolated from the AC mains supply) are not subject to transient overvoltages (i.e. reliably-grounded,
capacitive-filtered DC secondary circuits) shall be regarded as I/O signal/control PORTS.
d
Only in the case of LONG-DISTANCE LINES.

For equipment intended to be used in a HOME HEALTHCARE ENVIRONMENT, the immunity
requirements of Table 102 and Table 103 shall be applied.

– 12 – IEC 61326-2-6:2020 RLV © IEC 2020
Table 102 – Immunity test requirements for equipment intended
to be used in a HOME HEALTHCARE ENVIRONMENT
Perform-
PORT Phenomenon Basic standard Test value ance
criterion
ENCLOSURE Electrostatic discharge IEC 61000-4-2 ±6 kV contact B
±2 kV, ±4 kV, ±8 kV air B
Electrostatic discharge IEC 61000-4-2 ±8 kV contact C
±15 kV air C
Electromagnetic field IEC 61000-4-3 10 V/m (80 MHz to 1 GHz) A
3 V/m (1 GHz to 6 GHz) A
Magnetic field IEC 61000-4-8 30 A/m (50 Hz, 60 Hz) A
AC power Voltage dip IEC 61000-4-11 0 % during 0,5 cycles B
0 % during 1 cycle B
a
70 % during 25/30 cycles C
a
Short interruptions IEC 61000-4-11 0 % during 250/300 cycles C
Burst IEC 61000-4-4 ± 2 kV (5 kHz or 100 kHz) B
e
Surge IEC 61000-4-5 ± 0,5 kV, ± 1 kV line-to-line B
± 0,5 kV, ± 1 kV, ± 2 kV line-to- B
ground
Conducted RF IEC 61000-4-6 3 V (150 kHz to 80 MHz) A
6 V in ISM and amateur radio A
bands in the frequency range
b
150 kHz to 80 MHz
80 % AM at 1 kHz
DC power and/or Burst IEC 61000-4-4 ± 2 kV (5 kHz or 100 kHz) B
I/O signal/control
e
c, d
Surge IEC 61000-4-5 ± 0,5, ± 1 kV Line to line B

± 0,5 kV, ±1 kV, ±2 kV Line to B
including ground
protective earth
Conducted RF IEC 61000-4-6 3 V (150 kHz to 80 MHz) A
6 V in ISM and amateur radio A
bands in the frequency range
e
150 kHz to 80 MHz
80 % AM at 1 kHz
a
For example “25/30 cycles" means "25 cycles for 50 Hz test" or "30 cycles for 60 Hz test”.
b
The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to
6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The
amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz
to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz,
21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.
c
Only in the case of lines > 3 m.
d
DC connections between parts of equipment/system which are not connected to a DC DISTRIBUTION NETWORK
are treated as I/O signal/control PORTS (USB charging and communication combined). Using for example USB
connection only as a power source, it falls under DC power.
e
Only in the case of LONG-DISTANCE LINES.

The frequencies and services listed in Table 103 are representative examples that are based
on RF communications equipment in use at the time of publication of this document. The test
specification does not attempt to cover every frequency and service used in every country.
The risk management process should take the country specific communications services into
account. Testing should be performed at the additional frequencies identified that are not
represented in Table 103.
In addition, if, after this document is released, additional frequencies (new bands) become
official, they shall be tested or the risk management process should be performed.
While communication might not be possible when IVD MEDICAL EQUIPMENT that includes radio
equipment is tested in its passband, the IVD MEDICAL EQUIPMENT shall still be able to provide
its BASIC SAFETY and ESSENTIAL PERFORMANCE.
Table 103 – Immunity test requirements for equipment intended
to be used in a HOME HEALTHCARE ENVIRONMENT
Perform-
PORT Phenomenon Basic standard Test value ance
criterion
a
ENCLOSURE.1 Electromagnetic field  IEC 61000-4-3 9 V/m (710 MHz, 745 MHz, B
780 MHz)
28 V/m (1 720 MHz, 1 845 MHz,
1 970 MHz)
28 V/m (2 450 MHz)
9 V/m (5 240 MHz, 5 500 MHz,
5 785 MHz)
With a pulse modulation of
217 Hz. The carrier shall be
modulated using a 50 % duty
cycle square wave signal.
a
ENCLOSURE.2 Electromagnetic field IEC 61000-4-3 27 V/m (385 MHz) B
28 V/m (810 MHz, 870 MHz,
930 MHz)
With a pulse modulation of 18
Hz. The carrier shall be
modulated using a 50 % duty
cycle square wave signal.
a
ENCLOSURE.3 Electromagnetic field IEC 61000-4-3 28 V/m (430 MHz to 470 MHz) B
b
FM
± 5 kHz deviation, 1 kHz sine
a
If necessary to achieve the immunity test level, the distance between the transmitting antenna and the
equipment may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
b
As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not
represent actual modulation, it would be worst case sensitive equipment.

6.3 Random aspects
Subclause 6.3 of IEC 61326-1:20122020 applies.
6.4 Performance criteria
Subclause 6.4 of IEC 61326-1:20122020 applies except as follows.
Addition of the following text after the existing text in 6.4.1:
Performance criteria shall be determined to take into account the EUT operating modes that
can affect data and results, sample processing, and the user interface. Applicable immunity
test criteria shall be applied for each EUT operating mode and its acceptable performance
criterion.
Any change in performance that is within the performance criteria, A, B, or C listed in
Table 101, Table 102 or Table 103 shall be justified by an assessment of the residual risk.
Refer to ISO 14971 for guidelines for evaluation of residual risk acceptability.

– 14 – IEC 61326-2-6:2020 RLV © IEC 2020
Performance criteria which are less stringent than those specified in Table 101, Table 102 or
Table 103 shall be justified and reported in the test report, user documentation, and risk
management of the product.
In addition to the performance criteria A, B and C of 61326-1:2020 the EUT is not allowed to
report unacceptable results or fail in its ESSENTIAL PERFORMANCE or BASIC SAFETY. The test
plan shall list the acceptable BASIC SAFETY and ESSENTIAL PERFORMANCE parameters.
7 Emission requirements
Clause 7 of IEC 61326-1:20122020 applies.
8 Test results and test report
Clause 8 of IEC 61326-1:20122020 applies.
9 Instructions for use
Clause 9 of IEC 61326-1:2012 is replaced 2020 applies, except as follows:
Addition:
9.101 General requirements for the IVD MEDICAL EQUIPMENT instruction for use
The following information shall be in the instructions for use that accompany the IVD MEDICAL
EQUIPMENT.
NOTE 1 It is the manufacturer’s responsibility to provide equipment electromagnetic compatibility information to
the customer or user.
NOTE 2 It is the user’s responsibility to ensure that a compatible electromagnetic environment for the equipment
can be maintained in order that the device will perform as intended.
NOTE 3 The calculation formula to determine the separation distance between an IVD MEDICAL EQUIPMENT and a
mobile phone is given by d = 6/E ∙√P, where d is the minimum separation distance in metres, P is the maximum
power in watts, and E is the immunity test level in V/m.
9.102 Instructions for IVD medical equipment for self-testing
Additional requirements for the instruction for use for equipment to be used in a
HOME HEALTHCARE ENVIRONMENT
The instructions for use shall include the necessary preventive warnings with regard to EMC,
expressed e.g. by the following wording:
a) “Use of this instrument in a dry environment, especially if synthetic materials are present
(synthetic clothing, carpets etc.) may cause damaging electrostatic discharges that may
cause erroneous results.”
b) “Do not use this instrument in close proximity to sources of strong electromagnetic
radiation, as these may interfere with the proper operation.”
c) “This equipment is designed for use in a HOME HEALTHCARE ENVIRONMENT. If it is suspected
that performance is affected by electromagnetic interference, correct operation may be
restored by increasing the distance between the equipment and the source of the
interference.”
9.103 Instructions for IVD medical equipment for professional use
Additional requirements for the instruction for use for equipment to be used in a
PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT
The instructions for use shall include the following information and preventing preventive
warning:
a) A statement that the IVD MEDICAL EQUIPMENT complies with the emission and immunity
requirements described in this part of IEC 61326.
“This equipment has been designed
b) If emission compliance is Class A, state the warning:
and tested to CISPR 11 Class A. In a domestic environment it may cause radio
interference, in which case, you may need to take measures to mitigate the interference.”
This equipment is not intended for use in residential environments and may not provide
adequate protection to radio reception in such environments.
c) “This equipment is designed for use in a PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT.
It is likely to perform incorrectly if used in a HOME HEALTHCARE ENVIRONMENT. If it is
suspected that performance is affected by electromagnetic interference, correct operation
may be restored by increasing the distance between the equipment and the source of the
interference.”
d) An advisory that the electromagnetic environment should be evaluated prior to operation
of the device.
e) In addition, the instruction for use shall include the following preventive warnings with
regard to EMC, e.g. “Do not use this device in close proximity to sources of strong
electromagnetic radiation (e.g. unshielded intentional RF sources), as these can interfere
withproper operation.”
– 16 – IEC 61326-2-6:2020 RLV © IEC 2020
Annex A
(normative)
Immunity test requirements for PORTABLE TEST AND MEASUREMENT
EQUIPMENT powered by battery or from the circuit being measured
Annex A of IEC 61326-1:20122020 does not apply.
NOTE PORTABLE TEST AND MEASUREMENT EQUIPMENT is covered by Table 101 or Table 102.

Annex B
(informative)
Guide for analysis and assessment for electromagnetic compatibility
Annex B of IEC 61326-1:2020 does not apply.
NOTE The idea of the risk assessment is already implemented in Subclause 6.2.

– 18 – IEC 61326-2-6:2020 RLV © IEC 2020
Bibliography
The Bibliography of IEC 61326-1:2020 applies, except as follows:
Addition:
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
ISO 18113-1:2009, In vitro diagnostic medical devices – Information supplied by the
manufacturer (labelling) – Part 1: Terms, definitions and general requirements
AAMI TIR 18:19972010, Guidance on electromagnetic compatibility of medical devices for
clinical/ biomedical engineers – Part 1: Radiated radio-frequency electromagnetic energy in
healthcare facilities
ANSI C63.18:19972014, American National Standard – Recommended Practice for an On-Site,
Ad Hoc Test Method for Estimating Radiated Electromagnetic Immunity of Medical Devices to
Specific Radiated Radio-Frequency (RF) Emissions from RF Transmitters

___________
IEC 61326-2-6 ®
Edition 3.0 2020-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Electrical equipment for measurement, control and laboratory use –
EMC requirements –
Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment

Matériel électrique de mesure, de commande et de laboratoire –
Exigences relatives à la CEM –
Partie 2-6: Exigences particulières – Matériel médical de diagnostic in vitro (IVD)

– 2 – IEC 61326-2-6:2020 © IEC 2020
CONTENTS
FOREWORD . 3
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 General . 7
5 EMC test plan . 7
5.1 General . 7
5.2 Configuration of EUT during testing . 7
5.3 Operation conditions of EUT during testing . 7
5.4 Specification of FUNCTIONAL PERFORMANCE . 7
5.5 Test description . 7
6 Immunity requirements . 7
6.1 Conditions during the tests. 7
6.2 Immunity test requirements . 8
6.3 Random aspects . 11
6.4 Performance criteria . 11
7 Emission requirements . 12
8 Test results and test report . 12
9 Instructions for use . 12
Annex A (normative) Immunity test requirements for PORTABLE TEST AND MEASUREMENT
EQUIPMENT powered by battery or from the circuit being measured . 14
Annex B (informative) Guide for analysis and assessment for electromagnetic
compatibility. 15
Bibliography .
...

IEC 61326-2-6 ®
Edition 3.0 2020-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Electrical equipment for measurement, control and laboratory use –
EMC requirements –
Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment

Matériel électrique de mesure, de commande et de laboratoire –
Exigences relatives à la CEM –
Partie 2-6: Exigences particulières – Matériel médical de diagnostic in vitro (IVD)

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IEC 61326-2-6 ®
Edition 3.0 2020-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Electrical equipment for measurement, control and laboratory use –

EMC requirements –
Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment

Matériel électrique de mesure, de commande et de laboratoire –

Exigences relatives à la CEM –

Partie 2-6: Exigences particulières – Matériel médical de diagnostic in vitro (IVD)

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 17.220.20; 25.040.40; 33.100.20 ISBN 978-2-8322-8983-9

– 2 – IEC 61326-2-6:2020 © IEC 2020
CONTENTS
FOREWORD . 3
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 General . 7
5 EMC test plan . 7
5.1 General . 7
5.2 Configuration of EUT during testing . 7
5.3 Operation conditions of EUT during testing . 7
5.4 Specification of FUNCTIONAL PERFORMANCE . 7
5.5 Test description . 7
6 Immunity requirements . 7
6.1 Conditions during the tests. 7
6.2 Immunity test requirements . 8
6.3 Random aspects . 11
6.4 Performance criteria . 11
7 Emission requirements . 12
8 Test results and test report . 12
9 Instructions for use . 12
Annex A (normative) Immunity test requirements for PORTABLE TEST AND MEASUREMENT
EQUIPMENT powered by battery or from the circuit being measured . 14
Annex B (informative) Guide for analysis and assessment for electromagnetic
compatibility. 15
Bibliography . 16

Table 101 – Immunity test requirements for equipment intended to be used in
PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT . 9
Table 102 – Immunity test requirements for equipment intended to be used in a HOME
HEALTHCARE ENVIRONMENT . 10
Table 103 – Immunity test requirements for equipment intended to be used in a HOME
HEALTHCARE ENVIRONMENT . 11

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
ELECTRICAL EQUIPMENT FOR MEASUREMENT,
CONTROL AND LABORATORY USE –
EMC REQUIREMENTS –
Part 2-6: Particular requirements –
In vitro diagnostic (IVD) medical equipment

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
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2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
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3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 61326-2-6 has been prepared by subcommittee 65A: System
aspects, of IEC technical committee 65: Industrial-process measurement, control and
automation.
This third edition cancels and replaces the second published in 2012. This edition constitutes
a technical revision.
This edition includes the following significant technical change with respect to the previous
edition:
– update of the document with respect to IEC 61326-1:2020.

– 4 – IEC 61326-2-6:2020 © IEC 2020
The text of this International Standard is based on the following documents:
FDIS Report on voting
65A/979/FDIS 65A/990/RVD
Full information on the voting for the approval of this International Standard can be found in
the report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document the following print types are used:
– Terms used throughout this document which have been defined in Clause 3 of this
document and of IEC 61326-1:2020: SMALL CAPITALS.
This part of IEC 61326 is to be used in conjunction with IEC 61326-1:2020 and follows the
same numbering of clauses, subclauses, tables and figures.
When a particular subclause of IEC 61326-1 is not mentioned in this part, that subclause
applies as far as is reasonable. When this standard states “addition”, “modification” or
“replacement”, the relevant text in IEC 61326-1 is to be adapted accordingly.
NOTE The following numbering system is used:
– subclauses, tables and figures that are numbered starting from 101 are additional to those in
IEC 61326-1;
– unless notes are in a new subclause or involve notes in IEC 61326-1, they are numbered starting from 101
including those in a replaced clause or subclause;
– additional annexes are lettered AA, BB, etc.
A list of all parts of the IEC 61326 series, under the general title Electrical equipment for
measurement, control and laboratory use – EMC requirements, can be found on the IEC
website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
ELECTRICAL EQUIPMENT FOR MEASUREMENT,
CONTROL AND LABORATORY USE –
EMC REQUIREMENTS –
Part 2-6: Particular requirements –
In vitro diagnostic (IVD) medical equipment

1 Scope
In addition to the scope of IEC 61326-1, this part of IEC 61326 specifies minimum
requirements for immunity and emissions regarding electromagnetic compatibility for IN VITRO
DIAGNOSTIC (IVD) MEDICAL EQUIPMENT, taking into account the particularities and specific
aspects of this electrical equipment and their electromagnetic environment.
2 Normative references
Clause 2 of IEC 61326-1:2020 applies, except as follows:
Addition:
IEC 61326-1:2020, Electrical equipment for measurement, control and laboratory use – EMC
requirements – Part 1: General requirements
ISO 14971:2019, Medical devices – Application of risk management to medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 61326-1 apply,
except as follows.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
Addition:
3.101
in vitro diagnostic medical equipment
instruments and apparatus intended for use in the diagnosis of disease or other conditions,
including a determination of the state of health, in order to cure, mitigate, treat, or prevent
disease
Note 1 to entry: Such instruments or apparatus are intended for use in the collection, preparation, and
examination of specimens taken from the human body without direct or wired patient connection with the device.
Note 2 to entry: IVD: In vitro diagnostic.
3.102
professional healthcare facility environment
environment where professional healthcare is administered

– 6 – IEC 61326-2-6:2020 © IEC 2020
Note 1 to entry: Locations include hospitals, diagnostic laboratories, blood banks, blood donation centres,
physician offices, intensive care units, surgical centres, emergency rooms, surgery rooms, clinics, patient rooms,
dental offices, limited care facilities, nursing homes, drugstore with trained operator, and first aid rooms.
Note 2 to entry: Most environments and locations in the PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT are
considered to have a CONTROLLED ELECTROMAGNETIC ENVIRONMENT with regard to fixed electromagnetic sources.
However, mobile communication devices are widely used by healthcare professionals in providing efficient patient
care. For this reason, it is more difficult to control the environment for proximity electromagnetic disturbances.
Examples of electromagnetic sources that might be used adjacent to IVD MEDICAL EQUIPMENT are:
– high frequency surgical equipment;
– radio frequency identification (RFID) systems;
– wireless local area networks (WLAN);
– handheld mobile radios (e.g. TETRA, two-way radio);
– paging systems;
– other wireless devices (including consumer devices).
Note 3 to entry: It is assumed that IVD MEDICAL EQUIPMENT is not directly connected to the public mains network.
Note 4 to entry: IVD MEDICAL EQUIPMENT should have a suitable level of immunity to ensure the safe and effective
performance of the device in its intended use environment. IVD MEDICAL EQUIPMENT that might be used in
ambulances, or any ground vehicle or aircraft can require a higher level of immunity than the PROFESSIONAL
HEALTHCARE FACILITY ENVIRONMENT.
3.103
home healthcare environment
environment other than a PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT with a much more
diverse electromagnetic environment with electromagnetic disturbances that may be more
uncontrolled and less well-characterized in terms of amplitude and probability of occurrence
Note 1 to entry: Except in transportation or while operating under battery power, IVD MEDICAL EQUIPMENT is
usually connected to the public mains network.
Note 2 to entry: The characteristics of this environment justify higher immunity test levels for basic safety and
ESSENTIAL PERFORMANCE. Locations include the home, and any public place such as shops and libraries, offices,
transport stations and airports, etc. Examples of electromagnetic sources that might be used near IVD MEDICAL
EQUIPMENT in these environments or otherwise expose the IVD MEDICAL EQUIPMENT to intense electromagnetic
disturbances are:
– small mains frequency transformers (50 Hz and 60 Hz), e.g. in a clock radio on a bedside table;
– mains disturbances;
– mobile phones (often several);
– fixed radio broadcast stations;
– TV transmitting equipment;
– amateur Radio Equipment;
– mobile radio transmitters (e.g. taxi, police).
3.104
analyte
constituent of a sample with a measurable property
EXAMPLES In “mass of protein in 24-hour urine”, “protein” is the ANALYTE and “mass” is the property. In
“concentration of glucose in plasma”, “glucose” is the ANALYTE and “concentration” is the property. In both cases,
the full phrase designates the measured property.
[SOURCE: ISO 18113-1:2009, 3.3, modified – property has been added after measurand]
3.105
basic safety
freedom from unacceptable risk to the operator directly caused by physical hazards when IVD
MEDICAL EQUIPMENT is used under normal condition and single fault condition

3.106
essential performance
performance of a clinical function, other than that related to BASIC SAFETY, where loss or
degradation beyond the limits specified in the user documentation results in an unacceptable
risk
Note 1 to entry: ESSENTIAL PERFORMANCE is most easily understood by considering whether its absence or
degradation would result in an unacceptable risk.
3.2 Abbreviations
Subclause 3.2 of IEC 61326-1:2020 applies.
4 General
Clause 4 of IEC 61326-1:2020 applies.
5 EMC test plan
5.1 General
Subclause 5.1 of IEC 61326-1:2020 applies.
5.2 Configuration of EUT during testing
Subclause 5.2 of IEC 61326-1:2020 applies.
5.3 Operation conditions of EUT during testing
Subclause 5.3 of IEC 61326-1:2020 applies, except as follows:
Addition:
5.3.101 Operational conditions
The device shall be set to conditions specified in the user documentation in accordance with
the intended use.
For each mode of operation, the power option (e.g. battery, AC or DC supply) which
represents the most severe condition shall be specified in accordance with the product risk
analysis.
5.4 Specification of FUNCTIONAL PERFORMANCE
Subclause 5.4 of IEC 61326-1:2020 applies.
5.5 Test description
Subclause 5.5 of IEC 61326-1:2020 applies.
6 Immunity requirements
6.1 Conditions during the tests
Subclause 6.1 of IEC 61326-1:2020 is replaced as follows.

– 8 – IEC 61326-2-6:2020 © IEC 2020
6.101 Conditions during the tests
The configuration and modes of operation during the tests shall be precisely noted in the test
report.
Tests shall be applied to the relevant PORTS in accordance with Table 101 or Table 102 of this
document, as applicable.
The tests shall be carried out one at a time in accordance with the basic standards. If
additional methods are required, the method and rationale shall be documented in the test
report.
6.2 Immunity test requirements
Subclause 6.2 of IEC 61326-1:2020 and its title are replaced as follows.
6.2 Risk assessment and consideration of EMC immunity requirements
Powerful electromagnetic emission sources can lead to malfunctions in nearby medical
equipment under certain circumstances. Different types of medical electrical equipment have
different levels of risk with a malfunction. IVD MEDICAL EQUIPMENT however is not intended to
keep alive or resuscitate patients, so a malfunction would not directly cause the death or
serious injury of a patient. Such a malfunction in IVD MEDICAL EQUIPMENT can result in an
incorrect reading, which can in turn lead to a wrong therapeutic decision (misdiagnosis). For
ANALYTES and in some circumstances, an incorrect result could result in serious harm to
some
the patient. In the case of larger IVD MEDICAL EQUIPMENT, electromagnetic disturbances can
also cause malfunctions that pose a direct threat to the operator, for example through
unexpected mechanical movements.
The manufacturer shall perform risk management according to ISO 14971 for guidance in
assessing risk associated with direct hazards.
NOTE As a rule, results from IVD MEDICAL EQUIPMENT are checked for plausibility by medical personnel or
followed-up by decisions of a healthcare professional. IVD MEDICAL EQUIPMENT for self-testing by lay users is
always provided with advice on action to be taken in case of indeterminate results. The users are urged to contact
their medical practitioner before making any decision of medical relevance.
For equipment intended to be used in a PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT, the
immunity requirements of Table 101 shall be applied.
In addition, depending on the outcome of the risk assessment of the electromagnetic
environment, consideration shall be given to include the immunity test requirements
of Table 102 and Table 103.
The risk assessment shall include point-of-care testing equipment or other equipment used
close to patients, who might have home use electronics such as mobile phones even in the
professional environment.
Table 101 – Immunity test requirements for equipment intended
to be used in PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT
Perform
PORT Phenomenon Basic standard Test value ance
criterion
ENCLOSURE Electrostatic discharge IEC 61000-4-2 ± 4 kV contact B
± 2 kV, ± 4 kV, ± 8 kV air B
Electromagnetic field IEC 61000-4-3 3 V/m (80 MHz to 6 GHz) A
Power frequency
IEC 61000-4-8 3 A/m (50 Hz, 60 Hz) A
magnetic field
AC power Burst IEC 61000-4-4 ± 1 kV (5 kHz or 100 kHz) B
(including protective
Surge IEC 61000-4-5 ± 0,5 kV line-to-line B
earth)
± 1 kV line-to-ground B
Conducted RF IEC 61000-4-6 3 V (150 kHz to 80 MHz) A
Voltage dip IEC 61000-4-11 0 % during 0,5 cycles B
0 % during 1 cycle B
a
70 % during 25/30 cycles C
a
Short interruptions IEC 61000-4-11 0 % during 250/300 cycles C
b, c
DC power Burst IEC 61000-4-4 ± 1 kV (5 kHz or 100 kHz) B
(including protective
Surge IEC 61000-4-5 ± 0,5 kV line-to-line B
earth) ± 1 kV line-to-ground B
Conducted RF IEC 61000-4-6 3 V (150 kHz to 80 MHz) A
c
b
I/O signal/control  Burst IEC 61000-4-4 ± 0,5 kV (5 kHz or 100 kHz) B

e
Surge IEC 61000-4-5 ± 1 kV line-to-ground B
(including functional
earth)
b
Conducted RF IEC 61000-4-6 3 V (150 kHz to 80 MHz) A
c
b
I/O signal/control Burst IEC 61000-4-4 ± 1 kV (5 kHz or 100 kHz) B

d
Surge IEC 61000-4-5 ± 0,5 kV line-to-line B
connected directly
± 1 kV line-to-ground B
to mains supply
b
Conducted RF IEC 61000-4-6 3 V (150 kHz to 80 MHz) A
a
For example, “25/30 cycles" means "25 cycles for 50 Hz test" or "30 cycles for 60 Hz test”.
b
Only in the case of lines > 3 m.
c
DC POWER PORTS intended to be connected to a low voltage DC supply (≤ 60 V), where secondary circuits
(isolated from the AC mains supply) are not subject to transient overvoltages (i.e. reliably-grounded,
capacitive-filtered DC secondary circuits) shall be regarded as I/O signal/control PORTS.
d
Only in the case of LONG-DISTANCE LINES.

For equipment intended to be used in a HOME HEALTHCARE ENVIRONMENT, the immunity
requirements of Table 102 and Table 103 shall be applied.

– 10 – IEC 61326-2-6:2020 © IEC 2020
Table 102 – Immunity test requirements for equipment intended
to be used in a HOME HEALTHCARE ENVIRONMENT
Perform-
PORT Phenomenon Basic standard Test value ance
criterion
ENCLOSURE Electrostatic discharge IEC 61000-4-2 ±6 kV contact B
±2 kV, ±4 kV, ±8 kV air B
Electrostatic discharge IEC 61000-4-2 ±8 kV contact C
±15 kV air C
Electromagnetic field IEC 61000-4-3 10 V/m (80 MHz to 1 GHz) A
3 V/m (1 GHz to 6 GHz) A
Magnetic field IEC 61000-4-8 30 A/m (50 Hz, 60 Hz) A
AC power Voltage dip IEC 61000-4-11 0 % during 0,5 cycles B
0 % during 1 cycle B
a
70 % during 25/30 cycles C
a
Short interruptions IEC 61000-4-11 0 % during 250/300 cycles C
Burst IEC 61000-4-4 ± 2 kV (5 kHz or 100 kHz) B
e
Surge IEC 61000-4-5 ± 0,5 kV, ± 1 kV line-to-line B
± 0,5 kV, ± 1 kV, ± 2 kV line-to- B
ground
Conducted RF IEC 61000-4-6 3 V (150 kHz to 80 MHz) A
6 V in ISM and amateur radio A
bands in the frequency range
b
150 kHz to 80 MHz
80 % AM at 1 kHz
DC power and/or Burst IEC 61000-4-4 ± 2 kV (5 kHz or 100 kHz) B
I/O signal/control
e
c, d
Surge IEC 61000-4-5 ± 0,5, ± 1 kV Line to line B

± 0,5 kV, ±1 kV, ±2 kV Line to B
including ground
protective earth
Conducted RF IEC 61000-4-6 3 V (150 kHz to 80 MHz) A
6 V in ISM and amateur radio A
bands in the frequency range
e
150 kHz to 80 MHz
80 % AM at 1 kHz
a
For example “25/30 cycles" means "25 cycles for 50 Hz test" or "30 cycles for 60 Hz test”.
b
The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to
6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The
amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz
to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz,
21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.
c
Only in the case of lines > 3 m.
d
DC connections between parts of equipment/system which are not connected to a DC DISTRIBUTION NETWORK
are treated as I/O signal/control PORTS (USB charging and communication combined). Using for example USB
connection only as a power source, it falls under DC power.
e
Only in the case of LONG-DISTANCE LINES.

The frequencies and services listed in Table 103 are representative examples that are based
on RF communications equipment in use at the time of publication of this document. The test
specification does not attempt to cover every frequency and service used in every country.
The risk management process should take the country specific communications services into
account. Testing should be performed at the additional frequencies identified that are not
represented in Table 103.
In addition, if, after this document is released, additional frequencies (new bands) become
official, they shall be tested or the risk management process should be performed.
While communication might not be possible when IVD MEDICAL EQUIPMENT that includes radio
equipment is tested in its passband, the IVD MEDICAL EQUIPMENT shall still be able to provide
its BASIC SAFETY and ESSENTIAL PERFORMANCE.
Table 103 – Immunity test requirements for equipment intended
to be used in a HOME HEALTHCARE ENVIRONMENT
Perform-
PORT Phenomenon Basic standard Test value ance
criterion
a
ENCLOSURE.1 Electromagnetic field  IEC 61000-4-3 9 V/m (710 MHz, 745 MHz, B
780 MHz)
28 V/m (1 720 MHz, 1 845 MHz,
1 970 MHz)
28 V/m (2 450 MHz)
9 V/m (5 240 MHz, 5 500 MHz,
5 785 MHz)
With a pulse modulation of
217 Hz. The carrier shall be
modulated using a 50 % duty
cycle square wave signal.
a
ENCLOSURE.2 Electromagnetic field IEC 61000-4-3 27 V/m (385 MHz) B
28 V/m (810 MHz, 870 MHz,
930 MHz)
With a pulse modulation of 18
Hz. The carrier shall be
modulated using a 50 % duty
cycle square wave signal.
a
ENCLOSURE.3 Electromagnetic field IEC 61000-4-3 28 V/m (430 MHz to 470 MHz) B
b
FM
± 5 kHz deviation, 1 kHz sine
a
If necessary to achieve the immunity test level, the distance between the transmitting antenna and the
equipment may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
b
As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not
represent actual modulation, it would be worst case sensitive equipment.

6.3 Random aspects
Subclause 6.3 of IEC 61326-1:2020 applies.
6.4 Performance criteria
Subclause 6.4 of IEC 61326-1:2020 applies except as follows.
Addition of the following text after the existing text in 6.4.1:
Performance criteria shall be determined to take into account the EUT operating modes that
can affect data and results, sample processing, and the user interface. Applicable immunity
test criteria shall be applied for each EUT operating mode and its acceptable performance
criterion.
Any change in performance that is within the performance criteria, A, B, or C listed in
Table 101, Table 102 or Table 103 shall be justified by an assessment of the residual risk.
Refer to ISO 14971 for guidelines for evaluation of residual risk acceptability.

– 12 – IEC 61326-2-6:2020 © IEC 2020
Performance criteria which are less stringent than those specified in Table 101, Table 102 or
Table 103 shall be justified and reported in the test report, user documentation, and risk
management of the product.
In addition to the performance criteria A, B and C of 61326-1:2020 the EUT is not allowed to
report unacceptable results or fail in its ESSENTIAL PERFORMANCE or BASIC SAFETY. The test
plan shall list the acceptable BASIC SAFETY and ESSENTIAL PERFORMANCE parameters.
7 Emission requirements
Clause 7 of IEC 61326-1:2020 applies.
8 Test results and test report
Clause 8 of IEC 61326-1:2020 applies.
9 Instructions for use
Clause 9 of IEC 61326-1:2020 applies, except as follows:
Addition:
9.101 General requirements for the IVD MEDICAL EQUIPMENT instruction for use
The following information shall be in the instructions for use that accompany the IVD MEDICAL
EQUIPMENT.
NOTE 1 It is the manufacturer’s responsibility to provide equipment electromagnetic compatibility information to
the customer or user.
NOTE 2 It is the user’s responsibility to ensure that a compatible electromagnetic environment for the equipment
can be maintained in order that the device will perform as intended.
NOTE 3 The calculation formula to determine the separation distance between an IVD MEDICAL EQUIPMENT and a
mobile phone is given by d = 6/E ∙√P, where d is the minimum separation distance in metres, P is the maximum
power in watts, and E is the immunity test level in V/m.
9.102 Additional requirements for the instruction for use for equipment to be used in a
HOME HEALTHCARE ENVIRONMENT
The instructions for use shall include the necessary preventive warnings with regard to EMC,
expressed e.g. by the following wording:
a) “Use of this instrument in a dry environment, especially if synthetic materials are present
(synthetic clothing, carpets etc.) may cause damaging electrostatic discharges that may
cause erroneous results.”
b) “Do not use this instrument in proximity to sources of strong electromagnetic radiation, as
these may interfere with the proper operation.”
c) “This equipment is designed for use in a HOME HEALTHCARE ENVIRONMENT. If it is suspected
that performance is affected by electromagnetic interference, correct operation may be
restored by increasing the distance between the equipment and the source of the
interference.”
9.103 Additional requirements for the instruction for use for equipment to be used in a
PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT
The instructions for use shall include the following information and preventive warning:
MEDICAL EQUIPMENT complies with the emission and immunity
a) A statement that the IVD
requirements described in this part of IEC 61326.
b) If emission compliance is Class A, state the warning: This equipment is not intended for
use in residential environments and may not provide adequate protection to radio
reception in such environments.
c) “This equipment is designed for use in a PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT.
It is likely to perform incorrectly if used in a HOME HEALTHCARE ENVIRONMENT. If it is
suspected that performance is affected by electromagnetic interference, correct operation
may be restored by increasing the distance between the equipment and the source of the
interference.”
d) An advisory that the electromagnetic environment should be evaluated prior to operation
of the device.
e) In addition, the instruction for use shall include the following preventive warnings with
regard to EMC, e.g. “Do not use this device in proximity to sources of strong
electromagnetic radiation (e.g. unshielded intentional RF sources), as these can interfere
with proper operation.”
– 14 – IEC 61326-2-6:2020 © IEC 2020
Annex A
(normative)
Immunity test requirements for PORTABLE TEST AND MEASUREMENT
EQUIPMENT powered by battery or from the circuit being measured
Annex A of IEC 61326-1:2020 does not apply.
NOTE PORTABLE TEST AND MEASUREMENT EQUIPMENT is covered by Table 101 or Table 102.

Annex B
(informative)
Guide for analysis and assessment for electromagnetic compatibility
Annex B of IEC 61326-1:2020 does not apply.
NOTE The idea of the risk assessment is already implemented in Subclause 6.2.

– 16 – IEC 61326-2-6:2020 © IEC 2020
Bibliography
The Bibliography of IEC 61326-1:2020 applies, except as follows:
Addition:
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
ISO 18113-1:2009, In vitro diagnostic medical devices – Information supplied by the
manufacturer (labelling) – Part 1: Terms, definitions and general requirements
AAMI TIR 18:2010, Guidance on electromagnetic compatibility of medical devices in
healthcare facilities
ANSI C63.18:2014, American National Standard – Recommended Practice for an On-Site,
Ad Hoc Test Method for Estimating Radiated Electromagnetic Immunity of Medical Devices to
Radiated Radio-Frequency (RF) Emissions from RF Transmitters

___________
– 18 – IEC 61326-2-6:2020 © IEC 2020
SOMMAIRE
AVANT-PROPOS . 19
1 Domaine d’application. 21
2 Références normatives . 21
3 Termes et définitions . 21
4 Généralités . 23
5 Plan d’essai de CEM . 23
5.1 Généralités . 23
5.2 Configuration de l'EST lors des essais . 23
5.3 Conditions de fonctionnement de l'EST lors des essais. 23
5.4 Spécification des PERFORMANCES FONCTIONNELLES . 23
5.5 Description de l’essai . 23
6 Exigences relatives à l'immunité . 24
6.1 Conditions lors des essais . 24
6.2 Appréciation du risque et prise en considération des exigences relatives à
l'immunité CEM . 24
6.3 Aspects aléatoires . 27
6.4 Critères de performance . 28
7 Exigences relatives à l'émission . 28
8 Résultats d’essai et rapport d’essai . 28
9 Instructions pour l’utilisation . 28
Annexe A (normative) Exigences concernant les essais d'immunité pour le MATERIEL
D'ESSAI ET DE MESURE PORTABLE alimenté par batterie ou par le circuit mesuré . 30
Annexe B (informative) Guide destiné à l’analyse et l’évaluation de la compatibilité
électromagnétique . 31
Bibliographie . 32

Tableau 101 – Exigences d'essai relatives à l’immunité des matériels utilisés en
ENVIRONNEMENT D’INSTALLATION DE SOINS DE SANTE PROFESSIONNELS . 25
Tableau 102 – Exigences d'essai relatives à l’immunité des matériels utilisés en
ENVIRONNEMENT DE SOINS DE SANTE A DOMICILE . 26
Tableau 103 – Exigences d'essai relatives à l’immunité des matériels utilisés en
ENVIRONNEMENT DE SOINS DE SANTE A DOMICILE . 27

COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE
____________
MATÉRIEL ÉLECTRIQUE DE MESURE, DE COMMANDE ET DE
LABORATOIRE – EXIGENCES RELATIVES À LA CEM –

Partie 2-6: Exigences particulières –
Matériel médical de diagnostic in vitro (IVD)

AVANT-PROPOS
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selon des conditions fixées par accord entre les deux organisations.
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...