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

IEC 61326-2-6:2012 specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for in vitro diagnostic medical equipment, taking into account the particularities and specific aspects of this electrical equipment and their electromagnetic environment. This second edition cancels and replaces the first edition published in 2005 and constitutes a technical revision. It includes the following significant technical change: update of the document with respect to IEC 61326-1:2012.
This publication is to be read in conjunction with IEC 61326-1:2012.

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)

La CEI 61326-2-6:2012 spécifie les exigences minimales pour l'immunité et les émissions relatives à la compatibilité électromagnétique des matériels médicaux de diagnostic in vitro, en prenant en compte les particularités et aspects spécifiques de ces matériels et de leur environnement électromagnétique. Cette deuxième édition annule et remplace la première édition parue en 2005 et constitue une révision technique. Cette édition inclut la modification technique majeure suivante: mise à jour du document par rapport à la CEI 61326-1:2012.
Cette publication doit être lue conjointement avec la CEI 61326-1:2012.

General Information

• Status: Published
• Publication Date: 09-Jul-2012
• 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: DELPUB - Deleted Publication
• Start Date: 28-Oct-2020
• Completion Date: 30-Mar-2018

Relations

• Revised: 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
• Effective Date: 05-Sep-2023
• Revises: IEC 61326-2-6:2005/COR1:2007 - Corrigendum 1 - 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
• Revises: IEC 61326-2-6:2005 - 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

Overview

IEC 61326-2-6:2012 is an international standard published by the International Electrotechnical Commission (IEC) that defines the electromagnetic compatibility (EMC) requirements specific to in vitro diagnostic (IVD) medical equipment. This standard outlines minimum immunity and emission criteria to ensure that IVD devices operate safely and effectively within their electromagnetic environment. It accounts for the unique operational characteristics and environments of IVD medical equipment, providing essential guidelines to manufacturers, testing laboratories, and regulatory bodies.

As a part of the IEC 61326 series, this document complements IEC 61326-1:2012, which sets general EMC requirements for electrical equipment used in measurement, control, and laboratory applications. IEC 61326-2-6:2012 is a technical revision of the first edition from 2005 and integrates updated requirements aligned with the latest industry practices.

Key Topics

Scope and Application

• Specifies EMC immunity and emission requirements for IVD medical equipment.
• Focuses on electrical equipment intended for diagnosing diseases or monitoring health via specimen analysis.
• Addresses devices used across diverse environments, including homes, hospitals, clinics, ambulances, and aircraft.

Electromagnetic Environment Considerations

• Recognizes the varied electromagnetic environments in which IVD equipment operates.
• Requires devices to have immunity levels appropriate for healthcare and home settings.
• Calls for increased immunity standards for IVD devices used in mobile or specialized environments, like emergency vehicles and aircraft.

EMC Test Plan and Operation Conditions

• Defines precise test configurations and modes of operation during EMC testing.
• Requires testing under conditions specified by the manufacturer to cover the most critical operational scenarios.
• Mandates detailed documentation of test configurations and results.

Immunity Requirements

• Enumerates immunity tests applicable to IVD equipment, focusing on mitigating malfunction risks due to electromagnetic disturbances.
• Emphasizes risk assessment to determine relevant test parameters.
• Encourages performing immunity tests individually, with additional methods documented as necessary.

Emission Requirements

• Sets emission limits to reduce the likelihood of the IVD equipment interfering with other sensitive medical devices.
• Ensures emissions are within acceptable thresholds to maintain hospital and laboratory safety.

Instructions and Documentation

• Requires manufacturers to provide clear instructions on EMC considerations for device operation.
• Tailors information for both professional users and self-testing scenarios, ensuring end-users understand safe usage practices relating to electromagnetic interactions.

Applications

IEC 61326-2-6:2012 is crucial for manufacturers, regulatory agencies, and testing laboratories involved in the design, certification, and deployment of in vitro diagnostic medical equipment. Key practical applications include:

• Product Development: Guiding design and engineering teams to integrate appropriate EMC measures during device development.
• Compliance Testing: Assisting test laboratories in creating EMC test plans and executing immunity and emission tests specific to IVD devices.
• Risk Management: Supporting medical device manufacturers in assessing electromagnetic risks in accordance with ISO 14971 standards.
• Regulatory Approval: Enabling conformity assessments required for market access, ensuring IVD equipment meets internationally recognized EMC benchmarks.
• Healthcare Safety: Guaranteeing that diagnostic devices operate reliably within complex electromagnetic environments, protecting patients and healthcare professionals alike.

Related Standards

• IEC 61326-1:2012 – General EMC requirements for electrical equipment for measurement, control, and laboratory use; forms the baseline requirements used in conjunction with IEC 61326-2-6.
• ISO 14971:2007 – Medical devices – Application of risk management, referenced to ensure EMC testing aligns with overall risk control.
• IEC 61000 Series – Covers generic EMC testing methods and limits applicable to electrical and electronic devices.
• IEC 60601 Series – Specifies requirements for medical electrical equipment, including safety and EMC aspects that may affect IVD devices.

Conclusion

IEC 61326-2-6:2012 is an essential standard for ensuring electromagnetic compatibility in in vitro diagnostic medical equipment. By specifying test methods, immunity levels, and emission limits suited to the unique contexts of IVD devices, it helps maintain device safety, reliability, and performance in diverse and demanding electromagnetic environments. Compliance with this standard supports manufacturers in delivering high-quality diagnostic solutions and facilitates regulatory acceptance worldwide.

Standards Content (Sample)

IEC 61326-2-6 ®
Edition 2.0 2012-07
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 2.0 2012-07
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
PRICE CODE
INTERNATIONALE
CODE PRIX L
ICS 17.220; 19.080; 25.040.40; 33.100 ISBN 978-2-83220-210-4

– 2 – 61326-2-6 © IEC:2012
CONTENTS
FOREWORD . 3
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 General . 6
4.101 Electromagnetic environment of IVD medical equipment . 6
5 EMC test plan . 6
5.1 General . 6
5.2 Configuration of EUT during testing . 6
5.3 Operation conditions of EUT during testing . 6
5.3.101 Operational conditions . 6
5.4 Specification of functional performance . 6
5.5 Test description . 6
6 Immunity requirements . 7
6.1 Conditions during the tests . 7
6.2 Immunity test requirements . 7
6.3 Random aspects. 8
6.4 Performance criteria . 9
7 Emission requirements . 9
8 Test results and test report . 9
9 Instructions for use . 9
9.1 Requirements for the IVD medical equipment instruction for use . 9
9.2 Instructions for IVD medical equipment for self-testing . 9
9.3 Instructions for IVD medical equipment for professional use . 9
Annex A (normative) Immunity test requirements for portable test and measurement
equipment powered by battery or from the circuit being measured . 10
Bibliography . 11

Table 101 – Immunity requirements for IVD medical equipment . 8

61326-2-6 © IEC:2012 – 3 –
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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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
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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 second edition cancels and replaces the first edition published in 2005. This edition
constitutes a technical revision.

– 4 – 61326-2-6 © IEC:2012
This edition includes the following significant technical change with respect to the previous
edition:
– update of the document with respect to IEC 61326-1:2012.
The text of this standard is based on the following documents:
FDIS Report on voting
65A/631/FDIS 65A/640/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
This part of the IEC 61326 series is to be used in conjunction with IEC 61326-1:2012 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, control and laboratory use – EMC requirements can
be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
61326-2-6 © IEC:2012 – 5 –
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 series specifies minimum
requirements for immunity and emissions regarding electromagnetic compatibility for in vitro
diagnostic medical equipment, taking into account the particularities and specific aspects of
this electrical equipment and their electromagnetic environment.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and
are indispensable for its application. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any
amendments) applies.
Clause 2 of IEC 61326-1:2012 applies, except as follows:
Addition:
IEC 61326-1:2012, Electrical equipment for measurement, control and laboratory use – EMC
requirements – Part 1: General requirements
ISO 14971:2007, 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.
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.
3.102
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.

– 6 – 61326-2-6 © IEC:2012
[SOURCE: ISO 18113-1:2009, 3.3]
4 General
Clause 4 of IEC 61326-1:2012 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 61326-1:2012 applies.
5.2 Configuration of EUT during testing
Subclause 5.2 of IEC 61326-1:2012 applies.
5.3 Operation conditions of EUT during testing
Subclause 5.3 of IEC 61326-1:2012 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.
5.4 Specification of functional performance
Subclause 5.4 of IEC 61326-1:2012 applies.
5.5 Test description
Subclause 5.5 of IEC 61326-1:2012 applies.

61326-2-6 © IEC:2012 – 7 –
6 Immunity requirements
6.1 Conditions during the tests
Subclause 6.1 of IEC 61326-1:2012 is replaced as follows.
6.1 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.
The tests shall be conducted in accordance with the basic standards. The tests shall be
carried out one at a time. If additional methods are required, the method and rationale shall
be documented.
6.2 Immunity test requirements
Subclause 6.2 of IEC 61326-1:2012 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
is not intended to
different levels of risk with a malfunction. IVD medical equipment however
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 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.
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 are
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.
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.

– 8 – 61326-2-6 © IEC:2012
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.
6.3 Random aspects
Subclause 6.3 of IEC 61326-1:2012 applies.

61326-2-6 © IEC:2012 – 9 –
6.4 Performance criteria
Subclause 6.4 of IEC 61326-1:2012 applies.
7 Emission requirements
Clause 7 of IEC 61326-1:2012 applies.
8 Test results and test report
Clause 8 of IEC 61326-1:2012 applies.
9 Instructions for use
Clause 9 of IEC 61326-1:2012 is replaced as follows.
9.1 Requirements for the IVD medical equipment instruction for use
The following information shall be in the instructions for use that accompany the IVD
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.
9.2 Instructions for IVD medical equipment for self-testing
The instruction 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.”
9.3 Instructions for IVD medical equipment for professional use
The instruction for use shall include the following information and preventing warning:
a) A statement that the IVD medical equipment complies with the emission and immunity
requirements described in this part of the IEC 61326 series.
b) If emission compliance is Class A, state the warning: “This equipment has been designed
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.”
c) An advisory that the electromagnetic environment should be evaluated prior to operation
of the device.
d) In addition, the instruction for use shall include the following preventive wa
...