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 is available as IEC 61326-2-6:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.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)

IEC 61326-2-6:2020 est disponible sous forme de IEC 61326-2-6:2020 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.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
Technical Committee
Current Stage
PPUB - Publication issued
Completion Date
28-Oct-2020
Ref Project

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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)

IEC 61326-2-6:2020-10(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
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

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 3 ----------------------
– 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

---------------------- Page: 4 ----------------------
IEC 61326-2-6:2020 © IEC 2020 – 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

this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,

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Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested

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with the International Organization for Standardization (ISO) in accordance with conditions determined by

agreement between the two organizations.

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6) All users should ensure that they have the latest edition of this publication.

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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

indispensable for the correct application of this publication.

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.
---------------------- Page: 5 ----------------------
– 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.
---------------------- Page: 6 ----------------------
IEC 61326-2-6:2020 © IEC 2020 – 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 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
---------------------- Page: 7 ----------------------
– 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
---------------------- Page: 8 ----------------------
IEC 61326-2-6:2020 © IEC 2020 – 7 –
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.
---------------------- Page: 9 ----------------------
– 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.
---------------------- Page: 10 ----------------------
IEC 61326-2-6:2020 © IEC 2020 – 9 –
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
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
I/O signal/control Burst IEC 61000-4-4 ± 0,5 kV (5 kHz or 100 kHz) B
Surge IEC 61000-4-5 ± 1 kV line-to-ground B
(including functional
earth)
Conducted RF IEC 61000-4-6 3 V (150 kHz to 80 MHz) A
I/O signal/control Burst IEC 61000-4-4 ± 1 kV (5 kHz or 100 kHz) B
Surge IEC 61000-4-5 ± 0,5 kV line-to-line B
connected directly
± 1 kV line-to-ground B
to mains supply
Conducted RF IEC 61000-4-6 3 V (150 kHz to 80 MHz) A

For example, “25/30 cycles" means "25 cycles for 50 Hz test" or "30 cycles for 60 Hz test”.

Only in the case of lines > 3 m.

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.

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.
---------------------- Page: 11 ----------------------
– 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
70 % during 25/30 cycles C
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
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
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
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
150 kHz to 80 MHz
80 % AM at 1 kHz

For example “25/30 cycles" means "25 cycles for 50 Hz test" or "30 cycles for 60 Hz test”.

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.

Only in the case of lines > 3 m.
...

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