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)

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.

Elektrische Mess-, Steuer-, Regel- und Laborgeräte - EMV-Anforderungen - Teil 2-6: Besondere Anforderungen - Medizinische In-vitro-Diagnosegeräte (IVD) (IEC 61326-2-6:2020)

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)

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.

Električna oprema za merjenje, nadzor in laboratorijsko uporabo - Zahteve za elektromagnetno združljivost (EMC) - 2-6. del: Posebne zahteve - In vitro diagnostična (IVD) medicinska oprema (IEC 61326-2-6:2020)

General Information

Status
Published
Public Enquiry End Date
30-Oct-2019
Publication Date
16-Aug-2021
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
11-Jun-2021
Due Date
16-Aug-2021
Completion Date
17-Aug-2021

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SLOVENSKI STANDARD
SIST EN IEC 61326-2-6:2021
01-september-2021
Nadomešča:
SIST EN 61326-2-6:2013
Električna oprema za merjenje, nadzor in laboratorijsko uporabo - Zahteve za
elektromagnetno združljivost (EMC) - 2-6. del: Posebne zahteve - In vitro
diagnostična (IVD) medicinska oprema (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)

Elektrische Mess-, Steuer-, Regel- und Laborgeräte - EMV-Anforderungen - Teil 2-6:

Besondere Anforderungen - Medizinische In-vitro-Diagnosegeräte (IVD) (IEC 61326-2-

6:2020)

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)
Ta slovenski standard je istoveten z: EN IEC 61326-2-6:2021
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
19.080 Električno in elektronsko Electrical and electronic
preskušanje testing
33.100.01 Elektromagnetna združljivost Electromagnetic compatibility
na splošno in general
SIST EN IEC 61326-2-6:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN IEC 61326-2-6:2021
---------------------- Page: 2 ----------------------
SIST EN IEC 61326-2-6:2021
EUROPEAN STANDARD EN IEC 61326-2-6
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2021

ICS 25.040.40; 17.220.20; 33.100.20 Supersedes EN 61326-2-6:2013 and all of its

amendments and corrigenda (if any)
English Version
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)

Matériel électrique de mesure, de commande et de Elektrische Mess-, Steuer-, Regel- und Laborgeräte - EMV-

laboratoire - Exigences relatives à la CEM - Partie 2-6: Anforderungen - Teil 2-6: Besondere Anforderungen -

Exigences particulières - Matériel médical de diagnostic in Medizinische In-vitro-Diagnosegeräte (IVD)

vitro (IVD) (IEC 61326-2-6:2020)
(IEC 61326-2-6:2020)

This European Standard was approved by CENELEC on 2020-12-02. CENELEC members are bound to comply with the CEN/CENELEC

Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC

Management Centre or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation

under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the

same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,

Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the

Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. EN IEC 61326-2-6:2021 E
---------------------- Page: 3 ----------------------
SIST EN IEC 61326-2-6:2021
EN IEC 61326-2-6:2021 (E)
European foreword

The text of document 65A/979/FDIS, future edition 3 of IEC 61326-2-6, prepared by SC 65A "System

aspects" of IEC/TC 65 "Industrial-process measurement, control and automation" was submitted to the

IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 61326-2-6:2021.
The following dates are fixed:

• latest date by which the document has to be implemented at national (dop) 2021-12-04

level by publication of an identical national standard or by endorsement

• latest date by which the national standards conflicting with the (dow) 2024-06-04

document have to be withdrawn

This document supersedes EN 61326-2-6:2013 and all of its amendments and corrigenda (if any).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.

This document has been prepared under a mandate given to CENELEC by the European Commission

and the European Free Trade Association.
Endorsement notice

The text of the International Standard IEC 61326-2-6:2020 was approved by CENELEC as a

European Standard without any modification.

In the official version, for Bibliography, the following notes have to be added for the standards

indicated:
IEC 60601-1-2:2014 NOTE Harmonized as EN 60601-1-2:2015 (not modified)
ISO 18113-1:2009 NOTE Harmonized as EN ISO 18113-1:2011 (not modified)
---------------------- Page: 4 ----------------------
SIST EN IEC 61326-2-6:2021
EN IEC 61326-2-6:2021 (E)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments)

applies.

NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod),

the relevant EN/HD applies.

NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is

available here: www.cenelec.eu.
The Annex ZA of EN IEC 61326-1:2021 applies with the following addition:
Publication Year Title EN/HD Year
IEC 61326-1 2020 Electrical equipment for measurement, EN IEC 61326-1 2021
control and laboratory use - EMC
requirements - Part 1: General
requirements
ISO 14971 2019 Medical devices – Application of risk EN ISO 14971 2019
management to medical devices
---------------------- Page: 5 ----------------------
SIST EN IEC 61326-2-6:2021
---------------------- Page: 6 ----------------------
SIST EN IEC 61326-2-6:2021
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: 7 ----------------------
SIST EN IEC 61326-2-6:2021
– 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: 8 ----------------------
SIST EN IEC 61326-2-6:2021
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,

Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC

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

in the subject dealt with may participate in this preparatory work. International, governmental and non-

governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely

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

agreement between the two organizations.

2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

consensus of opinion on the relevant subjects since each technical committee has representation from all

interested IEC National Committees.

3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

misinterpretation by any end user.

4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

transparently to the maximum extent possible in their national and regional publications. Any divergence

between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

the latter.

5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity

assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any

services carried out by independent certification bodies.

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

7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

members of its technical committees and IEC National Committees for any personal injury, property damage or

other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

Publications.

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: 9 ----------------------
SIST EN IEC 61326-2-6:2021
– 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: 10 ----------------------
SIST EN IEC 61326-2-6:2021
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: 11 ----------------------
SIST EN IEC 61326-2-6:2021
– 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 i
...

SLOVENSKI STANDARD
oSIST prEN IEC 61326-2-6:2019
01-oktober-2019
Električna oprema za merjenje, kontrolo in laboratorijsko uporabo - Zahteve za
elektromagnetno združljivost (EMC) - 2-6. del: Posebne zahteve - Diagnostična
medicinska oprema in vitro (IVD)

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)

Ta slovenski standard je istoveten z: prEN IEC 61326-2-6:2019
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
19.080 Električno in elektronsko Electrical and electronic
preskušanje testing
33.100.01 Elektromagnetna združljivost Electromagnetic compatibility
na splošno in general
oSIST prEN IEC 61326-2-6:2019 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN IEC 61326-2-6:2019
---------------------- Page: 2 ----------------------
oSIST prEN IEC 61326-2-6:2019
65A/928/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 61326-2-6 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2019-08-23 2019-11-15
SUPERSEDES DOCUMENTS:
65A/903/CD, 65A/913A/CC
IEC SC 65A : SYSTEM ASPECTS
SECRETARIAT: SECRETARY:
United Kingdom Mr Petar Luzajic
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
TC 77, SC 77A
Other TC/SCs are requested to indicate their interest, if any, in
this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY

SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING

Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft for Vote
(CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.

This document is still under study and subject to change. It should not be used for reference purposes.

Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which they are

aware and to provide supporting documentation.
TITLE:

Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular

requirements – In vitro diagnostic (IVD) medical equipment
PROPOSED STABILITY DATE: 2023
NOTE FROM TC/SC OFFICERS:

Copyright © 2019 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download this

electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions.

You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without

permission in writing from IEC.
---------------------- Page: 3 ----------------------
oSIST prEN IEC 61326-2-6:2019
65A/928/CDV – 2 – IEC CDV 61326-2-6 © IEC 2019
1 CONTENTS

2 FOREWORD ........................................................................................................................... 3

3 1 Scope ............................................................................................................................... 5

4 2 Normative references ....................................................................................................... 5

5 3 Terms and definitions ....................................................................................................... 5

6 3.1 Terms and definitions .............................................................................................. 5

7 4 General ............................................................................................................................ 7

8 5 EMC test plan ................................................................................................................... 7

9 5.1 General ................................................................................................................... 7

10 5.2 Configuration of EUT during testing ......................................................................... 7

11 5.3 Operation conditions of EUT during testing .............................................................. 7

12 5.4 Specification of functional performance ................................................................... 7

13 5.5 Test description ....................................................................................................... 7

14 6 Immunity requirements ..................................................................................................... 8

15 6.1 Conditions during the tests ...................................................................................... 8

16 6.2 Immunity test requirements ..................................................................................... 8

17 6.201 Risk assessment and consideration of EMC immunity requirements ........................ 8

18 6.3 Random aspects.................................................................................................... 11

19 6.4 Performance criteria .............................................................................................. 11

20 7 Emission requirements ................................................................................................... 12

21 8 Test results and test report ............................................................................................. 12

22 9 Instructions for use ......................................................................................................... 12

23 9.101 General requirements for the IVD medical equipment instruction for use ............... 12

24 9.102 Additional requirements for the instruction for use for equipment to be used

25 in a HOME HEALTHCARE ENVIRONMENT ........................................................... 12

26 9.103 Additional requirements for the instruction for use for equipment to be used

27 in a PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT .......................... 12

28 Annex A (normative) Immunity test requirements for PORTABLE TEST AND MEASUREMENT

29 EQUIPMENT powered by battery or from the circuit being measured .................................. 14

30 Bibliography .......................................................................................................................... 15

32 Table 101 – Immunity test requirements for equipment intended to be used in

33 PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT .................................................................... 8

34 Table 102 – Immunity test requirements for equipment intended to be used in a HOME

35 HEALTHCARE ENVIRONMENT ..................................................................................................... 10

---------------------- Page: 4 ----------------------
oSIST prEN IEC 61326-2-6:2019
IEC CDV 61326-2-6 © IEC 2019 – 3 – 65A/928/CDV
37 INTERNATIONAL ELECTROTECHNICAL COMMISSION
38 ____________
40 ELECTRICAL EQUIPMENT FOR MEASUREMENT,
41 CONTROL AND LABORATORY USE –
42 EMC REQUIREMENTS –
44 Part 2-6: Particular requirements –
45 Invitro diagnostic (IVD) medical equipment
48 FOREWORD

49 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

50 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote

51 international co-operation on all questions concerning standardization in the electrical and electronic fields. To

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

53 Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC

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

55 in the subject dealt with may participate in this preparatory work. International, governmental and non-

56 governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely

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

58 agreement between the two organizations.

59 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

60 consensus of opinion on the relevant subjects since each technical committee has representation from all

61 interested IEC National Committees.

62 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

63 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

64 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

65 misinterpretation by any end user.

66 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

67 transparently to the maximum extent possible in their national and regional publications. Any divergence

68 between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

69 the latter.

70 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity

71 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any

72 services carried out by independent certification bodies.

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

74 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

75 members of its technical committees and IEC National Committees for any personal injury, property damage or

76 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

77 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

78 Publications.

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

80 indispensable for the correct application of this publication.

81 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

82 patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

83 International Standard IEC 61326-2-6 has been prepared by subcommittee 65A WG4: System

84 aspects, of IEC technical committee 65: Industrial-process measurement, control and

85 automation.

86 This third edition cancels and replaces the second published in 2012. This edition constitutes

87 a technical revision.
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89 This edition includes the following significant technical change with respect to the previous

90 edition:
91 – Update of the document with respect to IEC 61326-1:202x.
92 The text of this standard is based on the following documents:
FDIS Report on voting
65A/631/FDIS 65A/640/RVD

94 Full information on the voting for the approval of this standard can be found in the report on

95 voting indicated in the above table.

96 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

97 This part of the IEC 61326 series is to be used in conjunction with IEC 61326-1:202x and

98 follows the same numbering of clauses, subclauses, tables and figures.

99 When a particular subclause of IEC 61326-1 is not mentioned in this part, that subclause

100 applies as far as is reasonable. When this standard states “addition”, “modification” or

101 “replacement”, the relevant text in IEC 61326-1 is to be adapted accordingly.

102 NOTE The following numbering system is used:

103 – subclauses, tables and figures that are numbered starting from 101 are additional to those in

104 IEC 61326-1;

105 – unless notes are in a new subclause or involve notes in IEC 61326-1, they are numbered starting from

106 101 including those in a replaced clause or subclause;
107 – additional annexes are lettered AA, BB, etc.

108 A list of all parts of the IEC 61326 series, under the general title Electrical equipment for

109 measurement, control and laboratory use – EMC requirements can be found on the IEC

110 website.

111 The committee has decided that the contents of this publication will remain unchanged until

112 the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data

113 related to the specific publication. At this date, the publication will be
114 • reconfirmed,
115 • withdrawn,
116 • replaced by a revised edition, or
117 • amended.
118
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119 ELECTRICAL EQUIPMENT FOR MEASUREMENT,
120 CONTROL AND LABORATORY USE –
121 EMC REQUIREMENTS –
122
123 Part 2-6: Particular requirements –
124 In vitro diagnostic (IVD) medical equipment
125
126
127
128 1 Scope

129 In addition to the scope of IEC 61326-1, this part of IEC 61326 series specifies minimum

130 requirements for immunity and emissions regarding electromagnetic compatibility for IN VITRO

131 DIAGNOSTIC (IVD) MEDICAL EQUIPMENT, taking into account the particularities and specific

132 aspects of this electrical equipment and their electromagnetic environment.
133 2 Normative references
134 Clause 2 of IEC 61326-1:202x applies, except as follows:
135 Addition:

136 IEC 61326-1:202x, Electrical equipment for measurement, control and laboratory use – EMC

137 requirements – Part 1: General requirements

138 ISO 14971:201x Medical devices – Application of risk management to medical devices

139 3 Terms and definitions

140 For the purposes of this document, the terms and definitions given in IEC 61326-1 apply,

141 except as follows.
142 3.1 Terms and definitions
143 Addition:
144 3.101
145 In vitro diagnostic (IVD) medical equipment

146 Instruments and apparatus intended for use in the diagnosis of disease or other conditions,

147 including a determination of the state of health, in order to cure, mitigate, treat, or prevent

148 disease

149 NOTE to entry: Such instruments or apparatus are intended for use in the collection, preparation, and examination

150 of specimens taken from the human body. No direct or wired patient connection with the device.

151 3.102
152 professional healthcare facility environment
153 an environment where professional healthcare is administered

154 NOTE 1 to entry: Locations include hospitals, diagnostic laboratories, blood banks, blood donation centres,

155 physician offices, intensive care units, surgical centres, emergency rooms, surgery rooms, clinics, patient rooms,

156 dental offices, limited care facilities, nursing homes, drugstore with trained operator, and first aid rooms.

157 NOTE 2 to entry: Most environments and locations in the PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT are

158 considered to have a CONTROLLED ELECTROMAGNETIC ENVIRONMENT with regard to fixed electromagnetic sources.

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159 Mobile communication devices are widely used by healthcare professionals in providing efficient patient care. For

160 this reason, it is more difficult to control the environment for proximity electromagnetic disturbances.

161 NOTE 3 to entry: Examples of electromagnetic sources that might be used adjacent to IVD medical equipment are:

162 – High Frequency Surgical Equipment
163 – Radio Frequency Identification (RFID) systems
164 – Wireless local area networks (WLAN)
165 – Handheld mobile radios (e.g. TETRA, two-way radio)
166 – Paging systems
167 – Other wireless devices (including consumer devices)

168 NOTE 4 to entry: It is assumed that IVD equipment is not directly connected to the public mains network.

169 NOTE 5 to entry: IVD medical equipment should have a suitable level of immunity to ensure the safe and effective

170 performance of the device in its intended use environment. As such, IVD medical equipment used in ambulances,

171 aircraft, cars and helicopters can require a higher level of immunity than the typical PROFESSIONAL HEALTHCARE

172 FACILITY ENVIRONMENT.
173 3.103
174 home healthcare environment

175 an environment other than a PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT with a much

176 more diverse electromagnetic environment with electromagnetic disturbances that may be

177 more uncontrolled and less well-characterized in terms of amplitude and probability of

178 occurrence.

179 NOTE 1 to entry: Except in transportation, IVD equipment is usually connected to the public mains network.

180 NOTE 2 to entry: These reasons justify higher immunity test levels for basic safety and essential performance.

181 Locations include any public setting, including the home of the patient, shops and libraries where anti-theft

182 equipment are used, transportation (e.g. airport security) metal detectors, etc.

183 NOTE 3 to entry: Examples of electromagnetic sources that might be used near IVD medical equipment in these

184 environments or otherwise expose the IVD equipment to intense electromagnetic disturbances are:

185 – Small mains frequency transformers (50 Hz and 60 Hz), e.g. in a clock radio on a bedside table

186 – Main
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