EN 61326-2-6:2013

SLOVENSKI STANDARD
01-julij-2013
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SIST EN 61326-2-6:2007
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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)
Elektrische Mess-, Steuer-, Regel- und Laborgeräte - EMV-Anforderungen - Teil 2-6:
Besondere Anforderungen - Medizinische In-vitro-Diagnosegeräte (IVD) (IEC 61326-2-
6:2012)
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)
(CEI 61326-2-6:2012)
Ta slovenski standard je istoveten z: EN 61326-2-6:2013
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
19.080 (OHNWULþQRLQHOHNWURQVNR Electrical and electronic
SUHVNXãDQMH testing
33.100.01 Elektromagnetna združljivost Electromagnetic compatibility
na splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 61326-2-6
NORME EUROPÉENNE
May 2013
EUROPÄISCHE NORM
ICS 17.220; 25.040.40; 33.100 Supersedes EN 61326-2-6:2006

English version
Electrical equipment for measurement, control and laboratory use -
EMC requirements -
Part 2-6: Particular requirements -
In vitro diagnostic (IVD) medical equipment
(IEC 61326-2-6:2012)
Matériel électrique de mesure, de Elektrische Mess-, Steuer-, Regel- und
commande et de laboratoire - Laborgeräte - EMV-Anforderungen -
Exigences relatives à la CEM - Teil 2-6: Besondere Anforderungen -
Partie 2- 6: Exigences particulières - Medizinische In-vitro-Diagnosegeräte
Matériel médical de diagnostic in vitro (IVD)
(IVD) (IEC 61326-2-6:2012)
(CEI 61326-2-6:2012)
This European Standard was approved by CENELEC on 2013-02-04. 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, Former Yugoslav Republic of Macedonia, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels

© 2013 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 61326-2-6:2013 E
Foreword
The text of document 65A/631/FDIS, future edition 2 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 61326-2-6:2013.

The following dates are fixed:
• latest date by which the document has (dop) 2013-11-04
to be implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2016-02-04
• latest date by which the national
standards conflicting with the

document have to be withdrawn
This document supersedes EN 61326-2-6:2006.
EN 61326-2-6:2006:
− update of the document with respect to EN 61326-1:2013.
of clauses, subclauses, tables and figures.
When a particular subclause of EN 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
EN 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 EN 61326-1;
– unless notes are in a new subclause or involve notes in EN 61326-1, they are numbered starting from 101 including
those in a replaced clause or subclause;
– additional annexes are lettered AA, BB, etc.

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] 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, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive(s) see informative Annex ZZ, which is an integral part of this
document.
Endorsement notice
The text of the International Standard IEC 61326-2-6:2012 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated:
ISO 18113-1:2009 NOTE  Harmonized as EN ISO 18113-1:2011 (not modified).

- 3 - EN 61326-2-6:2013
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

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.

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Addition to the Annex ZA of EN 61326-1:2013

Publication Year Title EN/HD Year

IEC 61326-1 2012 Electrical equipment for measurement, control EN 61326-1 2013
and laboratory use - EMC requirements -
Part 1: General requirements
ISO 14971 2007 Medical devices - Application of risk EN ISO 14971 2012
management to medical devices
- 5 - EN 61326-2-6:2013
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives

This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers only the
essential requirements in B.3.3 (only with regard to electromagnetic disturbances) and B.6.2 as given in
Annex I of EU Directive 98/79/EC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
NOTE: Other requirements and other EU Directives may be applicable to the products falling within the scope of this
standard.
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
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
...