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.

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

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.

Električna oprema za merjenje, kontrolo in laboratorijsko uporabo - Zahteve za elektromagnetno združljivost (EMC) - 2-6. del: Posebne zahteve - Diagnostična medicinska oprema in vitro (IEC 61326-2-6:2012)

Dodatno k področju uporabe standarda IEC 61326-1 določa ta del standarda IEC 61326 minimalne zahteve za odpornost in emisije v zvezi z elektromagnetno združljivostjo diagnostične medicinske opreme in vitro, z upoštevanjem posebnosti in posebnih vidikov te električne opreme in njenega elektromagnetnega okolja.

General Information

Status
Published
Publication Date
02-May-2013
Technical Committee
Drafting Committee
Current Stage
6060 - Document made available
Due Date
03-May-2013
Completion Date
03-May-2013

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SLOVENSKI STANDARD
SIST EN 61326-2-6:2013
01-julij-2013
1DGRPHãþD
SIST EN 61326-2-6:2007
(OHNWULþQDRSUHPD]DPHUMHQMHNRQWURORLQODERUDWRULMVNRXSRUDER=DKWHYH]D
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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
SIST EN 61326-2-6:2013 en

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

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SIST EN 61326-2-6:2013
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SIST EN 61326-2-6:2013
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
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SIST EN 61326-2-6:2013
EN 61326-2-6:2013 - 2 -
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 61326-2-6:2013 includes the following significant technical change with respect to

EN 61326-2-6:2006:
− update of the document with respect to EN 61326-1:2013.

EN 61326-2-6:2013 is to be used in conjunction with EN 61326-1:2013 and follows the same numbering

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).
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SIST EN 61326-2-6:2013
- 3 - EN 61326-2-6:2013
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SIST EN 61326-2-6:2013
EN 61326-2-6:2013 - 4 -
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
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SIST EN 61326-2-6:2013
- 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.
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SIST EN 61326-2-6:2013
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SIST EN 61326-2-6:2013
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

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
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SIST EN 61326-2-6:2013
– 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

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SIST EN 61326-2-6:2013
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

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6) All users should ensu
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