EN 61326-2-6:2013

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
• Withdrawal Date: 03-Feb-2016
• ICS: 17.220 - Electricity. Magnetism. Electrical and magnetic measurements
• ICS: 25.040.40 - Industrial process measurement and control
• ICS: 33.100 - Electromagnetic compatibility (EMC)
• Technical Committee: CLC/TC 65X - Industrial-process measurement, control and automation
• Drafting Committee: IEC/SC 65A - IEC_SC_65A
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 03-May-2013
• Completion Date: 03-May-2013
• Directive: 2004/108/EU - DIRECTIVE 2004/108/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
• Ref Project: SIST EN 61326-2-6:2013 - 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)

Relations

• Replaces: EN 61326-2-6:2006 - Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
• Effective Date: 29-Jan-2023
• Replaced By: EN IEC 61326-2-6:2021 - Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
• Effective Date: 03-Apr-2018

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 61326-2-6:2013
01-julij-2013
1DGRPHãþD
SIST EN 61326-2-6:2007
(OHNWULþQDRSUHPD]DPHUMHQMHNRQWURORLQODERUDWRULMVNRXSRUDER=DKWHYH]D
HOHNWURPDJQHWQR]GUXåOMLYRVW(0&GHO3RVHEQH]DKWHYH'LDJQRVWLþQD
PHGLFLQVNDRSUHPDLQYLWUR,(&
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
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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

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© 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. W
...