EN IEC 61326-2-6:2021
(Main)Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
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.
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)
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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)
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
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
– 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
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
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9) Attention is drawn to the possibility that some of the elements of this IEC
...
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