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

Status
Published
Publication Date
03-Jun-2021
Current Stage
6060 - Document made available - Publishing
Start Date
04-Jun-2021
Completion Date
04-Jun-2021

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Standards Content (Sample)

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.

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SIST EN IEC 61326-2-6:2021

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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

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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 Europea
...

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.

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oSIST prEN IEC 61326-2-6:2019

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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.

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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 .
...

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