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

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. The contents of the corrigendum of September 2007 have been included in this copy.

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)

spécifie les exigences minimales pour l'immunité et à l'émission 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. Le contenu du corrigendum de septembre 2007 a été pris en considération dans cet exemplaire.

Električna oprema za merjenje, kontrolo in laboratorijsko uporabo - Zahteve za elektromagnetno združljivost (EMC) - 2-6. del: Posebne zahteve - Diagnostična medicinska oprema in vitro (IVD) (IEC 61326-2-6:2005)

General Information

• Status: Withdrawn
• Publication Date: 04-May-2006
• Withdrawal Date: 31-Jan-2009
• 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
• Parallel Committee: IEC/SC 65A - IEC_SC_65A
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 04-Feb-2016
• Completion Date: 04-Feb-2016
• 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
• Ref Project: SIST EN 61326-2-6:2007 - Electrical equipment for measurement, control and laboratory use - EMC requirements -- Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment

Relations

• Replaces: EN 61326:1997/A3:2003 - Electrical equipment for measurement, control and laboratory use - EMC requirements
• Effective Date: 29-Jan-2023
• Replaces: EN 61326:1997 - Electrical equipment for measurement, control and laboratory use - EMC requirements
• Effective Date: 29-Jan-2023
• Replaces: EN 61326:1997/A2:2001 - Electrical equipment for measurement, control and laboratory use - EMC requirements
• Effective Date: 29-Jan-2023
• Replaces: EN 61326:1997/A1:1998 - Electrical equipment for measurement, control and laboratory use - EMC requirements
• Effective Date: 29-Jan-2023
• Replaced By: 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
• Effective Date: 29-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2007
(OHNWULþQDRSUHPD]DPHUMHQMHNRQWURORLQODERUDWRULMVNRXSRUDER=DKWHYH]D
HOHNWURPDJQHWQR]GUXåOMLYRVW(0&GHO3RVHEQH]DKWHYH'LDJQRVWLþQD
PHGLFLQVNDRSUHPDLQYLWUR,9',(&
Electrical equipment for measurement, control and laboratory use - EMC requirements -
Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
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)
Ta slovenski standard je istoveten z: EN 61326-2-6:2006
ICS:
11.100.10
25.040.40
33.100.01
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 61326-2-6
NORME EUROPÉENNE
May 2006
EUROPÄISCHE NORM
ICS 25.040.40; 33.100 Supersedes EN 61326:1997 + A1:1998 + A2:2001 + A3:2003

English version
Electrical equipment for measurement, control and laboratory use –
EMC requirements
Part 2-6: Particular requirements –
In vitro diagnostic (IVD) medical equipment
(IEC 61326-2-6:2005)
Matériel électrique de mesure,  Elektrische Mess-, Steuer-, Regel-
de commande et de laboratoire – und Laborgeräte –
Exigences relatives à la CEM EMV-Anforderungen
Partie 2- 6: Exigences particulières – Teil 2-6: Besondere Anforderungen –
Matériel médical de diagnostic Medizinische In-vitro-Diagnosegeräte
in vitro (IVD) (IVD)
(CEI 61326-2-6:2005) (IEC 61326-2-6:2005)

This European Standard was approved by CENELEC on 2005-12-01. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, the Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

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

Central Secretariat: rue de Stassart 35, B - 1050 Brussels

© 2006 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 61326-2-6:2006 E
Foreword
The text of document 65A/455/FDIS, future edition 1 of IEC 61326-2-6, prepared by SC 65A, System
aspects, of IEC TC 65, Industrial-process measurement and control, was submitted to the IEC-CENELEC
parallel vote and was approved by CENELEC as EN 61326-2-6 on 2005-12-01.
The EN 61326 series supersedes EN 61326:1997 + corrigendum September 1998 + A1:1998 + A2:2001
+ A3:2003.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2006-12-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2009-02-01
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive 98/79/EC. See Annex ZZ.
Annexes ZA and ZZ have been added by CENELEC.
.
__________
Endorsement notice
The text of the International Standard IEC 61326-2-6:2005 was approved by CENELEC as a European
Standard without any modification.
__________
- 3 - EN 61326-2-6:2006
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following referenced documents are indispensable for the application 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 Where an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Publication Year Title EN/HD Year
IEC 60050-161 1990 International Electrotechnical Vocabulary – –
Chapter 161: Electromagnetic compatibility

IEC 61326-1 2005 Electrical equipment for measurement, EN 61326-1 2006
control and laboratory use –
EMC requirements
Part 1: General requirements
ISO 14971 2000 Medical devices – Application of risk EN ISO 14971 2000
management to medical devices
Annex ZZ
(informative)
Coverage of Essential Requirements of EC 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 all
relevant essential requirements as given in Annex I of the EC Directive 98/79/E.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
___________
NORME CEI
INTERNATIONALE
IEC
61326-2-6
INTERNATIONAL
Première édition
STANDARD
First edition
2005-12
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)

Electrical equipment for measurement,
control and laboratory use –
EMC requirements –
Part 2-6:
Particular requirements –
In vitro diagnostic (IVD) medical equipment
 IEC 2005 Droits de reproduction réservés  Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in any
utilisée sous quelque forme que ce soit et par aucun procédé, form or by any means, electronic or mechanical, including
électronique ou mécanique, y compris la photocopie et les photocopying and microfilm, without permission in writing from
microfilms, sans l'accord écrit de l'éditeur. the publisher.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: [phone] Telefax: [phone] E-mail: [e-mail] Web: www.iec.ch
CODE PRIX
K
PRICE CODE
Commission Electrotechnique Internationale
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
Pour prix, voir catalogue en vigueur
For price, see current catalogue

61326-2-6  IEC:2005 – 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 used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 61326-2-6 has been prepared by subcommittee 65A: System
aspects, of IEC technical committee 65: Industrial-process measurement and control.
The IEC 61326 series cancels and replaces IEC 61326:2002 and constitutes a technical
revision.
61326-2-6  IEC:2005 – 5 –
The text of this standard is based on the following documents:
FDIS Report on voting
65A/455/FDIS 65A/459/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
It consists of the following parts, under the general title Electrical equipment for
measurement, control and laboratory use – EMC requirements:
Part 1: General requirements – (Annexes A and B of IEC 61326: 2002 are integrated in
the main body of IEC 61326-1)
Part 2-1: Sensitive test and measurement equipment for EMC unprotected applications
(Annex D of IEC 61326:2002)
Part 2-2: Portable test, measuring and monitoring equipment used in low-voltage
distribution systems (Annex E of IEC 61326:2002)
Part 2-3: Transducers with integrated or remote signal conditioning (includes Annex F of
IEC 61326:2002)
Part 2-4: Insulation monitoring devices according to IEC 61557-8 and for equipment for
insulation fault location according to IEC 61557-9
Part 2-5: Test configurations, operational conditions and performance criteria for field
devices with interfaces according to communication profile Family 3 Profile 3/2
Part 2-6: In vitro diagnostic (IVD) medical equipment
Part 3-1: Immunity requirements for equipment performing or intended to perform safety
related functions (functional safety) – Part 3.1: General industrial applications
(The matter of functional safety in Table 2 of IEC 61326:2002 is incorporated into
IEC 61326-3-1)
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
To be published
61326-2-6  IEC:2005 – 7 –
ELECTRICAL EQUIPMENT FOR MEASUREMENT,
CONTROL AND LABORATORY USE –
EMC REQUIREMENTS –
Part 2-6: Particular requirements –
In vitro diagnostic (IVD) medical equipment

1 Scope
In addition to the scope of International Standard IEC 61326-1, this part 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.
2 Normative references
The following referenced documents are indispensable for the application 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.
IEC 60050-161:1990, International Electrotechnical Vocabulary (IEV) – Part 161: Electro-
magnetic compatibility
IEC 61326-1:2005, Electrical equipment for measurement, control and laboratory use – EMC
requirements – Part 1: General requirements
ISO 14971: 2000, Medical devices – application of risk management to medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 61326-1 and
IEC 60050(161) as well as the following apply.
3.101
in vitro diagnostic medical equipment
instruments and apparatus intended for use in t
...