IEC 61326-2-6:2025
(Main)Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical electrical equipment
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical electrical equipment
IEC 61326-2-6:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IN VITRO DIAGNOSTIC MEDICAL ELECTRICAL EQUIPMENT (IVD MEE). This part of IEC 61326 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IVD MEE in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by IVD MEE.
BASIC SAFETY with regard to electromagnetic disturbances is applicable to all IVD MEE.
NOTE 1 Performance with respect to electromagnetic disturbances other than ESSENTIAL PERFORMANCE is the subject of IEC 61326-1:2020
NOTE 2 IT equipment can be a part of an IVD MEE, if it is required to maintain BASIC SAFETY or ESSENTIAL PERFORMANCE.
This edition includes the following significant technical changes with respect to the previous edition:
- Update of the document with respect to test levels and documentation.
Matériel électrique de mesure, de commande et de laboratoire - Exigences relatives à la CEM - Partie 2-6: Exigences particulières - Matériel électromédical de diagnostic in vitro (DIV)
IEC 61326-2-6:2025 s'applique à la sécurité de base et aux performances essentielles du matériel électromédical de diagnostic in vitro. La présente partie de l'IEC 61326 s'applique à la sécurité de base et aux performances essentielles du matériel électromédical de diagnostic in vitro en présence de perturbations électromagnétiques, ainsi qu'aux perturbations électromagnétiques émises par le matériel électromédical de diagnostic in vitro.
La sécurité de base concernant les perturbations électromagnétiques s'applique à tous les matériels électromédicaux de diagnostic in vitro.
NOTE 1 Les performances en ce qui concerne les perturbations électromagnétiques autres que les performances essentielles font l'objet de l'IEC 61326-1:2020.
NOTE 2 Le matériel informatique peut faire partie d'un matériel électromédical de diagnostic in vitro s'il est exigé pour le maintien de la sécurité de base ou des performances essentielles.
Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
mise à jour du document par rapport aux niveaux d'essai et à la documentation.
General Information
Relations
Standards Content (Sample)
IEC 61326-2-6 ®
Edition 4.0 2025-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Electrical equipment for measurement, control and laboratory use - EMC
requirements -
Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical electrical
equipment
Matériel électrique de mesure, de commande et de laboratoire - Exigences
relatives à la CEM -
Partie 2-6: Exigences particulières - Matériel électromédical de diagnostic in
vitro (DIV)
ICS 17.220.20, 25.040.40, 33.100.20 ISBN 978-2-8327-0509-4
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or
by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either
IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC copyright
or have an enquiry about obtaining additional rights to this publication, please contact the address below or your local
IEC member National Committee for further information.
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni
utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie et
les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.
IEC Secretariat Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.
IEC publications search - IEC Products & Services Portal - products.iec.ch
webstore.iec.ch/advsearchform Discover our powerful search engine and read freely all the
The advanced search enables to find IEC publications by a publications previews, graphical symbols and the glossary.
variety of criteria (reference number, text, technical With a subscription you will always have access to up to date
committee, …). It also gives information on projects, content tailored to your needs.
replaced and withdrawn publications.
Electropedia - www.electropedia.org
IEC Just Published - webstore.iec.ch/justpublished The world's leading online dictionary on electrotechnology,
Stay up to date on all new IEC publications. Just Published containing more than 22 500 terminological entries in English
details all new publications released. Available online and and French, with equivalent terms in 25 additional languages.
once a month by email. Also known as the International Electrotechnical Vocabulary
(IEV) online.
IEC Customer Service Centre - webstore.iec.ch/csc
If you wish to give us your feedback on this publication or
need further assistance, please contact the Customer
Service Centre: sales@iec.ch.
A propos de l'IEC
La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.
A propos des publications IEC
Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possédez l’édition la
plus récente, un corrigendum ou amendement peut avoir été publié.
Recherche de publications IEC - IEC Products & Services Portal - products.iec.ch
webstore.iec.ch/advsearchform Découvrez notre puissant moteur de recherche et consultez
La recherche avancée permet de trouver des publications gratuitement tous les aperçus des publications, symboles
IEC en utilisant différents critères (numéro de référence, graphiques et le glossaire. Avec un abonnement, vous aurez
texte, comité d’études, …). Elle donne aussi des toujours accès à un contenu à jour adapté à vos besoins.
informations sur les projets et les publications remplacées
ou retirées. Electropedia - www.electropedia.org
Le premier dictionnaire d'électrotechnologie en ligne au
IEC Just Published - webstore.iec.ch/justpublished monde, avec plus de 22 500 articles terminologiques en
Restez informé sur les nouvelles publications IEC. Just anglais et en français, ainsi que les termes équivalents
Published détaille les nouvelles publications parues. dans 25 langues additionnelles. Egalement appelé
Disponible en ligne et une fois par mois par email. Vocabulaire Electrotechnique International (IEV) en ligne.
Service Clients - webstore.iec.ch/csc
Si vous désirez nous donner des commentaires sur cette
publication ou si vous avez des questions contactez-
nous: sales@iec.ch.
CONTENTS
FOREWORD . 3
1 Scope . 5
2 Normative references . 5
3 Terms, definitions and abbreviations . 5
3.1 Terms and definitions . 5
3.2 Abbreviations . 8
4 General . 8
4.101 ESSENTIAL PERFORMANCE. 8
4.102 BASIC SAFETY . 8
5 EMC test plan . 9
5.1 General . 9
5.2 Configuration of EUT during testing . 9
5.2.101 Subsystems. 9
5.3 Operation conditions of EUT during testing . 9
5.3.101 Operation conditions . 9
5.4 Specification of FUNCTIONAL PERFORMANCE . 10
5.5 Test description . 10
6 Immunity requirements . 10
6.1 Conditions during the tests . 10
6.101 Conditions during the tests . 10
6.2 Immunity test requirements . 10
6.201 Risk assessment and consideration of EMC immunity requirements . 11
6.3 Random aspects . 16
6.4 Performance criteria. 17
6.401 Pass/fail criteria. 17
7 Emission requirements . 17
8 Test results and test report . 17
9 Instructions for use . 17
9.101 General requirements for the IVD MEE instructions for use . 18
9.102 Additional requirements for the instructions for use for equipment to be used
in a HOME HEALTHCARE ENVIRONMENT . 19
9.103 Additional requirements for the instructions for use for equipment to be used
in a PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT . 19
Annex A (normative) Immunity test requirements for PORTABLE TEST AND MEASUREMENT
powered by battery or from the circuit being measured . 20
EQUIPMENT
Annex B (informative) General guidance and rationale for updating the IEC 61326-2-
6:2020 – Background for maintenance leading to edition 4 of this document . 21
Annex C (informative) How to apply this document and its intended use environments . 22
Annex D (informative) Guidance: Test plan . 23
Annex E (informative) Power input voltages and frequencies during tests . 25
Annex F (informative) Guidance on the application of risk management with regard to
electromagnetic disturbances and the Identification of immunity pass/fail criteria risks
of EUT to identify critical immunity testing . 26
F.1 Introductory remarks . 26
F.2 Immunity pass/fail criteria principles . 26
F.2.1 General. 26
F.2.2 Immunity pass/fail criteria for non-IVD MEE used in an IVD MEE . 26
F.2.3 Immunity pass/fail criteria determination . 26
F.3 BASIC SAFETY . 27
F.4 ESSENTIAL PERFORMANCE. 27
F.5 Immunity pass/fail criteria examples . 27
F.5.1 General examples . 27
F.5.2 Examples and guidance for developing test plan immunity pass/fail
criteria for ESSENTIAL PERFORMANCE and BASIC SAFETY for IVD
Immunoassay Analyzer . 28
Annex G (informative) Guidance on how to apply Table 104 . 30
Bibliography . 31
Figure C.1 – Standard/environment decision . 22
Figure F.1 – ESSENTIAL PERFORMANCE evaluation. 27
Figure F.2 – Relation of risk analysis and test plan . 29
Figure G.1 – Steps for evaluation of immunity to proximity magnetic fields . 30
Table 101 – Immunity test requirements for equipment intended to be used in the
PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT . 12
Table 102 – Immunity test requirements for equipment intended to be used in the HOME
HEALTHCARE ENVIRONMENT . 13
Table 103 – Test specifications for ENCLOSURE PORT immunity to RF wireless
communications equipment . 15
Table 104 – Test specifications for ENCLOSURE PORT immunity to proximity magnetic
fields . 16
Table D.1 – Recommended minimum test plan contents . 23
Table E.1 – Power input voltages and frequencies during the tests . 25
Table F.1 – Examples of ESSENTIAL PERFORMANCE Immunity pass criteria for an IVD
immunoassay analyzer . 29
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
Electrical equipment for measurement, control and laboratory use -
EMC requirements - Part 2-6: Particular requirements -
In vitro diagnostic (IVD) medical electrical 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 bet
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.