SIST EN IEC 61326-2-6:2025

SLOVENSKI STANDARD
01-oktober-2025
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 61326-2-6:2025)
Electrical equipment for measurement, control and laboratory use - EMC requirements -
Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment (IEC
61326-2-6:2025)
Elektrische Mess-, Steuer-, Regel- und Laborgeräte - EMV-Anforderungen - Teil 2-6:
Besondere Anforderungen - Medizinische In-vitro-Diagnosegeräte (IVD) (IEC 61326-2-
6:2025)
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 (IEC
61326-2-6:2025) (IVD)
Ta slovenski standard je istoveten z: EN IEC 61326-2-6:2025
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 August 2025
ICS 17.220.20; 25.040.40; 33.100.20 Supersedes EN IEC 61326-2-6:2021
English Version
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)
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 électromédical de Medizinische In-vitro-Diagnosegeräte (IVD)
diagnostic in vitro (DIV) (IEC 61326-2-6:2025)
(IEC 61326-2-6:2025)
This European Standard was approved by CENELEC on 2025-07-23. 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,
Türkiye 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
© 2025 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 61326-2-6:2025 E

European foreword
The text of document 65A/1174/FDIS, future edition 4 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 61326-2-6:2025.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2026-08-31
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2028-08-31
document have to be withdrawn
This document supersedes EN IEC 61326-2-6:2021 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 is read in conjunction with EN IEC 61326-1:2021.
This document has been prepared under a standardization request addressed to CENELEC by the
European Commission. The Standing Committee of the EFTA States subsequently approves these
requests for its Member States.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 61326-2-6:2025 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 standard indicated:
IEC 60601-1-2:2014 NOTE Approved as EN 60601-1-2:2015 (not modified)
IEC 60601-1-11:2015 NOTE Approved as EN 60601-1-11:2015 (not modified)
IEC 61010-2-101:2018 NOTE Approved as EN IEC 61010-2-101:2022 (not modified)
ISO 18113-1:2022 NOTE Approved as EN ISO 18113-1:2024 (not modified)
ISO/TR 24971:2020 NOTE Approved as CEN ISO/TR 24971:2020 (not modified)
ISO 14971:2007 NOTE Approved as EN ISO 14971:2019 (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.cencenelec.eu.
Annex ZA of Part 1 is applicable except as follows:
Addition:
Publication Year Title EN/HD Year
IEC 61010 series Safety requirements for electrical EN IEC 61010 series
equipment for measurement, control, and
laboratory use
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 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

IEC 61326-2-6:2025-06(en-fr)
IEC 61326-2-6:2025 © IEC 2025
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
IEC 61326-2-6:2025 © IEC 2025
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
...