SIST EN IEC 61326-2-6:2025/oprAA:2026

SLOVENSKI STANDARD
01-januar-2026
Električna oprema za merjenje, nadzor in laboratorijsko uporabo - Zahteve za
elektromagnetno združljivost (EMC) - 2-6. del: Posebne zahteve - In vitro
diagnostična (IVD) medicinska oprema
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 IEC 61326-2-6:2025/prAA: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 DRAFT
EN IEC 61326-2-6:2025
NORME EUROPÉENNE
EUROPÄISCHE NORM
prAA
November 2025
ICS 17.220.20; 25.040.40; 33.100.20 -
English Version
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 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)
This draft amendment prAA, if approved, will modify the European Standard EN IEC 61326-2-6:2025; it is submitted to CENELEC members
for enquiry.
Deadline for CENELEC: 2026-02-06.

It has been drawn up by CLC/TC 65X.

If this draft becomes an amendment, CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which
stipulate the conditions for giving this amendment the status of a national standard without any alteration.

This draft amendment was established by CENELEC 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.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.

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.
Project: 79798 Ref. No. EN IEC 61326-2-6:2025/prAA:2025 E

Contents Page
9 European foreword . 3
10 Introduction . 4
11 1 Modifications to Clause 4, “General” . 5
12 2 Modification to Clause 5, “EMC test plan” . 5
13 3 Modifications to Clause 6, “Immunity requirements” . 5
14 4 Modification to Clause 9, “Instruction for use” . 5
15 5 Addition of Annex H, “Guidance on the testing of laboratory automation systems” . 5
16 6 Replacement of Annex ZA, “Normative references to international publications with their
17 corresponding European publications” . 7
18 Annex ZA (normative) Normative references to international publications with their
19 corresponding European publications . 8
20 Annex ZZ (informative) Relationship between this European standard and the General Safety and
21 Performance Requirements of Regulation (EU) 2017/746 aimed to be covered .11
22 European foreword
23 This document (EN IEC 61326-2-6:2025/prAA:2025) has been prepared by CLC/TC 65X “Industrial-process
24 measurement, control and automation”.
25 This document is currently submitted to the Enquiry.
26 The following dates are proposed:
• latest date by which the existence of this (doa) dav + 6 months
document has to be announced at national
level
• latest date by which this document has to be (dop) dav + 12 months
implemented at national level by publication of
an identical national standard or by
endorsement
• latest date by which the national standards (dow) dav + 36 months
conflicting with this document have to be (to be confirmed or
withdrawn modified when voting)
27 This document has been prepared under a standardization request addressed to CENELEC by the European
28 Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
29 Member States.
30 For the relationship with EU Legislation, see informative Annex ZZ, which is an integral part of this document.
31 Introduction
32 The purpose of this amendment is to identify and modify the requirements that would not fit the IVDR
33 requirements, so that the amendment could be harmonized under Directive (EU) 2017/746 of 5 April 2017
34 concerning in vitro diagnostic medical devices [OJ L 117].
35 1 Modifications to Clause 4, “General”
36 In the modification to the last paragraph, replace “The MANUFACTURER” with “The MANUFACTURER and the EMC
37 test lab”.
st
38 In 4.101, replace the 1 paragraph with the following:
39 “During risk analysis, the performance of the diagnostic function(s) according to the intended use/user
40 documentation of the IVD MEE, other than that related to BASIC SAFETY, that is necessary to achieve its intended
41 use or that could affect the safety of the IVD MEE were it lost or degraded.”
st nd
42 In 4.101, replace the 1 part of the 2 paragraph with the following:
43 “To identify ESSENTIAL PERFORMANCE the MANUFACTURER and the EMC test lab shall:”
44 In 4.101, last paragraph, replace ”the MANUFACTURER” with ”THE MANUFACTURER and the EMC test lab”.
st nd rd th
45 In 4.102, 1 , 2 , 3 and 4 paragraphs, replace ”the MANUFACTURER” with ”THE MANUFACTURER and the EMC
46 test lab”.
47 2 Modification to Clause 5, “EMC test plan”
48 In 5.2.101, add the following note:
49 “NOTE  For automated diagnostic laboratories, consider Annex H for guidance on the testing of laboratory automation
50 systems.”
51 After 5.2.101, add the following subclause:
52 “5.2.102 Laboratory automation systems
53 Laboratory automation systems (LAS) help increase the automation in diagnostic laboratories. These systems
54 are typically designed to support various configurations, enhancing the automation of multiple IVD MEE
55 analysers, and can be flexibly adapted to the footprint and layout of diagnostic laboratories. Annex H provides
56 guidance on EMC testing for LAS, specifically on the configuration of the equipment under test (EUT) LAS
57 during EMC testing.”
nd
58 In 5.3.101, 2 paragraph, replace ”the MANUFACTURER” with ”THE MANUFACTURER and the EMC test lab” (twice).
59 3 Modifications to Clause 6, “Immunity requirements”
60 In 6.201, 4th paragraph, replace ”the MANUFACTURER” with ”THE MANUFACTURER and the EMC test lab” (twice).
61 In 6.201, Table 101 and Table 102, footnote g, replace “circuitry” with “circuitry with active electronics”.
62 In 6.201, 8th paragraphs, replace ”the MANUFACTURER” with ”THE MANUFACTURER and the EMC test lab”.
63 In 6.201, 10th paragraph, replace ”MANUFACTURERS” with ”MANUFACTURERS and the EMC test lab”.
64 In 6.201, 10th paragraph, a), replace “circuitry” with “circuitry with active electronics”.
65 4 Modification to Clause 9, “Instruction for use”
66 In 9.101, d), e) and f), replace ”the manufacturer” with ”the manufacturer and the EMC test lab”.
67 5 Addition of Annex H, “Guidance on the testing of laboratory automation systems”
68 Add the following annex:
69 “
70 Annex H
71 (informative)
73 Guidance on the testing of laboratory automation systems
75 H.1 Introduction
76 Annex H provides guidance on the test setup and EMC requirements for Laboratory Automation Systems for
77 the purpose of connecting and automating laboratory IVD analysers and related equipment.
78 A laboratory automation system (LAS) is a modular system designed to increase the automation in clinical
79 laboratories. For example:
80 — Automate pre-analytical and post analytical sample processing, including sample handling, transportation
81 and storage, in order to automate sample processing performed by attached analysers.
82 — Automate the preparation, processing, transportation and storage of laboratory chemicals like reagents and
83 buffer solutions, in order to automate laboratory chemicals handling.
84 — Automate the processing, transportation and storage of laboratory consumables, like empty sample tubes
85 and pipetting tips, in order to automate the consumables handling.
86 H.2 Configuration of a EUT lab automation system
87 H.2.1 General
88 The configuration of a LAS can be very large and modular in construction so that they are configurable according
89 to the layout of the laboratory and the IVD analysers contained within it. A LAS therefore does not have a defined
90 configuration and therefore may be broken down into subsystems (EUT LAS subsystem) and tested according
91 to subclause 5.2.101 Subsystems.
92 H.2.2 EUT LAS analyser interface
93 The LAS analyser interface is the LAS subsystem used for interfacing the LAS with the IVD analysers. The EUT
94 LAS analyser interface is composed of the combined LAS analyser interface and the analyser.
95 If multiple methods of communication (ethernet, serial, fibre optic, etc.) are available between the LAS and the
96 analyser, the most critical communication method, as determined by risk analysis, should be monitored and
97 immunity tested. If available communication methods are similar in criticality, they should all be monitored and
98 immunity tested.
99 If a LAS analyser interface is capable of interfacing with a variety of analyser types and/or manufacturers, it is
100 recommended to test the combination(s) of LAS analyser interface and analyser(s) that result(s) most likely in
101 unacceptable risk. The risk management process should be used to determine the EUT LAS subsystem(s)
102 combination.
103 H.3 Operation modes
104 H.3.1 General
105 Subclause 5.3 applies, except as follows:
106 Addition:
107 Each EUT LAS subsystem should be operated in a mode that simulates the operation of the LAS subsystem as
108 if it were connected to the entire LAS and analyser. It is recommended to test functions and modes that include
109 a feature or control such that the failure or malfunction would most likely result in an unacceptable risk or to not
110 achieve its intended use.
111 H.3.2 LAS Analyser interface operation mode
112 The EUT LAS analyser interfaces should simulate the delivery of the PATIENT sample either by pipetting or
113 transfer of the sample tube into the analyser, while maintaining the chain of custody of the PATIENT sample and
114 simulating processing of the sample by the analyser. If this operation mode is not feasible due to the analyser
115 manufacturer differing from that of the LAS, simulated operation of both systems independently of one another
116 according to subclause 5.2.101 is acceptable for the purpose of exercising the combined EUT LAS interface.
117 There may be other items delivered by the EUT LAS interface that are critical and need to be considered, for
118 example: reagents and consumables.
119 H.4 Immunity and Emission Test Requirements
120 A EUT LAS subsystems should meet the immunity test requirements described in 6.2, Table 101 (PROFESSIONAL
121 HEALTHCARE FACILITY ENVIRONMENT) and the emission test requirements describes in Clause 7.
122 H.5 BASIC SAFETY of a EUT Lab Automation System
123 The description in Clause F.3 is also applicable for the BASIC SAFETY of EUT LAS subsystem.
124 H.6 ESSENTIAL PERFORMANCE of a EUT Lab Automation System
125 In order to evaluate the ESSENTIAL PERFORMANCE of a EUT LAS subsystem, the procedure described in
126 Figure F.4 should be followed.
127 Table H.1 — Examples of ESSENTIAL PERFORMANCE Immunity pass criteria for a LAS EUT subsystem
Functions of a LAS EUT subsystem that are
No. I
...