EN 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 electrical equipment EN IEC 61326-2-6:2025

Publication date:   Sep 18, 2025

General information

90.93   Standard confirmed   Jul 13, 2026

CENELEC

CLC/TC 65X Industrial-process measurement, control and automation

European Norm

17.220.20   Measurement of electrical and magnetic quantities | 25.040.40   Industrial process measurement and control | 33.100.20   Immunity

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Scope

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.

Related legislation

Legislation related to this standard

2014/30/EU

Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (recast)

Life cycle

PREVIOUSLY

PUBLISHED
EN IEC 61326-2-6:2021

NOW

PUBLISHED
EN IEC 61326-2-6:2025
90.93 Standard confirmed
Jul 13, 2026

CORRIGENDA / AMENDMENTS

IN_DEVELOPMENT
EN IEC 61326-2-6:2025/prA1

IN_DEVELOPMENT
EN IEC 61326-2-6:2025/prAA:2025




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