Standard

NEK EN IEC 61326-2-6:2025

Aug 2025 Published

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Abstract

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 61326-1:2020NOTE 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.

Document information

Standard from NEK
Published: 26 August 2025
Edition: 2025-08
Version: 1
Document type: NAT
ISBN:

ICS 17.220.20
ICS 25.040.40
ICS 33.100.20
National Committee NEK/NK65

Product Relations

Replaces: NEK EN IEC 61326-2-6:2021
Adopted from: EN IEC 61326-2-6:2025

NEK EN IEC 61326-2-6:2025

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