Standard

IEC 61326-2-6:2025 ED4

Jun 2025 Published

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Language English/French

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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 61326-1:2020 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.

Document information

Standard from IEC
Published: 18 June 2025
Edition: 4
Document type: IS
Pages
ISBN: 9782832705094

Publisher IEC
Distributor IEC
ICS 17.220.20
ICS 25.040.40
ICS 33.100.20
ISO TC TC 65/SC 65A

Product Relations

Revises: IEC 61326-2-6:2020 ED3
Revises: IEC 61326-2-6:2020 RLV
FRANKFURT AGREEMENT: FprEN IEC 61326-2-6:2025

IEC 61326-2-6:2025 ED4

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