IEC 61326-2-6-ed.4.0

Annotation of standard text IEC 61326-2-6-ed.4.0 :

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. IEC 61326-2-6:2025 sapplique a la securite de base et aux performances essentielles du materiel electromedical de diagnostic in vitro. La presente partie de lIEC 61326 sapplique a la securite de base et aux performances essentielles du materiel electromedical de diagnostic in vitro en presence de perturbations electromagnetiques, ainsi quaux perturbations electromagnetiques emises par le materiel electromedical de diagnostic in vitro. La securite de base concernant les perturbations electromagnetiques sapplique a tous les materiels electromedicaux de diagnostic in vitro. NOTE 1 Les performances en ce qui concerne les perturbations electromagnetiques autres que les performances essentielles font lobjet de lIEC 61326-1:2020. NOTE 2 Le materiel informatique peut faire partie dun materiel electromedical de diagnostic in vitro sil est exige pour le maintien de la securite de base ou des performances essentielles. Cette edition inclut les modifications techniques majeures suivantes par rapport a ledition precedente: mise a jour du document par rapport aux niveaux dessai et a la documentation.