EN IEC 61326-2-6 was updated

The IEC pub­lished Edi­tion 4.0 of IEC 61326-2-6 on 18 June 2025; it applies to the basic safe­ty and essen­tial per­for­mance of in-vit­ro diag­nos­tic (IVD) med­ical elec­tri­cal equip­ment in the pres­ence of elec­tro­mag­net­ic disturbances. 

The main tech­ni­cal change is a revi­sion of test lev­els and doc­u­men­ta­tion require­ments for immu­ni­ty and emis­sions (i.e., updat­ed EMC test lev­els and report­ing expec­ta­tions). Man­u­fac­tur­ers of IVD med­ical devices should treat this as a sub­stan­tive update to how EMC per­for­mance is demon­strat­ed and recorded. 

Source: IEC 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• More stan­dards under MDR and IVDR harmonized
• Euro­pean har­monised stan­dards to be with­out charge
• Updat­ed Blue Guide and MDR and IVDR har­mo­nized standards