prBAS EN IEC 61326-2-6:2026
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical electrical equipment
General information
Status:Project
Number of pages:70
Adoption method:Proglašavanje
Language:engleski
Edition:2.
Realization date:17.11.2025
Forseen date for next stage code:27.11.2025
Technical committee:BAS/TC 51, Automation
Directives:
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)
ICS:
25.040.40, Industrial process measurement and control
17.220.20, Measurement of electrical and magnetic quantities
33.100.20, Immunity
17.220.20, Measurement of electrical and magnetic quantities
33.100.20, Immunity
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.
Lifecycle
...
Original document and degree of correspondence
EN IEC 61326-2-6:2025, identical
IEC 61326-2-6:2025, identical
Relation to BAS standards
Work material
Only members of the technical committee have access to work material. If you are a members of this technical committee you need to login to view the documents. Login