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IEC 61326-2-6 Ed.4.0 Edition 06/2025
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical electrical equipment
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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.

Status

Standard - Active

Origin

Technical Committee :
65A : System aspects

Implementation

start of the vote on the project      date of ratification (dor)   
end of the vote on the project      date of anouncement (doa)   
start of the vote on the final project      date of publication (dop)   
end of the vote on the final project      date of withdrawal (dow)   


Publication Official Journal
of the Grand-Duchy of Luxembourg
Reference

Relations

Relations to older standards
IEC 61326-2-6 Ed.3.0

International Classification for Standards (ICS codes) :

17.220.20 : Measurement of electrical and magnetic quantities
25.040.40 : Industrial process measurement and control
33.100.20 : Immunity

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