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IEC 61326-2-6 ED4

Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical electrical equipment

General information

50.60     4 pri 2025

IEC

TC 65/SC 65A

International Standard

17.220.20     25.040.40     33.100.20  

Scope

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.

Life cycle

PREVIOUSLY

PUBLISHED
IEC 61326-2-6:2020 ED3

NOW

IN_DEVELOPMENT
IEC 61326-2-6 ED4
50.60 Close of voting. Proof returned by secretariat
4 pri 2025