40.60 Close of voting Feb 6, 2026
CENELEC
CLC/TC 65X Industrial-process measurement, control and automation
European Norm
17.220.20 Measurement of electrical and magnetic quantities | 25.040.40 Industrial process measurement and control | 33.100.20 Immunity
Draft
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IN VITRO
DIAGNOSTIC MEDICAL ELECTRICAL EQUIPMENT. 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
Legislation related to this standard
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
PUBLISHED
EN IEC 61326-2-6:2025
IN_DEVELOPMENT
EN IEC 61326-2-6:2025/prAA:2025
40.60
Close of voting
Feb 6, 2026
