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EN IEC 61326-2-6:2025/prAA:2025

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

Draft Public enquiry
Comment end date 2026-01-16
Export comments Read draft and comment

Project stage codes

1. Decision on WI Proposal
2. Viešoji apklausa
From 2025-11-17 till 2026-01-16

Organisation

CENELEC Europos elektrotechnikos standartizacijos komitetas

ICS

33.100.20 - Immunity

ForeignTC'S

CLC/TC 65X

Number of comments

0

Comment start date

2025-11-17

Scope

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

Relations

Pagrindinis
LST EN IEC 61326-2-6:2025

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