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Projekto etapai

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

Organizacija

CENELEC Europos elektrotechnikos standartizacijos komitetas

ICS

33.100.20 - Atsparumas trukdžiams

Užsienio technikos komitetas

CLC/TC 65X

Komentarų skaičius

0

Komentavimo pradžia

2025-11-17

Taikymo sritis

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

Ryšiai

Pagrindinis
LST EN IEC 61326-2-6:2025

Elektrinė matavimo, valdymo ir laboratorinė įranga. EMS reikalavimai. 2-6 dalis. Ypatingieji reikalavimai. In vitro diagnostikos medicinos įranga