prEN IEC 61326-2-6/prAA

Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment prEN IEC 61326-2-6/prAA

General information

10.00 Proposal for new project registered   Mar 18, 2024

CENELEC

CLC/TC 65X Industrial-process measurement, control and automation

European Norm

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

Related legislation

Legislation related to this standard

2017/746

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

Life cycle

PREVIOUSLY

IN_DEVELOPMENT
prEN IEC 61326-2-6:2023

NOW

IN_DEVELOPMENT
prEN IEC 61326-2-6/prAA
10.00 Proposal for new project registered
Mar 18, 2024