oSIST prEN IEC 61326-2-6:2023

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

Elektrische Mess-, Steuer-, Regel- und Laborgeräte - EMV-Anforderungen - Teil 2-6: Besondere Anforderungen - Medizinische In-vitro-Diagnosegeräte (IVD)

Matériel électrique de mesure, de commande et de laboratoire - Exigences relatives à la CEM - Partie 2-6: Exigences particulières - Matériel médical de diagnostic in vitro (IVD)

Električna oprema za merjenje, nadzor in laboratorijsko uporabo - Zahteve za elektromagnetno združljivost (EMC) - 2-6. del: Posebne zahteve - In vitro diagnostična (IVD) medicinska oprema

General Information

• Status: Not Published
• Public Enquiry End Date: 19-Dec-2023
• ICS: 11.100.10 - In vitro diagnostic test systems
• ICS: 17.220.20 - Measurement of electrical and magnetic quantities
• ICS: 19.080 - Electrical and electronic testing
• ICS: 25.040.40 - Industrial process measurement and control
• ICS: 33.100.01 - Electromagnetic compatibility in general
• ICS: 33.100.20 - Immunity
• Technical Committee: MOV - Measuring equipment for electromagnetic quantities
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 03-Oct-2023
• Due Date: 20-Feb-2024
• Directive: 2014/30/EU - Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (recast)
• Directive: 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
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
• Mandate: M/552 - [C(2016) 7641 final] Standardisation request as regards harmonised standards in support of Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: prEN IEC 61326-2-6:2023 - Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment

Relations

• Revises: SIST EN IEC 61326-2-6:2021 - Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment (IEC 61326-2-6:2020)
• Effective Date: 03-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN IEC 61326-2-6:2023
01-december-2023
Električna oprema za merjenje, nadzor in laboratorijsko uporabo - Zahteve za
elektromagnetno združljivost (EMC) - 2-6. del: Posebne zahteve - In vitro
diagnostična (IVD) medicinska oprema
Electrical equipment for measurement, control and laboratory use - EMC requirements -
Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
Elektrische Mess-, Steuer-, Regel- und Laborgeräte - EMV-Anforderungen - Teil 2-6:
Besondere Anforderungen - Medizinische In-vitro-Diagnosegeräte (IVD)
Matériel électrique de mesure, de commande et de laboratoire - Exigences relatives à la
CEM - Partie 2-6: Exigences particulières - Matériel médical de diagnostic in vitro (IVD)
Ta slovenski standard je istoveten z: prEN IEC 61326-2-6:2023
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
19.080 Električno in elektronsko Electrical and electronic
preskušanje testing
33.100.01 Elektromagnetna združljivost Electromagnetic compatibility
na splošno in general
oSIST prEN IEC 61326-2-6:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN IEC 61326-2-6:2023

---------------------- Page: 2 ----------------------
oSIST prEN IEC 61326-2-6:2023
65A/1102/CDV

COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 61326-2-6 ED4
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2023-09-29 2023-12-22
SUPERSEDES DOCUMENTS:
65A/1070/CD, 65A/1097/CC

IEC SC 65A : SYSTEM ASPECTS
SECRETARIAT: SECRETARY:
United Kingdom Ms Stephanie Lavy
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:

TC 77,SC 77A
Other TC/SCs are requested to indicate their interest, if
any, in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.

This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of
which they are aware and to provide supporting documentation.
Recipients of this document are invited to submit, with their comments, notification of any relevant “In Some
Countries” clauses to be included should this proposal proceed. Recipients are reminded that the CDV stage is
the final stage for submitting ISC clauses. (SEE AC/22/2007 OR NEW GUIDANCE DOC).

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

PROPOSED STABILITY DATE: 2025

NOTE FROM TC/SC OFFICERS:

Copyright © 2023 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download this

electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions.
You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without
permission in writing from IEC.

---------------------- Page: 3 ----------------------
oSIST prEN IEC 61326-2-6:2023
– 2 – IEC CDV 61326-2-6 © IEC:2023
1 CONTENTS
2
3 FOREWORD . 4
4 1. Scope . 6
5 2. Normative references . 6
6 3. Terms and definitions . 6
7 Terms and definitions . 7
8 Abbreviations . 8
9 4. General . 9
10 Essential Performance . 9
11 Basic Safety . 9
12 5. EMC test plan .
...