IEC 61326-2-6:2020

IEC 61326-2-6 ®
Edition 3.0 2020-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Electrical equipment for measurement, control and laboratory use –
EMC requirements –
Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment

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)

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IEC 61326-2-6 ®
Edition 3.0 2020-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Electrical equipment for measurement, control and laboratory use –

EMC requirements –
Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment

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)

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 17.220.20; 25.040.40; 33.100.20 ISBN 978-2-8322-8983-9

– 2 – IEC 61326-2-6:2020 © IEC 2020
CONTENTS
FOREWORD . 3
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 General . 7
5 EMC test plan . 7
5.1 General . 7
5.2 Configuration of EUT during testing . 7
5.3 Operation conditions of EUT during testing . 7
5.4 Specification of FUNCTIONAL PERFORMANCE . 7
5.5 Test description . 7
6 Immunity requirements . 7
6.1 Conditions during the tests. 7
6.2 Immunity test requirements . 8
6.3 Random aspects . 11
6.4 Performance criteria . 11
7 Emission requirements . 12
8 Test results and test report . 12
9 Instructions for use . 12
Annex A (normative) Immunity test requirements for PORTABLE TEST AND MEASUREMENT
EQUIPMENT powered by battery or from the circuit being measured . 14
Annex B (informative) Guide for analysis and assessment for electromagnetic
compatibility. 15
Bibliography . 16

Table 101 – Immunity test requirements for equipment intended to be used in
PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT . 9
Table 102 – Immunity test requirements for equipment intended to be used in a HOME
HEALTHCARE ENVIRONMENT . 10
Table 103 – Immunity test requirements for equipment intended to be used in a HOME
HEALTHCARE ENVIRONMENT . 11

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
ELECTRICAL EQUIPMENT FOR MEASUREMENT,
CONTROL AND LABORATORY USE –
EMC REQUIREMENTS –
Part 2-6: Particular requirements –
In vitro diagnostic (IVD) medical equipment

FOREWORD
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International Standard IEC 61326-2-6 has been prepared by subcommittee 65A: System
aspects, of IEC technical committee 65: Industrial-process measurement, control and
automation.
This third edition cancels and replaces the second published in 2012. This edition constitutes
a technical revision.
This edition includes the following significant technical change with respect to the previous
edition:
– update of the document with respect to IEC 61326-1:2020.

– 4 – IEC 61326-2-6:2020 © IEC 2020
The text of this International Standard is based on the following documents:
FDIS Report on voting
65A/979/FDIS 65A/990/RVD
Full information on the voting for the approval of this International Standard can be found in
the report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document the following print types are used:
– Terms used throughout this document which have been defined in Clause 3 of this
document and of IEC 61326-1:2020: SMALL CAPITALS.
This part of IEC 61326 is to be used in conjunction with IEC 61326-1:2020 and follows the
same numbering of clauses, subclauses, tables and figures.
When a particular subclause of IEC 61326-1 is not mentioned in this part,
...