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IEC 61326-2-6
Edition 3.0 2020-10
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Electrical equipment for measurement, control and laboratory use –
EMC requirements –
Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment
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IEC 61326-2-6
Edition 3.0 2020-10
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Electrical equipment for measurement, control and laboratory use –
EMC requirements –
Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 17.220.20; 25.040.40; 33.100.20 ISBN 978-2-8322-9014-9
– 2 – IEC 61326-2-6:2020 RLV © IEC 2020
CONTENTS
FOREWORD . 3
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 General . 8
5 EMC test plan . 8
5.1 General . 8
5.2 Configuration of EUT during testing . 8
5.3 Operation conditions of EUT during testing . 8
5.4 Specification of FUNCTIONAL PERFORMANCE . 9
5.5 Test description . 9
6 Immunity requirements . 9
6.1 Conditions during the tests. 9
6.2 Immunity test requirements . 9
6.3 Random aspects . 10
6.4 Performance criteria . 13
7 Emission requirements . 14
8 Test results and test report . 14
9 Instructions for use . 14
Annex A (normative) Immunity test requirements for PORTABLE TEST AND MEASUREMENT
EQUIPMENT powered by battery or from the circuit being measured . 16
Annex B (informative) Guide for analysis and assessment for electromagnetic
compatibility. 17
Bibliography . 18
Table 101 – Immunity requirements for IVD medical equipment .
Table 101 – Immunity test requirements for equipment intended to be used in
PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT . 11
Table 102 – Immunity test requirements for equipment intended to be used in a HOME
HEALTHCARE ENVIRONMENT . 12
Table 103 – Immunity test requirements for equipment intended to be used in a HOME
HEALTHCARE ENVIRONMENT . 13
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
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
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2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
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6) All users should ensure that they have the latest edition of this publication.
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
This redline version of the official IEC Standard allows the user to identify the changes
made to the previous edition. A vertical bar appears in the margin wherever a change
has been made. Additions are in green text, deletions are in strikethrough red text.
– 4 – IEC 61326-2-6:2020 RLV © IEC 2020
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.
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, that subclause
applies as far as is reasonable. When this standard states “addition”, “modification” or
“replacement”, the relevant text in IEC 61326-1 is to be adapted accordingly.
NOTE The following numbering system is used:
– subclauses, tables and figures that are numbered starting from 101 are additional to those in
IEC 61326-1;
– unless notes are in a new subclause or involve notes in IEC 61326-1, they are numbered starting from 101
including those in a replaced clause or subclause;
– additional annexes are lettered AA, BB, etc.
A list of all parts of the IEC 61326 series, under the general title Electrical equipment for
measurement, control and laboratory use – EMC requirements, can be found on the IEC
website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
– 6 – IEC 61326-2-6:2020 RLV © IEC 2020
ELECTRICAL EQUIPMENT FOR MEASUREMENT,
CONTROL AND LABORATORY USE –
EMC REQUIREMENTS –
Part 2-6: Particular requirements –
In vitro diagnostic (IVD) medical equipment
1 Scope
In addition to the scope of IEC 61326-1, this part of IEC 61326 specifies minimum
requirements for immunity and emissions regarding electromagnetic compatibility for IN VITRO
DIAGNOSTIC (IVD) MEDICAL EQUIPMENT, taking into account the particularities and specific
aspects of this electrical equipment and their electromagnetic environment.
2 Normative references
Clause 2 of IEC 61326-1:20122020 applies, except as follows:
Addition:
IEC 61326-1:20122020, Electrical equipment for measurement, control and laboratory use –
EMC requirements – Part 1: General requirements
ISO 14971:20072019, Medical devices – Application of risk management to medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 61326-1 apply,
except as follows.
...