IEC 61326-2-6:2012
(Main)Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
IEC 61326-2-6:2012 specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for in vitro diagnostic medical equipment, taking into account the particularities and specific aspects of this electrical equipment and their electromagnetic environment. This second edition cancels and replaces the first edition published in 2005 and constitutes a technical revision. It includes the following significant technical change: update of the document with respect to IEC 61326-1:2012.
This publication is to be read in conjunction with IEC 61326-1:2012.
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)
La CEI 61326-2-6:2012 spécifie les exigences minimales pour l'immunité et les émissions relatives à la compatibilité électromagnétique des matériels médicaux de diagnostic in vitro, en prenant en compte les particularités et aspects spécifiques de ces matériels et de leur environnement électromagnétique. Cette deuxième édition annule et remplace la première édition parue en 2005 et constitue une révision technique. Cette édition inclut la modification technique majeure suivante: mise à jour du document par rapport à la CEI 61326-1:2012.
Cette publication doit être lue conjointement avec la CEI 61326-1:2012.
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IEC 61326-2-6 ®
Edition 2.0 2012-07
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 2.0 2012-07
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
PRICE CODE
INTERNATIONALE
CODE PRIX L
ICS 17.220; 19.080; 25.040.40; 33.100 ISBN 978-2-83220-210-4
– 2 – 61326-2-6 © IEC:2012
CONTENTS
FOREWORD . 3
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 General . 6
4.101 Electromagnetic environment of IVD medical equipment . 6
5 EMC test plan . 6
5.1 General . 6
5.2 Configuration of EUT during testing . 6
5.3 Operation conditions of EUT during testing . 6
5.3.101 Operational conditions . 6
5.4 Specification of functional performance . 6
5.5 Test description . 6
6 Immunity requirements . 7
6.1 Conditions during the tests . 7
6.2 Immunity test requirements . 7
6.3 Random aspects. 8
6.4 Performance criteria . 9
7 Emission requirements . 9
8 Test results and test report . 9
9 Instructions for use . 9
9.1 Requirements for the IVD medical equipment instruction for use . 9
9.2 Instructions for IVD medical equipment for self-testing . 9
9.3 Instructions for IVD medical equipment for professional use . 9
Annex A (normative) Immunity test requirements for portable test and measurement
equipment powered by battery or from the circuit being measured . 10
Bibliography . 11
Table 101 – Immunity requirements for IVD medical equipment . 8
61326-2-6 © IEC:2012 – 3 –
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 second edition cancels and replaces the first edition published in 2005. This edition
constitutes a technical revision.
– 4 – 61326-2-6 © IEC:2012
This edition includes the following significant technical change with respect to the previous
edition:
– update of the document with respect to IEC 61326-1:2012.
The text of this standard is based on the following documents:
FDIS Report on voting
65A/631/FDIS 65A/640/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
This part of the IEC 61326 series is to be used in conjunction with IEC 61326-1:2012 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, control and laboratory use – EMC requirements can
be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until
the stability
...
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