IEC 60601-1-2:2007

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

This collateral standard applies to electromagnetic compatibility of medical electrical equipment and medical electrical systems. The object of this collateral standard is to specify general requirements and tests for electromagnetic compatibility of medical electrical equipment and medical electrical systems. They are in addition to the requirements of the general standard and serve as the basis for particular standards. This edition of IEC 60601-1-2 was revised to structurally align it with the 2005 edition of IEC 60601-1 and to implement the decision of IEC subcommittee 62A that the clause numbering structure of collateral standards written to IEC 60601-1:2005 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The principle technical changes are in Clause 4, which now recognizes that there is a general requirement for a risk management process in IEC 60601-1:2005. The contents of the interpretation sheet of March 2010 have been included in this copy.

Appareils électromédicaux - Partie 1-2: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Compatibilité électromagnétique - Exigences et essais

Cette norme collatérale s'applique à la compatibilité électromagnétique des appareils et des systèmes électromédicaux. La présente norme collatérale a pour objet de spécifier les exigences générales ainsi que les essais pour la compatibilité électromagnétique des appareils et des systèmes electromédicaux. Elles viennent en complément des exigences de la norme générale et servent de base pour les normes particulières. La présente édition de la CEI 60601-1-2 a été révisée en vue d'un alignement structurel avec l'édition de 2005 de la CEI 60601-1 et pour implémenter la décision du sous-comité 62A de la CEI qui stipule que la structure de numérotation des articles des normes collatérales de la CEI 60601-1:2005 devrait respecter la forme spécifiée dans les Directives ISO/CEI, Partie 2:2004. Les modifications techniques principales se trouvent à l'Article 4, qui reconnaît à présent qu'il existe une exigence générale pour le processus de gestions des risques dans la CEI 60601-1:2005. Le contenu de la feuille d'interprétation de mars 2010 a été pris en considération dans cet exemplaire.

General Information

• Status: Published
• Publication Date: 29-Mar-2007
• ICS: 11.040.01 - Medical equipment in general
• ICS: 33.100.10 - Emission
• ICS: 33.100.20 - Immunity
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 25-Feb-2014

Relations

• Revises: IEC 60601-1-2:2001/AMD1:2004 - Amendment 1 - Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-1-2:2001 - Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
• Effective Date: 05-Sep-2023
• Revised: IEC 60601-1-2:2014 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
• Effective Date: 05-Sep-2023
• Revised: IEC 60601-1-2:2007/ISH1:2010 - Interpretation sheet 1 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL IEC
STANDARD 60601-1-2
Third edition
2007-03
Medical electrical equipment –
Part 1-2:
General requirements for basic
safety and essential performance –
Collateral standard:
Electromagnetic compatibility –
Requirements and tests
This English-language version is derived from the original
bilingual publication by leaving out all French-language
pages. Missing page numbers correspond to the French-
language pages.
Reference number
Publication numbering
As from 1 January 1997 all IEC publications are issued with a designation in the

60000 series. For example, IEC 34-1 is now referred to as IEC 60034-1.

Consolidated editions
The IEC is now publishing consolidated versions of its publications. For example,

edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the base publication, the

base publication incorporating amendment 1 and the base publication incorporating

amendments 1 and 2.
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thus ensuring that the content reflects current technology. Information relating to
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INTERNATIONAL IEC
STANDARD 60601-1-2
Third edition
2007-03
Medical electrical equipment –
Part 1-2:
General requirements for basic
safety and essential performance –
Collateral standard:
Electromagnetic compatibility –
Requirements and tests
© IEC 2007 Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical,
including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: [phone] Telefax: [phone] E-mail: [e-mail] Web: www.iec.ch
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Commission Electrotechnique Internationale
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
For price, see current catalogue

60601-1-2 © IEC:2007 – 3 –
CONTENTS
FOREWORD.9

INTRODUCTION.15

1 Scope, object and related standards.19

1.1 * Scope .19

1.2 Object .19

1.3 Related standards .19

2 Normative references .19
3 Terms and definitions .23
4 General requirements .29
4.1 General requirements for ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT
and ME SYSTEMS .29
4.2 * SINGLE FAULT CONDITION for ME EQUIPMENT.31
5 Identification, marking and documents.31
5.1 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts .31
5.2 ACCOMPANYING DOCUMENTS.33
6 ELECTROMAGNETIC COMPATIBILITY .77
6.1 EMISSIONS .77
6.2 IMMUNITY .83

Annex A (informative) General guidance and rationale.115
Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS.175
Annex C (informative) Example completion of Table 1 through Table 8 .181
Annex D (informative) Guidance in classification according to CISPR 11 .205
Annex E (informative) Guidance in the application of IEC 60601-1-2 to particular
standards.211
Annex F (informative) ELECTROMAGNETIC ENVIRONMENTS .217
Annex G (informative) Guidance for determining if electrical equipment that is not ME
EQUIPMENT and that is used in an ME SYSTEM is exempt from the EMC testing
requirements of this collateral standard .219
Annex H (informative) Mapping between the elements of the second edition of

IEC 60601-1-2 as amended and IEC 60601-1-2:2007 .223

Bibliography.239

Index of defined terms used in this collateral standard.241

Figure 1 – Instructions for completing Table 1 for CISPR 11 ME EQUIPMENT and
ME SYSTEMS.41
Figure 2 – Instructions for completing Table 1 for CISPR 14 and CISPR 15
ME EQUIPMENT .43
Figure 3 – Instructions for completing Table 2.49
Figure 4 – Instructions for completing Table 3 and Table 5 for LIFE-SUPPORTING
ME EQUIPMENT and ME SYSTEMS .61

60601-1-2 © IEC:2007 – 5 –
Figure 5 – Instructions for completing Table 4 and Table 6 for ME EQUIPMENT and

ME SYSTEMS that are not LIFE-SUPPORTING .63

Figure A.1 – Example of cable arrangement for radiated IMMUNITY test .171

Figure A.2 – Examples showing maximum dimension for ME EQUIPMENT with one and

with two cables .173

Figure G.1 – Procedure for determining if electrical equipment that is not ME EQUIPMENT

and that is used in an ME SYSTEM is exempt from the EMC testing requirements of this

collateral standard .221

Table 1 – Guidance and MANUFACTURER’S declaration – ELECTROMAGNETIC EMISSIONS –

for all ME EQUIPMENT and ME SYSTEMS .39
Table 2 – Guidance and MANUFACTURER’S declaration []– electromagnetic IMMUNITY –
for all ME EQUIPMENT and ME SYSTEMS .47
Table 3 – Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY – for
LIFE-SUPPORTING ME EQUIPMENT and ME SYSTEMS .53
Table 4 – Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY – for
ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING .55
Table 5 – Recommended separation distances between portable and mobile RF
communications equipment and the ME EQUIPMENT or ME SYSTEM – for LIFE-SUPPORTING
ME EQUIPMENT and ME SYSTEMS .57
Table 6 – Recommended separation distances between portable and mobile RF
communications equipment and the ME EQUIPMENT or ME SYSTEM – for ME EQUIPMENT
and ME SYSTEMS that are not LIFE-SUPPORTING.59
Table 7 – Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY – for
LIFE-SUPPORTING ME EQUIPMENT and ME SYSTEMS that are specified for use only in a
shielded location.71
Table 8 – Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY – for
ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING and are specified for use
only in a shielded location.73
Table 9 – Modulation frequency, PHYSIOLOGICAL SIMULATION FREQUENCY, and
OPERATING FREQUENCY .91
Table 10 – IMMUNITY TEST LEVELS for voltage dips .109
Table 11 – IMMUNITY TEST LEVEL for voltage interruption .109
Table B.1 – Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts .175
Table B.2 – ACCOMPANYING DOCUMENTS, instructions for use .177
Table B.3 – ACCOMPANYING DOCUMENTS, technical description.179

Table C.1 – Example (1) of completed Table 1.181
Table C.2 – Example (2) of completed Table 1.183
Table C.3 – Example (3) of completed Table 1.185
Table C.4 – Example of completed Table 2 .187
Table C.5 – Example (1) test, IMMUNITY and COMPLIANCE LEVELS .189
Table C.6 – Example of completed Table 3 .191
Table C.7 – Example of completed Table 5 .193
Table C.8 – Example of completed Table 4 .195
Table C.9 – Example of completed Table 6 .197
Table C.10 – Example (2) test, IMMUNITY and COMPLIANCE LEVELS .197

60601-1-2 © IEC:2007 – 7 –
Table C.11 – Example of completed Table 7 .199

Table C.12 – Example (3) test, IMMUNITY and COMPLIANCE LEVELS .201

Table C.13 – Example of completed Table 8 .203

Table F.1 – ELECTROMAGNETIC ENVIRONMENTS .217

Table H.1 – Mapping between the elements of the eecond edition of IEC 60601-1-2 as

amended and IEC 60601-1-2:2007.223

60601-1-2 © IEC:2007 – 9 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION

____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 1-2: General requirements for basic safety

and essential performance –
Collateral standard:
Electromagnetic compatibility – Requirements and tests

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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with the International Organization for Standardization (ISO
...

NORME CEI
INTERNATIONALE 60601-1-2
Troisième édition
2007-03
Appareils électromédicaux –
Partie 1-2:
Règles générales pour la sécurité
de base et les performances essentielles –
Norme collatérale:
Compatibilité électromagnétique –
Exigences et essais
Cette version française découle de la publication d’origine
bilingue dont les pages anglaises ont été supprimées.
Les numéros de page manquants sont ceux des pages
supprimées.
Numéro de référence
CEI 60601-1-2:2007(F)
Numérotation des publications
Depuis le 1er janvier 1997, les publications de la CEI sont numérotées à partir de

60000. Ainsi, la CEI 34-1 devient la CEI 60034-1.

Editions consolidées
Les versions consolidées de certaines publications de la CEI incorporant les

amendements sont disponibles. Par exemple, les numéros d’édition 1.0, 1.1 et 1.2

indiquent respectivement la publication de base, la publication de base incorporant

l’amendement 1, et la publication de base incorporant les amendements 1 et 2

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NORME CEI
INTERNATIONALE 60601-1-2
Troisième édition
2007-03
Appareils électromédicaux –
Partie 1-2:
Règles générales pour la sécurité
de base et les performances essentielles –
Norme collatérale:
Compatibilité électromagnétique –
Exigences et essais
© IEC 2007 Droits de reproduction réservés
Aucune partie de cette publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun
procédé, électronique ou mécanique, y compris la photocopie et les microfilms, sans l'accord écrit de l'éditeur.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: [phone] Telefax: [phone] E-mail: [e-mail] Web: www.iec.ch
CODE PRIX
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Commission Electrotechnique Internationale
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
Pour prix, voir catalogue en vigueur

– 2 – 60601-1-2 © CEI:2007
SOMMAIRE
AVANT-PROPOS.8

INTRODUCTION.14

1 Domaine d'application, objet et normes connexes .18

1.1 * Domaine d’application.18

1.2 Objet .18

1.3 Normes connexes.18

2 Références normatives.18
3 Termes et définitions .22
4 Exigences générales .28
4.1 Exigences générales concernant la COMPATIBILITÉ ÉLECTROMAGNÉTIQUE des
APPAREILS et des SYSTÈMES EM .28
4.2 * CONDITION DE PREMIER DÉFAUT pour les APPAREILS EM.30
5 Identification, marquage et documentation .30
5.1 Marquage sur l’extérieur des APPAREILS EM ou des parties d’APPAREIL EM.30
5.2 DOCUMENTS D'ACCOMPAGNEMENT .32
6 COMPATIBILITÉ ÉLECTROMAGNÉTIQUE .76
6.1 EMISSIONS .76
6.2 IMMUNITÉ .82

Annexe A (informative) Guide général et justifications .114
Annexe B (informative) Guide pour le marquage et exigences d'étiquetage pour les
APPAREILS EM et les SYSTÈMES EM .174
Annexe C (informative) Exemple pour remplir les Tableaux 1 à 8.180
Annexe D (informative) Lignes directrices relatives à la classification selon la
CISPR 11.204
Annexe E (informative) Lignes directrices pour l’application de la CEI 60601-1-2 aux
normes particulières .210
Annexe F (informative) ENVIRONNEMENTS ÉLECTROMAGNÉTIQUES .216
Annexe G (informative) Lignes directrices pour déterminer si un appareil électrique qui
n’est pas un APPAREIL EM et qui est utilisé dans un SYSTÈME EM est exempt des
exigences d’essai CEM de la présente norme collatérale .218

Annexe H (informative) Correspondance entre les éléments de la deuxième édition de
la CEI 60601-1-2 amendée et la CEI 60601-1-2:2007 .222

Bibliographie.238

Index des termes définis dans la présente norme collatérale .240

Figure 1 – Instructions pour remplir le Tableau 1 pour les APPAREILS ET SYSTÈMES EM CISPR
11 .40
Figure 2 – Instructions pour remplir le Tableau 1 pour les APPAREILS EM CISPR 14 et

CISPR 15.42
Figure 3 – Instructions pour remplir le Tableau 2 .48
Figure 4 – Instructions pour remplir le Tableau 3 et le Tableau 5 pour les APPAREILS et
les SYSTÈMES EM DE MAINTIEN DE LA VIE .60

– 4 – 60601-1-2 © CEI:2007
Figure 5 – Instructions pour remplir le Tableau 4 et le Tableau 6 pour les APPAREILS et

les SYSTÈMES EM autres que DE MAINTIEN DE LA VIE .62

Figure A.1 – Exemple de disposition de câbles pour l'essai D'IMMUNITÉ aux

rayonnements .170

Figure A.2 – Exemples montrant la dimension maximale pour un APPAREIL EM avec un
ou deux câbles .172

Figure G.1 – Procédure pour déterminer si un appareil électrique qui n’est pas un

APPAREIL EM et qui est utilisé dans un SYSTÈME EM est exempt des exigences d’essai

CEM de la présente norme collatérale .220

Tableau 1 – Directives et déclaration du FABRICANT – ÉMISSIONS ÉLECTROMAGNÉTIQUES
– pour tous les APPAREILS et SYSTÈMES EM.38
Tableau 2 – Directives et déclaration du FABRICANT – IMMUNITÉ électromagnétique –
pour tous les APPAREILS et SYSTÈMES EM .46
Tableau 3 – Directives et déclaration du FABRICANT – IMMUNITÉ électromagnétique –
pour tous les APPAREILS et SYSTÈMES EM DE MAINTIEN DE LA VIE .52
Tableau 4 – Directives et déclaration du FABRICANT – IMMUNITÉ électromagnétique –
pour tous les APPAREILS et SYSTÈMES EM DE MAINTIEN DE LA VIE .54
Tableau 5 – Distances de séparation recommandées entre les appareils portatifs et
mobiles de communications RF et l’APPAREIL ou le SYSTÈME EM – pour les APPAREILS et
les SYSTÈME EM DE MAINTIEN DE LA VIE .56
Tableau 6 – Distances de séparation recommandées entre les appareils portatifs et
mobiles de communications RF et l’APPAREIL ou le SYSTÈME EM – pour les APPAREILS et
les SYSTÈME EM autres que DE MAINTIEN DE LA VIE .58
Tableau 7 – Directives et déclaration du FABRICANT – IMMUNITÉ électromagnétique –
pour les APPAREILS et SYSTÈMES EM DE MAINTIEN DE LA VIE destinés à être utilisés
uniquement dans un emplacement blindé .70
Tableau 8 – Directives et déclaration du FABRICANT – IMMUNITÉ électromagnétique –
pour les APPAREILS et SYSTÈMES EM autres que DE MAINTIEN DE LA VIE destinés à être
utilisés uniquement dans un emplacement blindé .72
Tableau 9 – Fréquence de modulation, FRÉQUENCE DE SIMULATION PHYSIOLOGIQUE, et
FRÉQUENCE DE FONCTIONNEMENT .90
Tableau 10 – NIVEAUX D'ESSAI D'IMMUNITÉ relatifs aux creux de tension .108
Tableau 11 – NIVEAU D'ESSAI D'IMMUNITÉ relatif à une coupure de tension.108
Tableau B.1 – Marquage sur l’extérieur de L’APPAREIL EM, des SYSTÈMES EM ou de
leurs parties.174

Tableau B.2 – DOCUMENTS D’ACCOMPAGNEMENT, instructions d’utilisation.176
Tableau B.3 – DOCUMENTS D'ACCOMPAGNEMENT, description technique.178
Tableau C.1 – Exemple (1) de Tableau 1 complété .180
Tableau C.2 – Exemple (2) de Tableau 1 complété .182
Tableau C.3 – Exemple (3) de Tableau 1 complété .184
Tableau C.4 – Exemple de Tableau 2 complété .186
Tableau C.5 – Essai exemple (1), IMMUNITÉ et NIVEAUX DE CONFORMITÉ .188
Tableau C.6 – Exemple de Tableau 3 complété .190
Tableau C.7 – Exemple de Tableau 5 complété .192
Tableau C.8 – Exemple de Tableau 4 complété .194
Tableau C.9 – Exemple de Tableau 6 complété .196
Tableau C.10 – Essai exemple (2), IMMUNITÉ et NIVEAUX DE CONFORMITÉ .196

– 6 – 60601-1-2 © CEI:2007
Tableau C.11 – Exemple de Tableau 7 complété .198

Tableau C.12 – Essai exemple (3), IMMUNITÉ et NIVEAUX DE CONFORMITÉ .200

Tableau C.13 – Exemple de Tableau 8 complété .202

Tableau F.1 – ENVIRONNEMENTS ÉLECTROMAGNÉTIQUES .216

Tableau H.1 – Correspondance entre les éléments de la deuxième édition de la

CEI 60601-1-2 amendée et la CEI 60601-1-2:2007 .222

– 8 – 60601-1-2 © CEI:2007
COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE

____________
APPAREILS ÉLECTROMÉDICAUX –
Partie 1-2: Exigences générales pour la sécurité de base

et les performances essentielles –

Norme collatérale:
Compatibilité électromagnétique – Exigences et essais

AVANT-PROPOS
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composée de l'ensemble des comités électrotechniques nationaux (Comités nationaux de la CEI). La CEI a
pour objet de favoriser la coopération internationale pour toutes les questions de normalisation dans les
domaines de l'électricité et de l'électronique. A cet effet, la CEI – entre autres activités – publie des Normes
internationales, des Spécifications techniques, des Rapports techniques, des Spécifications accessib
...

IEC 60601-1-2
Edition 3.0 2007-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 1-2: General requirements for basic safety and essential performance –
Collateral standard: Electromagnetic compatibility – Requirements and tests

Appareils électromédicaux –
Partie 1-2: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Compatibilité électromagnétique –
Exigences et essais
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IEC 60601-1-2
Edition 3.0 2007-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 1-2: General requirements for basic safety and essential performance –
Collateral standard: Electromagnetic compatibility – Requirements and tests

Appareils électromédicaux –
Partie 1-2: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Compatibilité électromagnétique –
Exigences et essais
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XF
CODE PRIX
ICS 11.040.01; 33.100.10; 33.100.20 ISBN 2-8318-9050-0

– 1 –
SC 62A/Publication IEC 60601-1-2 (2007), Third edition/I-SH 01
MEDICAL ELECTRICAL EQUIPMENT –

Part 1-2: General requirements for
basic safety and essential performance –
Collateral standard: Electromagnetic compatibility –
Requirements and tests
INTERPRETATION SHEET
This interpretation sheet has been prepared by SC 62A: Common aspects of electrical
equipment used in medical practice.
The text of this interpretation sheet is based on the following documents:
ISH Report on voting
62A/685/ISH 62A/694/RVD
Full information on the voting for the approval of this interpretation sheet can be found in the
report on voting indicated in the above table.
___________
Subclause 6.2.2.2 e) (ESD IMMUNITY)
1)
(This is also applicable to Subclause 36.202.2 b) 5) in IEC 60601-1-2:2001 .)
This subclause states the following:
The test may be performed with the ME EQUIPMENT or ME SYSTEM powered at any one of its
NOMINAL input voltages and frequencies.
This is clarified by the following:
The test may be performed at any input power voltage and frequency within the ME
EQUIPMENT or ME SYSTEM RATED voltage and frequency range. If the ME EQUIPMENT or ME
SYSTEM is tested at one power input voltage and one power input frequency meeting this
specification, it is not necessary to re-test at additional voltages or frequencies.
Subclause 6.2.3.2 j) (Radiated RF IMMUNITY)
(This is also applicable to Subclause 36.202.3 b) 10) in IEC 60601-1-2:2001.)
This subclause states the following:
The test may be performed with the ME EQUIPMENT or ME SYSTEM powered at any one of its
NOMINAL input voltages and frequencies.
This is clarified by the following:
—————————
1)
A consolidated edition 2.1 exists (withdrawn) including IEC 60601-1-2:2001 and its Amendment 1 (2004).
March 2010 ICS 11.040.01; 33.100.10; 33.100.20 French text overleaf

– 2 –
The test may be performed at any power input voltage and frequency within the ME
EQUIPMENT or ME SYSTEM RATED voltage and frequency range. If the EQUIPMENT or SYSTEM is
tested at one power input voltage and one power input frequency meeting this
specification, it is not necessary to re-test at additional voltages or frequencies.
Subclause 6.2.4.2 e) (EFT/burst IMMUNITY)
(This is also applicable to Subclause 36.202.4 b) 5) in IEC 60601-1-2:2001.)
This subclause states the following:
For ME EQUIPMENT and ME SYSTEMS that have, for power input, multiple voltage settings or
autoranging voltage capability, the test is performed at the minimum and maximum RATED
input voltages. The test may be performed with the ME EQUIPMENT or ME SYSTEM powered at
any one of its NOMINAL power frequencies.
This is clarified by the following:
For ME EQUIPMENT and ME SYSTEMS that have, for power input, multiple voltage settings or
autoranging voltage capability, the test shall be performed at the minimum and maximum
ME EQUIPMENT or ME SYSTEM RATED power input voltages. The test may be performed at any
power input frequency within the ME EQUIPMENT or ME SYSTEM RATED range. If the ME
EQUIPMENT or ME SYSTEM is tested at power input voltages and a power input frequency
meeting these specifications, it is not necessary to re-test at additional voltages or
frequencies.
Subclause 6.2.5.2 f) (Surge IMMUNITY)
(This is also applicable to Subclause 36.202.5 b) 6) in IEC 60601-1-2:2001.)
This subclause states the following:
For ME EQUIPMENT and ME SYSTEMS that have, for power input, multiple voltage settings or
autoranging voltage capability, the test is performed at the minimum and maximum RATED
input voltages. The test may be performed with the ME EQUIPMENT or ME SYSTEM powered at
any one of its NOMINAL power frequencies.
This is clarified by the following:
For ME EQUIPMENT and ME SYSTEMS that have, for power input, multiple voltage settings or
autoranging voltage capability, the test shall be performed at the minimum and maximum
ME EQUIPMENT or ME SYSTEM RATED power input voltages. The test may be performed at any
power input frequency within the ME EQUIPMENT or ME SYSTEM RATED range. If the ME
EQUIPMENT or ME SYSTEM is tested at power input voltages and a power input frequency
meeting these specifications, it is not necessary to re-test at additional voltages or
frequencies.
Subclause 6.2.6.2 j) (Conducted RF IMMUNITY)
(This is also applicable to Subclause 36.202.6 b) 10) in IEC 60601-1-2:2001.)
This subclause states the following:
The test may be performed with the ME EQUIPMENT or ME SYSTEM powered at any one of its
NOMINAL input voltages and frequencies.
This is clarified by the following:
The test may be performed at any power input voltage and frequency within the ME
EQUIPMENT or ME SYSTEM RATED voltage and frequency range. If the EQUIPMENT or SYSTEM is
March 2010 ICS 11.040.01; 33.100.10; 33.100.20 French text overleaf

– 3 –
tested at one power input voltage and one power input frequency meeting this
specification, it is not necessary to re-test at additional voltages or frequencies.
Subclause 6.2.7.2 c) (Voltage dips and interruptions IMMUNITY)
(This is also applicable to Subclause 36.202.7 b) 4) in IEC 60601-1-2:2001.)
This subclause states the following:
For ME EQUIPMENT and ME SYSTEMS that have, for power input, multiple voltage settings or
autoranging voltage capability, the test is performed at the minimum and maximum RATED
input voltages. The test is performed at the minimum RATED power frequency.
This is clarified by the following:
For ME EQUIPMENT and ME SYSTEMS that have, for power input, multiple voltage settings or
autoranging voltage capability, the test shall be performed at the minimum and maximum
ME EQUIPMENT or ME SYSTEM RATED input voltages. The test shall be performed with the ME
EQUIPMENT or ME SYSTEM powered at the minimum RATED power frequency. If the ME
EQUIPMENT or ME SYSTEM is tested at power input voltages and a power input frequency
meeting these specifications, it is not necessary to re-test at additional voltages or
frequencies.
Subclause 6.2.8.1.2 (Power-frequency magnetic field IMMUNITY)
(This is also applicable to Subclause 36.202.8.1 b) in IEC 60601-1-2:2001.)
This subclause states the following:
a) (Item 1) in IEC 60601-1-2:2001)
Only the continuous field test shall be performed.
– The test is performed at both 50 Hz and 60 Hz, with the exception that ME
EQUIPMENT and ME SYSTEMS RATED for use only at one of these frequencies need
only be tested at that frequency. In either case, during the test, the ME EQUIPMENT or
ME SYSTEM is powered at the same frequency as the applied magnetic field.
– If the ME EQUIPMENT or ME SYSTEM is INTERNALLY POWERED or powered from an
external d.c. supply, the test is performed at both 50 Hz and 60 Hz, with the
exception that ME EQUIPMENT and ME SYSTEMS intended for use only in areas
supplied at one of these frequencies need be tested only at that frequency.
b) (Item 2) in IEC 60601-1-2:2001))
The test may be performed with the ME EQUIPMENT or ME SYSTEM powered at any one of
its NOMINAL power voltages.
Item b) is clarified by the following:
The test may be performed at any power input voltage within the ME EQUIPMENT or ME
SYSTEM RATED power input voltage range. If the EQUIPMENT or SYSTEM is tested at one
power input voltage, it is not necessary to re-test at additional voltages.
For EMISSIONS, IEC 60601-1-2 references CISPR 11. IEC 60601-1-2 does not add any
clarification regarding the power input voltage and frequency during EMISSIONS testing.
Subclause 7.5.3 of CISPR 11:2009 states the following:
Mains power at the nominal voltage shall be supplied.
This is clarified by the following:
March 2010 ICS 11.040.01; 33.100.10; 33.100.20 French text overleaf

– 4 –
The test may be performed at any input power voltage and frequency within the ME
EQUIPMENT or ME SYSTEM RATED voltage and frequency range. If the ME EQUIPMENT or ME
SYSTEM is tested at one power input voltage and one power input frequency meeting this
specification, it is not necessary to re-test at additional voltages or frequencies.
Subclause 9.1 of CISPR 11:2009 states the following:
Power at the nominal voltage shall be supplied.
This is clarified by the following:
The test may be performed at any input power voltage and frequency within the ME
EQUIPMENT or ME SYSTEM RATED voltage and frequency range. If the ME EQUIPMENT or ME
SYSTEM is tested at one power input voltage and one power input frequency meeting this
specification, it is not necessary to re-test at additional voltages or frequencies.
These clarifications will remain valid until a new version of IEC 60601-1-2 is published.

March 2010 ICS 11.040.01; 33.100.10; 33.100.20 French text overleaf

– 2 – 60601-1-2 © IEC:2007
CONTENTS
FOREWORD.5
INTRODUCTION.
...