IEC 60601-1-2:2014
(Main)Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-2:2014 applies to the basic safety and essential performance of Medical Equipment (ME) equipment and ME systems in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by me equipment and me systems. This collateral standard to IEC 60601-1 specifies general requirements and tests for basic safety and essential performance with regard to electromagnetic disturbances and for electromagnetic emissions of ME equipment and ME systems. They are in addition to the requirements of the general standard IEC 60601-1 and serve as the basis for particular standards. This fourth edition cancels and replaces the third edition of IEC 60601-1-2, and constitutes a technical revision. The most significant changes with respect to the previous edition include the following modifications:
- specification of immunity test levels according to the environments of intended use, categorized according to locations that are harmonized with IEC 60601-1-11: the professional healthcare facility environment, the home healthcare environment and special environments;
- specification of tests and test levels to improve the safety of medical electrical equipment and medical electrical systems when portable RF communications equipment is used closer to the medical electrical equipment than was recommended based on the immunity test levels that were specified in the third edition;
- specification of immunity tests and immunity test levels according to the ports of the medical electrical equipment or medical electrical system;
- specification of immunity test levels based on the reasonably foreseeable maximum level of electromagnetic disturbances in the environments of intended use, resulting in some immunity test levels that are higher than in the previous edition; and
- better harmonization with the risk concepts of basic safety and essential performance, including deletion of the defined term "life-supporting". This new edition includes the following main additions:
- guidance for determination of immunity test levels for special environments;
- guidance for adjustment of immunity test levels when special considerations of mitigations or intended use are applicable;
- guidance on risk management for basic safety and essential performance with regard to electromagnetic disturbances; and
- guidance on identification of immunity pass/fail criteria.
Appareils électromédicaux - Partie 1-2: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Perturbations électromagnétiques - Exigences et essais
L'IEC 60601-1-2:2014 s'applique à la sécurité de base et aux performances essentielles des appareils Electro Médicaux (EM) et systèmes EM en présence de perturbations électromagnétiques, ainsi qu'aux perturbations électromagnétiques émises par les appareils EM et systèmes EM. La présente norme collatérale à la norme générale IEC 60601-1 a pour objet de spécifier des exigences générales et des essais applicables à la sécurité de base et aux performances essentielles eu égard aux perturbations électromagnétiques et pour les émissions électromagnétiques des appareils EM et des systèmes EM. Ils viennent en complément des exigences de la norme générale IEC 60601-1 et servent de base pour les normes particulières. Cette quatrième édition annule et remplace la troisième édition de l'IEC 60601-1-2, dont elle constitue une révision technique. Les modifications majeures par rapport à l'édition précédente sont les suivantes:
- spécification des niveaux d'essai d'immunité selon les environnements d'utilisation prévue catégorisés selon les emplacements qui sont harmonisés avec l'IEC 60601-1-11: l'environnement d'un établissement de soins de santé professionnel, l'environnement de soins de santé a domicile et les environnements spéciaux;
- spécification des essais et des niveaux d'essai pour améliorer la sécurité des appareils électromédicaux et des systèmes électromédicaux lorsque des appareils de communication portatifs RF sont utilisés plus près des appareils électromédicaux qu'il n'a été recommandé sur la base des niveaux d'essai d'immunité qui ont été spécifiés dans la troisième édition;
- spécification des essais d'immunité et des niveaux d'essai d'immunité selon les accès des appareils électromédicaux ou des systèmes électromédicaux;
- spécification des niveaux d'essai d'immunité basés sur le niveau maximum raisonnablement prévisible des perturbations électromagnétiques dans les environnements d'utilisation prévue, résultant en des niveaux d'essai d'immunité qui sont supérieurs à ceux de l'édition précédente; et
- une meilleure harmonisation avec les concepts de risque de sécurité de base et des performances essentielles incluant la suppression du terme défini "maintien de la vie". Cette nouvelle édition inclut les ajouts majeurs suivants:
- lignes directrices pour la détermination des niveaux d'essai d'immunité pour les environnements spéciaux;
- lignes directrices pour l'ajustement des niveaux d'essai d'immunité lorsque des considérations spéciales d'atténuation ou d'utilisation prévue sont applicables;
- lignes directrices relatives à la gestion des risques pour la sécurité de base et les performances essentielles eu égard aux perturbations électromagnétiques; et
- lignes directrices relatives à l'identification des critères d'échec/réussite à l'essai d'immunité.
General Information
Relations
Buy Standard
Standards Content (Sample)
IEC 60601-1-2 ®
Edition 4.1 2020-09
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 1-2: General requirements for basic safety and essential performance –
Collateral Standard: Electromagnetic disturbances – Requirements and tests
All rights reserved. Unless otherwise specified, 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
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.
IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.
IEC publications search - webstore.iec.ch/advsearchform Electropedia - www.electropedia.org
The advanced search enables to find IEC publications by a The world's leading online dictionary on electrotechnology,
variety of criteria (reference number, text, technical containing more than 22 000 terminological entries in English
committee,…). It also gives information on projects, replaced and French, with equivalent terms in 16 additional languages.
and withdrawn publications. Also known as the International Electrotechnical Vocabulary
(IEV) online.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published IEC Glossary - std.iec.ch/glossary
details all new publications released. Available online and 67 000 electrotechnical terminology entries in English and
once a month by email. French extracted from the Terms and definitions clause of
IEC publications issued between 2002 and 2015. Some
IEC Customer Service Centre - webstore.iec.ch/csc entries have been collected from earlier publications of IEC
If you wish to give us your feedback on this publication or TC 37, 77, 86 and CISPR.
need further assistance, please contact the Customer Service
Centre: sales@iec.ch.
IEC 60601-1-2 ®
Edition 4.1 2020-09
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 1-2: General requirements for basic safety and essential performance –
Collateral Standard: Electromagnetic disturbances – Requirements and tests
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.01; 33.100.10; 33.100.20 ISBN 978-2-8322-8836-8
IEC 60601-1-2 ®
Edition 4.1 2020-09
CONSOLIDATED VERSION
REDLINE VERSION
colour
inside
Medical electrical equipment –
Part 1-2: General requirements for basic safety and essential performance –
Collateral Standard: Electromagnetic disturbances – Requirements and tests
– 2 – IEC 60601-1-2:2014+AMD1:2020 CSV
© IEC 2020
CONTENTS
FOREWORD . 6
INTRODUCTION . 9
INTRODUCTION to Amendment 1 . 10
1 Scope, object and related standards . 11
1.1 * Scope . 11
1.2 Object . 11
1.3 Related standards . 11
1.3.1 IEC 60601-1 . 11
1.3.2 Particular standards . 11
2 Normative references . 11
3 Terms and definitions . 14
4 General requirements . 17
4.1 RISK MANAGEMENT PROCESS for ME EQUIPMENT and ME SYSTEMS . 17
4.2 * Non-ME EQUIPMENT used in an ME SYSTEM . 17
4.3 General test conditions . 18
4.3.1 * Configurations . 18
4.3.2 Artificial hand. 18
4.3.3 * Power input voltages and frequencies . 19
5 ME EQUIPMENT and ME SYSTEMS identification, marking and documents . 22
5.1 Additional requirements for marking on the outside of ME EQUIPMENT and
ME SYSTEMS that are specified for use only in a shielded location SPECIAL
ENVIRONMENT . 22
5.2 ACCOMPANYING DOCUMENTS . 22
5.2.1 Instructions for use . 22
5.2.2 Technical description . 23
6 Documentation of the tests . 25
6.1 General . 25
6.2 Test plan . 25
6.3 Test report . 25
7 ELECTROMAGNETIC EMISSIONS requirements for ME EQUIPMENT and ME SYSTEMS . 25
7.1 Protection of radio services and other equipment . 25
7.1.1 * General . 25
7.1.2 Operating modes . 25
7.1.3 Multimedia equipment . 25
7.1.4 * Subsystems . 26
7.1.5 ME EQUIPMENT and ME SYSTEMS specified for use only in a
shielded location SPECIAL ENVIRONMENT . 26
7.1.6 ME EQUIPMENT and ME SYSTEMS that include radio equipment . 26
7.1.7 * ME EQUIPMENT whose main functions are performed by
motors and switching or regulating devices . 26
7.1.8 ME EQUIPMENT and ME SYSTEMS containing X-ray generators . 27
7.1.9 PATIENT physiological simulation . 27
7.1.10 Artificial hand. 27
7.1.11 PATIENT-coupled cables . 27
7.1.12 * PERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE
ME SYSTEMS . 27
© IEC 2020
7.2 Protection of the PUBLIC MAINS NETWORK . 27
7.2.1 * Harmonic distortion . 27
7.2.2 * Voltage fluctuations and flicker . 28
7.3 EMISSIONS requirements summary . 28
8 Electromagnetic IMMUNITY requirements for ME EQUIPMENT and ME SYSTEMS . 28
8.1 * General . 28
8.2 PATIENT physiological simulation . 32
8.3 Termination of PATIENT-COUPLED parts . 32
8.4 HAND-HELD ME EQUIPMENT and parts intended to be HAND-HELD . 32
8.5 * Subsystems . 33
8.6 * PERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE ME SYSTEMS . 33
8.7 * Operating modes . 33
8.8 * Non-ME EQUIPMENT . 34
8.9 * IMMUNITY TEST LEVELS . 34
8.10 * IMMUNITY to proximity fields from RF wireless communications
equipment . 41
8.11 * IMMUNITY to proximity magnetic fields in the frequency range 9 kHz to
13,56 MHz . 43
9 * Test report . 44
Annex A (informative) General guidance and rationale . 47
A.1 Safety and performance . 47
A.2 Testing of normally non-observable functions. 47
A.3 Rationale for particular clauses and subclauses . 47
Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS. 71
B.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts . 71
B.2 ACCOMPANYING DOCUMENTS, instructions for use . 71
B.3 ACCOMPANYING DOCUMENTS, technical description . 71
Annex C (informative) Guidance in classification according to CISPR 11 . 73
C.1 General . 73
C.2 Separation into groups . 73
C.3 Division into classes . 74
Annex D (informative) Guidance in the application of IEC 60601-1-2 to particular
standards . 75
D.1 General . 75
D.2 Recommended modifications . 75
D.2.1 Testing requirements . 75
D.2.2 ACCOMPANYING DOCUMENTS . 75
D.3 Cautions . 75
Annex E (informative) Determination of IMMUNITY TEST LEVELS for SPECIAL
ENVIRONMENTS . 77
E.1 General . 77
E.2 Summary of method for E.1 a) . 80
E.3 Summary of method for E.1 b), c) and d) . 80
E.4 Determination of EM DISTURBANCE level reduction . 80
E.5 Assessment of EM DISTURBANCE sources . 80
E.6 Reasonably foreseeable maximum EM DISTURBANCE levels . 81
E.7 Determination of IMMUNITY TEST LEVELS . 81
E.8 RF radiators in SPECIAL ENVIRONMENTS . 81
– 4 – IEC 60601-1-2:2014+AMD1:2020 CSV
© IEC 2020
E.9 Examples of mitigations and special conditions . 82
Annex F (informative) RISK MANAGEMENT for BASIC SAFETY and ESSENTIAL PERFORMANCE
with regard to ELECTROMAGNETIC DISTURBANCES .
F.1 General .
F.2 General requirements for RISK MANAGEMENT .
F.3 RISK ANALYSIS .
...
IEC 60601-1-2 ®
Edition 4.0 2014-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 1-2: General requirements for basic safety and essential performance –
Collateral Standard: Electromagnetic disturbances – Requirements and tests
Appareils électromédicaux –
Partie 1-2: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Perturbations électromagnétiques – Exigences
et essais
All rights reserved. Unless otherwise specified, 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
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.
Droits de reproduction réservés. Sauf indication contraire, 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'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.
IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé Fax: +41 22 919 03 00
CH-1211 Geneva 20 info@iec.ch
Switzerland www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.
IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bibliographical information on IEC International Standards, electrical terms containing more than 30 000 terms and
Technical Specifications, Technical Reports and other definitions in English and French, with equivalent terms in 14
documents. Available for PC, Mac OS, Android Tablets and additional languages. Also known as the International
iPad. Electrotechnical Vocabulary (IEV) online.
IEC publications search - www.iec.ch/searchpub IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a More than 55 000 electrotechnical terminology entries in
variety of criteria (reference number, text, technical English and French extracted from the Terms and Definitions
committee,…). It also gives information on projects, replaced clause of IEC publications issued since 2002. Some entries
and withdrawn publications. have been collected from earlier publications of IEC TC 37,
77, 86 and CISPR.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published IEC Customer Service Centre - webstore.iec.ch/csc
details all new publications released. Available online and If you wish to give us your feedback on this publication or
also once a month by email. need further assistance, please contact the Customer Service
Centre: csc@iec.ch.
A propos de l'IEC
La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.
A propos des publications IEC
Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possédez l’édition la
plus récente, un corrigendum ou amendement peut avoir été publié.
Catalogue IEC - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
Application autonome pour consulter tous les renseignements
Le premier dictionnaire en ligne de termes électroniques et
bibliographiques sur les Normes internationales,
électriques. Il contient plus de 30 000 termes et définitions en
Spécifications techniques, Rapports techniques et autres
anglais et en français, ainsi que les termes équivalents dans
documents de l'IEC. Disponible pour PC, Mac OS, tablettes
14 langues additionnelles. Egalement appelé Vocabulaire
Android et iPad.
Electrotechnique International (IEV) en ligne.
Recherche de publications IEC - www.iec.ch/searchpub
Glossaire IEC - std.iec.ch/glossary
Plus de 55 000 entrées terminologiques électrotechniques, en
La recherche avancée permet de trouver des publications IEC
en utilisant différents critères (numéro de référence, texte, anglais et en français, extraites des articles Termes et
comité d’études,…). Elle donne aussi des informations sur les Définitions des publications IEC parues depuis 2002. Plus
projets et les publications remplacées ou retirées. certaines entrées antérieures extraites des publications des
CE 37, 77, 86 et CISPR de l'IEC.
IEC Just Published - webstore.iec.ch/justpublished
Service Clients - webstore.iec.ch/csc
Restez informé sur les nouvelles publications IEC. Just
Published détaille les nouvelles publications parues. Si vous désirez nous donner des commentaires sur cette
Disponible en ligne et aussi une fois par mois par email. publication ou si vous avez des questions contactez-nous:
csc@iec.ch.
IEC 60601-1-2 ®
Edition 4.0 2014-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 1-2: General requirements for basic safety and essential performance –
Collateral Standard: Electromagnetic disturbances – Requirements and tests
Appareils électromédicaux –
Partie 1-2: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Perturbations électromagnétiques – Exigences
et essais
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XD
ICS 11.040.01, 33.100.10, 33.100.20 ISBN 978-2-8322-1413-8
– 2 – 60601-1-2 © IEC:2014
CONTENTS
CONTENTS . 2
FOREWORD . 6
INTRODUCTION . 9
1 Scope, object and related standards . 11
1.1 * Scope . 11
1.2 Object . 11
1.3 Related standards . 11
1.3.1 IEC 60601-1 . 11
1.3.2 Particular standards . 11
2 Normative references . 11
3 Terms and definitions . 13
4 General requirements . 17
4.1 RISK MANAGEMENT PROCESS for ME EQUIPMENT and ME SYSTEMS . 17
4.2 * Non-ME EQUIPMENT used in an ME SYSTEM . 17
4.3 General test conditions . 17
4.3.1 * Configurations . 17
4.3.2 Artificial hand. 18
4.3.3 * Power input voltages and frequencies . 18
5 ME EQUIPMENT and ME SYSTEMS identification, marking and documents . 20
5.1 Additional requirements for marking on the outside of ME EQUIPMENT and
ME SYSTEMS that are specified for use only in a shielded location SPECIAL
ENVIRONMENT . 20
5.2 ACCOMPANYING DOCUMENTS . 20
5.2.1 Instructions for use . 20
5.2.2 Technical description . 21
6 Documentation of the tests . 23
6.1 General . 23
6.2 Test plan . 23
6.3 Test report . 23
7 ELECTROMAGNETIC EMISSIONS requirements for ME EQUIPMENT and ME SYSTEMS . 23
7.1 Protection of radio services and other equipment . 23
7.1.1 * General . 23
7.1.2 Operating modes . 23
7.1.3 Multimedia equipment . 24
7.1.4 * Subsystems . 24
7.1.5 ME EQUIPMENT and ME SYSTEMS specified for use only in a
shielded location SPECIAL ENVIRONMENT . 24
7.1.6 ME EQUIPMENT and ME SYSTEMS that include radio equipment . 24
7.1.7 * ME EQUIPMENT whose main functions are performed by
motors and switching or regulating devices . 25
7.1.8 ME EQUIPMENT and ME SYSTEMS containing X-ray generators . 25
7.1.9 PATIENT physiological simulation . 25
7.1.10 Artificial hand. 25
7.1.11 PATIENT-coupled cables . 25
7.1.12 PERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE
ME SYSTEMS . 25
7.2 Protection of the PUBLIC MAINS NETWORK . 26
60601-1-2 © IEC:2014 – 3 –
7.2.1 * Harmonic distortion . 26
7.2.2 * Voltage fluctuations and flicker . 26
7.3 EMISSIONS requirements summary . 26
8 Electromagnetic IMMUNITY requirements for ME EQUIPMENT and ME SYSTEMS . 27
8.1 * General . 27
8.2 PATIENT physiological simulation . 30
8.3 Termination of PATIENT-COUPLED parts . 30
8.4 HAND-HELD ME EQUIPMENT and parts intended to be HAND-HELD . 30
8.5 * Subsystems . 31
8.6 PERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE ME SYSTEMS . 31
8.7 * Operating modes . 31
8.8 * Non-ME EQUIPMENT . 32
8.9 * IMMUNITY TEST LEVELS . 32
8.10 * IMMUNITY to proximity fields from RF wireless communications
equipment . 39
9 * Test report . 41
Annex A (informative) General guidance and rationale . 43
A.1 Safety and performance . 43
A.2 Testing of normally non-observable functions. 43
A.3 Rationale for particular clauses and subclauses . 43
Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 57
B.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts . 57
B.2 ACCOMPANYING DOCUMENTS, instructions for use . 57
B.3 ACCOMPANYING DOCUMENTS, technical description . 57
Annex C (informative) Guidance
...
IEC 60601-1-2 ®
Edition 4.1 2020-09
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 1-2: General requirements for basic safety and essential performance –
Collateral Standard: Electromagnetic disturbances – Requirements and tests
Appareils électromédicaux –
Partie 1-2: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Perturbations électromagnétiques – Exigences
et essais
All rights reserved. Unless otherwise specified, 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
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.
Droits de reproduction réservés. Sauf indication contraire, 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'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.
IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.
IEC publications search - webstore.iec.ch/advsearchform IEC online collection - oc.iec.ch
The advanced search enables to find IEC publications by a Discover our powerful search engine and read freely all the
variety of criteria (reference number, text, technical publications previews. With a subscription you will always
committee, …). It also gives information on projects, replaced have access to up to date content tailored to your needs.
and withdrawn publications.
Electropedia - www.electropedia.org
IEC Just Published - webstore.iec.ch/justpublished
The world's leading online dictionary on electrotechnology,
Stay up to date on all new IEC publications. Just Published
containing more than 22 000 terminological entries in English
details all new publications released. Available online and
and French, with equivalent terms in 18 additional languages.
once a month by email.
Also known as the International Electrotechnical Vocabulary
(IEV) online.
IEC Customer Service Centre - webstore.iec.ch/csc
If you wish to give us your feedback on this publication or
need further assistance, please contact the Customer Service
Centre: sales@iec.ch.
A propos de l'IEC
La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.
A propos des publications IEC
Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possédez l’édition la
plus récente, un corrigendum ou amendement peut avoir été publié.
Recherche de publications IEC - IEC online collection - oc.iec.ch
webstore.iec.ch/advsearchform Découvrez notre puissant moteur de recherche et consultez
La recherche avancée permet de trouver des publications IEC gratuitement tous les aperçus des publications. Avec un
en utilisant différents critères (numéro de référence, texte, abonnement, vous aurez toujours accès à un contenu à jour
comité d’études, …). Elle donne aussi des informations sur adapté à vos besoins.
les projets et les publications remplacées ou retirées.
Electropedia - www.electropedia.org
IEC Just Published - webstore.iec.ch/justpublished
Le premier dictionnaire d'électrotechnologie en ligne au
Restez informé sur les nouvelles publications IEC. Just
monde, avec plus de 22 000 articles terminologiques en
Published détaille les nouvelles publications parues.
anglais et en français, ainsi que les termes équivalents dans
Disponible en ligne et une fois par mois par email.
16 langues additionnelles. Egalement appelé Vocabulaire
Electrotechnique International (IEV) en ligne.
Service Clients - webstore.iec.ch/csc
Si vous désirez nous donner des commentaires sur cette
publication ou si vous avez des questions contactez-nous:
sales@iec.ch.
IEC 60601-1-2 ®
Edition 4.1 2020-09
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 1-2: General requirements for basic safety and essential performance –
Collateral Standard: Electromagnetic disturbances – Requirements and tests
Appareils électromédicaux –
Partie 1-2: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Perturbations électromagnétiques – Exigences
et essais
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01; 33.100.10; 33.100.20 ISBN 978-2-8322-4271-1
IEC 60601-1-2 ®
Edition 4.1 2020-09
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 1-2: General requirements for basic safety and essential performance –
Collateral Standard: Electromagnetic disturbances – Requirements and tests
Appareils électromédicaux –
Partie 1-2: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Perturbations électromagnétiques – Exigences
et essais
– 2 – IEC 60601-1-2:2014+AMD1:2020 CSV
© IEC 2020
CONTENTS
FOREWORD . 6
INTRODUCTION . 9
INTRODUCTION to Amendment 1 . 10
1 Scope, object and related standards . 11
1.1 * Scope . 11
1.2 Object . 11
1.3 Related standards . 11
1.3.1 IEC 60601-1 . 11
1.3.2 Particular standards . 11
2 Normative references . 11
3 Terms and definitions . 14
4 General requirements . 17
4.1 RISK MANAGEMENT PROCESS for ME EQUIPMENT and ME SYSTEMS . 17
4.2 * Non-ME EQUIPMENT used in an ME SYSTEM . 17
4.3 General test conditions . 18
4.3.1 * Configurations . 18
4.3.2 Artificial hand. 18
4.3.3 * Power input voltages and frequencies . 19
5 ME EQUIPMENT and ME SYSTEMS identification, marking and documents . 22
5.1 Additional requirements for marking on the outside of ME EQUIPMENT and
ME SYSTEMS that are specified for use only in a shielded location SPECIAL
ENVIRONMENT . 22
5.2 ACCOMPANYING DOCUMENTS . 22
5.2.1 Instructions for use . 22
5.2.2 Technical description . 23
6 Documentation of the tests . 25
6.1 General . 25
6.2 Test plan . 25
6.3 Test report . 25
7 ELECTROMAGNETIC EMISSIONS requirements for ME EQUIPMENT and ME SYSTEMS . 25
7.1 Protection of radio services and other equipment . 25
7.1.1 * General . 25
7.1.2 Operating modes . 25
7.1.3 Multimedia equipment . 25
7.1.4 * Subsystems . 26
7.1.5 ME EQUIPMENT and ME SYSTEMS specified for use only in a
shielded location SPECIAL ENVIRONMENT . 26
7.1.6 ME EQUIPMENT and ME SYSTEMS that include radio equipment . 26
7.1.7 * ME EQUIPMENT whose main functions are performed by
motors and switching or regulating devices . 26
7.1.8 ME EQUIPMENT and ME SYSTEMS containing X-ray generators . 27
7.1.9 PATIENT physiological simulation . 27
7.1.10 Artificial hand. 27
7.1.11 PATIENT-coupled cables . 27
7.1.12 * PERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE
ME SYSTEMS . 27
© IEC 2020
7.2 Protection of the PUBLIC MAINS NETWORK . 27
7.2.1 * Harmonic distortion . 27
7.2.2 * Voltage fluctuations and flicker . 28
7.3 EMISSIONS requirements summary . 28
8 Electromagnetic IMMUNITY requirements for ME EQUIPMENT and ME SYSTEMS . 28
8.1 * General . 28
8.2 PATIENT physiological simulation . 32
8.3 Termination of PATIENT-COUPLED parts . 32
8.4 HAND-HELD ME EQUIPMENT and parts intended to be HAND-HELD . 32
8.5 * Subsystems . 33
8.6 * PERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE ME SYSTEMS . 33
8.7 * Operating modes . 33
8.8 * Non-ME EQUIPMENT . 34
8.9 * IMMUNITY TEST LEVELS . 34
8.10 * IMMUNITY to proximity fields from RF wireless communications
equipment . 41
8.11 * IMMUNITY to proximity magnetic fields in the frequency range 9 kHz to
13,56 MHz . 43
9 * Test report . 44
Annex A (informative) General guidance and rationale . 47
A.1 Safety and performance . 47
A.2 Testing of normally non-observable functions. 47
A.3 Rationale for particular clauses and subclauses . 47
Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS. 71
B.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts . 71
B.2 ACCOMPANYING DOCUMENTS, instructions for use . 71
B.3 ACCOMPANYING DOCUMENTS, technical description . 71
Annex C (informative) Guidance in classi
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.