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

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

• Status: Published
• Publication Date: 24-Feb-2014
• 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: PPUB - Publication issued
• Start Date: 15-Mar-2014
• Completion Date: 25-Feb-2014

Relations

• Amended By: IEC 60601-1-2:2014/AMD1:2020 - Amendment 1 - 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
• Revises: 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
• Effective Date: 05-Sep-2023
• Revises: 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)

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
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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
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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.

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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
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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
...