IEC 60601-2-2:2017

Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

IEC 60601-2-2:2017 applies to the basic safety and essential performance of HF surgical equipment and HF surgical accessories.
HF surgical equipment having a rated output power not exceeding 50 W (for example for micro-coagulation, or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this particular standard. These exemptions are indicated in the relevant requirements.
The object of this particular standard is to establish particular basic safety and essential performance requirements for HF surgical equipment and HF surgical accessories. This sixth edition cancels and replaces the fifth edition published in 2009. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
- refinement and additions to the defined terms;
- additional separation of the requirements for HF surgical equipment and HF surgical accessories;
- a new requirement for adult neutral electrodes to be contact quality monitoring neutral electrodes;
- new requirements for devices that have or use a high current mode.

Appareils électromédicaux - Partie 2-2: Exigences particulières pour la sécurité de base et les performances essentielles des appareils d'électrochirurgie à courant haute fréquence et des accessoires d'électrochirurgie à courant haute fréquence

L'IEC 60601-2-2:2017 s’applique à la sécurité de base et aux performances essentielles des appareils d’électrochirurgie HF et des accessoires d'électrochirurgie HF. Les appareils d’électrochirurgie HF dont la puissance de sortie assignée est inférieure ou égale à 50 W (destinés, par exemple, à la micro coagulation, à l’ophtalmologie ou à l’usage dentaire) sont exemptés de certaines exigences de la présente norme particulière. Ces exemptions sont indiquées dans les exigences correspondantes.
La présente norme particulière a pour objet d’établir des exigences particulières relatives à la sécurité de base et aux performances essentielles des appareils d’électrochirurgie HF et des accessoires d’électrochirurgie HF.
Cette sixième édition annule et remplace la cinquième édition parue en 2009. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
- des précisions et des ajouts aux termes définis;
- une séparation supplémentaire des exigences relatives aux appareils d'électrochirurgie à courant haute fréquence (HF) et aux accessoires d'électrochirurgie à courant haute fréquence (HF);
- une nouvelle exigence concernant les électrodes neutres adultes devant servir d'électrodes neutres de surveillance de la qualité du contact;
- de nouvelles exigences relatives aux appareils ayant ou utilisant un mode de courant élevé.

General Information

• Status: Published
• Publication Date: 20-Feb-2023
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: MT 17 - TC 62/SC 62D/MT 17
• Current Stage: PPUB - Publication issued
• Start Date: 10-Mar-2017
• Completion Date: 31-Mar-2017

Relations

• Amended By: IEC 60601-2-2:2017/AMD1:2023 - Amendment 1 - Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-2:2009 - Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-2:2009/COR1:2014 - Corrigendum 1 - Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-2 ®
Edition 6.0 2017-03
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-2: Particular requirements for the basic safety and essential performance
of high frequency surgical equipment and high frequency surgical accessories

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.

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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
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IEC 60601-2-2 ®
Edition 6.0 2017-03
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –

Part 2-2: Particular requirements for the basic safety and essential performance

of high frequency surgical equipment and high frequency surgical accessories

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.30 ISBN 978-2-8322-4185-1

– 2 – IEC 60601-2-2:2017 RLV © IEC 2017
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 9
201.3 Terms and definitions . 10
201.4 General requirements . 14
201.5 General requirements for testing of ME EQUIPMENT . 15
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 16
201.7 ME EQUIPMENT identification, marking and documents . 16
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 21
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 36
201.10 Protection against unwanted and excessive radiation HAZARDS . 36
201.11 Protection against excessive temperatures and other HAZARDS . 37
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 38
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 45
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 45
201.15 Construction of ME EQUIPMENT . 45
201.16 ME SYSTEMS . 50
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 50
202 * ELECTROMAGNETIC compatibility DISTURBANCES – Requirements and tests . 50
208 General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems . 51
Annexes . 53
Annex AA (informative) Particular guidance and rationale . 54
Annex BB (informative) ELECTROMAGNETIC DISTURBANCES created by HF SURGICAL
EQUIPMENT . 81
Bibliography . 90
Index of defined terms used in this particular standard . 92

Figure 201.101 – Symbol used with an EARTH REFERENCED PATIENT CIRCUIT . 16
Figure 201.102 – Symbol used with a HF ISOLATED PATIENT CIRCUIT . 16
Figure 201.103 – Circuit suitable for testing compliance to 201.8.4.101 . 22
Figure 201.104 – Measurement of HF LEAKAGE CURRENT with NEUTRAL ELECTRODE
referenced to earth for EARTH REFERENCED PATIENT CIRCUITS and load between
electrodes . 25
Figure 201.105 – Measurement of HF LEAKAGE CURRENT WITH NEUTRAL ELECTRODE
REFERENCED TO EARTH for EARTH REFERENCED PATIENT CIRCUITS and a load resistance
from ACTIVE ELECTRODE to earth . 26
Figure 201.106 – Measurement of HF LEAKAGE CURRENT with NEUTRAL ELECTRODE
isolated from earth at high frequency for HF ISOLATED PATIENT CIRCUITS . 27
Figure 201.107 – Measurement of HF LEAKAGE CURRENT from a BIPOLAR ELECTRODE
ACCESSORY . 28
Figure 201.108 – Test apparatus for anchorages of cords of ACTIVE ACCESSORY . 35

Figure 201.109 – Measurement of output power – MONOPOLAR output . 40
Figure 201.110 – Measurement of output power – BIPOLAR output . 41
Figure 201.111 – Method of testing feedback from one active output to another in
simultaneous activation . 44
Figure AA.1 – Examples of various parts of an HF surgical ME SYSTEM . 56
Figure AA.2 – Example of MONOPOLAR method of HF surgery using a NEUTRAL
ELECTRODE . 56
Figure AA.3 – Example of BIPOLAR method of HF surgery . 57
Figure AA.4 – CREST FACTOR vs. peak voltage . 62
Figure AA.5 – Example of PATIENT circuit with NEUTRAL ELECTRODE referenced to earth
at operating frequencies . 66
Figure BB.1 – E-FIELD EMISSIONS test setup . 84
Figure BB.2 – H-FIELD EMISSIONS test setup . 85
Figure BB.3 – Conducted EMISSIONS test setup . 86
Figure BB.4 – Unit ad hoc test . 88
Figure BB.5 – Power cord ad hoc test . 89
Figure BB.6 – ACCESSORY cord ad hoc test . 89

Table 201.101 – Colours of indicator lights and their meaning for HF SURGICAL
EQUIPMENT . 17
Table 201.102 – Maximum output powers in SINGLE FAULT CONDITIONS . 43
Table 201.103 – Test currents by weight range . 47
Table AA.1 – Summary of measured current and durations for 25 TUR procedures . 75
Table AA.2 – Summary of measured currents and durations for general surgical
procedures. 76
Table BB.1 – Worst case EMISSIONS of spark gap type HF SURGICAL EQUIPMENT . 86
Table BB.2 – Worst case EMISSIONS of non-spark gap (modern) HF SURGICAL EQUIPMENT . 86

– 4 – IEC 60601-2-2:2017 RLV  IEC 2017
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-2: Particular requirements for the basic safety and essential
performance of high frequency surgical equipment and
high frequency surgical accessories

FOREWORD
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...

IEC 60601-2-2 ®
Edition 6.0 2017-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-2: Particular requirements for the basic safety and essential performance
of high frequency surgical equipment and high frequency surgical accessories

Appareils électromédicaux –
Partie 2-2: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils d'électrochirurgie à courant haute fréquence et des
accessoires d'électrochirurgie à courant haute fréquence

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
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International Standards for all electrical, electronic and related technologies.

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latest edition, a corrigenda or an amendment might have been published.

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documents. Available for PC, Mac OS, Android Tablets and languages. Also known as the International Electrotechnical
iPad. Vocabulary (IEV) online.

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IEC 60601-2-2 ®
Edition 6.0 2017-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –

Part 2-2: Particular requirements for the basic safety and essential performance

of high frequency surgical equipment and high frequency surgical accessories

Appareils électromédicaux –
Partie 2-2: Exigences particulières pour la sécurité de base et les performances

essentielles des appareils d'électrochirurgie à courant haute fréquence et des

accessoires d'électrochirurgie à courant haute fréquence

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.30 ISBN 978-2-8322-4008-3

– 2 – IEC 60601-2-2:2017  IEC 2017
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 9
201.3 Terms and definitions . 10
201.4 General requirements . 14
201.5 General requirements for testing of ME EQUIPMENT . 15
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 15
201.7 ME EQUIPMENT identification, marking and documents . 15
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 20
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 36
201.10 Protection against unwanted and excessive radiation HAZARDS . 36
201.11 Protection against excessive temperatures and other HAZARDS . 36
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 38
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 43
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 44
201.15 Construction of ME EQUIPMENT . 44
201.16 ME SYSTEMS . 49
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 49
202 * ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 49
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 50
Annexes . 51
Annex AA (informative) Particular guidance and rationale . 52
Annex BB (informative) ELECTROMAGNETIC DISTURBANCES created by HF SURGICAL
EQUIPMENT . 78
Bibliography . 87
Index of defined terms used in this particular standard . 89

Figure 201.101 – Symbol used with an EARTH REFERENCED PATIENT CIRCUIT . 16
Figure 201.102 – Symbol used with a HF ISOLATED PATIENT CIRCUIT . 16
Figure 201.103 – Circuit suitable for testing compliance to 201.8.4.101 . 22
Figure 201.104 – Measurement of HF LEAKAGE CURRENT for EARTH REFERENCED PATIENT
CIRCUITS and load between electrodes . 25
Figure 201.105 – Measurement of HF LEAKAGE CURRENT for EARTH REFERENCED PATIENT
CIRCUITS and a load resistance from ACTIVE ELECTRODE to earth . 26
Figure 201.106 – Measurement of HF LEAKAGE CURRENT for HF ISOLATED PATIENT
CIRCUITS . 27
Figure 201.107 – Measurement of HF LEAKAGE CURRENT from a BIPOLAR ACCESSORY . 28
Figure 201.108 – Test apparatus for anchorages of cords of ACTIVE ACCESSORY . 34
Figure 201.109 – Measurement of output power – MONOPOLAR output . 39
Figure 201.110 – Measurement of output power – BIPOLAR output . 40

Figure 201.111 – Method of testing feedback from one active output to another in
simultaneous activation . 43
Figure AA.1 – Examples of various parts of an HF surgical ME SYSTEM . 54
Figure AA.2 – Example of MONOPOLAR method of HF surgery using a NEUTRAL
ELECTRODE . 54
Figure AA.3 – Example of BIPOLAR method of HF surgery . 55
Figure AA.4 – CREST FACTOR vs. peak voltage . 60
Figure AA.5 – Example of PATIENT circuit with NEUTRAL ELECTRODE referenced to earth
at operating frequencies . 64
Figure BB.1 – E-FIELD EMISSIONS test setup . 81
Figure BB.2 – H-FIELD EMISSIONS test setup . 82
Figure BB.3 – Conducted EMISSIONS test setup . 83
Figure BB.4 – Unit ad hoc test . 85
Figure BB.5 – Power cord ad hoc test . 86
Figure BB.6 – ACCESSORY cord ad hoc test . 86

Table 201.101 – Colours of indicator lights and their meaning for HF SURGICAL
EQUIPMENT . 16
Table 201.102 – Maximum output powers in SINGLE FAULT CONDITIONS . 42
Table 201.103 – Test currents by weight range . 46
Table AA.1 – Summary of measured current and durations for 25 TUR procedures . 73
Table AA.2 – Summary of measured currents and durations for general surgical
procedures. 74
Table BB.1 – Worst case EMISSIONS of spark gap type HF SURGICAL EQUIPMENT . 84
Table BB.2 – Worst case EMISSIONS of non-spark gap (modern) HF SURGICAL EQUIPMENT . 84

– 4 – IEC 60601-2-2:2017  IEC 2017
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-2: Particular requirements for the basic safety and essential
performance of high freq
...

IEC 60601-2-2 ®
Edition 6.1 2023-02
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-2: Particular requirements for the basic safety and essential performance
of high frequency surgical equipment and high frequency surgical accessories

Appareils électromédicaux –
Partie 2-2: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils d'électrochirurgie à courant haute fréquence et des
accessoires d'électrochirurgie à courant haute fréquence

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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3, rue de Varembé [e-mail]
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
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Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

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IEC 60601-2-2 ®
Edition 6.1 2023-02
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-2: Particular requirements for the basic safety and essential performance
of high frequency surgical equipment and high frequency surgical accessories
Appareils électromédicaux –
Partie 2-2: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils d'électrochirurgie à courant haute fréquence et des
accessoires d'électrochirurgie à courant haute fréquence
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.30 ISBN 978-2-8322-6542-0

IEC 60601-2-2 ®
Edition 6.1 2023-02
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 2-2: Particular requirements for the basic safety and essential performance
of high frequency surgical equipment and high frequency surgical accessories

Appareils électromédicaux –
Partie 2-2: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils d'électrochirurgie à courant haute fréquence et des
accessoires d'électrochirurgie à courant haute fréquence

– 2 – IEC 60601-2-2:2017+AMD1:2023 CSV
 IEC 2023
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
INTRODUCTION to Amendment 1 . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 9
201.3 Terms and definitions . 10
201.4 General requirements . 14
201.5 General requirements for testing of ME EQUIPMENT . 15
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 16
201.7 ME EQUIPMENT identification, marking and documents . 16
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 21
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 37
201.10 Protection against unwanted and excessive radiation HAZARDS . 37
201.11 Protection against excessive temperatures and other HAZARDS . 38
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 39
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 45
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 46
201.15 Construction of ME EQUIPMENT . 46
201.16 ME SYSTEMS . 51
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS. 51
202 * ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 51
208 General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems . 52
Annexes . 53
Annex AA (informative) Particular guidance and rationale . 54
Annex BB (informative) ELECTROMAGNETIC DISTURBANCES created by HF SURGICAL
EQUIPMENT . 80
Bibliography . 89
Index of defined terms used in this particular standard . 91

Figure 201.101 – Symbol used with an EARTH REFERENCED PATIENT CIRCUIT . 16
Figure 201.102 – Symbol used with a HF ISOLATED PATIENT CIRCUIT . 16
Figure 201.103 – Circuit suitable for testing compliance to 201.8.4.101 . 23
Figure 201.104 – Measurement of HF LEAKAGE CURRENT for EARTH REFERENCED PATIENT
CIRCUITS and load between electrodes . 26
Figure 201.105 – Measurement of HF LEAKAGE CURRENT for EARTH REFERENCED PATIENT
CIRCUITS and a load resistance from ACTIVE ELECTRODE to earth . 27
Figure 201.106 – Measurement of HF LEAKAGE CURRENT for HF ISOLATED PATIENT
CIRCUITS . 28
Figure 201.107 – Measurement of HF LEAKAGE CURRENT from a BIPOLAR ACCESSORY . 29
Figure 201.108 – Test apparatus for anchorages of cords of ACTIVE ACCESSORY . 36
Figure 201.109 – Measurement of output power – MONOPOLAR output . 41
Figure 201.110 – Measurement of output power – BIPOLAR output . 42

 IEC 2023
Figure 201.111 – Method of testing feedback from one active output to another in
simultaneous activation . 45
Figure AA.1 – Examples of various parts of an HF surgical ME SYSTEM . 56
Figure AA.2 – Example of MONOPOLAR method of HF surgery using a NEUTRAL
ELECTRODE . 56
Figure AA.3 – Example of BIPOLAR method of HF surgery . 57
Figure AA.4 – CREST FACTOR vs. peak voltage . 62
Figure AA.5 – Example of PATIENT circuit with NEUTRAL ELECTRODE referenced to earth
at operating frequencies . 66
Figure BB.1 – E-FIELD EMISSIONS test setup . 83
Figure BB.2 – H-FIELD EMISSIONS test setup . 84
Figure BB.3 – Conducted EMISSIONS test setup . 85
Figure BB.4 – Unit ad hoc test . 87
Figure BB.5 – Power cord ad hoc test . 88
Figure BB.6 – ACCESSORY cord ad hoc test . 88

Table 201.101 – Colours of indicator lights and their meaning for HF SURGICAL
EQUIPMENT . 17
Table 201.102 – Maximum output powers in SINGLE FAULT CONDITIONS . 44
Table 201.103 – Test currents by weight range . 48
Table AA.1 – Summary of measured current and durations for 25 TUR procedures . 75
Table AA.2 – Summary of measured currents and durations for general surgical
procedures. 76
Table BB.1 – Worst case EMISSIONS of spark gap type HF SURGICAL EQUIPMENT . 86
Table BB.2 – Worst case EMISSIONS of non-spark gap (modern) HF SURGICAL EQUIPMENT . 86

– 4 – IEC 60601-2-2:2017+AMD1:2023 CSV
 IEC 2023
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

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