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 is also available as IEC 60601-2-2:2017 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
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

IEC 60601-2-2:2017 est disponible sous forme de IEC 60601-2-2:2017 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.
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: 30-Mar-2017
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: PPUB - Publication issued
• Start Date: 31-Mar-2017
• Completion Date: 31-Mar-2017

Standards Content (Sample)

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
IEC 60601-2-2:2017-03(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
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

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 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

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IEC 60601-2-2:2017  IEC 2017 – 3 –
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

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– 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 frequency surgical equipment and
high frequency surgical accessories
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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2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

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between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

the latter.

5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any

equipment declared to be in conformity with an IEC Publication.

6) All users should ensure that they have the latest edition of this publication.

7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

members of its technical committees and IEC National Committees for any personal injury, property damage or

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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

indispensable for the correct application of this publication.

9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

International standard IEC 60601-2-2 has been prepared by IEC subcommittee 62D:

Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical

practice.

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.
---------------------- Page: 6 ----------------------
IEC 60601-2-2:2017  IEC 2017 – 5 –
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/1427/FDIS 62D/1442/RVD

Full information on the voting for the approval of this particular standard can be found in the

report on voting indicated in the above table.

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

In this standard, the following print types are used:
– requirements and definitions: roman type;
– test specifications: italic type;

– informative material appearing outside of tables, such as notes, examples and references: in smaller type.

Normative text of tables is also in a smaller type;

– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS

NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term

– “clause” means one of the seventeen numbered divisions within the table of contents,

inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);

– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all

subclauses of Clause 7).

References to clauses within this standard are preceded by the term “Clause” followed by the

clause number. References to subclauses within this standard are by number only.

In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any

combination of the conditions is true.

The verbal forms used in this standard conform to usage described in Clause 7 of the ISO/IEC

Directives, Part 2. For the purposes of this standard, the auxiliary verb:

– “shall” means that compliance with a requirement or a test is mandatory for compliance

with this standard;

– “should” means that compliance with a requirement or a test is recommended but is not

mandatory for compliance with this standard;

– “may” is used to describe a permissible way to achieve compliance with a requirement or

test.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title

indicates that there is guidance or rationale related to that item in Annex AA.

A list of all parts of the IEC 60601 series, published under the general title Medical electrical

equipment, can be found on the IEC website.
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– 6 – IEC 60601-2-2:2017  IEC 2017

The committee has decided that the contents of this publication will remain unchanged until

the stability date indicated on the IEC website under "http://webstore.iec.ch" in the data

related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
---------------------- Page: 8 ----------------------
IEC 60601-2-2:2017  IEC 2017 – 7 –
INTRODUCTION

The minimum safety requirements specified in this particular standard are considered to

provide for a practical degree of safety in the operation of HIGH FREQUENCY SURGICAL

EQUIPMENT.

This particular standard amends and supplements IEC 60601-1:2005 and Amendment 1:2012,

Medical electrical equipment – Part 1: General requirements for basic safety and essential

performance, hereinafter referred to as the general standard (see 201.1.4).
The requirements are followed by specifications for the relevant tests.

A "Particular guidance and rationale" section giving some explanatory notes, where

appropriate, about the more important requirements is included in Annex AA.

Clauses or subclauses for which there are explanatory notes in Annex AA are marked with an

asterisk (*).

It is considered that a knowledge of the reasons for these requirements will not only facilitate

the proper application of the standard but will, in due course, expedite any revision neces-

sitated by changes in clinical practice or as a result of developments in technology. However,

this annex does not form part of the requirements of this document.
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– 8 – IEC 60601-2-2:2017  IEC 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
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HF

SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES as defined in 201.3.224 and 201.3.223.

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.
201.1.2 Object
Replacement:

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL

PERFORMANCE requirements for HF SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES as

defined in 201.3.224 and 201.3.223.
201.1.3 Collateral standards
Addition:

This particular standard refers to those applicable collateral standards that are listed in

Clause 2 of the general standard and Clause 201.2 of this particular standard.

IEC 60601-1-2:2014 and IEC 60601-1-8:2006 apply as modified in Clauses 202 and 208

respectively. IEC 60601-1-3, IEC 60601-1-10 and IEC 60601-1-11 do not apply. All other

published collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:

In the IEC 60601 series, particular standards may modify, replace or delete requirements

contained in the general standard and collateral standards as appropriate for the particular

ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
______________

The general standard is IEC 60601-1:2005/AMD1:2012, Medical electrical equipment – Part 1: General

requirements for basic safety and essential performance.
---------------------- Page: 10 ----------------------
IEC 60601-2-2:2017  IEC 2017 – 9 –
A requirement of a particular standard takes priority over the general standard.

For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.

Collateral standards are referred to by their document number.

The numbering of clauses and subclauses of this particular standard corresponds to that of

the general standard with the prefix “201” (e.g. 201.1 in this document addresses the content

of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”

where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this

particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral

standard, 203.4 in this particular standard addresses the content of Clause 4 of the

IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are

specified by the use of the following words:

"Replacement" means that the clause or subclause of the general standard or applicable

collateral standard is replaced completely by the text of this particular standard.

"Addition" means that the text of this particular standard is additional to the requirements of

the general standard or applicable collateral standard.

"Amendment" means that the clause or subclause of the general standard or applicable

collateral standard is amended as indicated by the text of this particular standard.

Subclauses, figures or tables which are additional to those of the general standard are

numbered starting from 201.101. However, due to the fact that definitions in the general

standard are numbered 3.1 through 3.147, additional definitions in this document are

numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and

additional items aa), bb), etc.

Subclauses, figures or tables which are additional to those of a collateral standard are

numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for

IEC 60601-1-2, 203 for IEC 60601-1-3, etc.

The term "this document" is used to make reference to the general standard, any applicable

collateral standards and this particular standard taken together.

Where there is no corresponding clause or subclause in this particular standard, the clause or

subclause of the general standard or applicable collateral standard, although possibly not

relevant, applies without modification; where it is intended that any part of the general

standard or applicable collateral standard, although possibly relevant, is not to be applied, a

statement to that effect is given in this particular standard.
201.2 Normative references
NOTE Informative references are listed in the bibliography beginning on page 87.
Clause 2 of the general standard applies, except as follows:
Replacement:

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 60601-1-8:2006, Medical electrical equipment – Part 1-8: General requirements for basic

safety and essential performance – Collateral Standard: General requirements, tests and

guidance for alarm systems in medical electrical equipment and medical electrical systems

---------------------- Page: 11 ----------------------
– 10 – IEC 60601-2-2:2017  IEC 2017
Addition:

CISPR 11:2015, Industrial, scientific and medical equipment – Radio-frequency disturbance

characteristics – Limits and methods of measurement
IEC 61000-4-3:2006, Electromagnetic compatibility (EMC) – Part 4-3: Testing and

measurement techniques – Radiated, radio-frequency electromagnetic field immunity test

IEC 61000-4-6:2013, Electromagnetic compatibility (EMC) – Part 4-6: Testing and

measurement techniques – Immunity to conducted disturbances, induced by radio-frequency

fields
201.3 Terms and definitions

For the purposes of this document, the terms and definitions given in IEC 60601-1 and the

following apply.

ISO and IEC maintain terminological databases for use in standardization at the following

addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
Replace NOTE 1 with the following:

NOTE 1 Where the terms “voltage” and “current” are used in this document, they mean the RMS values of an

alternating, direct or composite voltage or current averaged over 1 s unless stated otherwise.

Addition:
201.3.201
ACTIVE ACCESSORY

HF SURGICAL ACCESSORY intended for manipulation by the OPERATOR to produce an effect by

electrical conduction adjacent to the ACTIVE ELECTRODE at the intended site on the PATIENT,

generally comprising an ACTIVE HANDLE, the cord of an ACTIVE ACCESSORY, ACTIVE CONNECTOR

and ACTIVE
...