SIST EN IEC 60601-2-2:2018

SLOVENSKI STANDARD
01-julij-2018
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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)
Medizinische elektrische Geräte - Teil 2-2: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Hochfrequenz-Chirurgiegeräten
und HF-chirurgischem Zubehör (IEC 60601-2-2:2017)
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)
Ta slovenski standard je istoveten z: EN IEC 60601-2-2:2018
ICS:
11.040.30 Operacijski instrumenti in Surgical instruments and
materiali materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 60601-2-2

NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2018
ICS 11.040.30 Supersedes EN 60601-2-2:2009
English Version
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)
Appareils électromédicaux - Partie 2-2: Exigences Medizinische elektrische Geräte - Teil 2-2: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils d'électrochirurgie à courant haute wesentlichen Leistungsmerkmale von Hochfrequenz-
fréquence et des accessoires d'électrochirurgie à courant Chirurgiegeräten
haute fréquence (IEC 60601-2-2:2017)
(IEC 60601-2-2:2017)
This European Standard was approved by CENELEC on 2017-05-05. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden,
Switzerland, Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-2:2018 E

European foreword
The text of document 62D/1427/FDIS, future edition 6 of IEC 60601-2-2, prepared by SC 62D
"Electromedical equipment ", of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 60601-2-2:2018.

The following dates are fixed:
(dop) 2018-11-18
• latest date by which the document has to be
implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2021-05-18
standards conflicting with the
document have to be withdrawn
This document supersedes EN 60601-2-2:2009.

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.

Endorsement notice
The text of the International Standard IEC 60602-2-2:2017 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:

IEC 60529 NOTE Harmonized as EN 60529.
IEC 60601-2-4:2010 NOTE Harmonized as EN 60601-2-4:2011.
IEC 60601-2-18:2009 NOTE Harmonized as EN 60601-2-18:2015.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.

NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is
available here: www.cenelec.eu.

Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Replacement in Annex ZA of EN 60601-1:2006:
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: General 2015
EN 60601-1-2
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 EN 60601-1-8 2007
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
Publication Year Title EN/HD Year
Addition to Annex ZA of EN 60601-1:2006:
CISPR 11 2015 Industrial, scientific and medical equipment - EN 55011 2016
Radio-frequency disturbance characteristics -
Limits and methods of measurement
IEC 61000-4-3 2006 Electromagnetic compatibility (EMC) - Part 4-3: EN 61000-4-3 2006
Testing and measurement techniques -
Radiated, radio-frequency, electromagnetic
field immunity test
IEC 61000-4-6 2013 Electromagnetic compatibility (EMC) - Part 4-6: EN 61000-4-6 2014
Testing and measurement techniques -
Immunity to conducted disturbances, induced
by radio-frequency fields
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

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

– 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,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
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
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
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.

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.

– 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.
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.

– 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.

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

– 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 ELECTRODE
201.3.202
ACTIVE CONNECTOR
part of an ACTIVE ACCESSORY intended for connection to an ACTIVE OUTPUT TERMINAL, which
may include additional terminals for connection of a FINGERSWITCH to a SWITCH SENSOR
201.3.203
ACTIVE ELECTRODE
part of an ACTIVE ACCESSORY extending from the ACTIVE HANDLE to the surgical site and
intended to pass HF current into body tissue
201.3.204
ACTIVE ELECTRODE INSULATION
electrical insulation material affixed to part of an ACTIVE ELECTRODE intended to prevent
unintended injury to PATIENT tissue or the OPERATOR
201.3.205
ACTIVE HANDLE
part of an ACTIVE ACCESSORY intended to be held by the OPERATOR

IEC 60601-2-2:2017  IEC 2017 – 11 –
201.3.206
ACTIVE OUTPUT TERMINAL
part of HF SURGICAL EQUIPMENT or ASSOCIATED EQUIPMENT intended for connection to an ACTIVE
ACCESSORY and for delivery of HF current thereto
Note 1 to entry: An ACTIVE CONNECTOR is that which plugs into an ACTIVE OUTPUT TERMINAL.
Note 2 to entry: See Figure AA.1.
201.3.207
*ASSOCIATED EQUIPMENT
MEDICAL ELECTRICAL EQUIPMENT other than HF SURGICAL EQUIPMENT that may be electrically
connected to the PATIENT circuit
201.3.208
*BIPOLAR
method of applying HF current to a PATIENT between two or more ACTIVE ELECTRODES without
the need for a separately connected NEUTRAL ELECTRODE (or the need to use the PATIENT’S
body capacitance to earth) in which an effect is intended in tissue near one or more ACTIVE
ELECTRODES
Note 1 to entry: The BIPOLAR method includes devices energizing pairs of ACTIVE ELECTRODES as well as devices
energizing groups of ACTIVE ELECTRODES where the HF current source and return may have different numbers of
electrodes.
Note 2 to entry: See Figure AA.1 and Figure AA.3.
201.3.209
BIPOLAR ACCESSORY
ACTIVE ACCESSORY comprising two or more ACTIVE ELECTRODES on the same support, so
constructed that, when energized, the HF current flows mainly amongst these electrodes
201.3.210
COAGULATION
use of HF current to induce a thermal effect, e.g. to control or prevent bleeding, induce tissue
destruction, or induce tissue shrinkage
Note 1 to entry: COAGULATION may take the form of contact or non-contact COAGULATION.
Note 2 to entry: FULGURATION, desiccation, spray, forced, swift, soft and argon beam (plasma) COAGULATION are
all names of COAGULATION types.
201.3.211
CONTACT QUALITY MONITOR
CQM
circuit in HF SURGICAL EQUIPMENT or ASSOCIATED EQUIPMENT intended for connection to a
MONITORING NE providing an alarm in the event that NEUTRAL ELECTRODE (NE) contact with the
PATIENT becomes insufficient
Note 1 to entry: CONTACT QUALITY MONITOR is functional only when used with a MONITORING NE.
201.3.212
CONTINUITY MONITOR
circuit in HF SURGICAL EQUIPMENT or ASSOCIATED EQUIPMENT intended for connection to an NE
providing an alarm in the event of electrical discontinuity in the NE cable or its connections
201.3.213
*CREST FACTOR
dimensionless value equal to the peak output voltage divided by the RMS voltage as
HF SURGICAL EQUIPMENT in an open circuit condition
measured at the output of
Note 1 to entry: Specific information on the correct way to make the measurements needed to calculate this value
may be found in Annex AA.
– 12 – IEC 60601-2-2:2017  IEC 2017
201.3.214
*CUTTING
division of body tissue caused by the passage of HIGH FREQUENCY current of high current
density at the ACTIVE ELECTRODE (S)
201.3.215
*EARTH REFERENCED PATIENT CIRCUIT
PATIENT circuit which includes components, such as capacitors, installed to provide a low-
impedance path to earth for HF currents
201.3.216
FINGERSWITCH
device generally included with an ACTIVE ACCESSORY which, when manipulated by the
OPERATOR, enables HF output to be produced and, when released disables HF output
Note 1 to entry: Requirements for similar switches intended to perform functions other than activation of HF output
are under consideration.
201.3.217
*FULGURATION
the use of HF current to produce an effect on a tissue surface by electrical sparks from an
ACTIVE ELECTRODE that is not in physical contact with the tissue
201.3.218
*HEATING FACTOR
a value equal to I × t where I is the MONOPOLAR current in amperes and t is the duration of
the current flow in s
Note 1 to entry: The HEATING FACTOR is expressed as A s (amperes squared seconds).
Note 2 to entry: See subclause 201.15.101.5 in Annex AA for additional information.
201.3.219
*HIGH CURRENT MODE
MONOPOLAR output mode whose INTENDED USE (MAXIMUM OUTPUT CURRENT and maximum DUTY
CYCLE) results in a HEATING FACTOR of greater than 30 A s in any 60 s period
201.3.220
*HIGH FREQUENCY
HF
frequencies less than 5 MHz and generally greater than 200 kHz
201.3.221
HF ISOLATED PATIENT CIRCUIT
HF PATIENT CIRCUIT where there are no components installed to provide a low-impedance path
to earth for HF currents
201.3.222
HF PATIENT CIRCUIT
any electrical circuit which contains one or more PATIENT CONNECTIONS including all conductive
parts of the HF SURGICAL EQUIPMENT and ASSOCIATED EQUIPMENT circuits through which HF
current is intended to flow between the ME EQUIPMENT and the PATIENT in NORMAL CONDITION or
SINGLE FAULT CONDITION
201.3.223
HF SURGICAL ACCESSORY
ACCESSORY intended to conduct, supplement or monitor HF energy applied to the PATIENT from
HF SURGICAL EQUIPMENT
IEC 60601-2-2:2017  IEC 2017 – 13 –
Note 1 to entry: HF SURGICAL ACCESSORIES include ACTIVE ACCESSORIES, including cords and connectors for
attachment to HF SURGICAL EQUIPMENT, NEUTRAL ELECTRODES, as well as other ASSOCIATED EQUIPMENT intended for
connection to the HF surgical PATIENT circuit. See Figure AA.1.
Note 2 to entry: Not all accessories used with HF surgical equipment are HF surgical accessories.
201.3.224
HF SURGICAL EQUIPMENT
MEDICAL ELECTRICAL EQUIPMENT which generates HIGH FREQUENCY currents intended for the
performance of surgical tasks, such as the CUTTING or COAGULATION of biological tissue by
means of these HIGH FREQUENCY currents
Note 1 to entry: HF SURGICAL EQUIPMENT is also variously known as surgical diathermy, electrosurgical equipment,
electrosurgical generator, RF generator or HF generator.
Note 2 to entry: A footswitch is an example of an associated ACCESSORY that is part of HF SURGICAL EQUIPMENT.
See Figure AA.1.
201.3.225
*HF SURGICAL MODE
any of a number of OPERATOR selectable HF output characteristics intended to provide a
specific effect at a connected ACTIVE ACCESSORY, such as CUTTING, COAGULATION and the like
Note 1 to entry: Each available HF SURGICAL MODE may be provided with an OPERATOR-adjustable output control to
set the desired intensity or speed of the effect.
201.3.226
*MAXIMUM OUTPUT CURRENT
for each available HF SURGICAL MODE, the magnitude of the maximum possible HF output
current during INTENDED USE
201.3.227
*MAXIMUM OUTPUT VOLTAGE
for each available HF SURGICAL MODE, the magnitude of the maximum possible peak HF output
voltage appearing between PATIENT circuit connections
201.3.228
*MONITORING NE
NE intended for use with a CONTACT QUALITY MONITOR
Note 1 to entry: A MONITORING NEUTRAL ELECTRODE is also known as a split plate, dual plate, dual foil electrode or
CQM electrode.
201.3.229
*MONOPOLAR
method of applying HF output current to a PATIENT via an ACTIVE ELECTRODE and returning via a
separate PATIENT-connected NEUTRAL ELECTRODE (or via the PATIENT’S body capacitance to
earth) in which an effect is intended only in tissue at or near the ACTIVE ELECTRODE
Note 1 to entry: See Figures AA.1 and AA.2.
201.3.230
NEUTRAL ELECTRODE
NE
electrode intended to provide an electrical return path for the MONOPOLAR application of HIGH
FREQUENCY current with such a low current density in the PATIENT’S tissue that effects such as
excessive rise in temperature or unwanted burns are avoided
Note 1 to entry: The NEUTRAL ELECTRODE is also known as plate, plate electrode, electrosurgical pad, passive,
return or dispersive electrode.
Note 2 to entry: To keep the current density low enough to prevent unwanted heating, the NEUTRAL ELECTRODE
needs to have a large enough area.

– 14 – IEC 60601-2-2:2017  IEC 2017
Note 3 to entry: A NEUTRAL ELECTRODE is usually in contact with the PATIENT at a location that is separate from the
MONOPOLAR ACTIVE ELECTRODE.
Note 4 to entry: See Figures AA.1 and AA.2.
201.3.231.1
RATED ACCESSORY VOLTAGE
maximum peak HF output voltage which may be
applied with respect to an NE connected to the PATIENT
201.3.231.2
RATED ACCESSORY VOLTAGE
maximum peak HF output voltage which may be applied to
pairs of opposite polarity
201.3.232
RATED LOAD
results in the maximum HF
value of non-reactive load resistance which, when connected
output power from each HF SURGICAL MODE of the HF SURGICAL EQUIPMENT
201.3.233
RATED OUTPUT POWER
for each HF SURGICAL MODE set at its maximum output setting, the power in watts produced
when all ACTIVE OUTPUT TERMINALS which can be activated simultaneously are connected to
their respective RATED LOADS
201.3.234
SWITCH SENSOR
part of HF SURGICAL EQUIPMENT or ASSOCIATED EQUIPMENT which controls activation of HF output
in response to operation of a connected FINGERSWITCH or footswitch
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
Additional subclauses:
201.4.1.101 * Additional conditions for application
The compliance of HF SURGICAL EQUIPMENT to this document and the compliance of HF
SURGICAL ACCESSORIES to this document shall be independent of each other, except where
specifically required by conformance tests or by the MANUFACTURER.
201.4.2.3.101 * Evaluating RISK
MANUFACTURERS shall include, within their RISK ANALYSIS, the potential for their HF SURGICAL
EQUIPMENT and/or HF SURGICAL ACCESSORIES to be used in HIGH CURRENT MODE and the impact
this would have on the heating under the NEUTRAL ELECTRODE (for example, see
201.7.9.2.2.101 f)).
201.4.3 * ESSENTIAL PERFORMANCE
Addition:
The requirements listed in the third hyphen of 201.8.4.101 and in 201.12.4.101 shall be
considered ESSENTIAL PERFORMANCE requirements.
NOTE 101 Please refer to Annex AA.

IEC 60601-2-2:2017  IEC 2017 – 15 –
201.4.7 SINGLE FAULT CONDITION for ME EQUIPMENT
Additional subclause:
201.4.7.101 Specific SINGLE FAULT CONDITIONS
The following SINGLE FAULT CONDITIONS are the subject of specific requirements and tests in
this document:
a) failure in the CONTINUITY MONITOR or CONTACT QUALITY MONITOR which might cause a
unacceptable RISK (see 201.8.4.101);
b) a defect in the output switching circuit resulting in an excessive low-frequency PATIENT
LEAKAGE CURRENT (see 201.8.10.4.101.1);
c) any defect which results in the unwanted energization of the PATIENT circuit (see
201.12.4.2.101);
d) any defect which results in a significant increase in output power relative to the output
setting (see 201.12.4.4.101).
201.4.11 Power input
Replacement of first dash in compliance tests:
– The HF SURGICAL EQUIPMENT shall be operated in the output mode and using the load
which creates the greatest steady state input current. Input current is measured and
compared with markings and the contents of the technical description.
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.4 * Other conditions
Addition:
aa) Particular care shall be taken to ensure accuracy and safety during measurement of HF
output. See Annex AA for guidance.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2.8.2 Other power sources
Amendment:
Subclause 7.2.8.2 of the general standard does not apply to ACTIVE OUTPUT TERMINALS or NE
terminals.
201.7.2.10 APPLIED PARTS
Addition:
The relevant symbols required for marking DEFIBRILLATION-PROOF APPLIED PARTS shall be
attached to the front panel, but are not required on the APPLIED PARTS.

– 16 – IEC 60601-2-2:2017  IEC 2017
Connections on the HF SURGICAL EQUIPMENT and ASSOCIATED EQUIPMENT for the connection of
NE leads shall be marked with the symbols given in Figures 201.101 and 201.102 as follows:
IEC
Figure 201.101 – Symbol used with an EARTH REFERENCED PATIENT CIRCUIT
IEC
Figure 201.102 – Symbol used with a HF ISOLATED PATIENT CIRCUIT
Additional subclause:
201.7.2.10.101 * HF SURGICAL ACCESSORIES
HF SURGICAL ACCESSORIES (excluding HF ASSOCIATED EQUIPMENT) shall not be required t
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