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

IEC 60601-2-2:2009 specifies particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories. This particular standard amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. This fifth edition cancels and replaces the fourth edition published in 2006. This edition constitutes a technical revision. Revisions in this edition include new language for preconditioning accessories prior to insulation testing, refining the requirements for electromagnetic compatibility testing and correcting some of the equations used in deriving the thermal test for neutral electrodes.
The contents of the corrigendum of February 2014 have been included in this copy.

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

La CEI 60601-2-2:2009 spécifie des 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. La présente norme particulière modifie et complète la CEI 60601-1 (troisième édition, 2005): Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles. Cette cinquième édition annule et remplace la quatrième édition publiée en 2006 dont elle constitue une révision technique. Les révisions de la présente édition incluent de nouveaux termes relatifs au préconditionnement des accessoires préalablement à l'essai d'isolement, à l'affinement des exigences applicables aux essais de compatibilité électromagnétique et à la correction de certaines équations utilisées dans le calcul de l'essai thermique applicable aux électrodes neutres.
Le contenu du corrigendum de février 2014 a été pris en considération dans cet exemplaire.

General Information

• Status: Published
• Publication Date: 22-Feb-2009
• 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: DELPUB - Deleted Publication
• Completion Date: 31-Mar-2017

Relations

• Revised: 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
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-2
®
Edition 5.0 2009-02
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 60601-2-2:2009

---------------------- Page: 1 ----------------------
THIS PUBLICATION IS COPYRIGHT PROTECTED
Copyright © 2009 IEC, Geneva, Switzerland

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 la CEI ou du Comité national de la CEI du pays du demandeur.
Si vous avez des questions sur le copyright de la CEI ou si vous désirez obtenir des droits supplémentaires sur cette
publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence.

IEC Central Office
3, rue de Varembé
CH-1211 Geneva 20
Switzerland
Email: [e-mail]
Web: www.iec.ch

About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.
ƒ Catalogue of IEC publications: www.iec.ch/searchpub
The IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee,…).
It also gives information on projects, withdrawn and replaced publications.
ƒ IEC Just Published: www.iec.ch/online_news/justpub
Stay up to date on all new IEC publications. Just Published details twice a month all new publications released. Available
on-line and also by email.
ƒ Electropedia: www.electropedia.org
The world's leading online dictionary of electronic and electrical terms containing more than 20 000 terms and definitions
in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical
Vocabulary online.
ƒ Customer Service Centre: www.iec.ch/webstore/custserv
If you wish to give us your feedback on this publication or need further assistance, please visit the Customer Service
Centre FAQ or contact us:
Email: [e-mail]
Tel.: [phone]
Fax: [phone]


A propos de la CEI
La Commission Electrotechnique Internationale (CEI) est la première organisation mondiale qui élabore et publie des
normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

A propos des publications CEI
Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possédez
l’édition la plus récente, un corrigendum ou amendement peut avoir été publié.
ƒ Catalogue des publications de la CEI: www.iec.ch/searchpub/cur_fut-f.htm
Le Catalogue en-ligne de la CEI vous permet d’effectuer des recherches en utilisant différents critères (numéro de référence,
texte, comité d’études,…). Il donne aussi des informations sur les projets et les publications retirées ou remplacées.
ƒ Just Published CEI: www.iec.ch/online_news/justpub
Restez informé sur les nouvelles publications de la CEI. Just Published détaille deux fois par mois les nouvelles
publications parues. Disponible en-ligne et aussi par email.
ƒ Electropedia: www.electropedia.org
Le premier dictionnaire en ligne au monde de termes électroniques et électriques. Il contient plus de 20 000 termes et
définitions en anglais et en français, ainsi que les termes équivalents dans les langues additionnelles. Egalement appelé
Vocabulaire Electrotechnique International en ligne.
ƒ Service Clients: www.iec.ch/webstore/custserv/custserv_entry-f.htm
Si vous désirez nous donner des commentaires sur cette publication ou si vous avez des questions, visitez le FAQ du
Service clients ou contactez-nous:
Email: [e-mail]
Tél.: [phone]
Fax: [phone]

---------------------- Page: 2 ----------------------
IEC 60601-2-2
®
Edition 5.0 2009-02
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
PRICE CODE
INTERNATIONALE
XC
CODE PRIX
ICS 11.040.30 ISBN 978-2-88910-213-6
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

---------------------- Page: 3 ----------------------
– 2 – 60601-2-2 © IEC:2009
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.13
201.5 General requirements for testing of ME EQUIPMENT.14
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .14
201.7 ME EQUIPMENT identification, marking and documents.14
201.8 Protection against electrical HAZARDS from ME EQUIPMENT.19
201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS.33
201.10 Protection against unwanted and excessive radiation HAZARDS.33
201.11 Protection against excessive temperatures and other HAZARDS.34
201.12 Accuracy of controls and instruments and protection against hazardous
outputs.35
201.13 HAZARDOUS SITUATIONS and fault conditions.41
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .42
201.15 Construction of ME EQUIPMENT .42
201.16 ME SYSTEMs .46
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .46
202 * Electromagnetic compatibility – Requirements and tests .46
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems.47
Annexes .47
Annex AA (informative) Particular guidance and rationale.48
Annex BB (informative) ELECTROMAGNETIC DISTURBANCES created by HF SURGICAL
EQUIPMENT .70
Bibliography.79

Figure 201.101 – Symbol used with an EARTH REFERENCED PATIENT CIRCUIT.14
HF ISOLATED PATIENT CIRCUIT .15
Figure 201.102 – Symbol used with a
Figure 201.103 – Circuit suitable for testing compliance to 201.8.4.101 .20
Figure 201.104 – Measurement of HF LEAKAGE CURRENT with NEUTRAL ELECTRODE
referenced to earth and load between electrodes.23
Figure 201.105 – Measurement of HF LEAKAGE CURRENT with NEUTRAL ELECTRODE
referenced to earth and load from ACTIVE ELECTRODE to earth .24
Figure 201.106 – Measurement of HF LEAKAGE CURRENT with NEUTRAL ELECTRODE
isolated from earth at HIGH FREQUENCY.25
Figure 201.107 – Measurement of HF LEAKAGE CURRENT from a BIPOLAR ELECTRODE .26
Figure 201.108 – Test apparatus for anchorages of cords of ACTIVE ACCESSORY.32
Figure 201.109 – Measurement of output power – MONOPOLAR output .37
Figure 201.110 – Measurement of output power – BIPOLAR output.38

---------------------- Page: 4 ----------------------
60601-2-2 © IEC:2009 – 3 –
Figure 201.111 – Method of testing feedback from one active output to another in
simultaneous activation.41
Figure AA.1 – Example of various parts of an HF surgical system.49
Figure AA.2 – CREST FACTOR vs. peak voltage .53
Figure AA.3 – Example of PATIENT circuit with NEUTRAL ELECTRODE referenced to earth
at operating frequencies .57
Figure BB.1 – E-FIELD EMISSIONS test setup.73
Figure BB.2 – H-FIELD EMISSIONS test setup .74
Figure BB.3 – Conducted EMISSIONS test setup .75
Figure BB.4 – Unit ad hoc test .77
Figure BB.5 – Power cord ad hoc test.78
Figure BB.6 – ACCESSORY cord ad hoc test .78

Table 201.101 – Colours of indicator lights and their meaning for HF SURGICAL
EQUIPMENT .15
Table 201.102 – Maximum output powers in SINGLE FAULT CONDITIONS .40
Table 201.103 – Test currents by weight range.44
Table AA.1 – Summary of measured current and durations for 25 TUR procedures.65
Table AA.2 – Summary of measured currents and durations for general surgical
procedures .66
Table BB.1 – Worst case emissions of spark gap type HF SURGICAL EQUIPMENT .76
Table BB.2 – Worst case emissions of non-spark gap (modern) HF SURGICAL EQUIPMENT .76

---------------------- Page: 5 ----------------------
– 4 – 60601-2-2 © IEC:2009
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 fifth edition cancels and replaces the fourth edition published in 2006. This edition
constitutes a technical revision. Revisions in this edition include new language for
preconditioning accessories prior to insulation testing, refining the requirements for
electromagnetic compatibility testing and correcting some of the equations used in deriving
the thermal test for NEUTRAL ELECTRODES.

---------------------- Page: 6 ----------------------
60601-2-2 © IEC:2009 – 5 –
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/726/FDIS 62D/755/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 Annex H 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.

---------------------- Page: 7 ----------------------
– 6 – 60601-2-2  IEC:2009
The committee has decided that the contents of this particular standard will remain
unchanged until the maintenance result date indicated on the IEC web site 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
The contents of the corrigendum of February 2014 have been included in this copy.

---------------------- Page: 8 ----------------------
60601-2-2 © IEC:2009 – 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 (third edition, 2005): 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 standard.

---------------------- Page: 9 ----------------------
– 8 – 60601-2-2 © IEC: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



201.1 Scope, object and related standards
1)
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
BASIC SAFETY and ESSENTIAL PERFORMANCE of HF
This International Standard applies to the
SURGICAL EQUIPMENT as defined in 201.3.222.
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:
BASIC SAFETY and ESSENTIAL
The object of this particular standard is to establish particular
PERFORMANCE requirements for HF SURGICAL EQUIPMENT as defined in 201.3.222.
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 2 of this particular standard.
IEC 60601-1-2 and IEC 60601-1-8 apply as modified in Clauses 202 and 208 respectively.
2)
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
—————————
1)
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance.
2)
IEC 60601-1-11, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical
systems used in the home healthcare environment (in preparation).

---------------------- Page: 10 ----------------------
60601-2-2 © IEC:2009 – 9 –
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
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 standard 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 60601-1-2 collateral standard,
203.4 in this particular standard addresses the content of Clause 4 of the 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 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses or figures 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 standard" 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 79.
Clause 2 of the general standard applies, except as follows:
Replacement:
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

---------------------- Page: 11 ----------------------
– 10 – 60601-2-2 © IEC:2009
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
Addition:
IEC 61000-4-3:2006, Electromagnetic compatibility (EMC) – Part 4-3: Testing and
measurement techniques – Radiated, radio-frequency electromagnetic field immunity test
IEC 61000-4-6:2003, Electromagnetic compatibility (EMC) – Part 4-6: Testing and
measurement techniques – Immunity to conducted disturbances, induced by radio-frequency
fields
CISPR 11:2003, Industrial, scientific and medical (ISM) radio-frequency equipment –
Electromagnetic disturbance characteristics – Limits and methods of measurement
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
apply, except as follows:
Replace NOTE 1 with the following:
NOTE 1 Where the terms “voltage” and “current” are used in this document, they mean the r.m.s. 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 surgical
effects 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
201.3.204
ACTIVE ELECTRODE INSULATION
electrical insulation material affixed to part of an ACTIVE ELECTRODE intended to prevent
unintended injury to the OPERATOR or adjacent PATIENT tissue
201.3.205
ACTIVE HANDLE
part of an ACTIVE ACCESSORY intended to be held by the OPERATOR
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

---------------------- Page: 12 ----------------------
60601-2-2 © IEC:2009 – 11 –
201.3.207
*ASSOCIATED EQUIPMENT
equipment other than HF SURGICAL EQUIPMENT that may be electrically connected to the
PATIENT circuit and not intended for independent use
201.3.208
*BIPOLAR
method of applying HF output current to a PATIENT via multiple-pole ACTIVE ELECTRODES
201.3.209
BIPOLAR ELECTRODE
assembly of 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 elevate the temperature of tissue, e.g. to reduce or terminate undesired
bleeding
NOTE COAGULATION may take the form of contact or non-contact COAGULATION.
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 A 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 N
...