SIST EN 60601-2-2:2008

Medical electrical equipment -- Part 2-2: Particular requirements for the safety of high frequency surgical equipment

This Particular Standard specifies requirements for the safety of HIGH FREQUENCY SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES used in medical practice, as defined in 2.1.110 and hereinafter referred to as HF SURGICAL EQUIPMENT. 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.

Medizinische elektrische Geräte - Teil 2-2: Besondere Festlegungen für die Sicherheit von Hochfrequenz-Chirurgiegeräten

Appareils électromédicaux -- Partie 2-2: Exigences particulières pour la sécurité des appareils d'électrochirurgie à courant haute fréquence

La présente Norme Particulière spécifie des exigences relatives à la sécurité des appareils d'électrochirurgie hf et des accessoires d'électrochirurgie hf utilisés dans la pratique médicale. Les appareils d'électrochirurgie à courant haute fréquence 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.

Medicinska električna oprema - 2-2. del: Posebne zahteve za varnost visokofrekvenčne kirurške opreme (IEC 60601-2-2:2006)

General Information

• Status: Withdrawn
• Publication Date: 02-Jul-2007
• Withdrawal Date: 09-Jun-2009
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 09-Jun-2009
• Due Date: 02-Jul-2009
• Completion Date: 10-Jun-2009
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN 60601-2-2:2007 - Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment

Relations

• Replaced By: SIST EN 60601-2-2:2009 - Medical electrical equipment - Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (IEC 60601-2-2:2009)
• Effective Date: 01-Jul-2009
• Replaced By: SIST EN 60601-2-2:2009 - Medical electrical equipment - Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (IEC 60601-2-2:2009)
• Effective Date: 29-Jan-2023
• Replaced By: SIST EN 60601-2-2:2009 - Medical electrical equipment - Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (IEC 60601-2-2:2009)
• Effective Date: 07-Jun-2022
• Official Journal Project Relation: SIST EN 60601-2-2:2002 - Medical electrical equipment -- Part 2-2: Particular requirements for the safety of high frequency surgical equipment
• Effective Date: 15-May-2009
• Replaces: SIST EN 60601-2-2:2002 - Medical electrical equipment -- Part 2-2: Particular requirements for the safety of high frequency surgical equipment
• Effective Date: 29-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-2:2008
01-oktober-2008
1DGRPHãþD
SIST EN 60601-2-2:2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DYDUQRVW
YLVRNRIUHNYHQþQHNLUXUãNHRSUHPH,(&
Medical electrical equipment - Part 2-2: Particular requirements for the safety of high
frequency surgical equipment (IEC 60601-2-2:2006)
Medizinische elektrische Geräte - Teil 2-2: Besondere Festlegungen für die Sicherheit
von Hochfrequenz-Chirurgiegeräten (IEC 60601-2-2:2006)
Appareils électromédicaux - Partie 2-2: Exigences particulieres pour la sécurité des
appareils d'électrochirurgie a courant haute fréquence (IEC 60601-2-2:2006)
Ta slovenski standard je istoveten z: EN 60601-2-2:2007
ICS:
11.040.30 Operacijski instrumenti in Surgical instruments and
materiali materials
SIST EN 60601-2-2:2008 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-2:2008

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SIST EN 60601-2-2:2008


EUROPEAN STANDARD
EN 60601-2-2

NORME EUROPÉENNE
March 2007
EUROPÄISCHE NORM

ICS 11.040.30 Supersedes EN 60601-2-2:2000


English version


Medical electrical equipment -
Part 2-2: Particular requirements for the safety
of high frequency surgical equipment
(IEC 60601-2-2:2006)


Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-2: Exigences particulières Teil 2-2: Besondere Festlegungen
pour la sécurité des appareils für die Sicherheit
d'électrochirurgie à courant von Hochfrequenz-Chirurgiegeräten
haute fréquence (IEC 60601-2-2:2006)
(CEI 60601-2-2:2006)




This European Standard was approved by CENELEC on 2006-10-01. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels


© 2007 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-2:2007 E

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SIST EN 60601-2-2:2008
EN 60601-2-2:2007 - 2 -
Foreword
The text of document 62D/548/FDIS, future edition 4 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 was approved by CENELEC as EN 60601-2-2 on 2006-10-01.
This European Standard supersedes EN 60601-2-2:2000.
Significant revisions in EN 60601-2-2:2007 refer mainly to the following:
– revision of requirements and compliance testing for HF SURGICAL ACCESSORIES to make them
independent of specific HF surgical generators;
– revision and expansion of Clause 2 definitions;
– addition of thermal, electrical and adhesive requirements testing for NEUTRAL ELECTRODES;
– revision of dielectric strength requirements for HF SURGICAL ACCESSORIES;
– accommodation of HF surgical generators that don’t require continuous operation of the SWITCH
SENSOR;
– addition of Annex BB to provide EMD information about HF SURGICAL EQUIPMENT.
This Particular Standard amends and supplements EN 60601-1:1990, Medical Electrical Equipment –
Part 1: General requirements for safety, and its amendments, hereinafter referred to as the General
Standard. The requirements of this Particular Standard take priority over those of the General Standard.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
(dop) 2007-10-01
national standard or by endorsement
– latest date by which the national standards conflicting
(dow) 2009-10-01
with the EN have to be withdrawn
In this Particular Standard the following print types are used:
– requirements, compliance with which can be tested, and definitions: in roman type;
– notes, explanations, advice, introductions, general statements, exceptions and references: in smaller type;
– test specifications and headings of items: in italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD: SMALL CAPITALS.
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive 93/42/EEC (MDD). See Annex ZZ.
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-2:2006 was approved by CENELEC as a European
Standard without any modification.
__________

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SIST EN 60601-2-2:2008
- 3 - EN 60601-2-2:2007
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications

The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.

Publication Year Title EN/HD Year

IEC 60601-1-2 2001 Medical electrical equipment - EN 60601-1-2 2001
Part 1-2: General requirements for safety -
Collateral standard: Electromagnetic
compatibility - Requirements and tests


IEC 60601-2-2 1998 Medical electrical equipment - EN 60601-2-2 2000
Part 2-2: Particular requirements for the
safety of high frequency surgical equipment


IEC 60601-2-4 2005 Medical electrical equipment - - -
Part 2-4: Particular requirements for the
safety of cardiac defibrillators


IEC 60601-2-18 1996 Medical electrical equipment - EN 60601-2-18 1996
A1 2000 Part 2-18: Particular requirements for the A1 2000
safety of endoscopic equipment


IEC 60601-2-34 2000 Medical electrical equipment - EN 60601-2-34 2000
Part 2-34: Particular requirements for the
safety, including essential performance, of
invasive blood pressure monitoring
equipment


IEC 61000-4-3 2006 Electromagnetic compatibility (EMC) - EN 61000-4-3 2006
Part 4-3 : Testing and measurement
techniques - Radiated, radio-frequency,
electromagnetic field immunity test


IEC 61000-4-6 2003 Electromagnetic compatibility (EMC) -
1)
+ A1 2004 Part 4-6: Testing and measurement EN 61000-4-6 200X
techniques - Immunity to conducted
disturbances, induced by radio-frequency
fields


2)
CISPR 11 (mod) 2003 Industrial scientific and medical (ISM) EN 55011 2007
radio-frequency equipment - Electromagnetic
disturbance characteristics - Limits and
methods of measurement



1)
To be ratified; will also include A2:2006 to IEC 61000-4-6.
2)
EN 55011 includes A1:2004 to CISPR 11.

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SIST EN 60601-2-2:2008
EN 60601-2-2:2007 - 4 -
Publication Year Title EN/HD Year
CISPR 16-2-1 2003 Specification for radio disturbance and EN 55016-2-1 2004
immunity measuring apparatus and methods -
Part 2-1: Methods of measurement of
disturbances and immunity - Conducted
disturbance measurements


ANSI/AAMI HF18 2001 Electrosurgical devices - -

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SIST EN 60601-2-2:2008
- 5 - EN 60601-2-2:2007
Annex ZZ
(informative)

Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directives concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.

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SIST EN 60601-2-2:2008

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SIST EN 60601-2-2:2008
NORME CEI
INTERNATIONALE
IEC



60601-2-2
INTERNATIONAL


Quatrième édition
STANDARD

Fourth edition

2006-07


Appareils électromédicaux –
Partie 2-2:
Exigences particulières pour la sécurité
des appareils d’électrochirurgie à courant
haute fréquence

Medical electrical equipment –
Part 2-2:
Particular requirements for the safety
of high frequency surgical equipment


 IEC 2006 Droits de reproduction réservés  Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in any
utilisée sous quelque forme que ce soit et par aucun procédé, form or by any means, electronic or mechanical, including
électronique ou mécanique, y compris la photocopie et les photocopying and microfilm, without permission in writing from
microfilms, sans l'accord écrit de l'éditeur. the publisher.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: [phone] Telefax: [phone] E-mail: [e-mail] Web: www.iec.ch
CODE PRIX
XC
PRICE CODE
Commission Electrotechnique Internationale
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
Pour prix, voir catalogue en vigueur
For price, see current catalogue

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SIST EN 60601-2-2:2008
60601-2-2 © IEC:2006 – 3 –
CONTENTS
FOREWORD.7
INTRODUCTION.11

SECTION ONE – GENERAL
1 Scope and object.13
2 Terminology and definitions.15
3 General requirements .23
4 General requirements for tests .23
5 Classification.23
6 Identification, marking and documents.25
7 Power input .33

SECTION TWO – ENVIRONMENTAL CONDITIONS

SECTION THREE – PROTECTION AGAINST ELECTRICAL SHOCK HAZARDS
14 Requirements related to classification .35
17 Separation.35
18 Protective earthing, functional earthing and potential equalization.35
*19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS .35
*20 Dielectric strength .49

SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS

SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
36 Electromagnetic compatibility .51

SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE
ANAESTHETIC MIXTURES
39 Common requirements for CATEGORY AP and CATEGORY APG EQUIPMENT .53

SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
*42 Excessive temperatures .53
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility.53
46 Human errors .57

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SIST EN 60601-2-2:2008
60601-2-2 © IEC:2006 – 5 –
SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data .59
51 Protection against hazardous output.63

SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions .69

SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly .69
59 Construction and layout.79

Appendix L References – Publications mentioned in this standard .99
Annex AA (informative) Guidance and rationale for particular clauses and subclauses.101
Annex BB (informative) Electromagnetic disturbances created by HF SURGICAL
EQUIPMENT .149

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SIST EN 60601-2-2:2008
60601-2-2 © IEC:2006 – 7 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-2: Particular requirements for the safety
of high frequency surgical equipment



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 sub-committee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This fourth edition of IEC 60601-2-2 cancels and replaces the third edition published in 1998,
of which it constitutes a technical revision.
Significant revisions in this fourth edition refer mainly to the following:
– revision of requirements and compliance testing for HF SURGICAL ACCESSORIES to make
them independent of specific HF surgical generators;
– revision and expansion of Cause 2 definitions;
– addition of thermal, electrical and adhesive requirements testing for NEUTRAL ELECTRODES;

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SIST EN 60601-2-2:2008
60601-2-2 © IEC:2006 – 9 –
– revision of dielectric strength requirements for HF SURGICAL ACCESSORIES;
– accommodation of HF surgical generators that don’t require continuous operation of the
SWITCH SENSOR;
– addition of Annex BB to provide EMD information about HF SURGICAL EQUIPMENT.
The text of this standard is based on the following documents:
FDIS Report on voting
62D/548/FDIS 62D/560/RVD

Full information on the voting for the approval of this 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.
This Particular Standard amends and supplements IEC 60601-1:1998 (second edition)
Medical Electrical Equipment – Part 1: General requirements for safety, modified by
Amendment 1 and Amendment 2, hereinafter referred to as the General Standard. The
1)
requirements of this Particular Standard take priority over those of the General Standard.
In this Particular Standard the following print types are used:
– requirements, compliance with which can be tested, and definitions: in roman type;
– notes, explanations, advice, introductions, general statements, exceptions and references: in smaller type;
– test specifications, headings of subclauses and headings of items: in italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD:
SMALL CAPITALS.
The committee has decided that the contents of this publication 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.

———————
1)
 A third edition of IEC 60601-1 was published in 2005, incorporating significant structural modifications. Future
editions of this Part 2-2 will be based on the latest edition of Part 1 and any amendments.

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SIST EN 60601-2-2:2008
60601-2-2 © IEC:2006 – 11 –
INTRODUCTION
This fourth edition represents an extensive revision of the previous edition. It is being
released as a new edition to improve readability and usage. It was felt that the breadth of the
technical changes, and the improved safety that they will provide, were too important to wait
for the harmonization effort with the new edition of the General Standard.

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SIST EN 60601-2-2:2008
60601-2-2 © IEC:2006 – 13 –
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-2: Particular requirements for the safety of
high frequency surgical equipment



SECTION ONE – GENERAL
The clauses and subclauses of this section of the General Standard apply except as follows:
1 Scope and object
This clause of the General Standard applies except as follows:
*1.1 Scope
Addition:
This Particular Standard specifies requirements for the safety of HIGH FREQUENCY SURGICAL
EQUIPMENT and HF SURGICAL ACCESSORIES used in medical practice, as defined in 2.1.110 and
hereinafter referred to as HF SURGICAL EQUIPMENT.
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.
1.2 Object
Replacement:
The object of this Particular Standard is to establish particular requirements for the safety of
HF SURGICAL EQUIPMENT.
1.3 Particular Standards
Addition:
This Particular Standard amends and supplements a set of IEC publications consisting of
IEC 60601-1:1988, Medical electrical equipment – Part 1: General requirements for safety,
Amendment 1 (1991)
Amendment 2 (1995)
IEC 60601-1-1:2000, Medical electrical equipment – Part 1-1: General requirements for safety
– Collateral Standard: Safety requirements for medical electrical systems
IEC 60601-1-2:2001, Medical electrical equipment – Part 1-2: General requirements for safety
– Collateral Standard: Electromagnetic compatibility – Requirements and tests
Amendment 1 (2004)

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SIST EN 60601-2-2:2008
60601-2-2 © IEC:2006 – 15 –
IEC 60601-1-4:1996, Medical electrical equipment – Part 1: General requirements for safety –
4. Collateral Standard: Programmable electrical medical systems
Amendment 1 (1999)
For brevity, IEC 60601-1 is referred to, in this Particular Standard, either as the “General
Standard” or as the “General Requirement(s)”, IEC 60601-1-1, IEC 60601-1-2, and
IEC 60601-1-4 as the Collateral Standard(s).
The term "this Standard" covers the Particular Standard used together with the General
Standard and any Collateral Standards.
The numbering of sections, clauses and subclauses of this Particular Standard corresponds
with that of the General Standard. 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 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.
“Amendment” means that the clause or subclause of the General Standard is amended as
indicated by the text of this Particular Standard.
Subclauses or figures which are additional to those of the General Standard are numbered
starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb),
etc.
Clauses and subclauses for which there is a rationale are marked with an asterisk *. These
rationales can be found in an informative Annex AA. Annex AA should be used in determining
the relevance of the requirements addressed but should never be used to establish additional
test requirements.
Where there is no corresponding section, clause or subclause in this Particular Standard, the
section, clause or subclause of the General Standard or Collateral Standards applies without
modification. Where it is intended that any part of the General Standard or Collateral
Standards, although possibly relevant, is not to be applied, a statement to that effect is given
in this Particular Standard.
A requirement of this Particular Standard, replacing or modifying requirements of the General
Standard or Collateral Standards, takes precedence over the corresponding General
Requirement(s).
2 Terminology and definitions
This clause of the General Standard applies except as follows:
Addition:
2.1.101
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, active
cord, ACTIVE CONNECTOR and ACTIVE ELECTRODE

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SIST EN 60601-2-2:2008
60601-2-2 © IEC:2006 – 17 –
2.1.102
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
2.1.103
ACTIVE ELECTRODE
part of an ACTIVE ACCESSORY extending from the ACTIVE HANDLE to the surgical site
2.1.104
ACTIVE HANDLE
part of an ACTIVE ACCESSORY intended to be held by the OPERATOR
*2.1.105
ASSOCIATED EQUIPMENT
EQUIPMENT other than HF SURGICAL EQUIPMENT that may be electrically connected to the
PATIENT CIRCUIT and not intended for independent use
2.1.106
BIPOLAR ELECTRODE
assembly of two or more ACTIVE ELECTRODES on the same support, so constructed that, when
energized, the HF current flows mainly between these two electrodes
2.1.107
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 NE contact with the PATIENT becomes
insufficient
NOTE A CONTACT QUALITY MONITOR is functional only when used with a MONITORING NE.
2.1.108
ENDOSCOPICALLY USED ACCESSORY
an accessory, which may be the APPLIED PART of MEDICAL ELECTRICAL EQUIPMENT that is not
ENDOSCOPIC EQUIPMENT, introduced into a patient through the same orifice in the PATIENT as
the ENDOSCOPE
[IEC 60601-2-18, definition 2.1.102]
2.1.109
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 Requirements for similar switches intended to perform functions other than activation of HF output are
under consideration.
2.1.110
HF SURGICAL ACCESSORY
ACCESSORY intended to conduct, supplement or monitor HF energy applied to the PATIENT from
HF SURGICAL EQUIPMENT
NOTE HF SURGICAL ACCESSORIES include HF surgical application electrodes, including cords and connectors for
attachment to HF SURGICAL EQUIPMENT, as well as other ASSOCIATED EQUIPMENT intended for connection to the HF
surgical PATIENT CIRCUIT.

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SIST EN 60601-2-2:2008
60601-2-2 © IEC:2006 – 19 –
2.1.111
MONITORING NE
NEUTRAL ELECTRODE (NE) intended for use with a CONTACT QUALITY MONITOR
NOTE A CONTACT QUALITY MONITOR is functional only when used with a MONITORING NE.
2.1.112
NE CONTINUITY MONITOR
circuit in HF SURGICAL EQUIPMENT or ASSOCIATED EQUIPMENT intended for connection to an NE,
except MONITORING NE, providing an alarm in the event of electrical discontinuity in the NE
cable or its connections
NOTE An NE CONTINUITY MONITOR is intended for use only with NEs other than MONITORING NEs.
2.1.113
NEUTRAL ELECTRODE
NE
electrode of a relatively large area for connection to the body of the PATIENT, intended to
provide a return path for the HIGH FREQUENCY current with such a low current density in the
body tissue that physical effects such as unwanted burns are avoided
NOTE The NEUTRAL ELECTRODE is also known as plate, plate electrode, passive, return or dispersive electrode.
2.1.114
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
*2.2.101
HF SURGICAL EQUIPMENT
MEDICAL ELECTRICAL EQUIPMENT including its associated ACCESSORIES intended for the
performance of surgical operations, such as the CUTTING or COAGULATION of biological tissue
by means of HIGH FREQUENCY (HF) currents
2.3.101
ACTIVE ELECTRODE INSULATION
electrical insulation material affixed to part of an ACTIVE ELECTRODE
...