EN 60601-2-2:2007

SLOVENSKI STANDARD
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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.
__________
- 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.

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 - -

- 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.
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

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Pour prix, voir catalogue en vigueur
For price, see current catalogue

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

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

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;

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.

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.

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)
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

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.
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 intended to prevent
unintended injury to the OPERATOR or adjacent PATIENT tissue
*2.4.101
MAXIMUM OUTPUT VOLTAGE
for each available HF SURGICAL MODE, the magnitude of the maximum possible peak HF output
voltage appearing between PATIENT CIRCUIT connections
2.4.102
RATED ACCESSORY VOLTAGE
MAXIMUM OUTPUT VOLTAGE which may be applied to a MONOPOLAR HF SURGICAL ACCESSORY with
respect to an NE connected to the PATIENT. For a BIPOLAR HF SURGICAL ACCESSORY, the
MAXIMUM OUTPUT VOLTAGE which may be applied to pairs of opposite polarity
2.7.101
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

60601-2-2 © IEC:2006 – 21 –
*2.12.101
BIPOLAR
method of applying HF output current to a PATIENT via multiple-pole ACTIVE ELECTRODES
*2.12.102
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.
*2.12.103
CUTTING
resection or dissection of body tissue caused by the passage of HIGH FREQUENCY current of
high current density at the ACTIVE ELECTRODE(S)
*2.12.104
EARTH REFERENCED PATIENT CIRCUIT
PATIENT CIRCUIT which includes components, such as capacitors, installed to provide a low-
impedance path to earth for HF currents
*2.12.105
FULGURATION
form of COAGULATION using long (0,5 mm or more) electrical sparks to heat tissue surfaces
superficially, with no intentional mechanical contact between the ACTIVE ELECTRODE and the
tissue
2.12.106
HF ISOLATED PATIENT CIRCUIT
PATIENT CIRCUIT where there are no components installed to provide a low-impedance path to
earth for HF currents
*2.12.107
HF SURGICAL MODE
any of a number of OPERATOR selectable HF output characteristics intended to provide a
specific indicated surgical effect at a connected ACTIVE ACCESSORY, such as CUTTING,
COAGULATION and the like
NOTE Each available HF SURGICAL MODE may be provided with an OPERATOR adjustable output control to set the
desired intensity or speed of the surgical effect.
*2.12.108
HIGH FREQUENCY
HF
frequencies greater than 200 kHz
*2.12.109
MONOPOLAR
method of applying HF output current to a PATIENT via an ACTIVE ELECTRODE and returning via a
separately-connected NE or via the PATIENT’S body capacitance to earth
2.12.110
RATED LOAD
value of non-reactive load resistance connected to simulate the PATIENT that results in the
maximum HF output power from each HF SURGICAL MODE of the HF SURGICAL EQUIPMENT

60601-2-2 © IEC:2006 – 23 –
2.12.111
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 a
RATED LOAD
*2.12.112
CREST FACTOR
dimensionless value equal to the peak output voltage divided by the r.m.s. voltage as
measured at the output of HF SURGICAL EQUIPMENT in an open circuit condition
NOTE Specific information on the correct way to make the measurements needed to calculate this value may be
found in Annex AA.
3 General requirements
This clause of the General Standard applies except as follows:
3.6
Additional SINGLE FAULT CONDITIONS:
aa) failure in the NE CONTINUITY MONITOR or CONTACT QUALITY MONITOR which might cause a
SAFETY HAZARD (see 59.101);
bb) a defect in the output switching circuit resulting in an excessive low-frequency PATIENT
LEAKAGE CURRENT (see 56.11);
cc) any defect which results in the unwanted energization of the PATIENT CIRCUIT (see
59.102);
dd) any defect which results in a significant increase in output power relative to the output
setting (see 51.5).
4 General requirements for tests
This clause of the General Standard applies except as follows:
*4.7 Supply and test voltage, type of current, nature of supply, frequency
Add the following:
i) Particular care shall be taken to ensure accuracy and safety during measurement of HF
output. See Annex AA for guidance.
5 Classification
This clause of the General Standard applies except as follows:
*5.2 According to the degree of protection against electric shock:
Amendment:
Delete TYPE B APPLIED PART.
60601-2-2 © IEC:2006 – 25 –
6 Identification, marking and documents
This clause of the General Standard applies except as follows:
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts
l) Classification
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.
Connections on the HF SURGICAL EQUIPMENT and ASSOCIATED EQUIPMENT for the connection
of NE leads shall be marked with the following symbols:

IEC  1192/06
Figure 101 – Symbol used with an EARTH REFERENCED PATIENT CIRCUIT

IEC  1193/06
Figure 102 – Symbol used with a HF ISOLATED PATIENT CIRCUIT

NOTE These two symbols have been submitted to SC 3 for approval within IEC 60417.
* p) Output
This item of the General Standard does not apply.
*6.3 Marking of controls and instruments
Additional item:
aa) The output control shall have a scale and/or associated indicator showing the relative
units of HIGH FREQUENCY output. The indication shall not be marked in watts unless the
indicated power is delivered with an accuracy of ± 20 % over the total load resistance
range specified in 6.8.3.
The numeral "0" shall not be used unless no HF power in excess of 10 mW is delivered
from an ACTIVE or BIPOLAR ELECTRODE in this position.
NOTE The compliance test is the application of Clause 50.
*6.7 Indicator lights and push-buttons
a) Colours of indicator lights
Addition:
Where certain functions are indicated by lights, these indicator lights shall have the
following colours:
green: power supply switched on;
red: fault condition, for example in the PATIENT CIRCUIT;

60601-2-2 © IEC:2006 – 27 –
yellow: CUTTING mode activated;
blue: COAGULATION mode activated.
Blue and yellow lights shall not be used simultaneously for 'blend' modes.
b) Colours of unilluminated push-buttons
Addition:
The colour shall be similar with the colour coding of that pushbutton of FINGERSWITCH or of
that footswitch-pedal which is activated at this time.
NOTE Blended outputs are regarded as a CUTTING mode.
6.8 ACCOMPANYING DOCUMENTS
6.8.2 Instructions for use
Additional items:
*aa) For HF SURGICAL EQUIPMENT, information concerning the selection and use of HF
SURGICAL ACCESSORIES in order to avoid incompatibility and unsafe operation. (see also
56.103).
Advice for the OPERATOR to avoid HF output settings where MAXIMUM OUTPUT VOLTAGE,
according to 6.8.2 ee), may exceed RATED ACCESSORY VOLTAGE.
Advice concerning selection of a MONITORING NE with respect to compatibility with the
OPERATOR’s available CONTACT QUALITY MONITOR.
*bb) Notes on the application of HF SURGICAL EQUIPMENT. These notes shall draw the
attention of the OPERATOR to certain precautions which are necessary in order to reduce
the risk of accidental burns. In particular, advice, when appropriate, shall be given on
the following:
* 1) The entire area of the NEUTRAL ELECTRODE should be reliably attached to the
PATIENT'S body and as close to the operating field as possible (see Notes 1 and
2).
* 2) The PATIENT should not come into contact with metal parts which are earthed or
which have an appreciable capacitance to earth (for example operating table
supports, etc.). The use of antistatic sheeting is recommended for this purpose.
* 3) Skin-to-skin contact (for example between the arms and body of the PATIENT)
should be avoided, for example by insertion of dry gauze (see Notes 1 and 2).
* 4) When HF SURGICAL EQUIPMENT and physiological monitoring EQUIPMENT are used
simultaneously on the same PATIENT, any monitoring electrodes should be placed
as far as possible from the surgical electrodes. Needle monitoring electrodes are
not recommended.
In all cases, monitoring systems incorporating HIGH FREQUENCY current limiting
devices are recommended.
* 5) The cables to the surgical electrodes should be positioned in such a way that
contact with the PATIENT or other leads is avoided.
Temporarily unused ACTIVE ELECTRODES should be stored in a location that is
isolated from the PATIENT.
* 6) For surgical procedures where the HF current could flow through parts of the body
having a relatively small cross sectional area, the use of BIPOLAR techniques may
be desirable in order to avoid unwanted tissue damage.

60601-2-2 © IEC:2006 – 29 –
7) The output power selected should be as low as possible for the intended purpose.
Certain devices or accessories may present a SAFETY HAZARD at low power
settings. For example, with argon beam COAGULATION, the risk of gas embolism
rises if there is insufficient HF power to produce a rapid, impermeable eschar on
the target tissue.
*8) Apparent low output or failure of the HF SURGICAL EQUIPMENT to function correctly
at the normal operating settings may indicate faulty application of the NEUTRAL
ELECTRODE or poor contact in its connections. In this case, the application of the
NEUTRAL ELECTRODE and its connections should be checked before selecting a
higher output power (see Notes 1 and 2).
9) The use of flammable anaesthetics or oxidizing gases such as nitrous oxide (N O)
and oxygen should be avoided if a surgical procedure is carried out in the region
of the thorax or the head, unless these agents are sucked away.
Non-flammable agents should be used for cleaning and disinfection wherever
possible.
Flammable agents used for cleaning or disinfecting, or as solvents of adhesives,
should be allowed to evaporate before the application of HF surgery. There is a
risk of pooling of flammable solutions under the PATIENT or in body depressions
such as the umbilicus, and in body cavities such as the vagina. Any fluid pooled in
these areas should be mopped up before HF SURGICAL EQUIPMENT is used.
Attention should be called to the danger of ignition of endogenous gases. Some
materials, for example cotton, wool and gauze, when saturated with oxygen may
be ignited by sparks produced in NORMAL USE of the HF SURGICAL EQUIPMENT.
10) For PATIENTS with cardiac pacemakers or other active implants, a possible hazard
exists because interference with the action of the pacemaker may occur, or the
pacemaker may be damaged. In case of doubt, approved qualified advice should
be obtained.
11) For HF SURGICAL EQUIPMENT with an operating mode as described in 46.103 b), a
warning is required to the effect that the output from either ACTIVE ELECTRODE may
change during use.
NOTE 1 This requirement does not apply for HF SURGICAL EQUIPMENT only incorporating BIPOLAR output.
NOTE 2 This requirement does not apply for HF SURGICAL EQUIPMENT intended for use without a NEUTRAL
ELECTRODE.
cc) A warning that interference produced by the operation of HF SURGICAL EQUIPMENT may
adversely influence the operation of other electronic EQUIPMENT.
dd) Advice for the OPERATOR regularly to inspect the ACCESSORIES. In particular, electrode
cables and ENDOSCOPICALLY USED ACCESSORIES should be checked for possible damage.
*ee) For ASSOCIATED EQUIPMENT and ACTIVE ACCESSORIES, including separately supplied parts
thereof, the RATED ACCESSORY VOLTAGE.
*ff) For HF SURGICAL EQUIPMENT, the MAXIMUM OUTPUT VOLTAGE for each HF SURGICAL MODE
and instruction regarding the RATED ACCESSORY VOLTAGE as follows:
i) For situations where the MAXIMUM OUTPUT VOLTAGE (U ) is less than or equal to
max
1 600 V, provide instruction that ASSOCIATED EQUIPMENT and ACTIVE ACCESSORIES
should be selected that have a RATED ACCESSORY VOLTAGE equal to or greater than
the MAXIMUM OUTPUT VOLTAGE.
60601-2-2 © IEC:2006 – 31 –
ii) For situations where the MAXIMUM OUTPUT VOLTAGE (U ) is greater than 1 600 V,
max
calculate the variable y using the formula:
U − 400[Volts]
max
y =
600[Volts]
Take the smaller of variable y or the number 6. If the result is less than or equal to
the CREST FACTOR for that HF SURGICAL MODE, then provide instruction that
ASSOCIATED EQUIPMENT and ACTIVE accessories should be selected that have a
RATED ACCESSORY VOLTAGE equal to or greater than the MAXIMUM OUTPUT VOLTAGE.
iii) For situations where the MAXIMUM OUTPUT VOLTAGE (U ) is greater than 1 600 V,
max
and the CREST FACTOR is less than the variable y calculated above, a warning shall
be provided that any ASSOCIATED EQUIPMENT and ACTIVE ACCESSORIES used with
such mode or setting must be rated to withstand the combination of actual voltage
and CREST FACTOR.
Where the MAXIMUM OUTPUT VOLTAGE varies with the output setting, that information
shall be presented diagrammatically as a function of output setting.
NOTE The establishment of HF dielectric strength classes in order to make it easier for the user to judge
.
the suitability of accessories versus output settings is under consideration

*gg) A warning that failure of the HF SURGICAL EQUIPMENT could result in an unintended
increase of output power.
*hh) A statement of compatibility with specific MONITORING NE.
A warning that, unless a compatible MONITORING NE is used with a CONTACT QUALITY
MONITOR, loss of safe contact between the NE and the patient will not result in an
auditory alarm.
NOTE 1 This requirement does not apply for HF SURGICAL EQUIPMENT only incorporating BIPOLAR output.
NOTE 2 This requirement does not apply for HF SURGICAL EQUIPMENT intended for use without a NEUTRAL
ELECTRODE.
ii) On end use packaging for NEUTRAL ELECTRODES:
- If marked for SINGLE use, an expiration date.
- Precautions necessary to prevent burns at the NE site, e.g. limitation of output
setting and/or activation duration.
- If intended for use only on small PATIENTS, a marking in kg indicating the maximum
PATIENT weight for which it is intended to be used. See 59.104.5
jj) On instructions for use for MONITORING NEUTRAL ELECTRODES:
- For MONITORING NEs, a statement of compatibility with specific CONTACT QUALITY
MONITOR(s).
*kk) HF SURGICAL EQUIPMENT or HF SURGICAL ACCESSORIES intended for use where the applied
patient current is expected to exceed 500 mA for over 2 min at applied duty cycles
greater than 50 % shall be accompanied by instructions, warnings and cautions for the
proper use of NEU
...