IEC 60601-2-2:2009

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

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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
– 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

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

– 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-
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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.

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.

– 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.

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.

– 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).

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
– 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

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 NE,
except MONITORING NE, providing an alarm in the event of electrical discontinuity in the NE
cable or its connections
201.3.213
*CREST FACTOR
dimensionless value equal to the peak output voltage divided by the 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.
201.3.214
*CUTTING
resection or dissection of body tissue caused by the passage of HIGH FREQUENCY current of
high current density at the ACTIVE ELECTRODE(S)
201.3.215
*EARTH REFERENCED PATIENT CIRCUIT
PATIENT circuit which includes components, such as capacitors, installed to provide a low-
impedance path to earth for HF currents
201.3.216
FINGERSWITCH
ACTIVE ACCESSORY which, when manipulated by the
device generally included with an
OPERATOR, enables HF output to be produced and, when released disables HF output

– 12 – 60601-2-2 © IEC:2009
NOTE Requirements for similar switches intended to perform functions other than activation of HF output are
under consideration.
201.3.217
*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
201.3.218
*HIGH FREQUENCY
HF
frequencies generally greater than 200 kHz
201.3.219
HF ISOLATED PATIENT CIRCUIT
PATIENT circuit where there are no components installed to provide a low-impedance path to
earth for HF currents
201.3.220
HF PATIENT CIRCUIT
any electrical circuit which contains one or more PATIENT CONNECTIONS
201.3.221
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.
201.3.222
HF SURGICAL EQUIPMENT
MEDICAL ELECTRICAL EQUIPMENT including associated ACCESSORIES intended for the
performance of surgical operations, such as the CUTTING or COAGULATION of biological tissue
by means of HIGH FREQUENCY currents
NOTE HF SURGICAL EQUIPMENT is also known as surgical diathermy or electrosurgical equipment.
201.3.223
*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.
201.3.224
*MAXIMUM OUTPUT VOLTAGE
for each available HF SURGICAL MODE, the magnitude of the maximum possible peak HF output
voltage appearing between PATIENT circuit connections
201.3.225
*MONITORING NE
NE intended for use with a CONTACT QUALITY MONITOR

60601-2-2 © IEC:2009 – 13 –
201.3.226
*MONOPOLAR
method of applying HF output current to a PATIENT via an ACTIVE ELECTRODE and returning via
a separately-connected NEUTRAL ELECTRODE or via the PATIENT’S body capacitance to earth
201.3.227
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.
201.3.228
RATED ACCESSORY VOLTAGE
maximum peak HF 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 peak HF output voltage which may be applied to pairs of opposite
polarity
201.3.229
RATED LOAD
value of non-reactive load resistance which, when connected, results in the maximum HF
output power from each HF SURGICAL MODE of the HF SURGICAL EQUIPMENT
201.3.230
RATED OUTPUT POWER
for each HF SURGICAL MODE set at its maximum output setting, the power in watts produced
when all ACTIVE OUTPUT TERMINALS which can be activated simultaneously are connected to
their respective RATED LOADs
201.3.231
SWITCH SENSOR
HF SURGICAL EQUIPMENT or ASSOCIATED EQUIPMENT which controls activation of HF output
part of
in response to operation of a connected FINGERSWITCH or footswitch
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.2 * RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS
Addition:
MANUFACTURERS shall include, within their RISK ANALYSIS, the potential for their HF SURGICAL
EQUIPMENT and/or HF SURGICAL ACCESSORIES to be used in MONOPOLAR high current situations
and the impact this would have on the heating under the NEUTRAL ELECTRODE (for example,
see 201.7.9.2.2.101 f)).
201.4.3 * ESSENTIAL PERFORMANCE
Addition:
NOTE 101 Please refer to Annex AA.
201.4.7 SINGLE FAULT CONDITION for ME EQUIPMENT
Addition:
– 14 – 60601-2-2 © IEC:2009
Additional SINGLE FAULT CONDITIONS:
aa) failure in the CONTINUITY MONITOR or CONTACT QUALITY MONITOR which might cause a
unacceptable RISK (see 201.8.4.101);
bb) a defect in the output switching circuit resulting in an excessive low-frequency PATIENT
LEAKAGE CURRENT (see 201.8.10.4.101.1);
cc) any defect which results in the unwanted energization of the PATIENT circuit (see
201.12.4.2.101);
dd) any defect which results in a significant increase in output power relative to the output
setting (see 201.12.4.4.101).
201.4.11 Power input
Amendment:
The HF SURGICAL EQUIPMENT shall be operated in the output mode and using the load which
creates the greatest steady state current.
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.4 * Other conditions
Addition:
aa) Particular care shall be taken to ensure accuracy and safety during measurement of HF
output. See Annex AA for guidance.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2.8.2 Other power sources
Amendment:
Subclause 7.2.8.2 of the general standard does not apply to ACTIVE OUTPUT TERMINALS.
201.7.2.10 APPLIED PARTS
Addition:
The relevant symbols required for marking DEFIBRILLATION-PROOF APPLIED PARTS shall be
attached to the front panel, but are not required on the APPLIED PARTS.
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 201.101 – Symbol used with an EARTH REFERENCED PATIENT CIRCUIT

60601-2-2 © IEC:2009 – 15 –
IEC  1193/06
Figure 201.102 – Symbol used with a HF ISOLATED PATIENT CIRCUIT
201.7.4.2 * Control devices
Addition:
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
201.7.9.3.1.
The numeral "0" shall not be used unless no HF power in excess of 10 mW is delivered from
an ACTIVE ELECTRODE or BIPOLAR ELECTRODE in this position.
NOTE The compliance test is the application of subclause 201.12.1.102.
201.7.8.1 * Colours of indicator lights
Replace Table 2 in the general standard with the following:
Table 201.101 – Colours of indicator lights and their meaning
for HF SURGICAL EQUIPMENT
Colour Meaning
Red Warning – immediate response by the
OPERATOR is required, for example, a fault in
the PATIENT circuit
Yellow CUTTING mode
Blue COAGULATION mode
Green Ready for use
Any other colour Meaning other than that of red, yellow, blue or
green
201.7.8.2 * Colours of controls
Addition:
Where operating controls, output terminals, indicator lights, pedals (see 201.12.2) and
pushbuttons of FINGERSWITCHES (see 201.12.2) are associated with a particular HF SURGICAL
MODE, they shall be identified by a consistent, unique colour not in conflict with Table 201.101.
Compliance is checked by inspection.
201.7.9.2.2 Warning and safety notices
Additional subclause:
201.7.9.2.2.101 * Additional information in instructions for use
a) 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 a suitably
prepared and appropriate area of the PATIENT'S body as defined by the
MANUFACTURER.
– 16 – 60601-2-2  IEC:2009
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.).
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.
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 PATIENT leads 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.
7) The output power selected should be as low as possible for the intended purpose.
Certain devices or ACCESSORIES may present an unacceptable RISK 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.
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 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 201.12.2 c), a
warning is required to the effect that the output from either ACTIVE ELECTRODE may
change during use.
b) A warning that interference produced by the operation of HF SURGICAL EQUIPMENT may
adversely influence the operation of other electronic equipment.
c) * For HF SURGICAL EQUIPMENT, the MAXIMUM OUTPUT VOLTAGE for each HF SURGICAL MODE
and instruction regarding the RATED ACCESSORY VOLTAGE as follows:

60601-2-2 © IEC:2009 – 17 –
1) 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.
2) 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.
3) For situations where the MAXIMUM OUTPUT VOLTAGE (U ) is greater than 1 600 V, and
max
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.
d) A warning that failure of the HF SURGICAL EQUIPMENT could result in an unintended increase
of output power.
e) * 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. (See 201.15.101).
f) Where the temperature under the NEUTRAL ELECTRODE, during intended or foreseen use,
may exceed the li
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