IEC 60601-2-2:2017/AMD1:2023
(Amendment)Amendment 1 - 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
Amendment 1 - 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
Amendement 1 - 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 6.0 2023-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –
Part 2-2: Particular requirements for the basic safety and essential performance
of high frequency surgical equipment and high frequency surgical accessories
Appareils électromédicaux –
Partie 2-2: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils d'électrochirurgie à courant haute fréquence et des
accessoires d'électrochirurgie à courant haute fréquence
IEC 60601-2-2:2017-03/AMD1:2023-02(en-fr)
---------------------- Page: 1 ----------------------
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IEC 60601-2-2
®
Edition 6.0 2023-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –
Part 2-2: Particular requirements for the basic safety and essential performance
of high frequency surgical equipment and high frequency surgical accessories
Appareils électromédicaux –
Partie 2-2: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils d'électrochirurgie à courant haute fréquence et des
accessoires d'électrochirurgie à courant haute fréquence
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.30 ISBN 978-2-8322-6466-9
Warning! Make sure that you obtained this publication from an authorized distributor.
Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 3 ----------------------
– 2 – IEC 60601-2-2:2017/AMD1:2023
© IEC 2023
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
AMENDMENT 1
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 itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
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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 document may be the subject of patent
rights. IEC shall not be held responsible for identifying any or all such patent rights.
Amendment 1 to IEC 60601-2-2:2017 has been prepared by subcommittee 62D: Particular
medical equipment, software, and systems, of IEC technical committee 62: Medical equipment,
software, and systems.
The text of this Amendment is based on the following documents:
Draft Report on voting
62D/2010/FDIS 62D/2021/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this Amendment is English.
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IEC 60601-2-2:2017/AMD1:2023 – 3 –
© IEC 2023
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications/.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
___________
INTRODUCTION to Amendment 1
th
The 6 Edition of IEC 60601-2-2 was published in 2017. This amendment is intended to align
the standard to IEC 60601-1:2005/AMD2:2020. Additionally, this amendment is intended to
address several issues reported from the national committees, including but not limited to:
• requirement for including the length of an accessory in the instructions for use;
• clarification of test setup for HF LEAKAGE CURRENTS;
• considering modes with high DUTY CYCLES above 45 % in the risk management;
• including text of the interpretation sheet 62D/1703/INF regarding the HIGH CURRENT MODE
to Annex AA.
201.1 Scope, object and related standards
Replace, in footnote 1 to the first sentence, "IEC 60601-1:2005/AMD1:2012" with
"IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020".
201.1.3 Collateral standards
Replace the existing second paragraph with the following:
IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020 and IEC 60601-1-8:2006,
IEC 60601-1-8:2006/AMD1:2012 and IEC 60601-1-8:2006/AMD2:2020, apply as modified in
Clauses 202 and 208 respectively. IEC 60601-1-3, IEC 60601-1-10, IEC 60601-1-11 and
IEC 60601-1-12 do not apply. All other published collateral standards in the IEC 60601-1 series
apply as published.
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– 4 – IEC 60601-2-2:2017/AMD1:2023
© IEC 2023
201.2 Normative references
Replace the existing reference to IEC 60601-1-2:2014 with the following:
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral Standard: Electromagnetic disturbances –
Requirements and tests
IEC 60601-1-2:2014/AMD1:2020
Replace the existing reference to IEC 60601-1-8:2006 with the following:
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
IEC 60601-1-8:2006/AMD1:2012
IEC 60601-1-8:2006/AMD2:2020
Delete the existing references to IEC 61000-4-3:2006 and IEC 6100-4-6:2013.
Replace the existing reference to CISPR 11:2015 with the following:
CISPR 11:2015, Industrial, scientific and medical equipment – Radio-frequency disturbance
characteristics – Limits and methods of measurement
CISPR 11:2015/AMD1:2016
CISPR 11:2015/AMD2:2019
201.3.220
* HIGH FREQUENCY
Add, after the existing definition, the following new note:
Note 1 to entry: HIGH FREQUENCY (HF) and radio frequency (RF) are considered as equivalent in the context of this
document as long as the frequency is within the range defined in this definition.
201.4.2.3.101 * Evaluating risk
Add, at the end of the existing subclause, the following new text:
Additionally, the impact on the heating under the NEUTRAL ELECTRODE shall be considered within
RISK ANALYSIS for any mode with a duty cycle above 45 % according to its intended use even if
2
the HEATING FACTOR is below 30 A s in any 60 s interval.
201.4.11 Power input
Replace the text of this paragraph with the following:
Replacement of first dash in compliance tests:
– The HF SURGICAL EQUIPMENT shall be operated in the manner (combination of operating
setting, load, etc.) which creates the greatest steady state input current. Input current is
measured and compared with the markings and the contents of the technical description.
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IEC 60601-2-2:2017/AMD1:2023 – 5 –
© IEC 2023
Table 201.101 – Colours of indicator lights and their meaning for HF SURGICAL EQUIPMENT
Replace the existing table with the following new table:
Table 201.101 – Colours of indicator lights and their meaning
for HF SURGICAL EQUIPMENT
Name On when Indicator Alarm Accompanied Operator
a
indicator light by sound requirement
light
b
c
Warning Hazardous Red, flashing - Immediate response
-
situation or not by the operator is
required, for example,
a fault in the patient
circuit
d
CUTTING mode CUTTING Yellow, - -
Yes
activation flashing or not
d
COAGULATION COAGULATION Blue, flashing - -
Yes
mode activation or not
Ready for use ME EQUIPMENT Green - - -
is ready for use
Other Situations Any colour - - -
other than that other than red,
of red, yellow, yellow, blue or
blue or green green
a
These indicator lights are INFORMATION SIGNALS and IEC 60601-1-8 requires that they be perceived as different
than visual ALARM SIGNALS.
b
Such warnings and cautions are frequently accompanied by a SAFETY SIGN.
c
Sound may be utilized, but IEC 60601-1-8 requires that it be perceived as different than auditory ALARM
SIGNALS.
d
As defined in 201.12.4.2.101.
201.7.9.2.2.101 Additional information in instructions for use
Replace, in the first sentence of item c), "instruction" with “instructions”.
201.7.9.2.14 * ACCESSORIES, supplementary equipment, used material
Add, before NOTE 101, the following new item:
k) * the length of the HF SURGICAL ACCESSORY.
201.7.9.3.1 * General
Add, at the end of the existing subclause, the following new note:
NOTE 101 The manufacturer can describe the specific behaviour of the HF SURGICAL EQUIPMENT, e.g. short circuit
protection.
201.8.7.1 * General requirements
Add, after the last sentence, the following new note:
NOTE Temporary internal modifications to the HF SURGICAL EQUIPMENT can be used (e.g. bridging of relay contacts)
to ensure the correct measurement of low-frequency LEAKAGE CURRENTS.
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© IEC 2023
201.8.7.3.101 Thermal effects of HF LEAKAGE CURRENT
Replace, under item 2) for MONOPOLAR HF ISOLATED PATIENT CIRCUITS, the sentence beginning
with "The HF SURGICAL EQUIPMENT is set up as shown in Figure 201.106,…" with the following:
The HF SURGICAL EQUIPMENT is set up as shown in Figure 201.106. Each electrode is tested with
the output first being unloaded and then repeated with the output loaded at the RATED LOAD.
Replace, in item 3), the sentence beginning with "The test is conducted with the output…" in
the fourth paragraph with the following:
The test is conducted with the output first being unloaded or with the highest load resistance
that produces an HF output and then repeated with the output loaded at the RATED LOAD.
Figure 201.107 – Measurement of HF LEAKAGE CURRENT from a BIPOLAR ACCESSORY
Replace the existing figure with the following new figure:
Dimensions in meters
Key
1 SUPPLY MAINS
2 Table, made of insulating material
3 HF SURGICAL EQUIPMENT
5 NEUTRAL ELECTRODE, metallic or in contact with metal foil of the same size
7 Measuring resistance, 200 Ω
8 HF current meter
9 Earthed conductive plane
10 Activated BIPOLAR ACCESSORY
11 Load resistance as required with HF power measuring device
Figure 201.107 – Measurement of HF LEAKAGE CURRENT from a BIPOLAR ACCESSORY
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IEC 60601-2-2:2017/AMD1:2023 – 7 –
© IEC 2023
201.8.8.3.102 * ACTIVE ACCESSORY HF leakage
Replace the existing sentence starting with "The insulation applied to ACTIVE ACCESSORIES…”
with “The insulation applied to ACTIVE ACCESSORIES, including ACTIVE ELECTRODE INSULATION and
ACTIVE HANDLES, but excluding ACTIVE CONNECTORS, shall limit HF LEAKAGE CURRENT passing
through the external surface of the insulation to less than I .”
leakage
Add, at the end of item a), the following new note:
NOTE In this paragraph, ‘d’ is the outer diameter of an insulation with a circular cross section. It is noted that the
current formula can only be used for ACTIVE ACCESSORIES with circular cross section. For an ACTIVE ACCESSORY with
a non-circular cross section, a value ‘d’ is calculated from the circumference ‘c’ of the original shape. In this case,
the value d corresponds to the circumference divided by π.
d = c / π
201.12.4.3.101 * Output reduction means
Delete the existing asterisk in the subclause title.
Replace the first sentence of this subclause with the following:
th
Except as provided for in 201.7.9.2.2.101 a) item 7, and 201.7.9.3.1. – 5 dash, for each HF
SURGICAL MODE, HF SURGICAL EQUIPMENT shall incorporate means to enable the output power to
be reduced to not more than 5 % of the RATED OUTPUT POWER or 10 W, whichever is smaller
(see also 201.12.1.102).
201.12.4.4.102 * Output power during simultaneous activation
Delete the existing introductory sentence in the compliance statement: "For HF SURGICAL
EQUIPMENT as defined in 201.12.2 c)".
Add, before the sentence starting with "The output under test is activated at 20 %", the following
new sentence “For HF SURGICAL EQUIPMENT as defined in 201.12.2 c) 1):”.
Add, before the sentence starting with "The output under test is activated at 50 %", the following
new sentence “For HF SURGICAL EQUIPMENT as defined in 201.12.2 c) 2):”.
202 * ELECTROMAGNETIC DISTURBANCES – Requirements and tests
Replace “IEC 60601-1-2:2014 applies” with “IEC 60601-1-2:2014 and
IEC 60601-1-2:2014/AMD1:2020 apply”.
202.2 Normative references
Replace the existing reference to "IEC 60601-2-2:2016" with "IEC 60601-2-2:2017 and
IEC 60601-2-2:2017/AMD1:2023".
202.3 Terms and definitions
Replace the existing reference to "IEC 60601-2-2:2016" with "IEC 60601-2-2:2017 and
IEC 60601-2-2:2017/AMD1:2023".
202.101 Index of defined terms
Replace the existing reference to "IEC 60601-2-2:2016" with "IEC 60601-2-2:2017 and
IEC 60601-2-2:2017/AMD1:2023".
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© IEC 2023
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems
Replace "IEC 60601-1-8:2006 applies" with "IEC 60601-1-8:2006,
IEC 60601-1-8:2006/AMD1:2012 and IEC 60601-1-8:2006/AMD2:2020 apply".
Definition 201.3.219 – HIGH CURRENT MODE
Add, after the existing text, the following new text:
The definition of HIGH CURRENT MODE is being misinterpreted with the effect that conventional
HF SURGICAL EQUIPMENT used for many years with compatible, conventional NEUTRAL
ELECTRODES without incidents are now erroneously declared as HIGH CURRENT MODE devices.
This is not the intention of the document.
Users of the document should understand that
1) The load resistances specified in 201.7.9.3 and 201.12.1 do not define the INTENDED
USE. The INTENDED USE is defined by the MANUFACTURER according to IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, 3.44.
2) The MAXIMUM OUTPUT CURRENT is the RMS current at the lowest relevant impedance
determined by the MANUFACTURER ignoring transients of less than 1 s when the device
is operated according to the instructions for use.
3) The document requires that the MANUFACTURER performs a RISK ANALYSIS to review
situations and reasonably foreseeable misuse that could result in current levels higher
than the MAXIMUM OUTPUT CURRENT.
The HEATING FACTOR is calculated according to 201.3.218. The HEATING FACTOR is used to
determine if a generator contains a HIGH CURRENT MODE or not according to 201.3.219.
Subclause 201.4.2.3.101 – Evaluating RISK
Add, after the existing text, the following new text:
The requirements for conventional NEUTRAL ELECTRODES are based on data with a maximum
duty cycle of 45 % (see rationale for 201.15.101.5). For modes that are used with higher duty
cycles according to their intended use, this is addressed in risk management.
Subclause 201.7.9.2.14 – ACCESSORIES, supplementary equipment, used material
Add, after the existing text of Subclause 201.7.9.2.14 j), the following new item:
Subclause 201.7.9.2.14 k)
HF SURGICAL ACCESSORIES act as antennas from an EMC point of view, so the user needs the
HF SURGICAL EQUIPMENT and the accessory.
length to ensure length compatibility between the
Subclause 201.8.8.3.101 – ACTIVE ACCESSORY insulation
Replace the first sentence of the existing note with the following:
th
This subclause was completely redrafted in the 5 Edition of this document to cover only dielectric strength of the
various parts of ACTIVE ACCESSORY insulation, independent from any particular HF SURGICAL EQUIPMENT.
Subclause 201.12.4.3.101 – Output reduction means
Delete the existing title and text.
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IEC 60601-2-2:2017/AMD1:2023 – 9 –
© IEC 2023
Clause 202 – ELECTROMAGNETIC DISTURBANCES – Requirements and tests
Replace, in the fourth existing paragraph, the first sentence with “During the immunity tests, the
MANUFACTURER will need to specify how compliance to the standard is checked.”
Add, at the end of the existing subclause, the following new text:
HF SURGICAL EQUIPMENT is evaluated regarding EMC utilizing ACTIVE ACCESSORIES that represent
the least favourable configuration according to IEC 60601-1-2. This configuration is considered
when determining the maximum permissible length of accessories (see 201.7.9.2.2.101 i)). The
relevant length is for example the fully extended length between the ACTIVE CONNECTOR and the
distal end of the ACTIVE ELECTRODE.
The MANUFACTURER may choose not to re-evaluate EMC, if previously completed EMC testing
can be shown to be applicable by objective evidence for the configuration.
HF SURGICAL ACCESSORIES, including ASSOCIATED EQUIPMENT, that include active electronic
circuits should be evaluated for EMC.
Ensuring compatibility between HF SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES is an
OPERATOR responsibility.
Bibliography
Add the following new references [19] to [22] as follows:
[19] IEC 60601-1-3, Medical electrical equipment – Part 1-3: General requirements for basic
safety and essential performance – Collateral Standard: Radiation protection in diagnostic
X-ray equipment
[20] IEC 60601-1-10, Medical electrical equipment – Part 1-10: General requirements for basic
safety and essential performance – Collateral Standard: Requirements for the
development of physiologic closed-loop controllers
[21] 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
[22] IEC 60601-1-12, Medical electrical equipment – Part 1-12: General requirements for basic
safety and essential performance – Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems intended for use in the emergency
medical services environment
___________
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– 10 – IEC 60601-2-2:2017/AMD1:2023
© IEC 2023
COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE
____________
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
AMENDEMENT 1
AVANT-PROPOS
1) La Commission Électrotechnique Internationale (IEC) est une organisation mondiale de normalisation composée
de l'ensemble des comités électrotechniques nationaux (Comités nationaux de l’IEC). L’IEC a pour objet de
favoriser la coopération internationale pour toutes les questions de normalisation dans les domaines de
l'électricité et de l'électronique. A cet effet, l'IEC – entre autres activités – publie des Normes internationales,
des Spécifications techniques, des Rapports techniques, des Spécifications accessibles au public (PAS) et des
Guides (ci-après dénommés "Publication(s) de l'IEC"). Leur élaboration est confiée à des comités d'études, aux
travaux desquels tout Comité national intéressé par le sujet traité peut participer. Les organisations
internationales, gouvernementales et non gouvernementales, en liaison avec l’IEC, participent également aux
travaux. L’IEC collabore étroitement avec l'Organisation Internationale de Normalisation (ISO), selon des
conditions fixées par accord entre les deux organisations.
2) Les décisions ou accords officiels de l’IEC concernant les questions techniques représentent, dans la mesure du
possible, un accord international sur les sujets étudiés, étant donné que les Comités nationaux de
l’IEC intéressés sont représentés dans chaque comité d’études.
3) Les Publications de l’IEC se présentent sous la forme de recommandations internationales et sont agréées
comme telles par les Comités nationaux de l’IEC. Tous les efforts raisonnables sont entrepris afin que
l’IEC s'assure de l'exactitude du contenu technique de ses publications; l’IEC ne peut pas être tenue responsable
de l'éventuelle mauvaise utilisation ou interprétation qui en est faite par un quelconque utilisateur final.
4) Dans le but d'encourager l'uniformité internationale, les Comités nationaux de l’IEC s'engagent, dans toute la
mesure possible, à appliquer de façon transparente les Publications de l’IEC dans leurs publications nationales
et régionales. Toutes divergences entre toutes Publications de l’IEC et toutes publications nationales ou
régionales correspondantes doivent être indiquées en termes clairs dans ces dernières.
5) L’IEC elle-même ne fournit aucune attestation de conformité. Des organismes de certification indépendants
fournissent des services d'évaluation de conformité et, dans certains secteurs, accèdent aux marques de
conformité de l’IEC. L’IEC n'est responsable d'aucun des services effectués par les organismes de certification
indépendants.
6) Tous les utilisateurs doivent s'assurer qu'ils sont en possession de la dernière édition de cette publication.
7) Aucune responsabilité ne doit être imputée à l’IEC, à ses administrateurs, employés, auxiliaires ou mandataires,
y compris ses experts particuliers et les membres de ses comités d'études et des Comités nationaux de l’IEC,
pour tout préjudice causé en cas de dommages corporels et matériels, ou de tout autre dommage de quelque
nature que ce soit, directe ou indirecte, ou pour supporter les coûts (y compris les frais de justice) et les dépenses
découlant de la publication ou de l'utilisation de cette Publication de l’IEC ou de toute autre Publication de l’IEC,
ou au crédit qui lui est accordé.
8) L'attention est attirée sur les références normatives citées dans cette pu
...
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