IEC 60601-2-2:2017/AMD1:2023

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)

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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

– 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
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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
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
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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.

© 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.
– 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
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.
...