IEC 80601-2-77:2019/AMD1:2023

IEC 80601-2-77
Edition 1.0 2023-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
Medical electrical equipment –
Part 2-77: Particular requirements for the basic safety and essential performance
of robotically assisted surgical equipment

Appareils électromédicaux –
Partie 2-77: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils chirurgicaux robotiquement assistés

IEC 80601-2-77:2019-07/AMD1:2023-11(en-fr)

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IEC 80601-2-77
Edition 1.0 2023-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –

Part 2-77: Particular requirements for the basic safety and essential

performance of robotically assisted surgical equipment

Appareils électromédicaux –
Partie 2-77: Exigences particulières pour la sécurité de base et les

performances essentielles des appareils chirurgicaux robotiquement assistés

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01, 11.040.30 ISBN 978-2-8322-7786-7

– 2 – IEC 80601-2-77:2019/AMD1:2023
© IEC 2023
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-77: Particular requirements for the basic safety and essential
performance of robotically assisted surgical equipment

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.
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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) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights in
respect thereof. As of the date of publication of this document, IEC had not received notice of (a) patent(s), which
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the latest information, which may be obtained from the patent database available at https://patents.iec.ch. IEC
shall not be held responsible for identifying any or all such patent rights.
Amendment 1 to IEC 80601-2-77:2019 has been prepared by subcommittee 62D: Particular
medical equipment, software, and systems, of IEC technical committee 62: Medical equipment,
software, and systems, and ISO technical committee 299: Robotics.
The text of this Amendment is based on the following documents:
Draft Report on voting
62D/2070/FDIS 62D/2102/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
© IEC 2023
The language used for the development of this Amendment is English.
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, or
• revised.
NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC or
ISO publication in which to make products in accordance with the new requirements and to equip themselves for
conducting new or revised tests. It is the recommendation of the committee that the content of this publication be
adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.

_____________
INTRODUCTION to Amendment 1
At the October 2019 meeting of IEC SC 62D in Shanghai, China, the subcommittee discussed
the need for administrative/technical changes to most 62D standards after completion of the
amendment projects within the IEC 60601-1 series. Those projects were all completed and the
amendments published in 2020.
The full list of IEC SC 62D documents that will be amended or revised can be found within the
IEC document 62D/1792/DC. The results and comments on the DC can be found within
62D/1808/INF. The review report for this amendment is 62D/1881/RR.
201.1 Scope, object and related standards
Replace the text of the existing footnote with the following:
3 The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
201.1.3 * Collateral standards
Replace the text of the existing second paragraph with the following:
IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020,
IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020
apply as modified in Clauses 202 and 206 respectively.
IEC 60601-1-3:2008, IEC 60601-1-3:2008/AMD1:2013 and IEC 60601-1-3:2008/AMD2:2021
[8], IEC 60601-1-9:2007, IEC 60601-1-9:2007/AMD1:2013 and
IEC 60601-1-9:2007/AMD2:2020 [9], and IEC 60601-1-11:2015 and
IEC 60601-1-11:2015/AMD1:2020 [10] do not apply.

– 4 – IEC 80601-2-77:2019/AMD1:2023
© IEC 2023
201.1.4 Particular standards
Replace in the existing third paragraph, “IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012”
with “IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020”.
201.2 Normative references
Replace the existing text with the following:
NOTE Informative references are listed in the Bibliography.
Clause 2 of the general standard applies, except as follows:
Replacement:
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
IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
safety and essential performance – Collateral standard: Usability
IEC 60601-1-6:2010/AMD1:2013
IEC 60601-1-6:2010/AMD2:2020
IEC 62366-1:2015, Medical devices – Part 1: Application of usability engineering to medical
devices
IEC 62366-1:2015/AMD1:2020
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
201.3 Terms and definitions
Replace the existing text of the first paragraph with the following new text:
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and the following apply.
201.3.202
Replace the existing term, definition and source with the following new term, definition and
source:
* CAPACITIVELY COUPLED HF CURRENT
unavoidable HIGH FREQUENCY current flowing due to capacitive coupling from the APPLIED PART
of HF SURGICAL EQUIPMENT to another part of the RASE or RASS
[SOURCE: IEC 60601-2-18:2009, 201.3.201, modified – Replacement of " from an ENERGIZED
ENDOTHERAPY DEVICE that is the APPLIED PART of HF SURGICAL EQUIPMENT to the ENDOSCOPE" by
"from the APPLIED PART of HF SURGICAL EQUIPMENT to another part of the RASE or RASS".]

© IEC 2023
201.7.8.1 Colours of indicator lights
Replace the entire subclause, including Table 201.102, with the following:
201.7.8.1 * Colours of indicator lights
e f g
Add row 2 and 3 of Table 201.102 above the note of Table 2, and add note , and of
Table 201.102 to the note of Table 2:
Table 201.102 – Colours and meanings of indicator lights for RASE and RASS
a
Name On when Alarm Accompanied OPERATOR
Indicator light
indicator light by sound requirement
e g
Cutting Yellow, flashing – –
Cutting mode Yes
f
activation
or not
g
Coagulation Coagulation Blue, flashing or – –
Yes
e f
activation
mode not
a
These indicator lights are INFORMATION SIGNALS and IEC 60601-1-8 requires that they be perceived as different
than visual ALARM SIGNALS.
e
Applicable when RASE and RASS incorporate HF SURGICAL EQUIPMENT.
f
Yellow and blue indicator lights can also be used to indicate additional modes if multiple functions share the
same control device, provided the USABILITY ENGINEERING PROCESS demonstrates that this does not result in
unacceptable RISK.
g
As defined in 201.12.4.2.101 of IEC 60601-2-2:2017.

Addition at the end of subclause 201.7.8.1:
In addition to Table 2, red, yellow, and blue indicator colours may be used as the following,
provided the USABILITY ENGINEERING PROCESS demonstrates that this does not result in
unacceptable RISK.
• Red for situations where immediate response by the OPERATOR is required,
• Yellow for situations where prompt response by the OPERATOR is required,
• Blue for any situations other than those for red or yellow colours as indicated above.
202 ELECTROMAGNETIC DISTURBANCES – Requirements and test
Replace “IEC 60601-1-2:2014 applies” with “IEC 60601-1-2:2014 and
IEC 60601-1-2:2014/AMD1:2020 apply”.
206 * USABILITY
Replace “IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013” with “IEC 60601-1-6:2010
and IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020”.
206.4.2 USABILITY ENGINEERING PROCESS for ME EQUIPMENT
Replace, in the first and second paragraphs, “IEC 62366-1:2015” with “IEC 62366-1:2015 and
IEC 62366-1:2015/AMD1:2020” (2 occurrences).

– 6 – IEC 80601-2-77:2019/AMD1:2023
© IEC 2023
206.5 Replacement of requirements given in IEC 62366
Replace, in the existing note, “Clause 5 of IEC 60601-1-6:2010 and
IEC 60601-1-6:2010/AMD1:2013” with “Clause 5 of IEC 60601-1-6:2010,
IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020”.
AA.2 Rationale for particular clauses and subclauses
Add the following new subclause:
Subclause 201.7.8.1 – Colours of indicator lights
Subclause 201.7.8.1 was amended to be in line with the IEC 60601-1:2005/AMD2:2020,
subclause 7.8.1 and IEC 60601-2-2:2017/AMD:2023 for activating cutting and coagulation
modes of HF SURGICAL EQUIPMENT. The amended text and table do not change the allowable use
of colours of indicator light as previously indicated in IEC 80601-2-77:2019.
Figure 201.AA.105 – Example of RISK ASSESSMENT related to structural component
Replace in the existing note, “IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012” with
“IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020”.
Subclause 201.17 – ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS
Replace, in the existing subclause the reference “IEC 60601-1-2:2014” with
“IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020” (3 occurrences).
EE.2 Electromagnetic (EM) Phenomena aspects in RASE applications
Replace the reference “IEC 60601-1-2:2014” with “IEC 60601-1-2:2014 and
IEC 60601-1-2:2014/AMD1:2020”.

© IEC 2023
Bibliography
Replace the existing references [8], [9] and [10] with the following new references:
[8] IEC 60601-1-3:2008, Medical electrical equipment – Part 1-3: General requirements for
basic safety and essential performance – Collateral Standard: Radiation protection in
diagnostic X-ray equipment
IEC 60601-1-3:2008/AMD1:2013
IEC 60601-1-3:2008/AMD2:2021
[9] IEC 60601-1-9:2007, Medical electrical equipment – Part 1-9: General requirements for
basic safety and essential performance – Collateral Standard: Requirements for
environmentally conscious design
IEC 60601-1-9:2007/AMD1:2013
IEC 60601-1-9:2007/AMD2:2020
[10] IEC 60601-1-11:2015, 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
IEC 60601-1-11:2015/AMD1:2020
Replace, in the existing footnote 4 to reference [23], reference “IEC 60601-1-2:2014” with
“IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020”.

– 8 – IEC 80601-2-77:2019/AMD1:2023
© IEC 2023
Index of defined terms used in this particular standard
Replace the existing entries as follows:
AIR CLEARANCE . IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, 3.5
HARM .
...