IEC 80601-2-77:2019
(Main)Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
IEC 80601-2-77:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS), referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION CONDITIONS and INTERFACE CONDITIONS.
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 s'applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS CHIRURGICAUX ROBOTIQUEMENT ASSISTES (RASE) et des SYSTEMES CHIRURGICAUX ROBOTIQUEMENT ASSISTES (RASS), appelés APPAREILS EM et SYSTEMES EM, ainsi qu'à leurs CONDITIONS D’INTERACTION et leurs CONDITIONS D’INTERFACE.
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IEC 80601-2-77
Edition 1.0 2019-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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 SECURITE DE BASE et les performances
essentielles des APPAREILS CHIRURGICAUX ROBOTIQUEMENT ASSISTES
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International Standards for all electrical, electronic and related technologies.
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IEC 80601-2-77
Edition 1.0 2019-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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 SECURITE DE BASE et les performances
essentielles des APPAREILS CHIRURGICAUX ROBOTIQUEMENT ASSISTES
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01; 11.040.30 ISBN 978-2-8322-6999-2
– 2 – IEC 80601-2-77:2019 © IEC 2019
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 . 13
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. 17
201.9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 18
201.10 Protection against unwanted and excessive radiation HAZARDS . 21
201.11 Protection against excessive temperatures and other HAZARDS . 21
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 22
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 22
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 23
201.15 Construction of ME EQUIPMENT . 23
201.16 * ME SYSTEMS . 23
201.17 * ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 23
202 ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 23
206 * USABILITY . 24
Annexes . 25
Annex D (informative) Symbols on marking . 26
Annex AA (informative) Particular guidance and rationale . 27
Annex BB (informative) Equations for the calculation of the overall system stopping
performance and minimum distances . 39
Annex CC (informative) Stopping functions of the RASE . 41
Annex DD (informative) Alternative method to demonstrate structural integrity
throughout the EXPECTED SERVICE LIFE of the RASE . 43
Annex EE (informative) Example of a testing method of the IMMUNITY test for HF
SURGICAL EQUIPMENT emissions . 46
Bibliography . 49
Index of defined terms used in this particular standard . 51
Figure 201.101 – Graphic symbol for maximum PATIENT mass and SAFE WORKING LOAD . 14
Figure 201.102 – Graphic symbol for mass of MOUNTED PART . 14
Figure 201.AA.101 – Examples of MECHANICAL INTERFACE attachments . 28
Figure 201.AA.102 – Example 1 of ROBOTIC SURGERY CONFIGURATION: a case of
laparoscopic RASS . 30
Figure 201.AA.103 – Example 2 of ROBOTIC SURGERY CONFIGURATION: a case of bone
milling RASE . 30
Figure 201.AA.104 – Typical ESSENTIAL PERFORMANCE items of RASE . 32
Figure 201.AA.105 – Example of RISK ASSESSMENT related to structural component . 36
Figure 201.BB.101 – Relationship between t1 and t2 . 40
Table 201.101 – List of ESSENTIAL PERFORMANCE requirements. 13
Table 201.102 – Colours of indicator lights and their meaning for ME EQUIPMENT . 16
Table 201.D.101 – Symbols for marking RASE or its parts . 26
Table 201.CC.101 – Different stopping functions . 41
Table 201.DD.101 – Alternative to safety factors: life testing . 43
– 4 – IEC 80601-2-77:2019 © IEC 2019
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-77: Particular requirements for the BASIC SAFETY and essential
performance of ROBOTICALLY ASSISTED 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 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
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
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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 t
...
IEC 80601-2-77
Edition 1.1 2023-11
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni
utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie et
les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.
IEC Secretariat Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.
IEC publications search - webstore.iec.ch/advsearchform IEC Products & Services Portal - products.iec.ch
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Stay up to date on all new IEC publications. Just Published
containing more than 22 300 terminological entries in English
details all new publications released. Available online and once
and French, with equivalent terms in 19 additional languages.
a month by email.
Also known as the International Electrotechnical Vocabulary
(IEV) online.
IEC Customer Service Centre - webstore.iec.ch/csc
If you wish to give us your feedback on this publication or need
further assistance, please contact the Customer Service
Centre: sales@iec.ch.
A propos de l'IEC
La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.
A propos des publications IEC
Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possédez l’édition la
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Published détaille les nouvelles publications parues.
additionnelles. Egalement appelé Vocabulaire
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publication ou si vous avez des questions contactez-nous:
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IEC 80601-2-77
Edition 1.1 2023-11
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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 978-2-8322-7891-8
IEC 80601-2-77
Edition 1.1 2023-11
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
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
– 2 – IEC 80601-2-77:2019+AMD1:2023 CSV
© IEC 2023
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
INTRODUCTION to Amendment 1 . 8
201.1 Scope, object and related standards . 9
201.2 Normative references . 11
201.3 Terms and definitions . 11
201.4 General requirements . 14
201.5 General requirements for testing of ME EQUIPMENT . 15
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 15
201.7 ME EQUIPMENT identification, marking and documents . 15
201.8 Protection against electrical HAZARDS from ME EQUIPMENT. 18
201.9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 19
201.10 Protection against unwanted and excessive radiation HAZARDS . 22
201.11 Protection against excessive temperatures and other HAZARDS . 22
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 24
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 24
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 24
201.15 Construction of ME EQUIPMENT . 24
201.16 * ME SYSTEMS . 25
201.17 * ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 25
202 ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 25
206 * USABILITY . 26
Annexes . 27
Annex D (informative) Symbols on marking . 28
Annex AA (informative) Particular guidance and rationale . 29
Annex BB (informative) Equations for the calculation of the overall system stopping
performance and minimum distances . 41
Annex CC (informative) Stopping functions of the RASE . 43
Annex DD (informative) Alternative method to demonstrate structural integrity
throughout the EXPECTED SERVICE LIFE of the RASE . 45
Annex EE (informative) Example of a testing method of the IMMUNITY test for HF
SURGICAL EQUIPMENT emissions . 48
Bibliography . 51
Index of defined terms used in this particular standard . 53
Figure 201.101 – Graphic symbol for maximum PATIENT mass and SAFE WORKING LOAD . 15
Figure 201.102 – Graphic symbol for mass of MOUNTED PART . 16
Figure 201.AA.101 – Examples of MECHANICAL INTERFACE attachments . 30
Figure 201.AA.102 – Example 1 of ROBOTIC SURGERY CONFIGURATION: a case of
laparoscopic RASS . 32
Figure 201.AA.103 – Example 2 of ROBOTIC SURGERY CONFIGURATION: a case of bone
milling RASE . 32
© IEC 2023
Figure 201.AA.104 – Typical ESSENTIAL PERFORMANCE items of RASE . 34
Figure 201.AA.105 – Example of RISK ASSESSMENT related to structural component . 38
Figure 201.BB.101 – Relationship between t1 and t2 . 42
Table 201.101 – List of ESSENTIAL PERFORMANCE requirements. 14
Table 201.102 – Colours and meanings of indicator lights for RASE and RASS . 17
Table 201.D.101 – Symbols for marking RASE or its parts . 28
Table 201.CC.101 – Different stopping functions . 43
Table 201.DD.101 – Alternative to safety factors: life testing . 45
– 4 – IEC 80601-2-77:2019+AMD1:2023 CSV
© 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
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 ma
...
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