IEC 80601-2-77:2019/Amd 1:2023

Medical electrical equipment — Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment — Amendment 1

Appareils électromédicaux — Partie 2-77: Exigences particulières pour la sécurité de base et les performances essentielles des appareils chirurgicaux robotiquement assistés — Amendement 1

General Information

• Status: Published
• Publication Date: 16-Nov-2023
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: ISO/TC 299 - Robotics
• Drafting Committee: ISO/TC 299/JWG 5 - Joint ISO/TC 299 - IEC/SC 62A - IEC/SC 62D WG: Medical robot safety
• Parallel Committee: IEC/TC 62 - Electrical equipment in medical practice
• Current Stage: 6060 - International Standard published
• Start Date: 17-Nov-2023
• Due Date: 02-Jul-2023
• Completion Date: 17-Nov-2023

Standards Content (Sample)

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)

---------------------- Page: 1 ----------------------
THIS PUBLICATION IS COPYRIGHT PROTECTED
Copyright © 2023 IEC, Geneva, Switzerland

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.: [phone]
3, rue de Varembé [e-mail]
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
The advanced search enables to find IEC publications by a Discover our powerful search engine and read freely all the
variety of criteria (reference number, text, technical publications previews. With a subscription you will always have
committee, …). It also gives information on projects, replaced access to up to date content tailored to your needs.
and withdrawn publications.

Electropedia - www.electropedia.org
IEC Just Published - webstore.iec.ch/justpublished
The world's leading online dictionary on electrotechnology,
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: [e-mail].


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
plus récente, un corrigendum ou amendement peut avoir été publié.

Recherche de publications IEC - Découvrez notre puissant moteur de recherche et consultez
webstore.iec.ch/advsearchform gratuitement tous les aperçus des publications. Avec un
La recherche avancée permet de trouver des publications IEC abonnement, vous aurez toujours accès à un contenu à jour
en utilisant différents critères (numéro de référence, texte, adapté à vos besoins.
comité d’études, …). Elle donne aussi des informations sur les
projets et les publications remplacées ou retirées. Electropedia - www.electropedia.org

Le premier dictionnaire d'électrotechnologie en ligne au monde,
IEC Just Published - webstore.iec.ch/justpublished
avec plus de 22 300 articles terminologiques en anglais et en
Restez informé sur les nouvelles publications IEC. Just
français, ainsi que les termes équivalents dans 19 langues
Published détaille les nouvelles publications parues.
additionnelles. Egalement appelé Vocabulaire
Disponible en ligne et une fois par mois par email.
Electrotechniqu
...

FINAL
AMENDMENT ISO
DRAFT
80601-2-
77:2019
FDAM 1
ISO/TC 299
Medical electrical equipment —
Secretariat: SIS
Voting begins on:
Part 2-77:
2023-08-18
Particular requirements for the basic
Voting terminates on:
safety and essential performance
2023-10-13
of robotically assisted surgical
equipment
AMENDMENT 1
Appareils électromédicaux —
Partie 2-77: Exigences particulières pour la sécurité de base et les
performances essentielles des appareils chirurgicaux robotiquement
assistés
AMENDEMENT 1
Member bodies are requested to consult relevant national interests in IEC/TC
62 before casting their ballot to the e-Balloting application.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO 80601-2-77:2019/FDAM 1:2023(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2023

---------------------- Page: 1 ----------------------
ISO 80601-2-77:2019/FDAM 1:2023(E)
FINAL
AMENDMENT IEC
DRAFT
80601-2-
77:2019
FDAM 1
ISO/TC 299
Medical electrical equipment —
Secretariat: SIS
Voting begins on:
Part 2-77:
2023-08-18
Particular requirements for the basic
Voting terminates on:
safety and essential performance
2023-10-13
of robotically assisted surgical
equipment
AMENDMENT 1
Appareils électromédicaux —
Partie 2-77: Exigences particulières pour la sécurité de base et les
performances essentielles des appareils chirurgicaux robotiquement
assistés
AMENDEMENT 1
Member bodies are requested to consult relevant national interests in IEC/TC
62 before casting their ballot to the e-Balloting application.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: [phone]
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: [e-mail]
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
IEC 80601-2-77:2019/FDAM 1:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
  © ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © IEC 2023

---------------------- Page: 2 ----------------------
– 2 – IEC FDIS 80601-2-77:2019/AMD1
© 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 o
...