IEC 80601-2-78:2019/Amd 1:2024

Medical electrical equipment — Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation — Amendment 1

Appareils électromédicaux — Partie 2-78: Exigences particulières pour la sécurité de base et les performances essentielles des robots médicaux dédiés à la rééducation, l'évaluation, la compensation ou l'atténuation — Amendement 1

General Information

• Status: Published
• Publication Date: 12-Mar-2024
• 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: 13-Mar-2024
• Due Date: 02-Jul-2024
• Completion Date: 13-Mar-2024

Relations

• Amends: IEC 80601-2-78:2019 - Medical electrical equipment — Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
• Effective Date: 06-Jun-2022

Standards Content (Sample)

FINAL
AMENDMENT ISO
DRAFT
80601-2-
78:2019
FDAM 1
ISO/TC 299
Medical electrical equipment —
Secretariat: SIS
Voting begins on:
Part 2-78:
2023-10-09
Particular requirements for basic
Voting terminates on:
safety and essential performance of
2023-12-04
medical robots for rehabilitation,
assessment, compensation or
alleviation
AMENDMENT 1
Appareils électromédicaux —
Partie 2-78: Exigences particulières pour la sécurité de base et
les performances essentielles des robots médicaux dédiés à la
rééducation, l'évaluation, la compensation ou l'atténuation
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 80601-2-78:2019/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 80601-2-78:2019/FDAM 1:2023(E)
FINAL
AMENDMENT ISO
DRAFT
80601-2-
78:2019
FDAM 1
ISO/TC 299
Medical electrical equipment —
Secretariat: SIS
Voting begins on:
Part 2-78:
2023-10-09
Particular requirements for basic
Voting terminates on:
safety and essential performance of
2023-12-04
medical robots for rehabilitation,
assessment, compensation or
alleviation
AMENDMENT 1
Appareils électromédicaux —
Partie 2-78: Exigences particulières pour la sécurité de base et
les performances essentielles des robots médicaux dédiés à la
rééducation, l'évaluation, la compensation ou l'atténuation
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-
ISO 80601-2-78:2019/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. © ISO 2023

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ISO 80601-2-78:2019/FDAM 1:2023(E)
– 2 – IEC FDIS 80601-2-78:2019/AMD1
© IEC 2023
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-78: Particular requirements for basic safety and essential
performance of medical robots for rehabilitation, assessment,
compensation or alleviation

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
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