SIST EN IEC 80601-2-78:2020/A1:2024

SLOVENSKI STANDARD
01-november-2024
Medicinska električna oprema - 2-78. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti medicinskih robotov za rehabilitacijo, ocenjevanje,
nadomestitev funkcij ali lajšanje simptomov - Dopolnilo A1 (IEC 80601-2-
78:2019/AMD1:2024)
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and
essential performance of medical robots for rehabilitation, assessment, compensation or
alleviation (IEC 80601-2-78:2019/AMD1:2024)
Medizinische elektrische Geräte - Teil 2-78: Besondere Festlegungen an die Sicherheit,
einschließlich der wesentlichen Leistungsmerkmale von medizinischen Robotern zur
Rehabilitation, Beurteilung, Kompensation oder Linderung (IEC 80601-2-
78:2019/AMD1:2024)
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 (IEC 80601-2-78:2019/AMD1:2024)
Ta slovenski standard je istoveten z: EN IEC 80601-2-78:2020/A1:2024
ICS:
11.040.60 Terapevtska oprema Therapy equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 80601-2-78:2020/A1

NORME EUROPÉENNE
EUROPÄISCHE NORM September 2024
ICS 11.040.01
English Version
Medical electrical equipment - Part 2-78: Particular requirements
for basic safety and essential performance of medical robots for
rehabilitation, assessment, compensation or alleviation
(IEC 80601-2-78:2019/AMD1:2024)
Appareils électromédicaux - Partie 2-78: Exigences Medizinische elektrische Geräte - Teil 2-78: Besondere
particulières pour la sécurité de base et les performances Festlegungen an die Sicherheit, einschließlich der
essentielles des robots médicaux dédiés à la rééducation, wesentlichen Leistungsmerkmale von medizinischen
l'évaluation, la compensation ou l'atténuation Robotern zur Rehabilitation, Beurteilung, Kompensation
(IEC 80601-2-78:2019/AMD1:2024) oder Linderung
(IEC 80601-2-78:2019/AMD1:2024)
This amendment A1 modifies the European Standard EN IEC 80601-2-78:2020; it was approved by CENELEC on 2024-07-31. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment the
status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation under the
responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as
the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 80601-2-78:2020/A1:2024 E

European foreword
The text of document 62D/2085/FDIS, future edition 1 of IEC 80601-2-78/AMD1, prepared by SC 62D
"Particular medical equipment, software, and systems" of IEC/TC 62 "Medical equipment, software,
and systems" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2025-05-01
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2027-07-31
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 80601-2-78:2019/AMD1:2024 was approved by CENELEC
as a European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standard indicated:
IEC 60601-1-9:2007 NOTE Approved as EN 60601-1-9:2008 (not modified)
IEC 60601-1-9:2007/A1:2013 NOTE Approved as EN 60601-1-9:2008/A1:2013 (not modified)
IEC 60601-1-9:2007/A2:2020 NOTE Approved as EN 60601-1-9:2008/A2:2020 (not modified)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1  Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2  Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cencenelec.eu.
Replace :
Publication Year Title EN/HD Year
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
+ A1 2020 + A1 2021
IEC 60601-1-6 2010 Medical electrical equipment - Part 1-6: EN 60601-1-6 2010
General requirements for basic safety and
essential performance - Collateral
standard: Usability
+ A1 2013 + A1 2015
+ A2 2020 + A2 2021
IEC 60601-1-8 2006 Medical electrical equipment - Part 1-8: EN 60601-1-8 2007
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
- - + AC 2010
+ A1 2012 + A1 2013
- - + AC 2014
- - + A11 2017
+ A2 2020 + A2 2021
ISO 14971 2019 EN ISO 14971 2019
- - + A11 2021
Add :
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- - + AC 2010
+ A1 2012 + A1 2013
- - + AC 2014
- - + A12 2014
+ A2 2020 + A2 2021
- - + AC 2022
- - + A13 2024
IEC 60601-1-10 2007 Medical electrical equipment - Part 1-10: EN 60601-1-10 2008
General requirements for basic safety and
essential performance - Collateral
Standard: Requirements for the
development of physiologic closed-loop
controllers
+ A1 2013 + A1 2015
+ A2 2020 + A2 2021
IEC 60601-1-11 2015 Medical electrical equipment - Part 1-11: EN 60601-1-11 2015
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
+ A1 2020 + A1 2021
IEC 62366-1 2015 Medical devices - Part 1: Application of EN 62366-1 2015
usability engineering to medical devices
- - + AC 2015
- - + AC 2016
+ A1 2020 + A1 2020
ISO 22523 2006 EN ISO 22523 2006

IEC 80601-2-78
Edition 1.0 2024-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –

Part 2-78: Particular requirements for basic safety and essential performance of

medical robots for rehabilitation, assessment, compensation or alleviation

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

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01 ISBN 978-2-8322- 8125-3

– 2 – IEC 80601-2-78:2019/AMD1:2024
© IEC 2024
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 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.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
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 the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
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 and ISO draw attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC and ISO take 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 and ISO had not received notice of
(a) patent(s), which may be required to implement this document. However, implementers are cautioned that this
may not represent the latest information, which may be obtained from the patent database available at
https://patents.iec.ch and www.iso.org/patents. IEC and ISO shall not be held responsible for identifying any or
all such patent rights.
Amendment 1 to IEC 80601-2-78:2019 has been prepared by IEC subcommittee 62D: Particular
medical equipment, software, and systems, of IEC Technical Committee 62: Medical equipment,
software, and systems, and ISO Technical Committee 299: Robotics.
This publication is published as a double logo standard.

IEC 80601-2-78:2019/AMD1:2024 – 3 –
© IEC 2024
The text of this Amendment is based on the following documents:
Draft Report on voting
62D/2085A/FDIS 62D/2109/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.
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 co
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