IEC 80601-2-78:2019/AMD1:2024

IEC 80601-2-78
Edition 1.0 2024-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
AMENDMENT 1
AMENDEMENT 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
IEC 80601-2-78:2019-07/AMD1:2024-03(en-fr)

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
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, graphical symbols and the glossary.
committee, …). It also gives information on projects, replaced With a subscription you will always have access to up to date
and withdrawn publications. content tailored to your needs.

IEC Just Published - webstore.iec.ch/justpublished
Electropedia - www.electropedia.org
Stay up to date on all new IEC publications. Just Published
The world's leading online dictionary on electrotechnology,
details all new publications released. Available online and once
containing more than 22 500 terminological entries in English
a month by email.
and French, with equivalent terms in 25 additional languages.

Also known as the International Electrotechnical Vocabulary
IEC Customer Service Centre - webstore.iec.ch/csc
(IEV) online.
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
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, symboles
La recherche avancée permet de trouver des publications IEC graphiques et le glossaire. Avec un abonnement, vous aurez
en utilisant différents critères (numéro de référence, texte, toujours accès à un contenu à jour 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 22 500 articles terminologiques en anglais et en
Restez informé sur les nouvelles publications IEC. Just
français, ainsi que les termes équivalents dans 25 langues
Published détaille les nouvelles publications parues.
additionnelles. Egalement appelé Vocabulaire
Disponible en ligne et une fois par mois par email.
Electrotechnique International (IEV) en ligne.

Service Clients - webstore.iec.ch/csc
Si vous désirez nous donner des commentaires sur cette
publication ou si vous avez des questions contactez-nous:
sales@iec.ch.
IEC Products & Services Portal - products.iec.ch

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 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 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.

IMPORTANT – The "colour inside" logo on the cover page of this document indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this document using a colour printer.

– 4 – IEC 80601-2-78:2019/AMD1:2024
© IEC 2024
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/1882/RR.

_____________
201.1 Scope, object and related standards
Replace the text of the existing footnote 1 with the following new text:
1 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 existing second paragraph with the following new paragraph:
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, IEC 60601-1-8:2006,
IEC 60601-1-8:2006/AMD1:2012 and IEC 60601-1-8:2006/AMD2:2020, IEC 60601-1-10:2007,
IEC 60601-1-10:2007/AMD1:2013 and IEC 60601-1-10:2007/AMD2:2020, and
IEC 60601-1-11:2015 and IEC 60601-1-11:2015/AMD1:2020 apply as modified in Clauses 202,
206, 208, 210 and 211 respectively. IEC 60601-1-3 and IEC 60601-1-12 do not apply. All other
published collateral standards in the IEC 60601-1 series apply as published.

201.1.4 Particular standards
Replace the existing third paragraph with the following:
For brevity, IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 are referred to in this particular standard as the general
standard. Collateral standards are referred to by their document number.

© IEC 2024
201.2 Normative references
Replace the existing text with the following new text:
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 60601-1-8:2006, Medical electrical equipment – Part 1-8: 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
IEC 60601-1-8:2006/AMD1:2012
IEC 60601-1-8:2006/AMD2:2020
ISO 14971:2019, Medical devices – Application of risk management to medical devices
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
IEC 60601-1-10:2007, Medical electrical equipment – Part 1-10: General requirements for basic
safety and essential performance – Collateral Standard: Requirements for the development of
physiologic closed-loop controllers
IEC 60601-1-10:2007/AMD1:2013
IEC 60601-1-10:2007/AMD2:2020
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
IEC 62366-1:2015, Medical devices – Part 1: Application of usability engineering to medical
devices
IEC 62366-1:2015/AMD1:2020
ISO 22523:2006, External limb prostheses and external orthoses – Requirements and test
methods
– 6 – IEC 80601-2-78:2019/AMD1:2024
© IEC 2024
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/AMD1:2020 apply.

201.4.2.3.102 * RISK MANAGEMENT and SITUATION AWARENESS
Replace the existing first sentence of the third paragraph with “IEC 62366-1:2015 and
IEC 62366-1:2015/AMD1:2020, 5.5 requires HAZARD-RELATED USE SCENARIOS to be evaluated
using a SUMMATIVE EVALUATION including SITUATION AWARENESS“.

CCESSORIES
201.7.2.4 A
Replace, in the existing first paragraph, “6.2 of ISO 14971:2007” with “ 7.1 of ISO 14971:2019”.

201.15.3.101 Toppling for WALKING RACA ROBOT
Add, after the existing Note 2, the following new note:
NOTE 3 Toppling testing can be found in the IEC 60068-2-31:2008, 5.1.3.3.

202 ELECTROMAGNETIC DISTURBANCES – Requirements and test
Replace the existing text with the following new text:
IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020 apply except as follows:

206 USABILITY
Replace the existing text with the following new text:
IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020
apply, except as follows:
© IEC 2024
206.5 * Replacement of requirements given in IEC 62366-1
Replace the existing text with the following new text:
Replacement:
In addition to the requirements of IEC 62366-1:2015 and IEC 62366-1:2015/AMD1:2020, the
following shall apply.
The instructions for use shall include a brief description of the ME EQUIPMENT, its physical
operating principles and significant physical and performance characteristics relevant to its
USABILITY. The same information shall also be included in the technical description, if this is
provided as a separate document.
NOTE An important purpose of this description is to help the OPERATOR to develop adequate SITUATION AWARENESS
of the ME EQUIPMENT.
The instructions for use shall contain a summary of the application specification.
Add to 3.21 of IEC 62366-1:2015:
Note 101 to entry: USE ERRORS can occur to due to loss or lack of OPERATOR SITUATION AWARENESS.
Add, to the second paragraph of 5.2 of IEC 62366-1:2015 and IEC 62366-1:2015/AMD1:2020,
after the first sentence:
This identification shall include consideration of reasonably foreseeable loss or lack of
OPERATOR SITUATION AWARENESS as a source of USE ERROR.
Add to 5.2 of IEC 62366-1:2015 and IEC 62366-1:2015/AMD1:2020:
NOTE 101 USE ERRORS can occur in different ways and with different probabilities of occurrence due to the level or
condition of OPERATOR SITUATION AWARENESS.
Add, after NOTE 2 of 5.3 of IEC 62366-1:2015 and IEC 62366-1:2015/AMD1:2020:
NOTE 101 Application of the concept of SITUATION AWARENESS could make the identification of HAZARDS or
HAZARDOUS SITUATIONS more thorough.
Add, after NOTE 1 of 5.7.1 of IEC 62366-1:2015 and IEC 62366-1:2015/AMD1:2020:
NOTE 101 Examples of methods to evaluate adequate SITUATION AWARENESS can be found in Annex BB of this
document.
208 * General requirements, tests and guidance for alarm systems in MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS
Replace the existing text with the following new text:
IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012 and IEC 60601-1-8:2006/AMD2:2020
apply, except as follows:
– 8 – IEC 80601-2-78:2019/AMD1:2024
© IEC 2024
210 * Process requirements for the development of PHYSIOLOGIC CLOSED-LOOP
CONTROLLERS
Replace the existing text with the following new text:
IEC 60601-1-10:2007, IEC 60601-1-10:2007/AMD1:2013 and
IEC 60601-1-10:2007/AMD2:2020 apply, except as follows:
Addition:
NOTE Additional information can be found in Annex AA, Clause 210.

211 * Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL
ELECTRICAL SYSTEMS used in the HOME HEALTHCARE ENVIRONMENT
Replace the existing text with the following new text:
IEC 60601-1-11:2015 and IEC 60601-1-11:2015/AMD1:2020 apply, except as follows:

Annex AA (informative) ─ Particular guidance and rationale
Subclause 202.4.3 – General test conditions
Replace the existing last sentence of the first paragraph with the following new sentence:
However, IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020 does not explicitly exclude
EMC testing under SINGLE FAULT CONDITION.

Subclause 206.5 – Replacement of requirements given in IEC 62366-1
Replace the existing text with the following new text:
IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020
refer to IEC 62366:2007 and IEC 62366:2007/AMD1:2014 which do not align well with SITUATION
AWARENESS, in comparison to IEC 62366-1:2015. Clause 5 of IEC 60601-1-6:2010,
IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020 was updated to reflect
this change in reference to the newer version of the standard. In addition, the original text of
Clause 5 of IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013 and
IEC 60601-1-6:2010/AMD2:2020 referred to an OPERATOR’S mental model. The original text was
modified to align with the concept of SITUATION AWARENESS.
Although designing for USABILITY implicitly requires dealing with SITUATION AWARENESS, as
outlined in Clause BB.1, SITUATION AWARENESS has been dealt with poorly in many other
industries, often with catastrophic results. The intent of the addition to Clause 5 of
IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020 is
to explicitly require the MANUFACTURER to address SITUATION AWARENESS through the USABILITY
ENGINEERING PROCESS. For example, 5.2 of IEC 62366-1:2015 and
IEC 62366-1:2015/AMD1:2020 requires the MANUFACTURER to identify USER INTERFACE
characteristics related to SAFETY and potential USE ERRORS but does not explicitly mention that
USE ERRORS can occur due to loss of SITUATION AWARENESS. 9.3 of IEC TR 62366-2:2016, in

© IEC 2024
reference to FUNCTION ANALYSIS, provides the only explicit reference to SITUATION AWARENESS in
either IEC 62366-1:2015, IEC 62366-1:2015/AMD1:2020 or IEC TR 62366-2:2016.
Annex BB provides additional information on SITUATION AWARENESS, including how to design for
adequate SITUATION AWARENESS and how to assess it.

Clause 208 – General requirements, tests and guidance for alarm systems in MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS
Replace the existing text with the following new text:
When a RACA ROBOTs is provided with an ALARM SYSTEM according to IEC 60601-1-8:2006,
IEC 60601-1-8:2006/AMD1:2012 and IEC 60601-1-8:2006/AMD2:2020, the MANUFACTURER
should place particular emphasis on SITUATION AWARENESS in order to determine the OPERATOR’S
ability to be aware of the HAZARDOUS SITUATION causing the ALARM CONDITION and the appropriate
response required to avoid an unacceptable RISK.

Clause 210 – Process requirements for the development of PHYSIOLOGIC CLOSED-LOOP
CONTROLLERS
Replace the existing first sentence with the following new sentence:
The collateral standard IEC 60601-1-10:2007, IEC 60601-1-10:2007/AMD1:2013 and
IEC 60601-1-10:2007/AMD2:2020 uses the term "mental model" in numerous places, for
example, Annex A of IEC 60601-1-10:2007, IEC 60601-1-10:2007/AMD1:2013 and
IEC 60601-1-10:2007/AMD2:2020.

Annex BB (informative) ─ Guidance and examples of SITUATION AWARENESS
BB.2 Brief background on SITUATION AWARENESS
Replace the existing three paragraphs following the Figure BB.1 with the following new
paragraphs:
The relationship between SITUATION AWARENESS and existing processes can be seen in
Figure BB.2, which was modified from Figure A.5 of IEC 62366-1:2015 and
IEC 62366-1:2015/AMD1:2020. There are three changes to the figure (see the red text boxes)
that demonstrate two common scenarios in which SITUATION AWARENESS impacts these existing
processes.
• The first scenario relates to HAZARDS or HAZARDOUS SITUATIONS identified initially as part of
the USER INTERFACE specification (IEC 62366-1:2015 and IEC 62366-1:2015/AMD1:2020,
5.2). The link between USABILITY and RISK now includes a specific consideration for
SITUATION AWARENESS (201.4.2.3.102) as well as a NOTE (ISO 14971:2019, 7.1 and 7.2),
both in red text boxes in Figure BB.2, to remind the MANUFACTURER that RISK CONTROLS
should be designed for SITUATION AWARENESS.
• The second scenario relates to RISK CONTROLS identified and implemented to address
HAZARDS and HAZARDOUS SITUATIONS identified as part of the RISK MANAGEMENT process
(ISO 14971:2019, 7.1 and 7.2) after the initial use specification and identification of user
interface characteristics related to safety (IEC 62366-1:2015 and IEC 62366-
1:2015/AMD1:2020, 5.1 and 5.2). As per the new note (see the red text box in Figure BB.2)

– 10 – IEC 80601-2-78:2019/AMD1:2024
© IEC 2024
for ISO 14971:2019, 7.3, the MANUFACTURER needs to be aware that if these new RISK
CONTROLS require SITUATION AWARENESS, then the MANUFACTURER needs to loop back to
USABILITY ENGINEERING again to ensure that the OPERATOR will have adequate SITUATION
AWARENESS for the RISK CONTROL to be effective.

Figure BB.2 – Relationship between SITUATION AWARENESS, the RISK MANAGEMENT PROCESS
(ISO 14971:2007) and the USABILITY ENGINEERING PROCESS (IEC 62366-1:2015)
Replace the existing figure, text and title with the following:

© IEC 2024
Modified from IEC 62366-1:2015/AMD1:2020, Figure A.5.
Figure BB.2 – Relationship between SITUATION AWARENESS, the RISK MANAGEMENT PROCESS
(ISO 14971:2019) and the USABILITY ENGINEERING PROCESS (IEC 62366-1:2015 and
IEC 62366-1:2015/AMD1:2020)
– 12 – IEC 80601-2-78:2019/AMD1:2024
© IEC 2024
BB.4.2 SITUATION AWARENESS elements analysis
Replace the existing second last sentence of the first paragraph with the following new
sentence:
These unstructured interviews are related to the requirements of IEC 62366-1:2015 and
IEC 62366-1:2015/AMD1:2020, 5.2 and 5.4.
Replace the existing last paragraph with the following new paragraph:
The results of the SITUATION AWARENESS elements can be used as the check points to verify
RACA ROBOT has been designed and manufactured following the design principles
whether the
given in Clause BB.3 or, if they are related with the USER INTERFACE, then they can be integrated
into the USER INTERFACE SPECIFICATION (5.6 of IEC 62366-1:2015) and used in the FORMATIVE
EVALUATION of the USER INTERFACE (5.8 of IEC 62366-1:2015 and
IEC 62366-1:2015/AMD1:2020) as defined in IEC 62366-1:2015 and
IEC 62366-1:2015/AMD1:2020.
Figure BB.3 – Relationship between GDTA and RISK MANAGEMENT and USABILITY ENGINEERING
PROCESSES
Replace the existing figure with the following:

Key
SA SITUATION AWARENESS
Figure BB.3 – Relationship between GDTA and RISK MANAGEMENT and USABILITY
ENGINEERING PROCESSES
© IEC 2024
BB.5.2 Design process for RACA ROBOT for outdoors mobility assistance for a PATIENT
(HOME HEALTH CARE ENVIRONMENT)
Replace, in the existing second paragraph of this subclause, “ISO 14971:2007” with
“ISO 14971:2019”.
Replace the existing items 1), 2) and 3) with the following:
1) Identify the HAZARDOUS SITUATION (ISO 14971:2019, 5.4, 5.5).
• If the RACA ROBOT runs out of power, the PATIENT may be stranded, leading to related
HARM.
2) Estimate RISK and determine if RISK reduction is necessary (ISO 14971:2019, 5.5 and
Clause 6).
• Yes, RISK reduction is necessary.
3) Identify RISK CONTROL (ISO 14971:2019, 7.1).
• OPERATOR: plan, and then take any outdoor excursions so that they can be completed
prior to the battery running out of power.
Replace, in the existing item 4), the last sentence of the second paragraph with the following:
• Answering this question requires analysing the OPERATOR’S SITUATION AWARENESS
capabilities (see new note in red in Figure BB.2, adjacent to ISO 14971:2019, 7.3).

Replace, in the existing NOTE 2, “IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 11.8”
with “IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
11.8”.
Replace, in the existing item 6), the first paragraph with the following:
6) Implement RISK CONTROL measure/specify, design and implement user interface
(ISO 14971:2019, 7.1, and IEC 62366-1:2015 and IEC 62366-1:2015/AMD1:2020, 5.6 to
5.8).
BB.5.3 Design process for multiple RACA ROBOTs used simultaneously by a single
OPERATOR (therapist)
Replace the existing second paragraph with the following:
For each step in this example, the most relevant subclauses of each of ISO 14971:2019 and
IEC 62366-1:2015 and IEC 62366-1:2015/AMD1:2020 have been referenced in order to help
align this example with these processes and the flowchart shown in Figure BB.2.

Replace the existing items 1), 2) and 3) with the following:
1) Identify HAZARDOUS SITUATION (ISO 14971:2019, 5.4, 5.5).
• The RACA ROBOT may extend or flex a PATIENT’S joint too far and/or too fast.
2) Estimate RISK and determine if RISK reduction is necessary (ISO 14971:2019, 5.5 and
Clause 6).
RISK reduction is necessary.
• Yes,
– 14 – IEC 80601-2-78:2019/AMD1:2024
© IEC 2024
3) Identify RISK CONTROL (ISO 14971:2019, 7.1).
• Therapist: stop movement of the RACA ROBOT which is having the problem (e.g. with an
EMERGENCY STOP).
Replace, in the existing item 4), in the last sentence of the second paragraph, “(see new NOTE
in red in Figure BB.2, adjacent to ISO 14971:2007, 6.4)” with “(see new NOTE in red in Figure
BB.2, adjacent to ISO 14971:2019, 7.3)”.
Replace the first three paragraphs of the existing item 6) with the following:
6) Implement RISK CONTROL measure/specify, design and implement USER INTERFACE
(ISO 14971:2019, 7.1 and IEC 62366-1:2015 and IEC 62366-1:2015/AMD1:2020, 5.6 to
5.8).
• USER INTERFACE characteristics:
– to reduce the possibility of USE ERROR caused by the perception error (see
IEC 62366-1:2015 and IEC 62366-1:2015/AMD1:2020, Figure D.1), the signals or
indications to inform the HAZARDOUS SITUATION should be perceivable and
distinguishable for the OPERATOR in the USER INTERFACE design;
– to reduce the possibility of USE ERROR caused by the cognition (comprehension) error
(see IEC 62366-1:2015 and IEC 62366-1:2015/AMD1:2020, Figure D.1), the
ACCOMPANYING DOCUMENTS should sufficiently describe the HAZARDOUS SITUATION in
a way that the OPERATOR can understand it;

BB.5.4 Design process for a RACA ROBOT used for REHABILITATION as directed by a
therapist
Replace, in the existing third paragraph of this subclause, “ISO 14971:2007” with
“ISO 14971:2019”.
Replace the existing items 1), 2) and 3) with the following:
1) Identify the HAZARDOUS SITUATION (ISO 14971:2019, 5.4, 5.5).
PATIENT is in unsuitable condition for continuing the REHABILITATION, he/she may
• When
get hurt.
2) Estimate the RISK and determine if RISK CONTROL is necessary (ISO 14971:2019, 5.5 and
Clause 6).
• Yes, RISK CONTROL is necessary.
3) Identify RISK CONTROL measures (ISO 14971:2019, 7.1).
• Therapist: press the stop to halt the RACA ROBOT, call for first aid if necessary and then
release the PATIENT from the RACA ROBOT.
Replace, in the existing item 4), in the last sentence of the first paragraph, “(see new NOTE in
red in Figure BB.2, adjacent to ISO 14971:2007, 6.4)” with “(see new NOTE in red in Figure
BB.2, adjacent to ISO 14971:2019, 7.3)”.
Replace, in the existing item 5), in the last sentence of the second paragraph, “(see new NOTE
in red in Figure BB.2, adjacent to ISO 14971:2007, 6.4)” with “(see new NOTE in red in Figure
BB.2, adjacent to ISO 14971:2019, 7.3)”.

Replace the existing fourth paragraph of item 5) with the following:

© IEC 2024
– This example is a HAZARD-RELATED USE SCENARIO. Although IEC 62366-1:2015 and
IEC 62366-1:2015/AMD1:2020, 5.5, indicates that typically all HAZARD-RELATED USE
SCENARIOS should be evaluated using a SUMMATIVE EVALUATION, because of the subjective
nature of evaluating SITUATION AWARENESS, it should be considered sufficient to perform a
FORMATIVE EVALUATION of this HAZARD-RELATED USE SCENARIO instead.

Replace the existing first sentence of item 7) with the following:
RISK CONTROL measures (ISO 14971:2019, 7.1).
Implement
BB.5.5 Design process for lower extremity exoskeleton, utilizing crutches for support
Replace the existing fourth paragraph with the following:
For each step in this example, the most relevant subclauses of each of ISO 14971:2019 and
IEC 62366-1:2015 and IEC 62366-1:2015/AMD1:2020 have been referenced in order to help
align this example with these processes and the flowchart shown in Figure BB.2.

Replace the existing items 1), 2) and 3) with the following new items:
1) Identify HAZARDOUS SITUATION (ISO 14971:2019, 5.4, 5.5).
• The RACA ROBOT may abruptly stop due to the motor over-heat, and the PATIENT may lose
his/her balance and fall down, i.e. a HAZARDOUS SITUATION.
2) Estimate RISK and determine if RISK reduction is necessary (ISO 14971:2019, 5.5 and
Clause 6).
• Yes, RISK reduction is necessary.
3) Identify RISK CONTROL (ISO 14971:2019, 7.1).
ATIENT: press any key to stop the exoskeleton, use crutches to keep balance while
• P
standing, sitting down or crouching and then call for help.
• Therapist: bring a chair for the PATIENT to take a rest, and help the PATIENT to maintain
their stability.
Replace, in the existing item 4), in the last sentence of the second paragraph, “(see new NOTE
in red in Figure BB.2, adjacent to ISO 14971:2007, 6.4)” with “(see new NOTE in red in Figure
BB.2, adjacent to ISO 14971:2019, 7.3)”.

Replace the first three paragraphs of the existing item 6) with the following:
6) Implement RISK CONTROL measure/specify, design and implement USER INTERFACE
(ISO 14971:2019, 7.1 and IEC 62366-1:2015 and IEC 62366-1:2015/AMD1:2020, 5.6 to
5.8).
• USER INTERFACE characteristics:
– to reduce the possibility of USE ERROR caused by the perception error (see
IEC 62366-1:2015 and IEC 62366-1:2015/AMD1:2020, Figure D.1), the signals or
indications to inform on an imminent shut-down of the motor, for example due to

– 16 – IEC 80601-2-78:2019/AMD1:2024
© IEC 2024
over-heat, should be perceivable and distinguishable for the OPERATOR in the USER
INTERFACE design;
– to reduce the possibility of USE ERROR caused by the cognition (comprehension) error
(see IEC 62366-1:2015 and IEC 62366-1:2015/AMD1:2020, Figure D.1), the
ACCOMPANYING DOCUMENTS should sufficiently describe what are the motor shut-down
causes such that the OPERATOR can understand it;

Bibliography
Replace the existing reference [30] with the following new reference:
[30] 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
Add, at the end of the existing list, the following new reference:
[34] IEC 60068-2-31:2008, Environmental testing – Part 2-31: Tests – Test Ec: Rough
handling shocks, primarily for equipment-type specimens

Index of defined terms used in this particular standard
Replace the existing entries as follows:
HARM . IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020, 3.38
HAZARD. IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020, 3.39
HAZARDOUS SITUATION . IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020, 3.40
RISK CONTROL . IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020, 3.105
RISK MANAGEMENT FILE . IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020, 3.108
RISK MANAGEMENT . IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020, 3.107
RISK . IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020, 3.102

___________
– 18 – IEC 80601-2-78:2019/AMD1:2024
© IEC 2024
COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE
____________
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
AVANT-PROPOS
1) La Commission Électrotechnique Internationale (IEC) est une organisation mondiale de normalisation composée
de l’ensemble des comités électrotechniques nationaux (Comités nationaux de l’IEC). L’IEC a pour objet de
favoriser la coopération internationale pour toutes les questions de normalisation dans les domaines de
l’électricité et de l’électronique. À cet effet, l’IEC – entre autres activités – publie des Normes internationales,
des Spécifications techniques, des Rapports techniques, des Spécifications accessibles au public (PAS) et des
Guides (ci-après dénommés "Publication(s) de l’IEC"). Leur élaboration est confiée à des comités d'études, aux
travaux desquels tout Comité national intéressé par le sujet traité peut participer. Les organisations
internationales, gouvernementales et non gouvernementales, en liaison avec l’IEC, participent également aux
travaux. L’IEC collabore étroitement avec l'Organisation Internationale de Normalisation (ISO), selon des
conditions fixées par accord entre les deux organisations.
2) Les décisions ou accords officiels de l’IEC concernant les questions techniques représentent, dans la mesure du
possible, un accord international sur les sujets étudiés, étant donné que les Comités nationaux de
l’IEC intéressés sont représentés dans chaque comité d’études.
3) Les Publications de l’IEC se présentent sous la forme de recommandations internationales et sont agréées
comme telles par les Comités nationaux de l’IEC. Tous les efforts raisonnables sont entrepris afin que l’IEC
s’assure de l’exactitude du contenu technique de ses publications; l’IEC ne peut pas être tenue responsable de
l’éventuelle mauvaise utilisation ou interprétation qui en est faite par un quelconque utilisateur final.
4) Dans le but d’encourager l’uniformité internationale, les Comités nationaux de l’IEC s’engagent, dans toute la
mesure possible, à appliquer de façon transparente les Publications de l’IEC dans leurs publications nationales
et régionales. Toutes divergences entre toutes Publications de l’IEC et toutes publications nationales ou
régionales correspondantes doivent être indiquées en termes clairs dans ces dernières.
5) L’IEC elle-même ne fournit aucune attestation de conformité. Des organismes de certification indépendants
fournissent des services d'évaluation de conformité et, dans certains secteurs, accèdent aux marques de
conformité de l’IEC. L’IEC n'est responsable d'aucun des services effectués par les organismes de certification
indépendants.
6) Tous les utilisateurs doivent s'assurer qu'ils sont en possession de la dernière édition de cette publication.
7) Aucune responsabilité ne doit être imputée à l’IEC, à ses administrateurs, employés, auxiliaires ou mandataires,
y compris ses experts particuliers et les membres de ses comités d’études et des Comités nationaux de l’IEC,
pour tout préjudice causé en cas de dommages corporels et matériels, ou de tout autre dommage de quelque
nature que ce soit, directe ou indirecte, ou pour supporter les coûts (y compris les frais de justice) et les dépenses
découlant de la publication ou de l’utilisation de cette Publication de l’IEC ou de toute autre Publication de l’IEC,
ou au crédit qui lui est accordé.
8) L'attention est attirée sur les références normatives citées dans cette publication. L’utilisation de publications
référencées est obligatoire pour une application correcte de la présente publication.
9) L'IEC et l'ISO attirent l'attention sur le fait que la mise en application du présent document peut entraîner
l'utilisation d'un ou de plusieurs brevets. L'IEC et l'ISO ne prennent pas position quant à la preuve, à la validité
et à l'applicabilité de tout droit de brevet revendiqué à cet égard. À la date de publication du présent document,
l'IEC et l'ISO n'ont pas reçu notification qu'un ou plusieurs brevets pouvaient être nécessaires à sa mise en
application. Toutefois, il est rappelé aux responsables de cette mise en œuvre qu’il ne s’agit peut-être pas des
informations les plus récentes, qui peuvent être obtenues dans la base de données disponible à l’adresse
https://patents.iec.ch. L'IEC et l'ISO ne sauraient être tenues pour responsables de ne pas avoir identifié de tels
droits de propriété et de ne pas avoir signalé leur existence.
L’Amendement 1 de l’IEC 80601-2-78:2019 a été établi par le sous-comité 62D: Équipements,
logiciels et systèmes médicaux particuliers, du comité d’études 62 de l'IEC: Équipement
médical, logiciels et systèmes médicaux et du comité technique 299 l'ISO: Robotique.
Il est publié comme norme double logo.

© IEC 2024
Le texte de cet Amendement est issu des documents suivants:
Projet Rapport de vote
62D/2085A/FDIS 62D/2109/RVD
Le rapport de vote indiqué dans le tableau ci-dessus donne toute information sur le vote ayant
abouti à son approbation.
La langue employée pour l'élaboration de cet Amendement est l’anglais.
Ce document a été rédigé selon les Directives ISO/IEC, Partie 2, il a été développé selon les
Directives ISO/IEC, Partie 1 et les Directives ISO/IEC, Supplément IEC, disponibles sous
www.iec.ch/members_experts/refdocs. Les principaux types de documents développés par
l'IEC sont décrits plus en détail sous www.iec.ch/publications/.
Le comité a décidé que le contenu de ce document ne sera pas modifié avant la date de stabilité
indiquée sur le site web de l’IEC sous webstore.iec.ch dans les données relatives au document
recherché. À cette date, le document sera
• reconduit,
• supprimé, ou
• révisé.
NOTE L’attention des utilisateurs du présent document est attirée sur le fait que les fabricants d’appareils et les
organismes d’essai peuvent avoir besoin d’une période transitoire après la publication d’une nouvelle publication
IEC ou ISO, ou d’une publication amendée ou révisée, pour fabriquer des produits conformes aux nouvelles
exigences et pour adapter leurs équipements aux nouveaux essais ou aux essais révisés. Le comité recommande
que le contenu de cette publication soit adopté pour application nationale obligatoire au plus tôt 3 ans après la date
de publication.
IMPORTANT – Le logo "colour inside" qui se trouve sur la page de couverture de ce
document indique qu'il contient des couleurs qui sont considérées comme utiles à une
bonne compréhension de son contenu. Les utilisateurs devraient, par conséquent,
imprimer ce document en utilisant une imprimante couleur.

– 20 – IEC 80601-2-78:2019/AMD1
...