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

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

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.
© ISO 2023
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OF ANY RELEVANT PATENT RIGHTS OF WHICH
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DOCUMENTATION.
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IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: copyright@iso.org
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
NATIONAL REGULATIONS. © ISO 2023

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 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 Pu blications
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.
ISO 80601-2-78:2019/FDAM 1:2023(E)
IEC FDIS 80601-2-78:2019/AMD1 – 3 –
© IEC 2023
The text of this Amendment is based on the following documents:
Draft Report on voting
62D/XX/XXXX 62D/XX/XXX
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 the mselves 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.
ISO 80601-2-78:2019/FDAM 1:2023(E)
– 4 – IEC FDIS 80601-2-78:2019/AMD1
© IEC 2023
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.

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:
ISO 80601-2-78:2019/FDAM 1:2023(E)
IEC FDIS 80601-2-78:2019/AMD1 – 5 –
© IEC 2023
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
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.
ISO 80601-2-78:2019/FDAM 1:2023(E)
– 6 – IEC FDIS 80601-2-78:2019/AMD1
© IEC 2023
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“.

201.7.2.4 ACCESSORIES
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.
206.5 * Replacement of requirements given in IEC 62366-1
Replace the existing text with the following new text:
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.
ISO 80601-2-78:2019/FDAM 1:2023(E)
IEC FDIS 80601-2-78:2019/AMD1 – 7 –
© IEC 2023
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:
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.
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