SIST EN IEC 80601-2-78:2020

SLOVENSKI STANDARD
SIST EN IEC 80601-2-78:2020
01-julij-2020
Medicinska električna oprema - 2-78. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti medicinskih robotov za rehabilitacijo, ocenjevanje,
nadomestitev funkcij ali lajšanje simptomov (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 (IEC 80601-2-78:2019)
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)
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)
Ta slovenski standard je istoveten z: EN IEC 80601-2-78:2020
ICS:
11.040.60 Terapevtska oprema Therapy equipment
SIST EN IEC 80601-2-78:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 80601-2-78:2020

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SIST EN IEC 80601-2-78:2020


EUROPEAN STANDARD EN IEC 80601-2-78

NORME EUROPÉENNE

EUROPÄISCHE NORM
April 2020
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)
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) oder Linderung
(IEC 80601-2-78:2019)
This European Standard was approved by CENELEC on 2019-08-13. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard 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 European Standard 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,
Turkey 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
© 2020 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 E

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SIST EN IEC 80601-2-78:2020
EN IEC 80601-2-78:2020 (E)
European foreword
The text of document 62D/1676/FDIS, future edition 1 of IEC 80601-2-78, prepared by SC 62D
"Electromedical equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 80601-2-78:2020.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2020-10-03
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2023-04-03
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.
This document has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and supports essential requirements of EU
Directive(s).
For the relationship with EU Directive(s) see informative Annex ZZ, which is an integral part of this
document.
Endorsement notice
The text of the International Standard IEC 80601-2-78:2019 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 standards
indicated:
ISO 13482:2014 NOTE Harmonized as EN ISO 13482:2014 (not modified)
ISO 9999:2016 NOTE Harmonized as EN ISO 9999:2016 (not modified)
ISO 10535:2006 NOTE Harmonized as EN ISO 10535:2006 (not modified)
IEC 60601-2-33 NOTE Harmonized as EN 60601-2-33
ISO 10218-1:2011 NOTE Harmonized as EN ISO 10218-1:2011 (not modified)
IEC 60601-1-9:2007 NOTE Harmonized as EN 60601-1-9:2008 (not modified)
IEC 61924-2:2012 NOTE Harmonized as EN 61924-2:2013 (not modified)
ISO 11064-7:2006 NOTE Harmonized as EN ISO 11064-7:2006 (not modified)

2

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EN IEC 80601-2-78:2020 (E)
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.cenelec.eu.
The Annex ZA of EN 60601-1:2006 is applicable, except as follows:
Publication Year Title EN/HD Year
Replacement
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
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
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
ISO 14971 2007 Medical devices_- Application of risk - -
management to medical devices

Addition:
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
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
3

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EN IEC 80601-2-78:2020 (E)
Publication Year Title EN/HD Year
IEC 62366-1 2015 Medical devices - Part 1: Application of EN 62366-1 2015
usability engineering to medical devices
  +AC 2015
ISO 22523  External limb prostheses and external EN ISO 22523 2006
orthoses – Requirements and test methods

4

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SIST EN IEC 80601-2-78:2020




IEC 80601-2-78


Edition 1.0 2019-07





INTERNATIONAL



STANDARD




NORME



INTERNATIONALE
colour

inside










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 978-2-8322-7000-4





Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

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CONTENTS
FOREWORD . 4
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 9
201.4 General requirements . 13
201.5 General requirements for testing of ME EQUIPMENT . 14
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 14
201.7 ME EQUIPMENT identification, marking and documents . 14
201.8 Protection against electrical HAZARDS from ME EQUIPMENT. 15
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 15
201.10 Protection against unwanted and excessive radiation HAZARDS . 21
201.11 Protection against excessive temperatures and other HAZARDS . 21
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 21
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 22
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 22
201.15 Construction of ME EQUIPMENT . 22
201.16 ME SYSTEMS . 24
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 24
202 ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 24
206 USABILITY . 24
208 * General requirements, tests and guidance for alarm systems in MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 25
210 * Process requirements for the development of PHYSIOLOGIC CLOSED-LOOP
CONTROLLERS . 25
211 * Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL
SYSTEMS used in the HOME HEALTHCARE ENVIRONMENT . 26
Annexes . 27
Annex A (informative) General guidance and rationale . 27
Annex AA (informative) Particular guidance and rationale . 28
Annex BB (informative) Guidance and examples of SITUATION AWARENESS . 57
Bibliography . 71
Index of defined terms used in this particular standard . 74

Figure AA.1 – Relationship of the terms used to describe equipment, accessories or
equipment parts . 29
Figure AA.2 – Endsley's model of SITUATION AWARENESS (based on [10], drawn by Dr.
Peter Lankton, May 2007) . 33
Figure AA.3 – Model of user-medical device interaction . 34
Figure AA.4 – RACA ROBOT shared control system block diagram: control by PATIENT
and RACA ROBOT . 38
Figure AA.5 – RACA ROBOT shared control system block diagram: control by PATIENT,
OPERATOR and RACA ROBOT . 39

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Figure AA.6 – RACA ROBOT shared control system block diagram: control by PATIENT
and RACA ROBOT, and control modulation by OPERATOR . 40
Figure AA.7 – WALKING RACA ROBOT using motion-related biosignal input . 41
Figure AA.8 – System block diagram of a WALKING RACA ROBOT using a motion-related
biosignal as input . 41
Figure AA.9 – RACA ROBOT that is an arm exoskeleton for REHABILITATION that applies a
PATIENT-cooperative shared control strategy . 42
Figure AA.10 – System block diagram of an arm exoskeleton for REHABILITATIOn that
applies a PATIENT-cooperative shared control strategy . 43
Figure AA.11 – Cane-type RACA ROBOT for REHABILITATION of walking . 44
Figure AA.12 – System block diagram of a cane-type RACA ROBOT . 44
Figure AA.13 – Example of ROBOT arm type RACA ROBOT for lower extremities . 45
Figure AA.14 – Example of ROBOT arm type RACA ROBOT for upper extremities . 46
Figure AA.15 – Example of exoskeleton type RACA ROBOT for upper extremities . 47
Figure AA.16 – Example of exoskeleton type RACA ROBOT for knee joint . 49
Figure AA.17 – Example of soft artificial muscle-type RACA ROBOT for knee joint . 50
Figure AA.18 – Example of exoskeleton-type WALKING RACA ROBOT . 51
Figure AA.19 – Example of RACA ROBOT for balance control . 52
Figure AA.20 – Example of a body-weight support-type RACA ROBOT with gait following

function . 54
Figure BB.1 – All the proximate causes of loss of SITUATION AWARENESS [19] . 58
Figure BB.2 – Relationship between SITUATION AWARENESS, the RISK MANAGEMENT
PROCESS (ISO 14971:2007) and the USABILITY ENGINEERING PROCESS (IEC 62366-
1:2015) . 60
Figure BB.3 – Relationship between GDTA and RISK MANAGEMENT and USABILITY
........................................................................................................ 63
ENGINEERING PROCESSES
Figure BB.4 – WALKING exoskeleton RACA ROBOT . 69

Table 201.101 – List of potential ESSENTIAL PERFORMANCEs . 14
Table 19 – MECHANICAL HAZARDS covered by this clause . 16
Table 201.102 – Overview of different stopping procedures . 16
Table 28 – Mechanical strength test applicability . 23
Table 1 – Mechanical strength test applicability, non-TRANSIT-OPERABLE . 26
Table 2 – Mechanical strength test applicability, TRANSIT-OPERABLE . 26
Table AA.1 – Correlation mapping between Figure AA.2 and Figure AA.3 . 35
Table BB.1 – Example of using GDTA in BB.5.2 . 64
Table BB.2 – Example of using GDTA in BB.5.3 . 66
Table BB.3 – Example of using GDTA in BB.5.4 . 68
Table BB.4 – Example of using GDTA in BB.5.5 . 70

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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

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) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 80601-2-78 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC Technical Committee 62: Electrical equipment in medical
practice, and ISO Technical Committee 299: Robotics.
This publication is published as a double logo standard.
The text of this International Standard is based on the following documents:
FDIS Report on voting
62D/1676/FDIS 62D/1688/RVD
Full information on the voting for the approval of this International Standard can be found in
the report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.

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IEC 80601-2-78:2019 © IEC 2019 – 5 –
In this document, the following print types are used:
– requirements and definitions: roman type;
– test specifications: italic type;
informative material appearing outside of tables, such as notes, examples and references in smaller type.
–
Normative text of tables is also in a smaller type;
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term
– "clause" means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this document are preceded by the term "Clause" followed by the
clause number. References to subclauses within this particular standard are by number only.
In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in Clause 7 of the
ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance
with this document;
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– "may" is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 80601 and IEC 60601 International Standard, published under the
general title Medical electrical equipment, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
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 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 committees that the content of this publication be adopted for
implementation nationally not earlier than 3 years from the date of publication.

IMPORTANT – The 'colour inside' logo on the cover page of this publication 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.

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INTRODUCTION
This part of IEC 80601 International Standard was written at a time when technical evolution
of MEDICAL ROBOTS was in rapid progress and the scientific foundation of safe use was still
being expanded.
This document is the result of work that began in ISO/TC 184/SC 2/WG 7 in October 2006 on
personal care ROBOTS, to address an emerging type of MEDICAL ROBOT that was used outside
of an industrial environment. That group was working on a new standard, ISO 13482, which
was published as an International Standard (IS) in 2014. While initially focused on non-
medical applications, WG 7 recognized that work was needed on medical devices utilizing
robotic technology. In October 2009, ISO/TC 184/SC 2 established a WG 7, Study Group (SG)
on Medical care robots, comprised of experts from Canada, France, Germany, Japan, Korea,
Romania, Switzerland, UK and USA.

The work of ISO/TC 184/SC 2/WG 7 SG cumulated in a proposal to form a Joint Working
Group (JWG 9) with IEC/TC 62/SC 62A focusing on MEDICAL ELECTRICAL EQUIPMENT using
robotic technology. This JWG began developing a technical report (IEC TR 60601-4-1)
dealing with degree of autonomy. While developing this document, a particular standard was
deemed required for REHABILITATION type ROBOTS. This led to the creation of a Joint Working
Group 36 (MEDICAL ROBOTS for REHABILITATION) in April, 2015 within IEC/TC 62/SC 62D to
develop particular requirements of SAFETY of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL
ELECTRICAL SYSTEMS for REHABILITATION type ROBOTS. ISO/TC 184/SC 2 has since been
promoted to ISO/TC 299, and JWG 9 has merged with JWG35 and 36 to form JWG 5
(MEDICAL ROBOT Safety) on the ISO side. This proposal was approved from both IEC and
ISO and work began.
The minimum safety requirements specified in this particular standard are presented to
provide for an acceptable degree of BASIC SAFETY and ESSENTIAL PERFORMANCE for MEDICAL
ROBOTS that physically interact with a PATIENT with an IMPAIRMENT, to support or perform
REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION related to the PATIENT’S MOVEMENT
FUNCTIONS .
The requirements are followed by particular specifications for the relevant tests.

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MEDICAL ELECTRICAL EQUIPMENT –

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



201.1 Scope, object and related standards
1
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
This part of IEC 80601 applies to the general requirements for BASIC SAFETY and ESSENTIAL
PERFORMANCE of MEDICAL ROBOTS that physically interact with a PATIENT with an IMPAIRMENT to
support or perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION related to the
PATIENT’S MOVEMENT FUNCTIONS, as intended by the MANUFACTURER.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
NOTE See also 4.2 of the general standard.
This particular standard does not apply to
• external limb prosthetic devices (use ISO 22523),
• electric wheelchairs (use ISO 7176 (all parts)),
• diagnostic imaging equipment (e.g. MRI, use IEC 60601-2-33), and
• personal care ROBOTS (use ISO 13482).
201.1.2 Object
Replacement:
BASIC SAFETY and ESSENTIAL
The object of this particular standard is to establish particular
PERFORMANCE requirements for
...