IEC 80601-2-78:2019
(Main)Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
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 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.
IEC 80601-2-78:2019 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).
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 s'applique aux exigences générales pour la SECURITE DE BASE et les PERFORMANCES ESSENTIELLES des ROBOTS MEDICAUX avec interaction physique avec un PATIENT souffrant d’une DEFICIENCE de manière à permettre ou à effectuer une REEDUCATION, une EVALUATION, une COMPENSATION ou une ATTENUATION associée aux FONCTIONS LIEES AU MOUVEMENT DU PATIENT, comme cela est prévu par le FABRICANT.
IEC 80601-2-78:2019 ne s'applique pas aux
• prothèses de membres externes (utiliser l'ISO 22523),
• fauteuils roulants électriques (utiliser l'ISO 7176 (toutes les parties)),
• appareils d'imagerie de diagnostic (par exemple, imagerie par résonance magnétique, utiliser l'IEC 60601-2-33), et
• ROBOTS d'assistance à la personne (utiliser l'ISO 13482).
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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
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
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International Standards for all electrical, electronic and related technologies.
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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
– 2 – IEC 80601-2-78:2019 © IEC 2019
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
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
T
...
IEC 80601-2-78
Edition 1.1 2024-03
CONSOLIDATED VERSION
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
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.
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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
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IEC 80601-2-78
Edition 1.1 2024-03
CONSOLIDATED VERSION
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 978-2-8322-8522-0
REDLINE VERSION – 2 – IEC 80601-2-78:2019+AMD1:2024 CSV
© IEC 2024
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
INTRODUCTION to Amendment 1 . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions . 11
201.4 General requirements . 14
201.5 General requirements for testing of ME EQUIPMENT . 15
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 16
201.7 ME EQUIPMENT identification, marking and documents . 16
201.8 Protection against electrical HAZARDS from ME EQUIPMENT. 16
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 17
201.10 Protection against unwanted and excessive radiation HAZARDS . 22
201.11 Protection against excessive temperatures and other HAZARDS . 22
201.12 Accuracy of controls and instruments and protection against hazardous
outputs. 22
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 23
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 23
201.15 Construction of ME EQUIPMENT . 24
201.16 ME SYSTEMS . 25
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 25
202 ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 25
206 USABILITY . 26
208 * General requirements, tests and guidance for alarm systems in MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 26
210 * Process requirements for the development of PHYSIOLOGIC CLOSED-LOOP
CONTROLLERS . 27
211 * Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL
SYSTEMS used in the HOME HEALTHCARE ENVIRONMENT . 27
Annexes . 29
Annex A (informative) General guidance and rationale . 29
Annex AA (informative) Particular guidance and rationale . 30
Annex BB (informative) Guidance and examples of SITUATION AWARENESS . 59
Bibliography . 74
Index of defined terms used in this particular standard . 77
Figure AA.1 – Relationship of the terms used to describe equipment, accessories or
equipment parts . 31
Figure AA.2 – Endsley's model of SITUATION AWARENESS (based on [10], drawn by Dr.
Peter Lankton, May 2007) . 35
Figure AA.3 – Model of user-medical device interaction . 36
Figure AA.4 – RACA ROBOT shared control system block diagram: control by PATIENT
and RACA ROBOT . 40
© IEC 2024
Figure AA.5 – RACA ROBOT shared control system block diagram: control by PATIENT,
OPERATOR and RACA ROBOT . 41
Figure AA.6 – RACA ROBOT shared control system block diagram: control by PATIENT
RACA ROBOT, and control modulation by OPERATOR . 42
and
Figure AA.7 – WALKING RACA ROBOT using motion-related biosignal input . 43
Figure AA.8 – System block diagram of a WALKING RACA ROBOT using a motion-related
biosignal as input . 43
Figure AA.9 – RACA ROBOT that is an arm exoskeleton for REHABILITATION that applies a
PATIENT-cooperative shared control strategy . 44
Figure AA.10 – System block diagram of an arm exoskeleton for REHABILITATIOn that
applies a PATIENT-cooperative shared control strategy . 45
Figure AA.11 – Cane-type RACA ROBOT for REHABILITATION of walking . 46
Figure AA.12 – System block diagram of a cane-type RACA ROBOT . 46
Figure AA.13 – Example of ROBOT arm type RACA ROBOT for lower extremities . 47
Figure AA.14 – Example of ROBOT arm type RACA ROBOT for upper extremities . 48
Figure AA.15 – Example of exoskeleton type RACA ROBOT for upper extremities . 49
Figure AA.16 – Example of exoskeleton type RACA ROBOT for knee joint . 51
Figure AA.17 – Example of soft artificial muscle-type RACA ROBOT for knee joint . 52
Figure AA.18 – Example of exoskeleton-type WALKING RACA ROBOT . 53
Figure AA.19 – Example of RACA ROBOT for balance control . 54
Figure AA.20 – Example of a body-weight support-type RACA ROBOT with gait following
function . 56
Figure BB.1 – All the proximate causes of loss of SITUATION AWARENESS [19] . 60
Figure BB.2 – Relationship between SITUATION AWARENESS, the RISK MANAGEMENT
PROCESS (ISO 14971:20072019) and the USABILITY ENGINEERING PROCESS (IEC 62366-
1:2015 and IEC 62366-1:2015/AMD1:2020) . 63
Figure BB.3 – Relationship between GDTA and RISK MANAGEMENT and USABILITY
ENGINEERING PROCESSES. 66
Figure BB.4 – WALKING exoskeleton RACA ROBOT . 72
Table 201.101 – List of potential ESSENTIAL PERFORMANCEs . 15
Table 19 – MECHANICAL HAZARDS covered by this clause . 17
Table 201.102 – Overview of different stopping procedures . 17
Table 28 – Mechanical strength test applicability . 24
Table 1 – Mechanical strength test applicability, non-TRANSIT-OPERABLE . 27
Table 2 – Mechanical strength test applicability, TRANSIT-OPERABLE . 28
Table AA.1 – Correlation mapping between Figu
...
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