Medical electrical equipment

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

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 maničre ŕ permettre ou ŕ 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 • prothčses 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 ŕ la personne (utiliser l'ISO 13482).

General Information

Status
Published
Publication Date
10-Jul-2019
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
11-May-2019
Completion Date
10-May-2019
Ref Project

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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
IEC 80601-2-78:2019-07(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
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.

---------------------- Page: 3 ----------------------
– 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

---------------------- Page: 4 ----------------------
IEC 80601-2-78:2019 © IEC 2019 – 3 –
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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– 4 – IEC 80601-2-78:2019 © IEC 2019
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

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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.

---------------------- Page: 6 ----------------------
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.
---------------------- Page: 7 ----------------------
– 6 – IEC 80601-2-78:2019 © IEC 2019
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.

---------------------- Page: 8 ----------------------
IEC 80601-2-78:2019 © IEC 2019 – 7 –
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
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 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.
201.1.3 Collateral standards
Addition:

This particular standard refers to those applicable collateral standards that are listed in

Clause 2 of the general standard and Clause 201.2 of this particular standard.
____________

The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –

Part 1: General requirements for basic safety and essential performance.
---------------------- Page: 9 ----------------------
– 8 – IEC 80601-2-78:2019 © IEC 2019

IEC 60601-1-2:2014, IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013, IEC 60601-1-

8:2006 and IEC 60601-1-8:2006/AMD1:2012, IEC 60601-1-10:2007 and IEC 60601-1-

10:2007/AMD1:2013, and IEC 60601-1-11:2015 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
Replacement:

In the IEC 60601 series, particular standards may modify, replace or delete requirements

contained in the general standard and collateral standards as appropriate for the particular

ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.

For brevity, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 are referred to in this

particular standard as the general standard. Collateral standards are referred to by their

document number.

The numbering of clauses and subclauses of this particular standard corresponds to that of

the general standard with the prefix "201" (e.g. 201.1 in this document addresses the content

of Clause 1 of the general standard) or applicable collateral standard with the prefix "20x"

where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this

particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard,

203.4 in this particular standard addresses the content of Clause 4 of the IEC 60601-1-3

collateral standard, etc.). The changes to the text of the general standard are specified by the

use of the following words:

"Replacement" means that the clause or subclause of the general standard or applicable

collateral standard is replaced completely by the text of this particular standard.

"Addition" means that the text of this particular standard is additional to the requirements of

the general standard or applicable collateral standard.

"Amendment" means that the clause or subclause of the general standard or applicable

collateral standard is amended as indicated by the text of this particular standard.

Subclauses, figures or tables which are additional to those of the general standard are

numbered starting from 201.101. However, due to the fact that definitions in the general

standard are numbered 3.1 through 3.147, additional definitions in this document are

numbered beginning from 201.3.201. Additional Annexes are lettered AA, BB, etc., and

additional items aa), bb), etc.
Subclauses, figures
...

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