SIST EN IEC 80601-2-78:2020

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)

EN-IEC 62386-105 applies to control gear and control devices.Typically, a bus unit according to IEC 62386 (all parts) contains firmware. There arecircumstances where it might be necessary to change the firmware after production orshipping of the product. For example if the bus unit does not operate as intended. In such acase, a firmware update of a bus unit via the interface is beneficial.This firmware update process is primarily designed to be a bug fix process, not a featureextension process. Nevertheless the firmware update process can be used for featureextensions. But it is important that the risk of negative effects to the complete system isconsidered in detail.

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)

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).

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)

Standard EN-IEC 62386-105 se uporablja za krmilno opremo in krmilne naprave. Običajno enota vodila v skladu s standardom IEC 62386 (vsi deli) vključuje vdelano programsko opremo. V določenih okoliščinah bo po zaključku proizvodnje ali pošiljanju izdelka morda treba spremeniti vdelano programsko opremo (npr. če enota vodila ne deluje, kot je predvideno). V tem primeru se priporoča posodobitev vdelane programske opreme enote vodila prek vmesnika. Ta postopek posodobitve vdelane programske opreme je namenjen predvsem za odpravljanje napak in ne za razširitve funkcij. Postopek posodobitve vdelane programske opreme je kljub temu mogoče uporabiti za razširitve funkcij, vendar je pomembno pri tem upoštevati tveganje negativnih učinkov na celoten sistem.

General Information

• Status: Published
• Publication Date: 07-May-2020
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 22-Apr-2020
• Due Date: 27-Jun-2020
• Completion Date: 08-May-2020
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN IEC 80601-2-78:2020 - Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

Relations

• Amended By: SIST EN IEC 80601-2-78:2020/A1:2024 - 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/AMD1:2024)
• Effective Date: 26-Jul-2021

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

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)

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
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

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

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 .
...