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 i
...