SIST EN IEC 80601-2-77:2021/A1:2024
(Amendment)Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment (IEC 80601-2-77:2019/AMD1:2023)
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment (IEC 80601-2-77:2019/AMD1:2023)
Medizinische elektrische Geräte - Teil 2-77: Besondere Festlegungen an die Sicherheit, einschließlich der wesentlichen Leistungsmerkmale von durch Roboter unterstützte Chirurgiegeräte (IEC 80601-2-77:2019/AMD1:2023)
Appareils électromédicaux - Partie 2-77: Exigences particulières pour la sécurité de base et les performances essentielles des appareils chirurgicaux robotiquement assistés (IEC 80601-2-77:2019/AMD1:2023)
Medicinska električna oprema - 2-77. del: Posebne zahteve za osnovno varnost in bistvene lastnosti robotsko podprte kirurške opreme - Dopolnilo A1 (IEC 80601-2-77:2019/AMD1:2023)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN IEC 80601-2-77:2021/A1:2024
01-februar-2024
Medicinska električna oprema - 2-77. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti robotsko podprte kirurške opreme - Dopolnilo A1 (IEC 80601-2-
77:2019/AMD1:2023)
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and
essential performance of robotically assisted surgical equipment (IEC 80601-2-
77:2019/AMD1:2023)
Medizinische elektrische Geräte - Teil 2-77: Besondere Festlegungen an die Sicherheit,
einschließlich der wesentlichen Leistungsmerkmale von durch Roboter unterstützte
Chirurgiegeräte (IEC 80601-2-77:2019/AMD1:2023)
Appareils électromédicaux - Partie 2-77: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils chirurgicaux robotiquement assistés (IEC
80601-2-77:2019/AMD1:2023)
Ta slovenski standard je istoveten z: EN IEC 80601-2-77:2021/A1:2023
ICS:
11.040.30 Operacijski instrumenti in Surgical instruments and
materiali materials
SIST EN IEC 80601-2-77:2021/A1:2024 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN IEC 80601-2-77:2021/A1:2024
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SIST EN IEC 80601-2-77:2021/A1:2024
EUROPEAN STANDARD EN IEC 80601-2-77:2021/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM December 2023
ICS 11.040.01; 11.040.30
English Version
Medical electrical equipment - Part 2-77: Particular requirements
for the basic safety and essential performance of robotically
assisted surgical equipment
(IEC 80601-2-77:2019/AMD1:2023)
Appareils électromédicaux - Partie 2-77: Exigences Medizinische elektrische Geräte - Teil 2-77: Besondere
particulières pour la sécurité de base et les performances Festlegungen an die Sicherheit, einschließlich der
essentielles des appareils chirurgicaux robotiquement wesentlichen Leistungsmerkmale von durch Roboter
assistés unterstützte Chirurgiegeräte
(IEC 80601-2-77:2019/AMD1:2023) (IEC 80601-2-77:2019/AMD1:2023)
This amendment A1 modifies the European Standard EN IEC 80601-2-77:2021; it was approved by CENELEC on 2023-12-20. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment 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 amendment 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,
Türkiye 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
© 2023 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 80601-2-77:2021/A1:2023 E
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SIST EN IEC 80601-2-77:2021/A1:2024
EN IEC 80601-2-77:2021/A1:2023 (E)
European foreword
The text of document 62D/2070/FDIS, future IEC 80601-2-77/AMD1, 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 80601-2-77:2021/A1:2023.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2024-09-20
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2026-12-20
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.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 80601-2-77:2019/AMD1:2023 was approved by CENELEC
as a European Standard without any m
...
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