EN IEC 80601-2-77:2021

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 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS), referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION CONDITIONS and INTERFACE CONDITIONS.

Medizinische elektrische Geräte - Teil 2-77: Besondere Festlegungen an die Sicherheit, einschließlich der wesentlichen Leistungsmerkmale von durch Roboter unterstützte Chirurgiegeräte

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 s'applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS CHIRURGICAUX ROBOTIQUEMENT ASSISTES (RASE) et des SYSTEMES CHIRURGICAUX ROBOTIQUEMENT ASSISTES (RASS), appelés APPAREILS EM et SYSTEMES EM, ainsi qu'à leurs CONDITIONS D’INTERACTION et leurs CONDITIONS D’INTERFACE.

Medicinska električna oprema - 2-77. del: Posebne zahteve za osnovno varnost in bistvene lastnosti robotsko podprte kirurške opreme (IEC 80601-2-77:2019)

General Information

• Status: Published
• Publication Date: 30-Sep-2021
• ICS: 11.040.01 - Medical equipment in general
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 01-Oct-2021
• Completion Date: 01-Oct-2021
• 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: SIST EN IEC 80601-2-77:2021 - 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)

Relations

• Amended By: EN IEC 80601-2-77:2021/A1:2023 - Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
• Effective Date: 31-Aug-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN IEC 80601-2-77:2021
01-december-2021
Medicinska električna oprema - 2-77. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti robotsko podprte kirurške opreme (IEC 80601-2-77:2019)
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)
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)
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)
Ta slovenski standard je istoveten z: EN IEC 80601-2-77:2021
ICS:
11.040.30 Operacijski instrumenti in Surgical instruments and
materiali materials
SIST EN IEC 80601-2-77:2021 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

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SIST EN IEC 80601-2-77:2021


EUROPEAN STANDARD EN IEC 80601-2-77

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2021
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)
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) (IEC 80601-2-77:2019)
This European Standard was approved by CENELEC on 2020-01-08. 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
© 2021 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 E

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SIST EN IEC 80601-2-77:2021
EN IEC 80601-2-77:2021 (E)
European foreword
The text of document 62D/1675/FDIS, future edition 1 of IEC 80601-2-77, 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.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2022-04-01
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024-10-01
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 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)
IEC 60601-2-
...