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)

Ta del standarda IEC 80601 se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI ROBOTSKO PODPRTE KIRURŠKE OPREME (RASE) in ROBOTSKO PODPRTIH KIRURŠKIH SISTEMOV (RASS), v nadaljevanju ELEKTROMEDICINSKA OPREMA in SISTEMI, skupaj s POGOJI INTERAKCIJE in VMESNIMI POGOJI. Če je točka ali podtočka namenjena samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME.
Če ROBOTSKO PODPRTA KIRURŠKA OPREMA, ROBOTSKO PODPRTI KIRURŠKI SISTEMI ali njihova DODATNA OPREMA spada v področje uporabe drugega določenega standarda, potem se ta določen standard uporablja poleg tega standarda.
PRIMERI standard IEC 60601-2-2[3] za VISOKOFREKVENČNO KIRURŠKO OPREMO; standard IEC 60601-2-18[4] za ENDOSKOPSKO OPREMO,
standard IEC 60601-2-22[5] za lasersko opremo; standard IEC 60601-2-37[6] za ultrazvočno opremo; standard IEC 60601-2-46[7] za operacijske mize itd.

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

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

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 60601-2-2:2017 NOTE Harmonized as EN IEC 60601-2-2:2018 (not modified)
IEC 60601-2-18:2009 NOTE Harmonized as EN 60601-2-18:2015 (not modified)
IEC 60601-2-22:2007 NOTE Harmonized as EN 60601-2-22:2013 (not modified)
IEC 60601-2-37:2007 NOTE Harmonized as EN 60601-2-37:2008 (not modified)
IEC 60601-2-46:2016 NOTE Harmonized as EN IEC 60601-2-46:2019 (not modified)
IEC 60601-1-3:2008 NOTE Harmonized as EN 60601-1-3:2008 (not modified)
IEC 60601-1-9:2007 NOTE Harmonized as EN 60601-1-9:2008 (not modified)
IEC 60601-1-11:2015 NOTE Harmonized as EN 60601-1-11:2015 (not modified)
ISO 17664:2017 NOTE Harmonized as EN ISO 17664:2017 (not modified)
ISO 10218-1:2011 NOTE Harmonized as EN ISO 10218-1:2011 (not modified)
ISO 13855:2010 NOTE Harmonized as EN ISO 13855:2010 (not modified)
ISO 10993 series NOTE Harmonized as EN ISO 10993 series
IEC 60601-1-2:2007 NOTE Harmonized as EN 60601-1-2:2007 (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.
Publication Year Title EN/HD Year

Addition
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- -  + corrigendum Mar. 2010
+ A1 2012  + A1 2013
- -  + A12 2014
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
+ A1 2013  + A1 2015
IEC 62366-1 2015 Medical devices - Part 1: Application of EN 62366-1 2015
usability engineering to medical devices
- -  + AC 2015
IEC 80601-2-77
Edition 1.0 2019-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –

Part 2-77: Particular requirements for the BASIC SAFETY and essential

performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT

Appareils électromédicaux –
Partie 2-77: Exigences particulières pour la SECURITE DE BASE et les performances

essentielles des APPAREILS CHIRURGICAUX ROBOTIQUEMENT ASSISTES

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01; 11.040.30 ISBN 978-2-8322-6999-2

– 2 – IEC 80601-2-77:2019 © IEC 2019
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 9
201.3 Terms and definitions . 10
201.4 General requirements . 13
201.5 General requirements for testing of ME EQUIPMENT . 13
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. 17
201.9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 18
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 . 22
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 22
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 23
201.15 Construction of ME EQUIPMENT . 23
201.16 * ME SYSTEMS . 23
201.17 * ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 23
202 ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 23
206 * USABILITY . 24
Annexes . 25
Annex D (informative) Symbols on marking . 26
Annex AA (informative) Particular guidance and rationale . 27
Annex BB (informative) Equations for the calculation of the overall system stopping
performance and minimum distances . 39
Annex CC (informative) Stopping functions of the RASE . 41
Annex DD (informative) Alternative method to demonstrate structural integrity
throughout the EXPECTED SERVICE LIFE of the RASE . 43
Annex EE (informative) Example of a testing method of the IMMUNITY test for HF
SURGICAL EQUIPMENT emissions . 46
Bibliography . 49
Index of defined terms used in this particular standard . 51

Figure 201.101 – Graphic symbol for maximum PATIENT mass and SAFE WORKING LOAD . 14
Figure 201.102 – Graphic symbol for mass of MOUNTED PART . 14
Figure 201.AA.101 – Examples of MECHANICAL INTERFACE attachments . 28
Figure 201.AA.102 – Example 1 of ROBOTIC SURGERY CONFIGURATION: a case of
laparoscopic RASS . 30
Figure 201.AA.103 – Example 2 of ROBOTIC SURGERY CONFIGURATION: a case of bone
milling RASE . 30
Figure 201.AA.104 – Typical ESSENTIAL PERFORMANCE items of RASE . 32

IEC 80601-2-77:2019 © IEC 2019 – 3 –
Figure 201.AA.105 – Example of RISK ASSESSMENT related to structural component . 36
Figure 201.BB.101 – Relationship between t1 and t2 . 40

Table 201.101 – List of ESSENTIAL PERFORMANCE requirements. 13
Table 201.102 – Colours of indicator lights and their meaning for ME EQUIPMENT . 16
Table 201.D.101 – Symbols for marking RASE or its parts . 26
Table 201.CC.101 – Different stopping functions . 41
Table 201.DD.101 – Alternative to safety factors: life testing . 43

– 4 – IEC 80601-2-77:2019 © IEC 2019
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-77: Particular requirements for the BASIC SAFETY and essential
performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT

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 promo
...