EN IEC 80601-2-77:2021
(Main)Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
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
Relations
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 promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as
"IEC Publication(s)"). Their preparation is entrusted to technical committees; any IEC National Committee
interested in the subject dealt with may participate in this preparatory work. International, governmental and
non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates
closely with the International Organization for Standardization (ISO) in accordance with conditions determined
by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of
IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other
IEC Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 80601-2-77 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice, and ISO technical committee 299: Robotics.
This publication is published as a double logo standard.
The text of this International Standard is based on the following documents:
FDIS Report on voting
62D/1675/FDIS 62D/1689/RVD
Full information on the voting for the approval of this International Standard can be found in
the report on voting indicated in the above table.
IEC 80601-2-77:2019 © IEC 2019 – 5 –
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document, the following print types are used:
– requirements and definitions: roman type;
– test specifications: italic type;
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type;
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term
– "clause" means one of the nineteen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this document are preceded by the term "Clause" followed by
the clause number. References to subclauses within this particular standard are by number
only.
In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in Clause 7 of the
ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance
with this document;
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– "may" is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 and IEC 80601 International Standard, published under the
general title Medical electrical equipment, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
– 6 – IEC 80601-2-77:2019 © IEC 2019
NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC publication in
which to make products in accordance with the new requirements and to equip themselves for conducting new or
revised tests. It is the recommendation of the committees that the content of this publication be adopted for
implementation nationally not earlier than 3 years from the date of publication.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
IEC 80601-2-77:2019 © IEC 2019 – 7 –
INTRODUCTION
This part of IEC 80601 is written at a time when technical evolution of medical robots is in
rapid progress and the scientific foundation of safe use is still being expanded.
This document is the result of work that began in ISO/TC 184/SC 2/WG 7 in October 2006 on
personal care robots, to address an emerging type of medical robot that was used outside of
1 2
an industrial environment . That group was working on a new standard, ISO 13482[1] , which
was published as an International Standard (IS) in 2014. While initially focused on non-
medical applications, WG 7 recognized that work was likely to be needed on medical devices
utilizing robotic technology. In October 2009, ISO/TC 184/SC 2 established a WG 7, Study
Group (SG) on Medical care robots, comprised of experts from Canada, France, Germany,
Japan, Korea, Romania, Switzerland, UK and USA.
The work of ISO/TC 184/SC 2/WG 7 SG cumulated in a proposal to form a Joint Working
Group (JWG 9) with IEC/TC 62/SC 62A focusing on MEDICAL ELECTRICAL EQUIPMENT using
robotic technology. This JWG began developing a technical report (IEC TR 60601-4-1:2017[2])
dealing with degree of autonomy. While developing this document, a particular standard was
proposed for robotic equipment used in surgical applications. This led to the creation of a
Joint Working Group 35 in April 2015 within IEC/TC 62/SC 62D to develop particular
requirements of safety of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS
that utilize robotic technology. The work would include medical robots for SURGERY. This
proposal was approved, resulting in the formation of Joint Working Group (JWG 35).
During IEC/TC 62/SC 62D discussion, there was a strong opinion that some types of MEDICAL
ELECTRICAL EQUIPMENT could be a medical robot, but not all MEDICAL ELECTRICAL EQUIPMENT
were medical robots. According to this opinion, JWG 35 discussed and agreed that the
majority of existing MEDICAL ELECTRICAL EQUIPMENT, including those used for surgical
PROCEDURES, were not considered medical robots, so it would be better to capture this type of
ME EQUIPMENT through a different definition – ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
(RASE).
JWG 9 defined medical robots as ME EQUIPMENT with a degree of autonomy
(IEC TR 60601-4-1:2017). JWG 35 found that some RASE have zero autonomy. Therefore, by
definition, RASE could not be equivalent to a medical robot. Regulatory agencies objected to
employ the term robot as defined in IEC TR 60601-4-1 and felt that it implied that the RASE
were performing the surgical PROCEDURE rather than the surgeon. The consensus in JWG 35
was that the RASE only assists the surgeon. The surgeon maintains some level of control or
supervision of the RASE.
The minimum safety requirements specified in this particular standard for ROBOTICALLY
ASSISTED SURGICAL EQUIPMENT are presumed to establish that the RESIDUAL RISKS have been
reduced to acceptable levels unless there is OBJECTIVE EVIDENCE to the contrary.
The requirements are followed by particular specifications for the relevant tests.
___________
ISO TC 184/SC 2 was reorganized as ISO TC 299 in 2016.
Numbers in square brackets refer to the Bibliography.
– 8 – IEC 80601-2-77:2019 © IEC 2019
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-77: Particular requirements for the BASIC SAFETY and essential
performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL
SYSTEMS (RASS), hereafter referred to as ME EQUIPMENT and ME SYSTEMS together with their
INTERACTION CONDITIONS and INTERFACE CONDITIONS. If a clause or subclause is specifically
intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of
that clause or subclause will say so. If that is not the case, the clause or subclause applies
both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
If RASE or RASS, or its ACCESSORIES fall within scope of another particular standard, then the
particular standard applies in addition to this standard.
EXAMPLES IEC 60601-2-2[3] for HF SURGICAL EQUIPMENT; IEC 60601-2-18[4] for ENDOSCOPIC EQUIPMENT;
IEC 60601-2-22[5] for laser equipment; IEC 60601-2-37[6] for ultrasound equipment; IEC 60601-2-46[7] for
operating tables, etc.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for ROBOTICALLY ASSISTED SURGICAL EQUIPMENT and ROBOTICALLY
ASSISTED SURGICAL SYSTEMS.
201.1.3 * Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2:2014 and IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013 apply as
modified in Clauses 202 and 206 respectively. IEC 60601-1-3:2008 and
IEC 60601-1-3:2008/AMD1:2013[8], IEC 60601-1-9:2007 and
IEC 60601-1-9:2007/AMD1:2013[9], and IEC 60601-1-11:2015[10] do not apply.
___________
The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance.
IEC 80601-2-77:2019 © IEC 2019 – 9 –
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular ME
EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 are referred to in this
particular standard as the general standard. Collateral standards are referred to by their
document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix "201" (e.g. 201.1 in this document addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix "20x",
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are
specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.147, additional definitions in this document are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where "x" is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this document" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
201.2 Normative references
NOTE Informative references are listed in the Bibliography.
Clause 2 of the general standard applies, except as follows:
– 10 – IEC 80601-2-77:2019 © IEC 2019
Replacement:
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: 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: General requirements for basic
safety and essential performance – Collateral standard: Usability
IEC 60601-1-6:2010/AMD1:2013
IEC 62366-1:2015, Medical devices – Part 1: Application of usability engineering to medical
devices
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005, and
IEC 60601-1:2005/AMD1:2012 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
NOTE An index of defined terms is found beginning on page 51.
Addition:
201.3.201
BODY ORIFICE
natural opening in the body, as well as the external surface of the eyeball, or any permanent
artificial opening, such as a stoma or permanent tracheostomy
[SOURCE: GHTF/SG1/N77:2012[11]]
201.3.202
* CAPACITIVELY COUPLED HF CURRENT
unavoidable HIGH FREQUENCY current flowing due to capacitive coupling from the APPLIED PART
of HF SURGICAL EQUIPMENT to an another part of the RASE or RASS
[SOURCE: IEC 60601-2-18:2009, 201.3.201, modified – Replacement of " from an ENERGIZED
ENDOTHERAPY DEVICE that is the APPLIED PART of HF SURGICAL EQUIPMENT to the ENDOSCOPE"
by " from the APPLIED PART of HF SURGICAL EQUIPMENT to an another part of the RASE or RASS".]
201.3.203
ENDOSCOPIC EQUIPMENT
energized endoscope together with its supply unit(s), as required for its INTENDED USE
[SOURCE: IEC 60601-2-18:2009, 201.3.204]
IEC 80601-2-77:2019 © IEC 2019 – 11 –
201.3.204
HIGH FREQUENCY
HF
frequencies less than 5 MHz and generally greater than 200 kHz
[SOURCE: IEC 60601-2-2:2017, 201.3.220]
201.3.205
HF SURGICAL ACCESSORY
ACCESSORY intended to conduct, supplement or monitor HF energy applied to the PATIENT from
HF SURGICAL EQUIPMENT
[SOURCE: IEC 60601-2-2:2017, 201.3.223, modified – The notes have been deleted.]
201.3.206
HF SURGICAL EQUIPMENT
MEDICAL ELECTRICAL EQUIPMENT which generates HIGH FREQUENCY currents intended for the
performance of surgical tasks, such as the cutting or coagulation of biological tissue by
means of these HIGH FREQUENCY currents
[SOURCE: IEC 60601-2-2:2017, 201.3.224, modified – The notes have been deleted.]
201.3.207
INTERACTION CONDITIONS
*
conditions that shall be fulfilled to achieve BASIC SAFETY when RASE or RASS is used
simultaneously with multiple ROBOTIC SURGICAL INSTRUMENTS or with an APPLIED PARTS of other
ME EQUIPMENT, at least one APPLIED PART of which uses energy for providing its INTENDED USE,
e.g. HF current, ultrasound, or laser
201.3.208
INTERFACE CONDITIONS
*
conditions that shall be fulfilled to achieve BASIC SAFETY for any FUNCTIONAL CONNECTION
between RASE or RASS and other ME EQUIPMENT or non-ME EQUIPMENT in the ROBOTIC SURGERY
CONFIGURATION
[SOURCE: IEC 60601-2-18:2009, 201.3.211, modified – Replacement of "endoscopic
EQUIPMENT" by "RASE or RASS", and of "configuration for ENDOSCOPIC EQUIPMENT" by "ROBOTIC
".]
SURGERY CONFIGURATION
201.3.209
INVASIVE DEVICE
device, which, in whole or in part, penetrates inside the body, either through a BODY ORIFICE or
through the surface of the body
[SOURCE: GHTF/SG1/N77:2012[11]]
201.3.210
* MECHANICAL INTERFACE
mounting surface on RASE or RASS that allows for attachment of detachable ACCESSORIES,
components, or parts that are mechanically manipulated by the RASE or RASS
Note 1 to entry: A MECHANICAL INTERFACE can be used to attach items that are sterile.
Note 2 to entry: A MECHANICAL INTERFACE can provide insulation and other functions (e.g., sterile boundary) to
achieve BASIC SAFETY.
Note 3 to entry: RASE or RASS can have zero, one, or more MECHANICAL INTERFACE per each ROBOTIC SURGICAL
INSTRUMENT.
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201.3.211
MOUNTED PART
any part of RASE or RASS, including ACCESSORIES intended to be mounted to an operating table
or on another supporting structure which is not part of the RASE or RASS
201.3.212
RASE PROTECTIVE STOP
type of interruption of operation that allows a cessation of motion as a RISK CONTROL measure
and which retains the ability of PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) to
facilitate resumption of the operation of the RASE or RASS
Note 1 to entry: A RASE PROTECTIVE STOP can be manually initiated, or automatically initiated by means of PEMS.
Note 2 to entry: A RASE PROTECTIVE STOP can be coordinated with deactivation of energy of ROBOTIC SURGICAL
INSTRUMENT and ACCESSORIES if required as a RISK CONTROL measure.
Note 3 to entry: Annex CC tabulates differences between emergency stop and RASE PROTECTIVE STOP.
201.3.213
* ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
RASE
MEDICAL ELECTRICAL EQUIPMENT that incorporates PEMS actuated mechanism intended to
facilitate the placement or manipulation of ROBOTIC SURGICAL INSTRUMENT(s)
Note 1 to entry: "Placement" includes INTENDED PURPOSE of positioning, maintaining, or holding of a ROBOTIC
SURGICAL INSTRUMENT.
Note 2 to entry: RASE can be referred to as surgical robots, robotically assisted surgical devices, computer-
assisted surgical systems, surgical manipulators, etc.
Note 3 to entry: A ROBOTIC SURGICAL INSTRUMENT is considered to be a part of the RASE or RASS in this document.
Note 4 to entry: This note applies to the French language only.
201.3.214
ROBOTICALLY ASSISTED SURGICAL SYSTEM
RASS
MEDICAL ELECTRICAL SYSTEM that incorporates PEMS actuated mechanism intended to facilitate
the placement or manipulation of ROBOTIC SURGICAL INSTRUMENT(s)
Note 1 to entry: This note applies to the French language only.
201.3.215
* ROBOTIC SURGERY CONFIGURATION
combination of RASE or RASS by means of INTERACTION CONDITIONS and INTERFACE CONDITIONS
with one or more of the following:
– ACCESSORIES;
– other RASE or RASS;
– other ME EQUIPMENT;
– non-ME EQUIPMENT; or
– ME SYSTEM
201.3.216
* ROBOTIC SURGICAL INSTRUMENT
INVASIVE DEVICE with APPLIED PART, intended to be manipulated by the RASE or RASS to perform
tasks in SURGERY
Note 1 to entry: Tasks include visualization.
Note 2 to entry: A ROBOTIC SURGICAL INSTRUMENT can be detachable by means of a MECHANICAL INTERFACE. See
definition of MECHANICAL INTERFACE (201.3.206) and Annex AA about the attachment of ROBOTIC SURGICAL
INSTRUMENT to RASE.
IEC 80601-2-77:2019 © IEC 2019 – 13 –
Note 3 to entry: A ROBOTIC SURGICAL INSTRUMENT can be an ACCESSORY of RASE or RASS.
201.3.217
SURGERY
PROCEDURE involving the incision, excision, manipulation or suturing of tissue which usually
requires regional or general anaesthesia or profound sedation to control pain
[SOURCE: WHO/IER/PSP/2008.07[12], modified – The words "conducted in the operating
room" have been deleted.]
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS
Additional subclause:
201.4.1.101 * ROBOTIC SURGICAL INSTRUMENTS and other ME EQUIPMENT
Where requirements for ROBOTIC SURGICAL INSTRUMENTS and other ME EQUIPMENT given in
other applicable particular standards conflict with the requirements for INTERACTION
CONDITIONS of this particular standard, the requirements of this particular standard shall take
precedence.
201.4.3 * ESSENTIAL PERFORMANCE
Addition:
Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in
Table 201.101.
Table 201.101 – List of ESSENTIAL PERFORMANCE requirements
Requirement Subclause
To ensure there is no unacceptable RISK if information essential to 201.13.1.101 Information essential to
perform SURGERY is degraded. perform SURGERY
To ensure there is no unacceptable RISK if motion control of the 201.13.1.102 Motion control of the ROBOTIC
ROBOTIC SURGICAL INSTRUMENT has performance degradation. SURGICAL INSTRUMENT
201.4.6 * ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT
Addition:
NOTE Additional information is provided in Annex AA.
201.4.7 SINGLE FAULT CONDITION for ME EQUIPMENT
Addition:
When applying 4.7, the INTERACTION CONDITIONS and INTERFACE CONDITIONS shall be taken into
account.
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
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201.5.4 Other conditions
Addition to a):
Before carrying out tests, RASE shall be prepared for operation as specified by the
MANUFACTURER.
201.5.7 Humidity preconditioning treatment
Addition:
Single-use equipment drapes are not subject to humidity preconditioning treatment.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2.2 Identification
Additional subclauses:
201.7.2.2.101 Marking of maximum PATIENT mass and SAFE WORKING LOAD
If an operating table is a part of RASE, it shall be marked with the corresponding maximum
PATIENT mass and SAFE WORKING LOAD (for symbol, see Figure 201.101).
IEC
Figure 201.101 – Graphic symbol for maximum PATIENT mass and SAFE WORKING LOAD
201.7.2.2.102 Marking of the mass of MOUNTED PART
If RASE has one or more MOUNTED PARTS, each MOUNTED PART shall be marked with its
maximum mass unless the HAZARD related to the mass would not lead to an unacceptable RISK
(for example, when the mass is negligible) or the marking is not practicable (for symbol, see
Figure 201.102).
IEC
Figure 201.102 – Graphic symbol for mass of MOUNTED PART
IEC 80601-2-77:2019 © IEC 2019 – 15 –
Mass of the MOUNTED PART should include the maximum mass of the attached instruments and
ACCESSORIES.
201.7.2.9 * IP classification
Addition:
If marking an IP classification is required for a RASE, and if a protective cover, for example, an
equipment drape, is required to meet the classification, the IP symbol marking shall be
applied to the protective cover.
ROBOTIC SURGICAL INSTRUMENTS supplied with specific instructions detailing allowable
reprocessing methods and parameters are excluded from this requirement. No symbol is
required to identify the reprocessing PROCEDURE by this particular standard. See also 7.9.2.12
of the general standard.
201.7.2.10 APPLIED PARTS
Addition:
If marking of an APPLIED PART is not practicable and the APPLIED PART is single-use, the
required marking shall be on the individual packaging, or on the equipment adjacent to the
APPLIED PART.
connector for the
Compliance is checked by inspection.
Additional subclause:
201.7.2.101 Alternative marking
Information which is accessible by the OPERATOR on an output device (e.g. display) of ME
EQUIPMENT is considered equivalent to marking on the equipment for requirements of 7.2 of
the general standard, as long as the marking is visible at the time the information is required.
Compliance is checked by inspection.
201.7.4.2 Control devices
Addition:
Alternative or no markings of control devices (for example, multi-function buttons) is
acceptable if the USABILITY ENGINEERING PROCESS demonstrates that this does not result in
unacceptable RISK.
NOTE Visual cues such as colour, tactile, location, shape can be used in lieu of markings.
Compliance is checked by inspecting the USABILITY ENGINEERING FILE.
201.7.8.1 Colours of indicator lights
Replacement of Table 2 by the following Table 201.102, and replacement of references to
Table 2 to Table 201.102:
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Table 201.102 – Colours of indicator lights and their meaning for ME EQUIPMENT
Colour Meaning
Red Warning – immediate response by the OPERATOR is required
Yellow – Caution – prompt response by the OPERATOR is required;
– Cutting mode of HF SURGICAL EQUIPMENT if applicable; or
– Additional modes if multiple functions share the same control device, provided the
USABILITY ENGINEERING PROCESS demonstrates that this does not result in unacceptable
RISK.
Blue – Coagulation mode of HF SURGICAL EQUIPMENT if applicable, or;
– Additional modes if multiple functions share the same control device, provided the
USABILITY ENGINEERING PROCESS demonstrates that this does not result in unacceptable
RISK;
– Any meaning other than red or yellow colour if the USABILITY ENGINEERING PROCESS
demonstrates that this does not result in unacceptable RISK.
Green Ready for use
Any other colour Any meaning other than red, yellow, blue or green colour
201.7.9.2.2 Warning and safety notices
Addition:
In addition to requirements in other particular standards that can be relevant, the following
warning and safety notices shall be provided as applicable:
Warnings regarding INTERACTION CONDITIONS:
a) warning that, if the ROBOTIC SURGERY CONFIGURATION requires TYPE CF APPLIED PARTS, the
APPLIED PARTS of other ME EQUIPMENT used within the ROBOTIC SURGERY CONFIG
...
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