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.

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.

General Information

Status
Published
Publication Date
08-Jul-2019
Current Stage
PPUB - Publication issued
Completion Date
09-Jul-2019
Ref Project

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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
IEC 80601-2-77:2019-07(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
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

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

---------------------- Page: 3 ----------------------
– 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

---------------------- Page: 4 ----------------------
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

---------------------- Page: 5 ----------------------
– 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

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IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

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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

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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.
---------------------- Page: 6 ----------------------
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.
---------------------- Page: 7 ----------------------
– 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.
---------------------- Page: 8 ----------------------
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.
---------------------- Page: 9 ----------------------
– 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.
---------------------- Page: 10 ----------------------
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:
---------------------- Page: 11 ----------------------
– 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 6
...

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