IEC 60601-2-40:2024
(Main)Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
IEC 60601-2-40:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT, hereafter referred to as ME EQUIPMENT.
The following ME EQUIPMENT are excluded:
- ME EQUIPMENT intended for therapeutic application;
- ME EQUIPMENT intended for transcutaneous electrical nerve stimulators and electrical muscle stimulators (ME EQUIPMENT covered by IEC 60601-2-10).
IEC 60601-2-40:2024 cancels and replaces the second edition published in 2016. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) added requirements for constant voltage stimulators;
b) clarified requirements for VISUAL STIMULATORS.
Appareils électromédicaux - Partie 2-40: Exigences particulières pour la sécurité de base et les performances essentielles des électromyographes et des appareils à potentiel évoqué
L'IEC 60601-2-40:2024 s'applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des ELECTROMYOGRAPHES et des APPAREILS A POTENTIEL EVOQUE, désignés ci-après sous le terme APPAREILS EM.
Les APPAREILS EM suivants sont exclus de la liste:
- APPAREILS EM destinés à une application thérapeutique;
- APPAREILS EM destinés à être utilisés avec les neurostimulateurs électriques transcutanés et les stimulateurs musculaires électriques (APPAREILS EM couverts par l'IEC 60601-2-10).
L'IEC 60601-2-40:2024 annule et remplace la deuxième édition parue en 2016. Cette édition constitue une révision technique.
Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
a) des exigences relatives aux stimulateurs à tension constante ont été ajoutées;
b) des exigences relatives aux STIMULATEURS VISUELS ont été clarifiées.
General Information
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Standards Content (Sample)
IEC 60601-2-40 ®
Edition 3.0 2024-12
REDLINE VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-40: Particular requirements for the basic safety and essential performance
of electromyographs and evoked response equipment
Appareils électromédicaux –
Partie 2-40: Exigences particulières pour la sécurité de base et les performances
essentielles des électromyographes et des appareils à potentiel évoqué
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IEC 60601-2-40 ®
Edition 3.0 2024-12
REDLINE VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-40: Particular requirements for the basic safety and essential performance
of electromyographs and evoked response equipment
Appareils électromédicaux –
Partie 2-40: Exigences particulières pour la sécurité de base et les performances
essentielles des électromyographes et des appareils à potentiel évoqué
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.20; 11.040.55; 11.040.99 ISBN 978-2-8327-0122-5
– 2 – IEC 60601-2-40:2024 RLV © IEC 2024
CONTENTS
FOREWORD . 3
INTRODUCTION . 2
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 9
201.4 General requirements . 11
201.5 General requirements for testing ME EQUIPMENT . 11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 11
201.7 ME EQUIPMENT identification, marking and documents . 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14
201.10 Protection against unwanted and excessive radiation HAZARDS . 15
201.11 Protection against excessive temperatures and other HAZARDS . 15
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 15
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 18
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 18
201.15 Construction of ME EQUIPMENT . 18
201.16 ME SYSTEMS . 18
201.17 ELECTROMAGNETIC compatibility of ME EQUIPMENT and ME SYSTEMS . 19
202 * ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 19
Annexes . 24
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 24
Annex AA (informative) Particular guidance and rationale . 25
Bibliography . 31
Index of defined terms used in this particular standard . 32
Figure AA.1 – Suggested test cable layout for EMISSION and radiated IMMUNITY testing. 28
Figure AA.2 – Example of test setup for protection against the effects of HF SURGICAL
ME EQUIPMENT . 29
Figure AA.3 – Example of test setup for protection against the effects of HF SURGICAL
ME EQUIPMENT . 30
Table 202.101 – Pass/fail criteria for Table 4 of IEC 60601-1-2:2014 and IEC 60601-1-
2:2014/AMD1:2020 . 21
Table 202.102 – Pass/fail criteria for Table 7 of IEC 60601-1-2:2014 . 22
Table 202.103 – Pass/fail criteria for Table 8 of IEC 60601-1-2:2014 and IEC 60601-1-
2:2014/AMD1:2020 . 23
Table 202.104 – Pass/fail criteria for Table 5, Table 6, Table 9 of IEC 60601-1-2:2014
and IEC 60601-1-2:2014/AMD1:2020 . 23
Table 201.C.101 – Marking on the outside of ELECTROMYOGRAPHS and EVOKED
RESPONSE EQUIPMENT or its parts . 24
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-40: Particular requirements for the basic safety and
essential performance of electromyographs and
evoked response 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
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4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
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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) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights in
respect thereof. As of the date of publication of this document, IEC had not received notice of (a) patent(s), which
may be required to implement this document. However, implementers are cautioned that this may not represent
the latest information, which may be obtained from the patent database available at https://patents.iec.ch. IEC
shall not be held responsible for identifying any or all such patent rights.
This redline version of the official IEC Standard allows the user to identify the changes
made to the previous edition IEC 60601-2-40:2016. A vertical bar appears in the margin
wherever a change has been made. Additions are in green text, deletions are in
strikethrough red text.
– 4 – IEC 60601-2-40:2024 RLV © IEC 2024
IEC 60601-2-40 has been prepared by subcommittee 62D: Particular medical equipment,
software, and systems, of IEC technical committee 62: Medical equipment, software, and
systems. It is an International Standard.
This third edition cancels and replaces the second edition published in 2016. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) added requirements for constant voltage stimulators;
b) clarified requirements for VISUAL STIMULATORS.
The text of this International Standard is based on the following documents:
Draft Report on voting
62D/2168/FDIS 62D/2191/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications.
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 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, AND
IEC 60601-1:2005/AMD2:2020, IN THIS DOCUMENT OR AS NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term
– "clause" means one of the seventeen 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 document 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 series, 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 webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn, or
• revised.
IMPORTANT – The "colour inside" logo on the cover page of this document 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.
– 6 – IEC 60601-2-40:2024 RLV © IEC 2024
INTRODUCTION
This document concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROMYOGRAPHS
and EVOKED RESPONSE EQUIPMENT. It amends and supplements IEC 60601-1, Medical electrical
equipment – Part 1: General requirements for basic safety and essential performance
(IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, and IEC 60601-1:2005/AMD2:2020).
The aim of this revision is to bring this document up to date with reference to the latest edition
of the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, and IEC 60601-
1:2005/AMD2:2020.
The requirements of this document take priority over those of IEC 60601-1.
A "General guidance and rationale" for the more important requirements of this document is
included in Annex AA. It is considered that knowledge of the reasons for these requirements
will not only facilitate the proper application of the document but will, in due course, expedite
any revision necessitated by changes in clinical practice or as a result of developments in
technology. However, Annex AA does not form part of the requirements of this document.
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-40: Particular requirements for the basic safety and
essential performance of electromyographs and
evoked response equipment
201.1 Scope, object and related standards
Clause 1 of the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.1.1 Scope
Replacement:
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT, hereafter referred to as ME EQUIPMENT.
NOTE 1 Myofeedback equipment, where the capturing of muscle contraction is based on electromyography, is
within the scope of this document.
NOTE 2 ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT is intended for diagnostic and monitoring
applications.
NOTE 3 If the ME EQUIPMENT supports both ELECTROMYOGRAPHY and EVOKED RESPONSE STIMULATION, clauses for
electrical, auditory, and visual stimulators are applicable. In case the equipment supports ELECTROMYOGRAPHY, but
not EVOKED RESPONSE STIMULATION, clauses concerning solely requirements for stimulators are NOT within the scope
of this document.
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.
The following ME EQUIPMENT are excluded:
• ME EQUIPMENT intended for therapeutic application;
• ME EQUIPMENT intended for transcutaneous electrical nerve stimulators and electrical
muscle stimulators (ME EQUIPMENT covered by IEC 60601-2-10).
201.1.2 Object
Replacement:
The object of this document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT [as defined in
201.3.201 and 201.3.202.]
___________
The general standard is IEC 60601-1:2005/AMD1:2012, Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance
– 8 – IEC 60601-2-40:2024 RLV © IEC 2024
201.1.3 Collateral standards
Addition:
This document refers to those applicable collateral standards that are listed in Clause 2 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and
Clause 201.2 of this document.
IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020 apply as modified in Clause 202.
IEC 60601-1-3, IEC 60601-1-8 and IEC 60601-1-10 do not apply. All other published collateral
standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 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 IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
For brevity, IEC 60601-1 is 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 document corresponds to that of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 with the
prefix "201" (e.g. 201.1 in this document addresses the content of Clause 1 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020) 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 addresses the content of Clause 4 of the IEC 60601-1-
2 collateral standard, 203.4 addresses the content of Clause 4 of the IEC 60601-1-3 collateral
standard, etc.). The changes to the text of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012
and IEC 60601-1:2005/AMD2:2020 are specified by the use of the following words:
"Replacement" means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard is replaced completely by the text of this document.
"Addition" means that the text of this document is additional to the requirements of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or
applicable collateral standard.
"Amendment" means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard is amended as indicated by the text of this document.
Subclauses, figures or tables which are additional to those of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered starting from
201.101. However, due to the fact that definitions in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered 3.1 through
3.147154, 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, for example 202
for IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this document" is used to make reference to IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, any applicable collateral
standards and this document taken together.
Where there is no corresponding clause or subclause in this document, the clause or subclause
of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or
applicable collateral standard, although possibly not relevant, applies without modification;
where it is intended that any part of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 or applicable collateral standard, although possibly relevant, is
not to be applied, a statement to that effect is given in this document.
201.2 Normative references
Clause 2 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
NOTE Informative references are listed in the bibliography.
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
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 60601-1-2:2014/AMD1:2020
IEC 60318 (all parts), Electroacoustics – Simulators of human head and ear
ISO 15004-2, Ophthalmic instruments – Fundamental requirements and test methods – Part 2:
Light hazard protection
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 apply, except as follows:
ISO and IEC maintain terminology databases for use in standardization at the following
addresses:
• IEC Electropedia: available at https://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp
NOTE An index of defined terms is found beginning on page 30.
Additional terms and definitions:
201.3.201
ELECTROMYOGRAPH
ME EQUIPMENT for the detection or recording of biopotentials accompanying nerve and muscle
action, either spontaneously, intentionally or evoked by electrical or other stimulation
– 10 – IEC 60601-2-40:2024 RLV © IEC 2024
201.3.202
EVOKED RESPONSE EQUIPMENT
ME EQUIPMENT for the detection or recording of biopotentials resulting from an evoking stimulus
Note 1 to entry: The stimulus may can be electrical, tactile, auditory, visual, olfactory, etc.
201.3.203
ELECTRICAL STIMULATOR
part of ELECTROMYOGRAPHS and EVOKED RESPONSE ME EQUIPMENT for the application of electric
currents via ELECTRODES in direct contact with the PATIENT, for the evoking of biopotentials
201.3.204
PULSE DURATION
duration of the electrical stimulus pulse WAVEFORM at 50 % of the peak amplitude
201.3.205
WAVEFORM
variations in magnitude of an electrical stimulus output (either voltage or current) as a function
of time appearing in the APPLIED PART(S) of the ELECTRICAL STIMULATOR or the collected
biopotentials by the BIOPOTENTIALS INPUT PART
201.3.206
AUDITORY STIMULATOR
part of ELECTROMYOGRAPHS and EVOKED RESPONSE ME EQUIPMENT for the application of sound
pressure from a transducer (headphone, bone conductor or free-field) to the ear(s) of the
PATIENT, for the evoking of biopotentials
201.3.207
VISUAL STIMULATOR
part of ELECTROMYOGRAPHS and EVOKED RESPONSE ME EQUIPMENT for the application of pulsed
electromagnetic radiation in the visible spectrum from a transducer to the eyes of the PATIENT,
for the evoking of biopotentials
201.3.208
BIOPOTENTIAL INPUT PART
APPLIED PART(S) of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT for the collection of
biopotentials
201.3.209
ELECTRODE
conductive portion that is applied to the PATIENT to detect electrical activity and/or to apply the
stimulus from the ELECTRICAL STIMULATOR to the PATIENT
201.3.210
PATIENT LEAD
cable connected between an ELECTRODE and either a PATIENT CABLE or the ME EQUIPMENT
201.3.211
PATIENT CABLE
multiwire cable used to connect PATIENT LEADS to ME EQUIPMENT
201.4 General requirements
Clause 4 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.4.2 *RISK MANAGEMENT PROCESS for ME EQUIPMENT and or ME SYSTEMS
Addition:
MANUFACTURERS shall include, within their RISK MANAGEMENT FILE, the RISK associated with the
potential use of their STIMULATORS and accessories to deliver current exceeding 10 mA RMS or
current densities for any ELECTRODE exceeding 2 mA/cm .
201.4.3 ESSENTIAL PERFORMANCE
Addition:
NOTE Because of the variety of clinical applications for ELECTROMYOGRAPHS and EVOKED
RESPONSE, no additional ESSENTIAL PERFORMANCE is specified in this document. However,
ESSENTIAL PERFORMANCE shall be is determined by the manufacturer in accordance with the
requirements of 4.3 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020.
201.4.11 Power input
Replacement:
The power input is measured with a load resistance of the lowest value specified in the technical
description (see 201.7.9.3.101 a)), and with any output controls set to result in maximum power
input.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, and
IEC 60601-1:2005/AMD2:2020 applies, except as follows.
201.5.4 Other conditions
Addition:
Where values of voltage and current are used in this document, they mean the RMS values of
an alternating, direct or composite voltage or current averaged over 1 s unless stated otherwise.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.6.2 * Protection against electric shock
Amendment:
Delete TYPE B APPLIED PART.
– 12 – IEC 60601-2-40:2024 RLV © IEC 2024
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
ACCOMPANYING DOCUMENTS
201.7.2.3 * Consult
Replacement:
Safety sign ISO 7010-M002 shall be used (see Table D.2, safety sign 10 in Annex D of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, and IEC 60601-1:2005/AMD2:2020).
201.7.2.7 Electrical input power from the SUPPLY MAINS
Replacement:
The RATED power input of MAINS operated ME EQUIPMENT shall be the maximum power input
averaged over any period of 5 s under the specified operating conditions set out by the
manufacturer.
201.7.2.8 Output connectors
201.7.2.8.2 Other power sources
Addition:
See also 201.12.4.102.
201.7.2.13 * Physiological effects (SAFETY SIGNS and warning statements)
Addition:
ME EQUIPMENT capable of delivering electrical stimulus outputs into a load resistance of 1 000 Ω
in excess of 10 mA RMS or 10 V RMS averaged over any period of 5 s shall be marked near
the ELECTRODE connections with the safety sign ISO 7010-M002 (see safety sign 10 in Table D.2
of Annex D of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, and
IEC 60601-1:2005/AMD2:2020).
201.7.4 Marking of controls and instruments
201.7.4.2 * Control devices
Replacement:
An output control for the ELECTRICAL STIMULATOR shall be incorporated which will control the
ELECTRICAL STIMULATOR output from minimum to maximum of the range continuously, or in
discrete increments of not more than 1 mA peak amplitude or 5 V peak amplitude per increment.
At its minimum setting, the output shall not exceed 2 % of that available at the maximum setting
of the control.
The type of stimulator output, constant voltage and/or constant current shall be described and
specified in the ACCOMPANYING DOCUMENTS. Compliance is checked by inspection and
measurement, using the load impedance which is the least favourable within the range specified
in the ACCOMPANYING DOCUMENTS.
Or, as an alternate method of compliance, the following may be chosen:
An output control for the ELECTRICAL STIMULATOR shall be incorporated which will control the
ELECTRICAL STIMULATOR output from minimum to maximum of the range, continuously or in
discrete increments as specified in the ACCOMPANYING DOCUMENTS or indicated on the ME
EQUIPMENT (see 201.7.9.2.101).
The following shall be addressed in the RISK MANAGEMENT FILE:
Voltage range, current range, increment, accuracy.
Compliance is checked by inspection of ACCOMPANYING DOCUMENTS and the RISK MANAGEMENT
FILE.
The following information shall be provided in the instructions for use:
a) electrical stimulator output range: specify minimum and maximum values;
b) type of control used: specify if the output control is continuous or in discrete increments;
c) if discrete increments are used, the minimum increment shall be specified;
d) load impedance range: specify minimum and maximum load.
Compliance is checked by inspection of ACCOMPANYING DOCUMENTS.
201.7.9 ACCOMPANYING DOCUMENTS
201.7.9.2 Instructions for use
Additional subclause:
201.7.9.2.101 Additional information in instructions for use
The instructions for use shall contain additionally:
a) * Information on the output WAVEFORM(s), including any DC component, PULSE DURATIONS,
pulse repetition frequencies, maximum amplitude of output voltage and/or current, and the
effect of load impedance on the demanded parameters.
b) * Advice on the size of ELECTRODES to be used and the method of application for each
particular type of examination for which the ELECTRICAL STIMULATOR is intended.
c) Advice on any necessary precautions to be taken when the output contains a DC component
larger than 10 µA when averaged over 1 s.
d) * Advice that a PATIENT with an implanted electronic device (for example a cardiac
pacemaker) should not be subjected to electrical stimulation unless specialist medical
opinion has first been obtained.
e) Advice to avoid trans-thoracic stimulation.
f) A warning on the following potential HAZARDS:
– Connection of a PATIENT to a high frequency (HF) surgical equipment and to an
ELECTROMYOGRAPH or EVOKED RESPONSE EQUIPMENT simultaneously may can result in
burns at the site of the ELECTRODES and possible damage to the APPLIED PARTS;
– Operation in close proximity to a shortwave or microwave therapy equipment may can
produce instability in the APPLIED PARTS.
g) * For ME EQUIPMENT capable of delivering output values in excess of 10 mA RMS or
10 V RMS into the specified load impedance (see 201.7.9.3.101a)), averaged over 1 s, or
having an energy greater than 10 mJ per pulse into the specified load impedance:
– a list of recommended ELECTRODES that can be used with the ME EQUIPMENT.
h) * Advice to avoid accidental contact between connected but unapplied APPLIED PARTS and
other conductive parts including those connected to protective earth.
– 14 – IEC 60601-2-40:2024 RLV © IEC 2024
i) * Any known susceptibilities to electromagnetic phenomena.
201.7.9.3 Technical description
Additional subclause:
201.7.9.3.101 Additional information in the technical description
The technical description shall additionally contain the following:
a) The technical description shall specify the parameters mentioned in 201.7.9.2.101 along
with the range of load impedances for which these parameters are valid.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.8.3 * Classification of APPLIED PARTS
Replacement:
The APPLIED PARTS of ELECTRICAL STIMULATORS, VISUAL STIMULATORS, AUDITORY STIMULATORS and
BIOPOTENTIAL INPUT PARTS shall be TYPE BF APPLIED PARTS or TYPE CF APPLIED PARTS.
PATIENT LEADS or PATIENT CABLES
201.8.5.2.3
Addition:
PATIENT LEADS of ELECTROMYOGRAPHS are usually kept short (30 cm or less) and tied together;
therefore, any PATIENT LEAD which falls off will stay in the vicinity of the PATIENT and thus there
are no additional requirements for the ELECTRODE.
Where the PATIENT LEADS are long (longer than 30 cm) or not tied together, compliance is
verified by inspection of the RISK MANAGEMENT FILE.
201.8.8.3 * Dielectric strength
Addition to item a):
Where the voltage to which the relevant insulation is subjected in NORMAL USE is non-sinusoidal
z or 60 Hz test voltage. Where this
AC, the test may can be performed using a sinusoidal 50 H
method is used, the value of test voltage shall be determined from Table 6 of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 using a reference voltage
(U) V DC equal to the measured peak-to peak voltage divided by 22 .
This reduction is only allowed for non-sinusoidal working voltages equal to or greater than 700 V
peak.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Clause 9 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies except as follows:
Addition:
201.9.6.2.1 Audible acoustic energy
Addition:
The limits specified in 9.6.2.1 do not apply to auditory stimulation delivered to the PATIENT for
the purpose of evoking a physiological response during NORMAL USE of the ME EQUIPMENT or ME
SYSTEM. Requirements for diagnostic acoustic pressure are found in 201.12.4.6.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.11.1 Excessive temperatures in ME EQUIPMENT
201.11.1.1 Maximum temperature during NORMAL USE
Addition:
Compliance with the requirements for maximum temperatures specified in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 shall be checked under the
condition specified in 201.4.11.
SUPPLY MAINS to ME EQUIPMENT
201.11.8 Interruption of the power supply /
Addition:
When ME EQUIPMENT is switched off and on again or when the SUPPLY MAINS is interrupted and
re-established, the subsequent operation shall be as follows:
All stimulators (electrical, visual, auditory) shall be disabled upon power reset. Manual
intervention shall be required to re-start any stimulation.
Compliance is checked by interruption and restoration of relevant power supplies.
201.12 Accuracy of controls and instruments and protection against hazardous
outputs
Clause 12 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.12.1 * Accuracy of controls and instruments
Replacement:
201.12.1.101 * ELECTRICAL STIMULATOR accuracy
The accuracy of PULSE DURATION, pulse repetition frequencies and pulse amplitudes shall
comply with one of the following:
a) The values of PULSE DURATION, pulse repetition frequencies and amplitudes, as described in
the ACCOMPANYING DOCUMENTS or indicated on the ME EQUIPMENT (see 201.7.9.2.101), shall
– 16 – IEC 60601-2-40:2024 RLV © IEC 2024
not deviate by more than ±30 %, when measured with an error not exceeding ±10 % into a
load resistance within the range specified in the ACCOMPANYING DOCUMENTS (see
201.7.9.3.101).
Compliance is checked by measurement.
b) The accuracy of the PULSE DURATION, pulse repetition frequencies and amplitudes, as
described in the ACCOMPANYING DOCUMENTS or indicated on the ME EQUIPMENT (see
201.7.9.2.101), shall not exceed the tolerances established by the RISK MANAGEMENT
for acceptable values, when measured with an error not exceeding ±10 % into a
PROCESS
load resistance within the range specified in the ACCOMPANYING DOCUMENTS (see
201.7.9.3.101).
Compliance is checked by measurement and by inspection of ACCOMPANYING DOCUMENTS
RISK MANAGEMENT FILE.
and the
201.12.1.102 Output control of ELECTRICAL STIMULATOR
An output control for the ELECTRICAL STIMULATOR shall be incorporated which will continuously
control the ELECTRICAL STIMULATOR output range from minimum to maximum, or in discrete
increments of not more than 1 mA peak amplitude or 5 V peak amplitude per increment.
Either the type of stimulator output, the constant voltage or the constant current, or one of
these, shall be described and specified in the ACCOMPANYING DOCUMENTS.
Compliance is checked by inspection and measurement, using the load impedance which is the
least favourable within the range specified in the ACCOMPANYING DOCUMENTS.
Or, as an alternate method of compliance, the following can be chosen:
An output control for the ELECTRICAL STIMULATOR shall be incorporated which will continuously
control the ELECTRICAL STIMULATOR output from minimum to maximum of the range, or in discrete
increments as specified in the ACCOMPANYING DOCUMENTS or indicated on the ME EQUIPMENT
(see 201.7.9.2.101).
The following shall be addressed in the RISK MANAGEMENT FILE:
Voltage range, current range, increment, accuracy.
Compliance is checked by inspection of ACCOMPANYING DOCUMENTS and the RISK MANAGEMENT
FILE.
201.12.1.103 * Constant voltage stimulator limit
For constant voltage stimulators, the maximum output current shall be limited. The
manufacturer shall state the maximum output current over the range of load impedances
specified in the ACCOMPANYING DOCUMENTS.
Compliance is checked by measurement and by inspection of ACCOMPANYING DOCUMENTS.
201.12.2 USABILITY of ME EQUIPMENT
Additional subclause:
201.12.2.201 * Additional USABILITY requirement
The ELECTRICAL STIMULATOR shall not become unsafe if the output is switched on inadvertently
with open circuited or short circuited ELECTRODES, even if such an operation is considered to
be misuse.
Compliance is checked by operating the ELECTRICAL STIMULATOR at maximum output settings for
5 min, with the ELECTRODES open circuited and for 5 min with the ELECTRODES short circuited.
After these tests all safety requirements of this document shall b
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