IEC 60601-2-40:2016
(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 60601-2-40:2016 applies to the basic safety and essential performance of electromyographs and evoked response equipment, hereafter referred to as ME equipment. ME equipment intended for transcutaneous electrical nerve stimulators and electrical muscle stimulators are excluded (covered by IEC 60601-2-10). This second edition cancels and replaces the first edition of IEC 60601-2-40 published in 1998. This edition constitutes a technical revision.
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 60601-2-40:2016 s'applique à la sécurité de base et aux performances essentielles des électromyographes et des appareils à potentiel évoqué, désignés ci-après par appareils EM. Les appareils EM destinés à être utilisés avec les neurostimulateurs électriques transcutanés et les stimulateurs de muscles électriques sont exclus (couverts par l'IEC 60601-2-10). Cette deuxième édition annule et remplace la première édition de l'IEC 60601-2-40 parue en 1998. Cette édition constitue une révision technique.
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IEC 60601-2-40 ®
Edition 2.0 2016-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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 2.0 2016-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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 978-2-8322-3592-8
– 2 – IEC 60601-2-40:2016 IEC 2016
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 8
201.3 Terms and definitions . 9
201.4 General requirements . 10
201.5 General requirements for testing of ME EQUIPMENT . 10
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 11
201.7 ME EQUIPMENT identification, marking and documents . 11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 13
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14
201.10 Protection against unwanted and excessive radiation HAZARDS . 14
201.11 Protection against excessive temperatures and other HAZARDS . 14
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 14
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 16
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 16
201.15 Construction of ME EQUIPMENT . 17
201.16 ME SYSTEMS . 17
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 17
202 * ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 17
Annexes . 22
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 22
Annex AA (informative) Particular guidance and rationale . 23
Bibliography . 29
Index of defined terms used in this particular standard . 30
Figure AA.1 – Suggested test layout for EMISSION and IMMUNITY testing . 26
Figure AA.2 – Example of test setup for protection against the effects of HF SURGICAL
ME EQUIPMENT . 27
Figure AA.3 – Example of test setup for protection against the effects of HF SURGICAL
ME EQUIPMENT . 28
Table 202.101 – Pass/fail criteria for Table 4 of IEC 60601-1-2:2014 . 19
Table 202.102 – Pass/fail criteria for Table 7 of IEC 60601-1-2:2014 . 20
Table 202.103 – Pass/fail criteria for Table 8 of IEC 60601-1-2:2014 . 20
Table 201.C.101 – Marking on the outside of ELECTROMYOGRAPHS and EVOKED
RESPONSE EQUIPMENT or its parts . 22
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
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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
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4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
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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
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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 60601-2-40 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition cancels and replaces the first edition of IEC 60601-2-40 published in
1998. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) no special test phantom used for EMC testing;
b) test method for continuous masking sound pressure level;
c) test method for visual stimulators;
– 4 – IEC 60601-2-40:2016 IEC 2016
d) allows use of equipment not intended for continuous operation;
e) clarification that audible and visible indicators are not to be considered ALARM SYSTEMS as
per IEC 60601-1-8.
The text of this standard is based on the following documents:
FDIS Report on voting
62D/1366/FDIS 62D/1394/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, 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 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 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 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 publication will remain unchanged until
the stability date indicated on the IEC website under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
– 6 – IEC 60601-2-40:2016 IEC 2016
INTRODUCTION
This particular standard 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 and IEC 60601-1:2005/AMD1:2012),
hereinafter referred to as the general standard.
The aim of this second edition is to bring this particular standard up to date with reference to
the latest edition of the general standard.
The requirements of this particular standard take priority over those of the general standard.
A “General guidance and rationale” for the more important requirements of this particular
standard 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 applies, except as follows:
201.1.1 Scope
Replacement:
This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT, hereafter referred to as ME EQUIPMENT.
NOTE Myofeedback equipment, where the capturing of muscle contraction is based on electromyography, is
within the scope of this particular standard.
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 is excluded:
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 particular standard 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.]
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 applies 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.
___________
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 60601-2-40:2016 IEC 2016
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 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 particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”,
where × 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 standard 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 standard" 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
Clause 2 of the general standard applies, except as follows:
NOTE Informative references are listed in the bibliography beginning on page 29.
Addition:
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 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 30.
Addition:
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
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 be electrical, tactile, auditory, visual, olfactory, etc.
201.3.203
ELECTRICAL STIMULATOR
part of ELECTROMYOGRAPHS and EVOKED RESPONSE 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 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
– 10 – IEC 60601-2-40:2016 IEC 2016
201.3.207
VISUAL STIMULATOR
part of ELECTROMYOGRAPHS and EVOKED RESPONSE 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 the general standard applies, except as follows:
201.4.2 RISK MANAGEMENT PROCESS for ME EQUIPMENT and 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 r.m.s
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 particular standard. However, ESSENTIAL PERFORMANCE shall be
determined by the manufacturer in accordance with the requirements of sub-clause 4.3 of the general standard.
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 of ME EQUIPMENT
Clause 5 of the general standard applies, except as follows.
201.5.4 Other conditions
Addition:
Where values of voltage and current are used in this document, they mean the r.m.s. 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 the general standard applies, except as follows:
201.6.2 * Protection against electric shock
Amendment:
Delete TYPE B APPLIED PART.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
201.7.2.3 * Consult accompanying documents
Replacement:
Safety sign ISO 7010-M002 shall be used (see Table D.2, safety sign 10 in Annex D of the
general standard).
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)
ME EQUIPMENT capable of delivering electrical stimulus outputs into a load resistance of
1 000 Ω in excess of 10 mA r.m.s or 10 V r.m.s. averaged over any period of 5 s shall be
marked near the ELECTRODE connections with the safety sign ISO 7010-M002 (see safety sign
No. 10 in Table D.2 of Annex D of the general standard).
– 12 – IEC 60601-2-40:2016 IEC 2016
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.
201.7.9 ACCOMPANYING DOCUMENTS
201.7.9.2 Instructions for use
Addition:
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 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
produce instability in the APPLIED PARTS.
g) * For ME EQUIPMENT capable of delivering output values in excess of 10 mA r.m.s. or 10 V
r.m.s. 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.
i) * Any known susceptibilities to electromagnetic phenomena.
201.7.9.3 Technical description
Addition:
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 the general standard 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.
201.8.5.2.3 PATIENT LEADS or PATIENT CABLES
Addition:
PATIENT LEADS of ELECTROMYOGRAPHS are usually kept short 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 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 AC, the test may be performed using a sinusoidal 50 Hz or 60 Hz test voltage.
Where this method is used, the value of test voltage shall be determined from Table 6 of the
general standard using a reference voltage (U) V DC equal to the measured peak-to peak
voltage divided by
2 2
– 14 – IEC 60601-2-40:2016 IEC 2016
This reduction is only allowed for nonsinusoidal 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 the general standard applies except as follows:
Addition:
201.9.6.2.1 Audible acoustic energy
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 subclause 201.12.4.6
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard 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 the general
standard shall be checked under the condition specified in 201.4.11.
201.11.8 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT
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
intervation 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 the general standard applies, except as follows:
201.12.1 * Accuracy of controls and instruments
Replacement:
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 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
PROCESS for acceptable values, 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 and by inspection of ACCOMPANYING DOCUMENTS and
the RISK MANAGEMENT FILE.
201.12.2 USABILITY
Addition:
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 be satisfied.
201.12.3 ALARM SYSTEMS
Addition:
Audible and visible indicators of the ME EQUIPMENT that are not intended to meet the definition
of an ALARM SIGNAL in IEC 60601-1-8 are allowed.
201.12.4 Protection against hazardous output
201.12.4.6 * Diagnostic or therapeutic acoustic pressure
Replacement:
If a continuous masking output is available, the maximum continuous masking sound level
shall not exceed 100 dB SPL(A) when the sound pressure level is measured at the minimum
distance from the PATIENT as specified by the manufacturer from the source of acoustic
energy (masking noise) in NORMAL USE.
Measurement shall be performed with an ear simulator that conforms to applicable part(s) of
IEC 60318 (all parts). Sound level meter used in the measurement shall conform to
IEC 61672-1, Class 1.
Applications which need an output value beyond the 100 dB SPL(A) shall not exceed 125 dB
SPL(A). To enable this extended output limit the OPERATOR shall be informed and confirm a
– 16 – IEC 60601-2-40:2016 IEC 2016
warning statement before continuing. The manufacturer shall provide the following information
in the instructions for use:
Where applicable, warning(s) regarding the possibility of hearing damage
Compliance is checked by measurement and inspection of ACCOMPANYING DOCUMENTS.
Addition:
201.12.4.101 * Supply voltage variations
Supply voltage fluctuations of ±10 % of the nominal voltage shall not affect the ELECTRICAL
STIMULATOR output amplitude, PULSE DURATION or pulse repetition frequencies by more than
±10 %.
Compliance is checked by measurement.
201.12.4.102 * ELECTRICAL STIMULATOR output indicator
ME EQUIPMENT which can deliver into a load resistance of 1 000 Ω an output in excess of 10
mA r.m.s. or 10 V r.m.s. or pulses having an energy exceeding 10 mJ per pulse, shall provide
visual indication that the ELECTRICAL STIMULATOR is delivering stimuli, or is primed to deliver
stimuli. The colour of the visual indicator shall be yellow.
Compliance is checked by inspection and by a functional test.
201.12.4.103 * Limitation of ELECTRICAL STIMULATOR output parameters
The pulse energy with load resistance of 1 000 Ω shall not exceed 50 mJ per pulse.
Compliance is checked by measurement.
201.12.4.104 Limitation of VISUAL STIMULATOR output parameters
When the transducer of the VISUAL STIMULATOR consists of light emitting diodes, the optical
radiation shall not exceed the EMISSION limits specified by ISO 15004-2.
Compliance is checked by measurement.
Displays that are compliant with applicable IT requirements such as IEC 60950-1 (ITE
Standard), or, IEC 62368-1 and are used at normal operating distances from the PATIENT shall
not be required to be tested to ISO 15004-2.
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT
Clause 13 of the general standard applies.
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
Clause 14 of the general standard applies.
201.15 Construction of ME EQUIPMENT
Clause 15 of the general standard applies.
201.16 ME SYSTEMS
Clause 16 of the general standard applies except as follows:
201.16.8 Interruption of the power supply to parts of an ME SYSTEM
Addition:
When ME SYSTEM is switched off and on again or when any part of the ME SYSTEM 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.
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS
Clause 17 of the general standard applies.
202 * ELECTROMAGNETIC DISTURBANCES – Requirements and tests
IEC 60601-1-2:2014 applies except as follows:
202.8 Electromagnetic IMMUNITY requirements for ME EQUIPMENT and ME SYSTEMS
202.8.1 General
Addition:
MMUNITY pass/fail criteria
202.8.1.101 * I
The IMMUNITY pass/fail criteria of the ME EQUIPMENT or ME SYSTEMS shall be one or more of the
following as determined by the manufacturer.
a) The ME EQUIPMENT or ME SYSTEMS shall maintain BASIC SAFETY and ESSENTIAL
PERFORMANCE during and after the IMMUNITY test. No DEGRADATION of ESSENTIAL
PERFORMANCE is allowed below a level specified by the manufacturer.
b) The ME EQUIPMENT or ME SYSTEMS shall maintain BASIC SAFETY and ESSENTIAL
PERFORMANCE during and after the IMMUNITY test. However, temporary loss of ESSENTIAL
PERFORMANCE is allowed, provided it can be restored without manual intervention. No
DEGRADATION of ESSENTIAL PERFORMANCE is allowed below a level specified by the
manufacturer.
c) The ME EQUIPMENT or ME SYSTEMS shall maintain BASIC SAFETY and ESSENTIAL
PERFORMANCE during and after the IMMUNITY test. However, temporary loss of ESSENTIAL
PERFORMANCE is allowed, provided it can be restored with manual intervention. No
DEGRADATION of ESSENTIAL PERFORMANCE is allowed below a level specified by the
manufacturer.
Compliance is determined as follows:
– 18 – IEC 60601-2-40:2016 IEC 2016
The manufacturer shall define a method for determining whether ESSENTIAL PERFORMANCE has
been maintained during and/or after IMMUNITY tests as appropriate based on the
manufacturer’s RISK ASSESSMENT. Where manual intervention is required to restore ESSENTIAL
PERFORMANCE, the method shall be provided in the instructions for use.
Where automatic recovery, or manual intervention is allowed (criteria B, C) to
restore ESSENTIAL PERFORMANCE, the time necessary to achieve restoration shall be justifi
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