IEC 60601-2-10:2012
(Main)Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
IEC 60601-2-10:2012 specifies the requirements for the safety and essential performance of nerve and muscle stimulators, for use in the practice of physical medicine. This includes transcutaneous electrical nerve stimulators (TENS) and electrical muscle stimulators (EMS). This second edition cancels and replaces the first edition, published in 1987 and its Amendment 1 (2001). This edition constitutes a technical revision and is aligned with IEC 60601-1:2005+A1:2012.
Appareils électromédicaux - Partie 2-10: Exigences particulières pour la sécurité de base et les performances essentielles des stimulateurs de nerfs et de muscles
La CEI 60601-2-10:2012 spécifie des exigences pour la sécurité de base et les performances essentielles des stimulateurs de nerfs et de muscles, utilisés dans la pratique de la médecine physique. Ceci comprend les neurostimulateurs électriques transcutanés (TENS) et les stimulateurs de muscles électriques (EMS). Cette deuxième édition annule et remplace la première édition parue en 1987 et son amendement 1 (2001). Elle constitue une révision technique et est alignée sur la CEI 60601-1:2005+A1:2012.
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IEC 60601-2-10 ®
Edition 2.0 2012-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-10: Particular requirements for the basic safety and essential performance
of nerve and muscle stimulators
Appareils électromédicaux –
Partie 2-10: Exigences particulières pour la sécurité de base et les performances
essentielles des stimulateurs de nerfs et de muscles
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IEC 60601-2-10 ®
Edition 2.0 2012-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-10: Particular requirements for the basic safety and essential performance
of nerve and muscle stimulators
Appareils électromédicaux –
Partie 2-10: Exigences particulières pour la sécurité de base et les performances
essentielles des stimulateurs de nerfs et de muscles
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX S
ICS 11.040.60 ISBN 978-2-83220-193-0
– 2 – 60601-2-10 IEC:2012
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 7
201.3 Terms and definitions. 8
201.4 General requirements . 8
201.5 General requirements for testing of ME EQUIPMENT . 9
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 9
201.7 ME EQUIPMENT identification, marking and documents . 9
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 11
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 11
201.10 Protection against unwanted and excessive radiation HAZARDS . 11
201.11 Protection against excessive temperatures and other HAZARDS . 11
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 11
201.13 HAZARDOUS SITUATIONS and fault conditions . 13
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 13
201.15 Construction of ME EQUIPMENT . 13
201.16 ME SYSTEMS . 13
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 13
202 Electromagnetic compatibility – Requirements and tests . 14
Annexes . 15
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 16
Annex AA (informative) Particular guidance and rationale . 17
Index of defined terms used in this particular standard. 20
Figure 202.101 – Testing layout . 15
Table 201.101 – Pulse frequency versus applied current limits . 13
Table 201.C.101 – Marking on the outside of STIMULATORS or their parts . 16
60601-2-10 IEC:2012 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-10: Particular requirements for the basic safety
and essential performance of nerve and muscle stimulators
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
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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 60601-2-10 has been prepared by IEC subcommittee 62D:
Electromedical equipment of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition cancels and replaces the first edition, published in 1987 and its
Amendment 1 (2001). This edition constitutes a technical revision and is aligned with
IEC 60601-1:2005+A1:2012.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/1003/FDIS 62D/1015/RVD
Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.
– 4 – 60601-2-10 IEC:2012
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 standard, 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 standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, 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 standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “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 web site 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.
60601-2-10 IEC:2012 – 5 –
INTRODUCTION
The minimum safety requirements specified in this particular standard are considered to
provide for a practical degree of safety in the operation of nerve and muscle stimulators.
This particular standard amends and supplements IEC 60601-1 (third edition, 2005 plus
Amendment 1, 2012): Medical electrical equipment – Part 1: General requirements for safety
and essential performance hereinafter referred to as the General Standard (see 201.1.4).
The requirements are followed by specifications for the relevant tests.
A "Particular guidance and rationale" section giving some explanatory notes, where
appropriate, about the more important requirements is included in Annex AA.
Clauses or subclauses for which there are explanatory notes in Annex AA are marked with an
asterisk (*).
It is considered that a knowledge of the reasons for these requirements will not only facilitate
the proper application of the standard but will, in due course, expedite any revision
necessitated by changes in clinical practice or as a result of developments in technology.
However, this annex does not form part of the requirements of this standard.
– 6 – 60601-2-10 IEC:2012
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-10: Particular requirements for the basic safety
and essential performance of nerve and muscle stimulators
201.1 Scope, object and related standards
1)
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This International Standard specifies the requirements for the safety of nerve and muscle
STIMULATORS, defined in subclause 201.3.204, for use in the practice of physical medicine,
hereinafter referred to as ME EQUIPMENT. This includes transcutaneous electrical nerve
STIMULATORS (TENS) and electrical muscle STIMULATORS (EMS).
NOTE A muscle STIMULATOR may also be known as a neuromuscular STIMULATOR.
The following ME EQUIPMENT is excluded:
– ME EQUIPMENT intended to be implanted or to be connected to implanted electrodes;
– ME EQUIPMENT intended for the stimulation of the brain (e.g. electroconvulsive therapy ME
EQUIPMENT);
– ME EQUIPMENT intended for neurological research;
– external cardiac pacemakers (see IEC 60601-2-31);
– ME EQUIPMENT intended for averaged evoked potential diagnosis (see IEC 60601-2-40);
– ME EQUIPMENT intended for electromyography (see IEC 60601-2-40);
– ME EQUIPMENT intended for cardiac defibrillation (see IEC 60601-2-4).
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for nerve and muscle STIMULATORS as defined in 201.3.204.
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 60601-1-2:2007 applies as modified in Clause 202. IEC 60601-1-3 does not apply. All
other published collateral standards in the IEC 60601-1 series apply as published.
—————————
1)
The general standard is IEC 60601-1:2005+A1:2012, Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance
60601-2-10 IEC:2012 – 7 –
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 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 3.139, 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 with the following exception:
Replacement:
– 8 – 60601-2-10 IEC:2012
IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
Amendment 1:2012
201.3 Terms and definitions
Replacement:
For the purposes of this document, the terms and definitions given in
IEC 60601-1:2005+A1:2012 apply, except as follows:
NOTE 1 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.
201.3.8
APPLIED PART
Addition:
STIMULATOR electrodes and all parts conductively connected to them
the
Addition:
201.3.201
LEAD
insulated conductor having a means of connecting to a STIMULATOR at one end and a means
of connecting to an electrode at the other end, and intended for conducting output signals
STIMULATOR to an electrode
from a
201.3.202
PULSE
portion of WAVEFORM between two zero voltage levels
201.3.203
PULSE DURATION
PULSE at 50 % of the maximum amplitude
duration of the output
201.3.204
STIMULATOR
ME EQUIPMENT for the application of electric currents via electrodes in direct contact with the
PATIENT for the diagnosis and/or therapy of neuromuscular disorders.
201.3.205
WAVEFORM
variations in amplitude of an electrical signal which is output from the APPLIED PART (in either
voltage or current) as a function of time .
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
60601-2-10 IEC:2012 – 9 –
201.4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS
Additional subclause:
201.4.1.101 Additional conditions for application to ME EQUIPMENT or ME SYSTEMS
In the case of combined ME EQUIPMENT (e.g. a STIMULATOR provided with a function or an
APPLIED PART for ultrasonic therapy), the additional part shall comply with any relevant
particular standard.
201.4.2 RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS
Addition:
MANUFACTURERS shall include, within their RISK ANALYSIS, the risk associated with the potential
use of their STIMULATORS and accessories to deliver current exceeding 10 mA or current
densities for any electrode exceeding 2 mA/cm .
201.4.11 Power input
Addition:
The EQUIPMENT shall be operated in the output mode and using the load which creates the
highest amplitude steady state current.
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies.
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.
201.6.6 * Mode of operation
Amendment:
Delete all except CONTINUOUS OPERATION.
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
201.7.2.7 Electrical input power from the SUPPLY MAINS
Replacement of the fourth paragraph:
– 10 – 60601-2-10 IEC:2012
The RATED input power of a mains powered STIMULATOR shall be the maximum power
averaged over any period of 5 s under the specified operating conditions set out by the
manufacturer.
Additional subclause:
201.7.2.101 * Output
ME EQUIPMENT capable of delivering outputs in excess of 10 mA or 10 V averaged over any
period of 1 s shall be marked near the electrode connections with symbol No. 10 of Table D.2
of the general standard.
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 d.c. component, PULSE DURATIONS,
PULSE repetition frequencies, maximum amplitude of output voltage and/or current, and the
effect of load impedance on these parameters.
b) * Advice on the size and type of electrodes to be used and the method of application for
each particular type of treatment for which the STIMULATOR is intended.
c) Advice on any necessary precautions to be taken when the output contains a d.c.
component.
d) * Advice that a PATIENT with an implanted electronic device (for example a cardiac
pacemaker) should not be subjected to stimulation unless specialist medical opinion has
first been obtained.
e) A warning on the following potential hazards:
– Simultaneous connection of a PATIENT to a high frequency surgical ME EQUIPMENT may
result in burns at the site of the STIMULATOR electrodes and possible damage to the
STIMULATOR.
– Operation in close proximity (e.g. 1 m) to a shortwave or microwave therapy
ME EQUIPMENT may produce instability in the STIMULATOR output.
– Application of electrodes near the thorax may increase the risk of cardiac fibrillation.
f) * For ME EQUIPMENT capable of delivering output values in excess of 10 mA or 10 V:
– Information on maximum output values available at the electrodes recommended by
the manufacturer for use with the STIMULATOR.
g) Advice that any electrodes that have current densities exceeding 2 mA/cm may require
the special attention of the OPERATOR.
h) Advice that stimulation should not be applied across or through the head, directly on the
eyes, covering the mouth, on the front of the neck, (especially the carotid sinus), or from
electrodes placed on the chest and the upper back or crossing over the heart.
201.7.9.3 Technical description
201.7.9.3.1 General
Addition:
– The technical description shall specify the parameters mentioned in item a) of
201.7.9.2.101 along with the range of load impedances for which these parameters are
valid.
60601-2-10 IEC:2012 – 11 –
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
Amendment:
The APPLIED PARTS of STIMULATORS shall be TYPE BF or TYPE CF APPLIED PARTS.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and
ME SYSTEMS
Clause 9 of the general standard applies.
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.
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
Additional subclauses:
201.12.1.101 * Output amplitude
A means shall be provided to control the STIMULATOR output from minimum to maximum
continuously, or in discrete increments of not more than 1 mA or 1 V per increment. At its
minimum setting, the output shall not exceed 2 % of that available at the maximum setting of
the control.
Compliance is checked by inspection and measurement using the load impedance which is
the least favourable within the load impedance range specified in the ACCOMPANYING
DOCUMENTS.
201.12.1.102 * PULSE parameters
The values of PULSE DURATIONS, PULSE repetition frequencies and amplitudes, including any
d.c. component, whether caused by an offset or by an unsymmetrical waveform, as described
in the ACCOMPANYING DOCUMENTS or indicated on the ME EQUIPMENT (see 201.7.9.2), shall not
deviate by more than ± 20 % when measured with a load resistance within the range specified
in the ACCOMPANYING DOCUMENTS (see 201.7.9.3).
Compliance is checked by measurement with an error not exceeding ± 10 %.
– 12 – 60601-2-10 IEC:2012
201.12.2 USABILITY
Additional subclause:
201.12.2.101 * Electrodes
The STIMULATOR shall comply with this standard when operated with either open-circuited or
short-circuited electrodes.
Compliance is checked by the following test:
Operate the STIMULATOR with all output controls set to the maximum position and each pair of
output terminals left open-circuited for a period of 10 min and then short-circuited for a further
period of 5 min. After this test the ME EQUIPMENT shall comply with all the requirements of this
standard.
201.12.4 Protection against hazardous output
Additional subclauses:
201.12.4.101 * Supply voltage fluctuations
Supply voltage fluctuations of ± 10 % shall not affect the STIMULATOR output amplitude, PULSE
DURATION or PULSE repetition frequency by more than ± 10 %.
Compliance is checked by measurement.
201.12.4.102 * Output interlock
A stimulator that is capable of delivering an output in excess of 10 mA or 10 V shall not be
energizeable unless the output amplitude control(s) is (are) first set to its (their) minimum
position.
This requirement shall also apply upon the restoration of the SUPPLY MAINS following a
temporary interruption or following replacement of the INTERNAL ELECTRICAL POWER SOURCE.
This requirement shall not apply when a stimulator is released from a pause mode, having
been operating prior to being paused.
Compliance is checked by functional check.
201.12.4.103 * Output indicator
In NORMAL CONDITION and SINGLE FAULT CONDITION, ME EQUIPMENT shall indicate when it can
deliver an output of more than 10 mA or 10 V, or can deliver PULSES having an energy
exceeding 10 mJ per PULSE, into a load resistance of 1 000 Ω. If the indication is by means of
a signal lamp, its colour shall be yellow.
Compliance is checked by inspection and functional test.
201.12.4.104 * Limitation of output parameters
a) ME EQUIPMENT intended for therapeutic applications:
With a load resistance of 500 Ω the output current shall not exceed the limits in
Table 201.101:
60601-2-10 IEC:2012 – 13 –
Table 201.101 – Pulse frequency versus applied current limits
Pulse Frequency Current limit
d.c. 80 mA
≤ 400 Hz 50 mA
80 mA
> 400 Hz to ≤ 1 500 Hz
> 1 500 Hz 100 mA
If the output has a.c. and d.c. components, then these components shall be measured
separately and compared with the allowable limits.
For PULSE DURATIONS of less than 0,1 s the PULSE energy with a load resistance of 500 Ω shall
PULSE. For longer PULSE DURATIONS, the above-mentioned current limit
not exceed 300 mJ per
for d.c. applies.
Additionally, the output voltage shall not exceed a peak value of 500 V, when measured under
open-circuit condition.
Where the APPLIED PART(S) is (are) energized by more than one patient circuit simultaneously
(for example for interferential therapy), the above limits shall apply to each of these patient
circuits.
b) ME EQUIPMENT intended for diagnostic applications:
For ME EQUIPMENT intended for dentistry and ophthalmology, the d.c. current with a load
resistance of 2 000 Ω shall not exceed 10 mA.
Compliance is checked by measurement.
201.13 Hazardous situations and fault conditions
Clause13 of the general standard applies.
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
Clause14 of the general standard applies.
201.15 Construction of ME EQUIPMENT
Clause15 of the general standard applies
201.16 ME SYSTEMS
Clause16 of the general standard applies.
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
Clause17 of the general standard applies.
– 14 – 60601-2-10 IEC:2012
202 Electromagnetic compatibility – Requirements and tests
IEC60601-1-2:2007 applies except as follows:
202.6.1 Emissions
202.6.1.1.2 Tests
a) Patient cables
Addition:
Connect all relevant electrodes to the contents of a 1 litre capacity phantom filled with 0,9 %
saline. Position the phantom within 0,4 m of the ME EQUIPMENT as shown in Figure 202.101.
60601-2-10 IEC:2012 – 15 –
Electrodes in saline
STIMULATOR
1 litre 0,9 % saline
<0,4 m
Wooden table
IEC 1189/12
Figure 202.101 – Testing layout
202.6.2 * Immunity
202.6.2.1.5 PATIENT-COUPLED ME EQUIPMENT and ME SYSTEMS
Addition:
Connect all relevant electrodes and apply them to the contents of a 1 litre capacity phantom
filled with 0,9 % saline. Position the phantom within 0,4 m of the ME EQUIPMENT as shown in
Figure 202.101.
Annexes
The annexes of the general standard apply except as follows:
– 16 – 60601-2-10 IEC:2012
Annex C
(informative)
Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS
201.C.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts
Addition:
Additional requirements for marking on the outside of nerve and muscle STIMULATORS are
found in Table 201.C.101.
Table 201.C.101 – Marking on the outside of STIMULATORS or their parts
Description of marking Subclause
The RATED power input 201.7.2
Symbol No. 10 of Table D.2 in the general standard 201.7.2.101
60601-2-10 IEC:2012 – 17 –
Annex AA
(informative)
Particular guidance and rationale
AA.1 General guidance
This appendix provides a concise rationale for the important requirements of the standard and
is intended for those who are familiar with the subject of the standard but who have not
participated in its development. An understanding of the reasons for the main requirements is
considered to be essential for the proper application of the standard. Furthermore, as clinical
practice and technology change, it is believed that a rationale for the present requirements
will facilitate any revision of the standard necessitated by these developments.
AA.2 Rationale for particular clauses and subclauses
The following are rationales for specific clauses and subclauses in this particular standard,
with clause and subclause numbers parallel to those in the body of the document.
Subclause 201.1.1 – Scope
The types of ME EQUIPMENT which are excluded from the scope of this standard differ
considerably with respect to technique and/or application from the ME EQUIPMENT normally
used in physical medicine; therefore these types require different safety measures.
Subclause 201.6.2 – Protection against electric shock
The APPLIED PART needs to be isolated to avoid unwanted current paths through the PATIENT
due to the capacitance or a possible conductive connection to earth.
Subclause 201.6.6 – Mode of operation
The ME EQUIPMENT is usually operated with one PATIENT for extended periods. It may also be
used immediately with the next PATIENT. Therefore it needs to be suitable for CONTINUOUS
OPERATION.
Subclause 201.7.2.101 – Output
The symbols alert the OPERATOR to consult the instructions for use because of the higher
levels of output.
Subclause 201.7.9.2.101 a) – Additional instructions for use
Because of the electrolytic effects, any d.c. components of the PULSES needs to be declared.
Subclause 201.7.9.2.101 b) – Additional instructions for use
Electrodes of inadequate size or unsuitable application could provoke skin reactions or burns.
Subclause 201.7.9.2.101 d) – Additional instructions for use
A HAZARD could exist if the stimulating current interferes with the operation of the implanted
devices
– 18 – 60601-2-10 IEC:2012
Subclause 201.7.9.2.101 f) – Additional instructions for use
Maximum output values are needed by OPERATORS and PATIENTS to make informed decisions.
A HAZARD could exist if excessive current densities are present.
Subclause 201.8.3 – Classification of APPLIED PARTS
See rationale for subclause 201.6.2.
Subclause 201.12.1.101 – Output amplitude
A small increase in output amplitude may disproportionately stimulate the PATIENT. A control
which allows the OPERATOR to adjust the output amplitude smoothly or in small steps is an
important safety feature. Limitation of the output available at the minimum setting of the
output control enables the OPERATOR to commence the treatment by increasing the output
amplitude from an initial low (and therefore safe) level. As stated in Note 1 of 201.3, all values
for voltage and current are r.m.s. unless specifically stated otherwise.
Subclause 201.12.1.102 – PULSE parameters
An accuracy of ± 20 % is adequately safe for therapeutic application, since the pulse
parameters are set based upon the subjective reaction of the PATIENT. A considerably higher
accuracy may be needed for diagnostic purposes.
Subclause 201.12.2.101 – Electrodes
The STIMULATOR should not become unsafe if the output is switched on inadvertently with
open or short-circuited electrodes even if such operation is considered to be misuse.
Subclause 201.12.4.101 – Supply voltage fluctuations
Supply voltage fluctuations within the limits of the general standard should not affect the
output parameters.
Subclause 201.12.4.102 – Output interlock
To avoid excessive stimulation of the PATIENT, sudden increases in the output current needs
to be avoided in NORMAL USE and in the case of interruption and restoration of the SUPPLY
MAINS or following replacement of the INTERNAL ELECTRICAL POWER SOURCE.
The exception for use of a pause mode is because many devices now have this mode so that
electrodes can be repositioned,
Subclause 201.12.4.103 – Output indicator
An output indication is required for this single fault condition because a fault in the
STIMULATOR could unintentionally make energization of the electrodes possible. The
requirement may be met by a power on indicator with zero actual output or by an indicator
activated by the STIMULATOR output.
60601-2-10 IEC:2012 – 19 –
Subclause 201.12.4.104 – Limitation of output parameters
For this standard, the pulse frequency is the inverse of the period of time for the pulse
waveform to repeat itself. The specified current limits support all known therapeutic and/or
diagnostic applications without greatly exceeding the values needed.
Subclause 202.6.2 – Immunity
The tests using the saline-filled phantom (see Figure 202.101) simulate NORMAL USE.
A STIMULATOR may be used in close proximity to ME EQUIPMENT that intentionally radiates radio
frequency energy. STIMULATORS which are not adequately protected may produce
considerable changes of output which could be hazardous to the PATIENT.
The test ensures that the STIMULATOR has been adequately protected against the effect of
strong r.f. currents entering the STIMULATOR via the PATIENT LEADS and/or the mains cable.
Simple filter networks in the PATIENT output and mains input circuits have proved effective.
– 20 – 60601-2-10 IEC:2012
Index of defined terms used in this particular standard
ACCOMPANYING DOCUMENT . IEC 60601-1:2005+A1:2012, 3.4
APPLIED PART . IEC 60601-1:2005+A1:2012, 3.8
BASIC SAFETY . IEC 60601-1:2005+A1:2012, 3.10
ESSENTIAL PERFORMANCE . IEC 60601-1:2005+A1:2012, 3.27
HAZARD . IEC 60601-1:2005+A1:2012, 3.39
INTERNAL ELECTRICAL POWER SOURCE . IEC 60601-1:2005+A1:2012, 3.45
LEAD . 201.3.201
LEAKAGE CURRENT . IEC 60601-1:2005+A1:2012, 3.47
MANUFACTURER . IEC 60601-1:2005+A1:2012, 3.55
MEDICAL ELECTRICAL EQUIPMENT (ME EQUIPMENT) . IEC 60601-1:2005+A1:2012, 3.63
MEDICAL ELECTRICAL SYSTEM (ME SYSTEM) . IEC 60601-1:2005+A1:2012, 3.64
NORMAL CONDITION . IEC 60601-1:2005+A1:2012, 3.70
OPERATOR . IEC 60601-1:2005+A1:2012, 3.73
PATIENT . IEC 60601-1:2005+A1:2012, 3.76
PATIENT AUXILIARY CURRENT . IEC 60601-1:2005+A1:2012, 3.77
PULSE . 201.3.202
PULSE DURATION . 201.3.203
RATED . IEC 60601-1:2005+A1:2012, 3.97
RISK ANALYSIS . IEC 60601-1:2005+A1:2012, 3.103
SINGLE FAULT CONDITION . IEC 60601-1:2005+A1:2012, 3.116
STIMULATOR . 201.3.204
SUPPLY MAINS . IEC 60601-1:2005+A1:2012, 3.120
TYPE B APPLIED PART . IEC 60601-1:2005+A1:2012, 3.132
TYPE BF APPLIED PART . IEC 60601-1:2005+A1:2012, 3.133
TYPE CF APPLIED PART . IEC 60601-1:2005+A1:2012, 3.134
WAVEFORM . 201.3.205
___________
– 22 – 60601-2-10 CEI:2012
SOMMAIRE
AVANT-PROPOS .
...
IEC 60601-2-10 ®
Edition 2.2 2023-01
CONSOLIDATED VERSION
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Medical electrical equipment –
Part 2-10: Particular requirements for the basic safety and essential performance
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Appareils électromédicaux –
Partie 2-10: Exigences particulières pour la sécurité de base et les performances
essentielles des stimulateurs de nerfs et de muscles
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IEC 60601-2-10 ®
Edition 2.2 2023-01
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-10: Particular requirements for the basic safety and essential performance
of nerve and muscle stimulators
Appareils électromédicaux –
Partie 2-10: Exigences particulières pour la sécurité de base et les performances
essentielles des stimulateurs de nerfs et de muscles
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.60 ISBN 978-2-8322-6396-9
IEC 60601-2-10 ®
Edition 2.2 2023-01
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 2-10: Particular requirements for the basic safety and essential performance
of nerve and muscle stimulators
Appareils électromédicaux –
Partie 2-10: Exigences particulières pour la sécurité de base et les performances
essentielles des stimulateurs de nerfs et de muscles
– 2 – IEC 60601-2-10:2012+AMD1:2016
+AMD2:2023 CSV © IEC 2023
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
INTRODUCTION to Amendment 2 . 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 . 10
201.7 ME EQUIPMENT identification, marking and documents . 10
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 12
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 12
201.10 Protection against unwanted and excessive radiation HAZARDS . 12
201.11 Protection against excessive temperatures and other HAZARDS . 12
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 12
201.13 Hazardous situations and fault conditions for ME EQUIPMENT . 14
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 14
201.15 Construction of ME EQUIPMENT . 14
201.16 ME SYSTEMS . 15
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 15
202 Electromagnetic compatibility disturbances – requirements and tests . 15
Annexes . 16
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 17
Annex AA (informative) Particular guidance and rationale . 18
Index of defined terms used in this particular standard. 21
Figure 202.101 – Testing layout . 16
Table 201.101 – Pulse frequency versus applied current limits . 14
Table 201.C.101 – Marking on the outside of STIMULATORS or their parts . 17
+AMD2:2023 CSV © IEC 2023
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-10: Particular requirements for the basic safety
and essential performance of nerve and muscle stimulators
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
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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
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3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
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5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
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6) All users should ensure that they have the latest edition of this publication.
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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.
This consolidated version of the official IEC Standard and its amendments has been
prepared for user convenience.
IEC 60601-2-10 edition 2.1 contains the second edition (2012-06) [documents
62D/1003/FDIS and 62D/1015/RVD], its amendment 1 (2016-04) [documents
62D/1332/FDIS and 62D/1352/RVD] and its amendment 2 (2023-01) [documents
62D/2004/FDIS and 62D/2015/RVD].
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendments 1 and 2. Additions are in green text, deletions are in
strikethrough red text. A separate Final version with all changes accepted is available
in this publication.
– 4 – IEC 60601-2-10:2012+AMD1:2016
+AMD2:2023 CSV © IEC 2023
International standard IEC 60601-2-10 has been prepared by IEC subcommittee 62D:
Electromedical equipment of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition cancels and replaces the first edition, published in 1987 and its
Amendment 1 (2001). This edition constitutes a technical revision and is aligned with
IEC 60601-1:2005+A1:2012.
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 standard, 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 standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, 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 standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “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.
+AMD2:2023 CSV © IEC 2023
The committee has decided that the contents of the base publication and its amendments will
remain unchanged until the stability date indicated on the IEC web site under 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.
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.
– 6 – IEC 60601-2-10:2012+AMD1:2016
+AMD2:2023 CSV © IEC 2023
INTRODUCTION
The minimum safety requirements specified in this particular standard are considered to
provide for a practical degree of safety in the operation of nerve and muscle stimulators.
This particular standard amends and supplements IEC 60601-1 (third edition, 2005 plus
Amendment 1, 2012):, Medical electrical equipment – Part 1: General requirements for safety
and essential performance hereinafter referred to as the General Standard (see 201.1.4).
The requirements are followed by specifications for the relevant tests.
A "Particular guidance and rationale" section giving some explanatory notes, where
appropriate, about the more important requirements is included in Annex AA.
Clauses or subclauses for which there are explanatory notes in Annex AA are marked with an
asterisk (*).
It is considered that a knowledge of the reasons for these requirements will not only facilitate
the proper application of the standard but will, in due course, expedite any revision
necessitated by changes in clinical practice or as a result of developments in technology.
However, this annex does not form part of the requirements of this standard.
INTRODUCTION to Amendment 2
At the October 2019 meeting of IEC SC 62D in Shanghai, China, the subcommittee discussed
the need for administrative/technical changes to most 62D standards after completion of the
amendment projects within the IEC 60601-1 series. Those projects were all completed and
the amendments published in 2020.
The full list of IEC SC 62D documents that will be amended or revised may be found within
the IEC document 62D/1792/DC. The results and comments on the DC may be found within
62D/1808/INF. The review report for this amendment is 62D/1831/RR.
+AMD2:2023 CSV © IEC 2023
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-10: Particular requirements for the basic safety
and essential performance of nerve and muscle stimulators
201.1 Scope, object and related standards
1)
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This International Standard specifies the requirements for the safety of nerve and muscle
STIMULATORS, defined in subclause 201.3.204, for use in the practice of physical medicine,
hereinafter referred to as ME EQUIPMENT. This includes transcutaneous electrical nerve
STIMULATORS (TENS) and electrical muscle STIMULATORS (EMS).
NOTE A muscle STIMULATOR may also be known as a neuromuscular STIMULATOR.
The following ME EQUIPMENT is excluded:
– ME EQUIPMENT intended to be implanted or to be connected to implanted electrodes;
– ME EQUIPMENT intended for the stimulation of the brain (e.g. electroconvulsive therapy ME
);
EQUIPMENT
– ME EQUIPMENT intended for neurological research;
– external cardiac pacemakers (see IEC 60601-2-31);
– ME EQUIPMENT intended for averaged evoked potential diagnosis (see IEC 60601-2-40);
ME EQUIPMENT intended for electromyography (see IEC 60601-2-40);
–
– ME EQUIPMENT intended for cardiac defibrillation (see IEC 60601-2-4).
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for nerve and muscle STIMULATORS as defined in 201.3.204.
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 60601-1-2:2007 applies as modified in Clause 202. IEC 60601-1-3 does not apply. All
other published collateral standards in the IEC 60601-1 series apply as published.
—————————
1)
The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
– 8 – IEC 60601-2-10:2012+AMD1:2016
+AMD2:2023 CSV © IEC 2023
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 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 3.139, 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 with the following exception, except as follows:
Replacement:
+AMD2:2023 CSV © IEC 2023
IEC 60601-1-2:20072014, Medical electrical equipment – Part 1-2: General requirements for
basic safety and essential performance – Collateral standard: Electromagnetic compatibility
disturbances – Requirements and tests
Amendment 1:2020
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
Amendment 1:2012
Amendment 2:2020
201.3 Terms and definitions
Replacement:
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:
NOTE 1 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.
201.3.8
APPLIED PART
Addition:
the STIMULATOR electrodes and all parts conductively connected to them
Addition:
201.3.201
LEAD
insulated conductor having a means of connecting to a STIMULATOR at one end and a means
of connecting to an electrode at the other end, and intended for conducting output signals
from a STIMULATOR to an electrode
201.3.202
PULSE
WAVEFORM between two zero voltage levels
portion of
201.3.203
PULSE DURATION
duration of the output PULSE at 50 % of the maximum amplitude
201.3.204
STIMULATOR
ME EQUIPMENT for the application of electric currents via electrodes in direct contact with the
PATIENT for the diagnosis and/or therapy of neuromuscular disorders.
201.3.205
WAVEFORM
variations in amplitude of an electrical signal which is output from the APPLIED PART (in either
voltage or current) as a function of time .
– 10 – IEC 60601-2-10:2012+AMD1:2016
+AMD2:2023 CSV © IEC 2023
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS
Additional subclause:
201.4.1.101 Additional conditions for application to ME EQUIPMENT or ME SYSTEMS
ME EQUIPMENT (e.g. a STIMULATOR provided with a function or an
In the case of combined
APPLIED PART for ultrasonic therapy), the additional part shall comply with any relevant
particular standard.
201.4.2 RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS
Addition:
MANUFACTURERS shall include, within their RISK ANALYSIS, the risk associated with the potential
use of their STIMULATORS and accessories to deliver current exceeding 10 mA or current
densities for any electrode exceeding 2 mA/cm .
201.4.11 Power input
Addition:
EQUIPMENT shall be operated in the output mode and using the load which creates the
The
highest amplitude steady state current.
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies.
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.
201.6.6 * Mode of operation
Amendment:
CONTINUOUS OPERATION.
Delete all except
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
+AMD2:2023 CSV © IEC 2023
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
SUPPLY MAINS
201.7.2.7 Electrical input power from the
Replacement of the fourth paragraph:
The RATED input power of a mains powered STIMULATOR shall be the maximum power
averaged over any period of 5 s under the specified operating conditions set out by the
manufacturer.
Additional subclause:
201.7.2.101 * Output
ME EQUIPMENT capable of delivering outputs in excess of 10 mA or 10 V averaged over any
period of 1 s shall be marked near the electrode connections with symbol No. 10 of Table D.2
of the general standard.
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 d.c. component, PULSE DURATIONS,
PULSE repetition frequencies, maximum amplitude of output voltage and/or current, and the
effect of load impedance on these parameters.
b) * Advice on the size and type of electrodes to be used and the method of application for
each particular type of treatment for which the STIMULATOR is intended.
c) Advice on any necessary precautions to be taken when the output contains a d.c.
component.
d) * Advice that a PATIENT with an implanted electronic device (for example a cardiac
pacemaker) should not be subjected to stimulation unless specialist medical opinion has
first been obtained.
e) A warning on the following potential hazards:
PATIENT to a high frequency surgical ME EQUIPMENT may
– Simultaneous connection of a
result in burns at the site of the STIMULATOR electrodes and possible damage to the
STIMULATOR.
– Operation in close proximity (e.g. 1 m) to a shortwave or microwave therapy
ME EQUIPMENT may produce instability in the STIMULATOR output.
– Application of electrodes near the thorax may increase the risk of cardiac fibrillation.
ME EQUIPMENT capable of delivering output values in excess of 10 mA or 10 V:
f) * For
– Information on maximum output values available at the electrodes recommended by
the manufacturer for use with the STIMULATOR.
g) Advice that any electrodes that have current densities exceeding 2 mA/cm may require
the special attention of the OPERATOR.
h) Advice that stimulation should not be applied across or through the head, directly on the
eyes, covering the mouth, on the front of the neck, (especially the carotid sinus), or from
electrodes placed on the chest and the upper back or crossing over the heart.
– 12 – IEC 60601-2-10:2012+AMD1:2016
+AMD2:2023 CSV © IEC 2023
201.7.9.3 Technical description
201.7.9.3.1 General
Addition:
– The technical description shall specify the parameters mentioned in item a) of
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
Amendment:
The APPLIED PARTS of STIMULATORS shall be TYPE BF or TYPE CF APPLIED PARTS.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and
ME SYSTEMS
Clause 9 of the general standard applies.
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.
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
Additional subclauses:
201.12.1.101 * Output amplitude
A means shall be provided to control the STIMULATOR output from minimum to maximum
continuously, or in discrete increments of not more than 1 mA or 1 V per increment. At its
minimum setting, the output shall not exceed 2 % of that available at the maximum setting of
the control.
Compliance is checked by inspection and measurement using the load impedance which is
the least favourable within the load impedance range specified in the ACCOMPANYING
DOCUMENTS.
+AMD2:2023 CSV © IEC 2023
201.12.1.102 * PULSE parameters
The values of PULSE DURATIONS, PULSE repetition frequencies and amplitudes, including any
d.c. component, whether caused by an offset or by an unsymmetrical waveform, as described
in the ACCOMPANYING DOCUMENTS or indicated on the ME EQUIPMENT (see 201.7.9.2), shall not
deviate by more than ± 20 % when measured with a load resistance within the range specified
in the ACCOMPANYING DOCUMENTS (see 201.7.9.3).
Compliance is checked by measurement with an error not exceeding ± 10 %.
201.12.2 USABILITY Usability of ME EQUIPMENT
Additional subclause:
201.12.2.101 * Electrodes
The STIMULATOR shall comply with this standard when operated with either open-circuited or
short-circuited electrodes.
Compliance is checked by the following test:
Operate the STIMULATOR with all output controls set to the maximum position and each pair of
output terminals left open-circuited for a period of 10 min and then short-circuited for a further
period of 5 min. After this test the ME EQUIPMENT shall comply with all the requirements of this
standard.
201.12.4 Protection against hazardous output
Additional subclauses:
201.12.4.101 * Supply voltage fluctuations
Supply voltage fluctuations of ± 10 % shall not affect the STIMULATOR output amplitude, PULSE
DURATION or PULSE repetition frequency by more than ± 10 %.
Compliance is checked by measurement.
201.12.4.102 * Output interlock
A stimulator that is capable of delivering an output in excess of 10 mA or 10 V shall not be
energizeable unless the output amplitude control(s) is (are) first set to its (their) minimum
position.
This requirement shall also apply upon the restoration of the SUPPLY MAINS following a
temporary interruption or following replacement of the INTERNAL ELECTRICAL POWER SOURCE.
This requirement shall not apply when a stimulator is released from a pause mode, having
been operating prior to being paused.
Compliance is checked by functional check.
201.12.4.103 * Output indicator
In NORMAL CONDITION and SINGLE FAULT CONDITION, ME EQUIPMENT shall indicate when it can
deliver an output of more than 10 mA or 10 V, or can deliver PULSES having an energy
exceeding 10 mJ per PULSE, into a load resistance of 1 000 Ω. If the indication is by means of
a signal lamp, its colour shall be yellow.
– 14 – IEC 60601-2-10:2012+AMD1:2016
+AMD2:2023 CSV © IEC 2023
Compliance is checked by inspection and functional test.
201.12.4.104 * Limitation of output parameters
a) ME EQUIPMENT intended for therapeutic applications:
With a load resistance of 500 Ω the output current shall not exceed the limits in
Table 201.101:
Table 201.101 – Pulse frequency versus applied current limits
Pulse Frequency Current limit
d.c. 80 mA
50 mA
≤ 400 Hz
> 400 Hz to ≤ 1 500 Hz 80 mA
> 1 500 Hz 100 mA
If the output has a.c. and d.c. components, then these components shall be measured
separately and compared with the allowable limits.
For PULSE DURATIONS of less than 0,1 s the PULSE energy with a load resistance of 500 Ω shall
not exceed 300 mJ per PULSE. For longer PULSE DURATIONS, the above-mentioned current limit
for d.c. applies.
Additionally, the output voltage shall not exceed a peak value of 500 V, when measured under
open-circuit condition.
Where the APPLIED PART(S) is (are) energized by more than one patient circuit simultaneously
(for example for interferential therapy), the above limits shall apply to each of these patient
circuits.
b) ME EQUIPMENT intended for diagnostic applications:
For ME EQUIPMENT intended for dentistry and ophthalmology, the d.c. current with a load
resistance of 2 000 Ω shall not exceed 10 mA.
Compliance is checked by measurement.
201.13 Hazardous situations and fault conditions for ME EQUIPMENT
Clause13 of the general standard applies.
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
Clause14 of the general standard applies.
201.15 Construction of ME EQUIPMENT
Clause15 of the general standard applies
+AMD2:2023 CSV © IEC 2023
201.16 ME SYSTEMS
Clause16 of the general standard applies.
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
Clause17 of the general standard applies.
202 Electromagnetic compatibility disturbances – requirements and tests
IEC 60601-1-2:20072014 and IEC 60601-1-2:2014/AMD1:2020 applies apply except as
follows:
202.6.1 Emissions
202.6.1.1.2 Tests
a) Patient cables
202.7.1.11 PATIENT-coupled cables
Addition:
Connect all relevant electrodes to the contents of a 1 litre capacity phantom filled with 0,9 %
saline. Position the phantom within 0,4 m of the ME EQUIPMENT as shown in Figure 202.101.
NOTE The phantom is a material and does not need to be placed in a container. The material of the phantom can
be plexiglass.
– 16 – IEC 60601-2-10:2012+AMD1:2016
+AMD2:2023 CSV © IEC 2023
Electrodes in saline
STIMULATOR
1 litre 0,9 % saline
<0,4 m
Wooden table
IEC 1189/12
Figure 202.101 – Testing layout
202.6.2 * Immunity
202.6.2.1.5 PATIENT-COUPLED ME EQUIPMENT and ME SYSTEMS
202.8.3 Termination of PATIENT-coupled parts
Addition:
Connect all relevant electrodes and apply them to the contents of a 1 litre capacity phantom
filled with 0,9 % saline. Position the phantom within 0,4 m of the ME EQUIPMENT as shown in
Figure 202.101.
Annexes
The annexes of the general standard apply except as follows:
+AMD2:2023 CSV © IEC 2023
Annex C
(informative)
Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS
201.C.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts
Addition:
Additional requirements for marking on the outside of nerve and muscle STIMULATORS are
found in Table 201.C.101.
Table 201.C.101 – Marking on the outside of STIMULATORS or their parts
Description of marking Subclause
The RATED power input 201.7.2
Symbol No. 10 of Table D.2 in the general standard 201.7.2.101
– 18 – IEC 60601-2-10:2012+AMD1:2016
+AMD2:2023 CSV © IEC 2023
Annex AA
(informative)
Particular guidance and rationale
AA.1 General guidance
This appendix provides a concise rationale for the important requirements of the standard and
is intended for those who are familiar with the subject of the standard but who have not
participated in its development. An understanding of the reasons for the main requirements is
considered to be essential for the proper application of the standard. Furthermore, as clinical
practice and technology change, it is believed that a rationale for the present requirements
will facilitate any revision of the standard necessitated by these developments.
AA.2 Rationale for particular clauses and subclauses
The following are rationales for specific clauses and subclauses in this particular standard,
with clause and subclause numbers parallel to those in the body of the document.
Subclause 201.1.1 – Scope
The types of ME EQUIPMENT which are excluded from the scope of this standard differ
considerably with respect to technique and/or application from the ME EQUIPMENT normally
used in physical medicine; therefore these types require different safety measures.
Subclause 201.6.2 – Protection against electric shock
The APPLIED PART needs to be isolated to avoid unwanted current paths through the PATIENT
due to the capacitance or a possible conductive connection to earth.
Subclause 201.6.6 – Mode of operation
The ME EQUIPMENT is usually operated with one PATIENT for extended periods. It may also be
used immediately with the next PATIENT. Therefore it needs to be suitable for CONTINUOUS
OPERATION.
Subclause 201.7.2.101 – Output
The symbols alert the OPERATOR to consult the instructions for use because of the higher
levels of output.
Subclause 201.7.9.2.101 a) – Additional instructions for use
Because of the electrolytic effects, any d.c. components of the PULSES needs to be declared.
Subclause 201.7.9.2.101 b) – Additional instructions for use
Electrodes of inadequate size or unsuitable application could provoke skin reactions or burns.
Subclause 201.7.9.2.101 d) – Additional instructions for use
A HAZARD could exist if the stimulating current interferes with the operation of the implanted
devices
+AMD2:2023 CSV © IEC 2023
Subclause 201.7.9.2.101 f) – Additional instructions for use
Maximum output values are needed by OPERATORS and PATIENTS to make informed decisions.
A HAZARD could exist if excessive current densities are present.
Subclause 201.8.3 – Classification of APPLIED PARTS
See rationale for subclause 201.6.2.
Subclause 201.12.1.101 – Output amplitude
A small increase in output amplitude may disproportionately stimulate the PATIENT. A control
which allows the OPERATOR to adjust the output amplitude smoothly or in small steps is an
important safety feature. Limitation of the output available at the minimum setting of the
output control enables the OPERATOR to commence the treatment by increasing the output
amplitude from an initial low (and therefore safe) level. As stated in Note 1 of 201.3, all values
for voltage and current are r.m.s. unless specifically stated otherwise.
Subclause 201.12.1.102 – PULSE parameters
An accuracy of ± 20 % is adequately safe for therapeutic application, since the pulse
parameters are set based upon the subjective reaction of the PATIENT. A considerably higher
accuracy may be needed for diagnostic purposes.
Subclause 201.12.2.101 – Electrodes
The STIMULATOR should not become unsafe if the output is switched on inadvertently with
open or short-circuited electrodes even if such operation is considered to be misuse.
Subclause 201.12.4.101 – Supply voltage fluctuations
Supply voltage fluctuations within the limits of the general standard should not affect the
output parameters.
Subclause 201.12.4.102 – Output interlock
To avoid excessive stimulation of the PATIENT, sudden increases in the output current needs
to be avoided in NORMAL USE and in the case of interruption and restoration of the SUPPLY
MAINS or following replacement of the INTERNAL ELECTRICAL POWER SOURCE.
The exception for use of a pause mode is because many devices now have this mode so that
electrodes can be repositioned,
Subclause 201.12.4.103 – Output indicator
An output indication is required for this single fault condition because a fault in the
STIMULATOR could unintentionally make energization of the electrodes possible. The
requirement may be met by a power on indicator with zero actual output or by an indicator
activated by the STIMULATOR output.
– 20 – IEC 60601-2-10:2012+AMD1:2016
+AMD2:2023 CSV © IEC 2023
Subclause 201.12.4.104 – Limitation of output parameters
For this standard, the pulse frequency is the inverse of the period of time for the pulse
waveform to repeat itself. The specified current limits support all known therapeutic and/or
diagnostic applications without greatly exceeding the values needed.
Subclause 202.6.2 – Immunity
The tests using the saline-filled phantom (see Figure 202.101) simulate NORMAL USE.
A STIMULATOR may be used in close proximity to ME EQUIPMENT that intentionally radiates radio
frequency energy. STIMULATORS which are not adequately protected may produce
considerable changes of output which could be hazardous to the PATIENT.
The test ensures that the STIMULATOR has been adequately protected against the effect of
strong r.f. currents entering the STIMULATOR via the PATIENT LEADS and/or the mains cabl
...
IEC 60601-2-10 ®
Edition 2.1 2016-04
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-10: Particular requirements for the basic safety and essential performance
of nerve and muscle stimulators
Appareils électromédicaux –
Partie 2-10: Exigences particulières pour la sécurité de base et les performances
essentielles des stimulateurs de nerfs et de muscles
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IEC 60601-2-10 ®
Edition 2.1 2016-04
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-10: Particular requirements for the basic safety and essential
performance of nerve and muscle stimulators
Appareils électromédicaux –
Partie 2-10: Exigences particulières pour la sécurité de base et les
performances essentielles des stimulateurs de nerfs et de muscles
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.60 ISBN 978-2-8322-3374-0
IEC 60601-2-10 ®
Edition 2.1 2016-04
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 2-10: Particular requirements for the basic safety and essential performance
of nerve and muscle stimulators
Appareils électromédicaux –
Partie 2-10: Exigences particulières pour la sécurité de base et les performances
essentielles des stimulateurs de nerfs et de muscles
– 2 – IEC 60601-2-10:2012+AMD1:2016 CSV
© 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 . 9
201.5 General requirements for testing of ME EQUIPMENT. 10
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 10
201.7 ME EQUIPMENT identification, marking and documents. 10
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 12
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 12
201.10 Protection against unwanted and excessive radiation HAZARDS . 12
201.11 Protection against excessive temperatures and other HAZARDS . 12
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 12
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 14
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 14
201.15 Construction of ME EQUIPMENT . 14
201.16 ME SYSTEMS . 14
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 14
202 Electromagnetic compatibility disturbances – requirements and tests . 15
Annexes . 16
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 17
Annex AA (informative) Particular guidance and rationale . 18
Index of defined terms used in this particular standard . 21
Figure 202.101 – Testing layout . 16
Table 201.101 – Pulse frequency versus applied current limits . 14
Table 201.C.101 – Marking on the outside of STIMULATORS or their parts . 17
© IEC 2016
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-10: Particular requirements for the basic safety
and essential performance of nerve and muscle stimulators
FOREWORD
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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,
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This consolidated version of the official IEC Standard and its amendment has been prepared
for user convenience.
IEC 60601-2-10 edition 2.1 contains the second edition (2012-06) [documents 62D/1003/FDIS
and 62D/1015/RVD] and its amendment 1 (2016-04) [documents 62D/1332/FDIS and 62D/1352/
RVD].
In this Redline version, a vertical line in the margin shows where the technical content is
modified by amendment 1. Additions are in green text, deletions are in strikethrough red text.
A separate Final version with all changes accepted is available in this publication.
– 4 – IEC 60601-2-10:2012+AMD1:2016 CSV
© IEC 2016
International standard IEC 60601-2-10 has been prepared by IEC subcommittee 62D:
Electromedical equipment of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition cancels and replaces the first edition, published in 1987 and its
Amendment 1 (2001). This edition constitutes a technical revision and is aligned with
IEC 60601-1:2005+A1:2012.
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 standard, 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 standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, 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 standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “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.
© IEC 2016
The committee has decided that the contents of the base publication and its amendment will
remain unchanged until the stability date indicated on the IEC web site 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.
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.
– 6 – IEC 60601-2-10:2012+AMD1:2016 CSV
© IEC 2016
INTRODUCTION
The minimum safety requirements specified in this particular standard are considered to
provide for a practical degree of safety in the operation of nerve and muscle stimulators.
This particular standard amends and supplements IEC 60601-1 (third edition, 2005 plus
Amendment 1, 2012):, Medical electrical equipment – Part 1: General requirements for safety
and essential performance hereinafter referred to as the General Standard (see 201.1.4).
The requirements are followed by specifications for the relevant tests.
A "Particular guidance and rationale" section giving some explanatory notes, where
appropriate, about the more important requirements is included in Annex AA.
Clauses or subclauses for which there are explanatory notes in Annex AA are marked with an
asterisk (*).
It is considered that a knowledge of the reasons for these requirements will not only facilitate
the proper application of the standard but will, in due course, expedite any revision
necessitated by changes in clinical practice or as a result of developments in technology.
However, this annex does not form part of the requirements of this standard.
© IEC 2016
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-10: Particular requirements for the basic safety
and essential performance of nerve and muscle stimulators
201.1 Scope, object and related standards
1)
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This International Standard specifies the requirements for the safety of nerve and muscle
STIMULATORS, defined in subclause 201.3.204, for use in the practice of physical medicine,
hereinafter referred to as ME EQUIPMENT. This includes transcutaneous electrical nerve
STIMULATORS (TENS) and electrical muscle STIMULATORS (EMS).
NOTE A muscle STIMULATOR may also be known as a neuromuscular STIMULATOR.
The following ME EQUIPMENT is excluded:
– ME EQUIPMENT intended to be implanted or to be connected to implanted electrodes;
– ME EQUIPMENT intended for the stimulation of the brain (e.g. electroconvulsive therapy ME
EQUIPMENT);
– ME EQUIPMENT intended for neurological research;
– external cardiac pacemakers (see IEC 60601-2-31);
– ME EQUIPMENT intended for averaged evoked potential diagnosis (see IEC 60601-2-40);
– ME EQUIPMENT intended for electromyography (see IEC 60601-2-40);
– ME EQUIPMENT intended for cardiac defibrillation (see IEC 60601-2-4).
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for nerve and muscle STIMULATORS as defined in 201.3.204.
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 60601-1-2:2007 applies as modified in Clause 202. IEC 60601-1-3 does not apply. All
other published collateral standards in the IEC 60601-1 series apply as published.
—————————
1)
The general standard is IEC 60601-1:2005+A1:2012, Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance
– 8 – IEC 60601-2-10:2012+AMD1:2016 CSV
© 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 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 3.139, 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 with the following exception:
Replacement:
© IEC 2016
IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
Amendment 1:2012
201.3 Terms and definitions
Replacement:
For the purposes of this document, the terms and definitions given in
IEC 60601-1:2005+A1:2012 apply, except as follows:
NOTE 1 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.
201.3.8
APPLIED PART
Addition:
the STIMULATOR electrodes and all parts conductively connected to them
Addition:
201.3.201
LEAD
insulated conductor having a means of connecting to a STIMULATOR at one end and a means
of connecting to an electrode at the other end, and intended for conducting output signals
from a STIMULATOR to an electrode
201.3.202
PULSE
portion of WAVEFORM between two zero voltage levels
201.3.203
PULSE DURATION
duration of the output PULSE at 50 % of the maximum amplitude
201.3.204
STIMULATOR
ME EQUIPMENT for the application of electric currents via electrodes in direct contact with the
PATIENT for the diagnosis and/or therapy of neuromuscular disorders.
201.3.205
WAVEFORM
variations in amplitude of an electrical signal which is output from the APPLIED PART (in either
voltage or current) as a function of time .
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
– 10 – IEC 60601-2-10:2012+AMD1:2016 CSV
© IEC 2016
201.4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS
Additional subclause:
201.4.1.101 Additional conditions for application to ME EQUIPMENT or ME SYSTEMS
In the case of combined ME EQUIPMENT (e.g. a STIMULATOR provided with a function or an
APPLIED PART for ultrasonic therapy), the additional part shall comply with any relevant
particular standard.
201.4.2 RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS
Addition:
MANUFACTURERS shall include, within their RISK ANALYSIS, the risk associated with the potential
use of their STIMULATORS and accessories to deliver current exceeding 10 mA or current
densities for any electrode exceeding 2 mA/cm .
201.4.11 Power input
Addition:
The EQUIPMENT shall be operated in the output mode and using the load which creates the
highest amplitude steady state current.
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies.
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.
201.6.6 * Mode of operation
Amendment:
Delete all except CONTINUOUS OPERATION.
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
201.7.2.7 Electrical input power from the SUPPLY MAINS
Replacement of the fourth paragraph:
© IEC 2016
The RATED input power of a mains powered STIMULATOR shall be the maximum power
averaged over any period of 5 s under the specified operating conditions set out by the
manufacturer.
Additional subclause:
201.7.2.101 * Output
ME EQUIPMENT capable of delivering outputs in excess of 10 mA or 10 V averaged over any
period of 1 s shall be marked near the electrode connections with symbol No. 10 of Table D.2
of the general standard.
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 d.c. component, PULSE DURATIONS,
PULSE repetition frequencies, maximum amplitude of output voltage and/or current, and the
effect of load impedance on these parameters.
b) * Advice on the size and type of electrodes to be used and the method of application for
each particular type of treatment for which the STIMULATOR is intended.
c) Advice on any necessary precautions to be taken when the output contains a d.c.
component.
d) * Advice that a PATIENT with an implanted electronic device (for example a cardiac
pacemaker) should not be subjected to stimulation unless specialist medical opinion has
first been obtained.
e) A warning on the following potential hazards:
– Simultaneous connection of a PATIENT to a high frequency surgical ME EQUIPMENT may
result in burns at the site of the STIMULATOR electrodes and possible damage to the
STIMULATOR.
– Operation in close proximity (e.g. 1 m) to a shortwave or microwave therapy
ME EQUIPMENT may produce instability in the STIMULATOR output.
– Application of electrodes near the thorax may increase the risk of cardiac fibrillation.
f) * For ME EQUIPMENT capable of delivering output values in excess of 10 mA or 10 V:
– Information on maximum output values available at the electrodes recommended by
the manufacturer for use with the STIMULATOR.
g) Advice that any electrodes that have current densities exceeding 2 mA/cm may require
the special attention of the OPERATOR.
h) Advice that stimulation should not be applied across or through the head, directly on the
eyes, covering the mouth, on the front of the neck, (especially the carotid sinus), or from
electrodes placed on the chest and the upper back or crossing over the heart.
201.7.9.3 Technical description
201.7.9.3.1 General
Addition:
– The technical description shall specify the parameters mentioned in item a) of
201.7.9.2.101 along with the range of load impedances for which these parameters are
valid.
– 12 – IEC 60601-2-10:2012+AMD1:2016 CSV
© IEC 2016
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
Amendment:
The APPLIED PARTS of STIMULATORS shall be TYPE BF or TYPE CF APPLIED PARTS.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and
ME SYSTEMS
Clause 9 of the general standard applies.
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.
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
Additional subclauses:
201.12.1.101 * Output amplitude
A means shall be provided to control the STIMULATOR output from minimum to maximum
continuously, or in discrete increments of not more than 1 mA or 1 V per increment. At its
minimum setting, the output shall not exceed 2 % of that available at the maximum setting of
the control.
Compliance is checked by inspection and measurement using the load impedance which is
the least favourable within the load impedance range specified in the ACCOMPANYING
DOCUMENTS.
PULSE parameters
201.12.1.102 *
The values of PULSE DURATIONS, PULSE repetition frequencies and amplitudes, including any
d.c. component, whether caused by an offset or by an unsymmetrical waveform, as described
in the ACCOMPANYING DOCUMENTS or indicated on the ME EQUIPMENT (see 201.7.9.2), shall not
deviate by more than ± 20 % when measured with a load resistance within the range specified
in the ACCOMPANYING DOCUMENTS (see 201.7.9.3).
Compliance is checked by measurement with an error not exceeding ± 10 %.
© IEC 2016
201.12.2 USABILITY Usability of ME EQUIPMENT
Additional subclause:
201.12.2.101 * Electrodes
The STIMULATOR shall comply with this standard when operated with either open-circuited or
short-circuited electrodes.
Compliance is checked by the following test:
Operate the STIMULATOR with all output controls set to the maximum position and each pair of
output terminals left open-circuited for a period of 10 min and then short-circuited for a further
period of 5 min. After this test the ME EQUIPMENT shall comply with all the requirements of this
standard.
201.12.4 Protection against hazardous output
Additional subclauses:
201.12.4.101 * Supply voltage fluctuations
Supply voltage fluctuations of ± 10 % shall not affect the STIMULATOR output amplitude, PULSE
DURATION or PULSE repetition frequency by more than ± 10 %.
Compliance is checked by measurement.
201.12.4.102 * Output interlock
A stimulator that is capable of delivering an output in excess of 10 mA or 10 V shall not be
energizeable unless the output amplitude control(s) is (are) first set to its (their) minimum
position.
This requirement shall also apply upon the restoration of the SUPPLY MAINS following a
temporary interruption or following replacement of the INTERNAL ELECTRICAL POWER SOURCE.
This requirement shall not apply when a stimulator is released from a pause mode, having
been operating prior to being paused.
Compliance is checked by functional check.
201.12.4.103 * Output indicator
In NORMAL CONDITION and SINGLE FAULT CONDITION, ME EQUIPMENT shall indicate when it can
deliver an output of more than 10 mA or 10 V, or can deliver PULSES having an energy
exceeding 10 mJ per PULSE, into a load resistance of 1 000 Ω. If the indication is by means of
a signal lamp, its colour shall be yellow.
Compliance is checked by inspection and functional test.
201.12.4.104 * Limitation of output parameters
a) ME EQUIPMENT intended for therapeutic applications:
With a load resistance of 500 Ω the output current shall not exceed the limits in
Table 201.101:
– 14 – IEC 60601-2-10:2012+AMD1:2016 CSV
© IEC 2016
Table 201.101 – Pulse frequency versus applied current limits
Pulse Frequency Current limit
d.c. 80 mA
≤ 400 Hz 50 mA
80 mA
> 400 Hz to ≤ 1 500 Hz
> 1 500 Hz 100 mA
If the output has a.c. and d.c. components, then these components shall be measured
separately and compared with the allowable limits.
For PULSE DURATIONS of less than 0,1 s the PULSE energy with a load resistance of 500 Ω shall
PULSE. For longer PULSE DURATIONS, the above-mentioned current limit
not exceed 300 mJ per
for d.c. applies.
Additionally, the output voltage shall not exceed a peak value of 500 V, when measured under
open-circuit condition.
Where the APPLIED PART(S) is (are) energized by more than one patient circuit simultaneously
(for example for interferential therapy), the above limits shall apply to each of these patient
circuits.
b) ME EQUIPMENT intended for diagnostic applications:
For ME EQUIPMENT intended for dentistry and ophthalmology, the d.c. current with a load
resistance of 2 000 Ω shall not exceed 10 mA.
Compliance is checked by measurement.
201.13 Hazardous situations and fault conditions for ME EQUIPMENT
Clause13 of the general standard applies.
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
Clause14 of the general standard applies.
201.15 Construction of ME EQUIPMENT
Clause15 of the general standard applies
201.16 ME SYSTEMS
Clause16 of the general standard applies.
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
Clause17 of the general standard applies.
© IEC 2016
202 Electromagnetic compatibility disturbances – requirements and tests
IEC60601-1-2:2007 applies except as follows:
202.6.1 Emissions
202.6.1.1.2 Tests
a) Patient cables
202.7.1.11 PATIENT-coupled cables
Addition:
Connect all relevant electrodes to the contents of a 1 litre capacity phantom filled with 0,9 %
saline. Position the phantom within 0,4 m of the ME EQUIPMENT as shown in Figure 202.101.
– 16 – IEC 60601-2-10:2012+AMD1:2016 CSV
© IEC 2016
Electrodes in saline
STIMULATOR
1 litre 0,9 % saline
<0,4 m
Wooden table
IEC 1189/12
Figure 202.101 – Testing layout
202.6.2 * Immunity
202.6.2.1.5 PATIENT-COUPLED ME EQUIPMENT and ME SYSTEMS
202.8.3 Termination of PATIENT-coupled parts
Addition:
Connect all relevant electrodes and apply them to the contents of a 1 litre capacity phantom
filled with 0,9 % saline. Position the phantom within 0,4 m of the ME EQUIPMENT as shown in
Figure 202.101.
Annexes
The annexes of the general standard apply except as follows:
© IEC 2016
Annex C
(informative)
Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS
201.C.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts
Addition:
Additional requirements for marking on the outside of nerve and muscle STIMULATORS are
found in Table 201.C.101.
Table 201.C.101 – Marking on the outside of STIMULATORS or their parts
Description of marking Subclause
The RATED power input 201.7.2
Symbol No. 10 of Table D.2 in the general standard 201.7.2.101
– 18 – IEC 60601-2-10:2012+AMD1:2016 CSV
© IEC 2016
Annex AA
(informative)
Particular guidance and rationale
AA.1 General guidance
This appendix provides a concise rationale for the important requirements of the standard and
is intended for those who are familiar with the subject of the standard but who have not
participated in its development. An understanding of the reasons for the main requirements is
considered to be essential for the proper application of the standard. Furthermore, as clinical
practice and technology change, it is believed that a rationale for the present requirements
will facilitate any revision of the standard necessitated by these developments.
AA.2 Rationale for particular clauses and subclauses
The following are rationales for specific clauses and subclauses in this particular standard,
with clause and subclause numbers parallel to those in the body of the document.
Subclause 201.1.1 – Scope
The types of ME EQUIPMENT which are excluded from the scope of this standard differ
considerably with respect to technique and/or application from the ME EQUIPMENT normally
used in physical medicine; therefore these types require different safety measures.
Subclause 201.6.2 – Protection against electric shock
The APPLIED PART needs to be isolated to avoid unwanted current paths through the PATIENT
due to the capacitance or a possible conductive connection to earth.
Subclause 201.6.6 – Mode of operation
The ME EQUIPMENT is usually operated with one PATIENT for extended periods. It may also be
used immediately with the next PATIENT. Therefore it needs to be suitable for CONTINUOUS
OPERATION.
Subclause 201.7.2.101 – Output
The symbols alert the OPERATOR to consult the instructions for use because of the higher
levels of output.
Subclause 201.7.9.2.101 a) – Additional instructions for use
Because of the electrolytic effects, any d.c. components of the PULSES needs to be declared.
Subclause 201.7.9.2.101 b) – Additional instructions for use
Electrodes of inadequate size or unsuitable application could provoke skin reactions or burns.
Subclause 201.7.9.2.101 d) – Additional instructions for use
A HAZARD could exist if the stimulating current interferes with the operation of the implanted
devices
© IEC 2016
Subclause 201.7.9.2.101 f) – Additional instructions for use
Maximum output values are needed by OPERATORS and PATIENTS to make informed decisions.
A HAZARD could exist if excessive current densities are present.
Subclause 201.8.3 – Classification of APPLIED PARTS
See rationale for subclause 201.6.2.
Subclause 201.12.1.101 – Output amplitude
A small increase in output amplitude may disproportionately stimulate the PATIENT. A control
which allows the OPERATOR to adjust the output amplitude smoothly or in small steps is an
important safety feature. Limitation of the output available at the minimum setting of the
output control enables the OPERATOR to commence the treatment by increasing the output
amplitude from an initial low (and therefore safe) level. As stated in Note 1 of 201.3, all values
for voltage and current are r.m.s. unless specifically stated otherwise.
Subclause 201.12.1.102 – PULSE parameters
An accuracy of ± 20 % is adequately safe for therapeutic application, since the pulse
parameters are set based upon the subjective reaction of the PATIENT. A considerably higher
accuracy may be needed for diagnostic purposes.
Subclause 201.12.2.101 – Electrodes
The STIMULATOR should not become unsafe if the output is switched on inadvertently with
open or short-circuited electrodes even if such operation is considered to be misuse.
Subclause 201.12.4.101 – Supply voltage fluctuations
Supply voltage fluctuations within the limits of the general standard should not affect the
output parameters.
Subclause 201.12.4.102 – Output interlock
To avoid excessive stimulation of the PATIENT, sudden increases in the output current needs
to be avoided in NORMAL USE and in the case of interruption and restoration of the SUPPLY
MAINS or following replacement of the INTERNAL ELECTRICAL POWER SOURCE.
The exception for use of a pause mode is because many devices now have this mode so that
electrodes can be repositioned,
Subclause 201.12.4.103 – Output indicator
An output indication is required for this single fault condition because a fault in the
STIMULATOR could unintentionally make energization of the electrodes possible. The
requirement may be met by a power on indicator with zero actual output or by an indicator
activated by the STIMULATOR output.
– 20 – IEC 60601-2-10:2012+AMD1:2016 CSV
© IEC 2016
Subclause 201.12.4.104 – Limitation of output parameters
For this standard, the pulse frequency is the inverse of the period of time for the pulse
waveform to repeat itself. The specified current limits support all known therapeutic and/or
diagnostic applications without greatly exceeding the values needed.
Subclause 202.6.2 – Immunity
The tests using the saline-filled phantom (see Figure 202.101) simulate NORMAL USE.
A STIMULATOR may be used in close proximity to ME EQUIPMENT that intentionally radiates radio
frequency energy. STIMULATORS which are not adequately protected may produce
considerable changes of output which could be hazardous to the PATIENT.
The test ensures that the STIMULATOR has been adequately protected against the effect of
strong r.f. currents entering the STIMULATOR via the PATIENT LEADS and/or the mains cable.
Simple filter networks in the PATIENT output and mains input circuits have proved effective.
© IEC 2016
Index of defined terms used in this particular standard
ACCOMPANYING DOCUMENT . IEC 60601-1:2005+A1:2012, 3.4
APPLIED PART . IEC 60601-1:2005+A1:2012, 3.8
BASIC SAFETY .
...
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