IEC 60601-2-5:2009

IEC 60601-2-5 ®
Edition 3.0 2009-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-5: Particular requirements for the basic safety and essential performance
of ultrasonic physiotherapy equipment

Appareils électromédicaux –
Partie 2-5: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à ultrasons pour physiothérapie

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IEC 60601-2-5 ®
Edition 3.0 2009-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-5: Particular requirements for the basic safety and essential performance
of ultrasonic physiotherapy equipment

Appareils électromédicaux –
Partie 2-5: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à ultrasons pour physiothérapie

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
V
CODE PRIX
ICS 11.040.60 ISBN 978-2-88910-214-3
– 2 – 60601-2-5 © IEC:2009
CONTENTS
FOREWORD.0H3
INTRODUCTION.1H6
201.1 Scope, object and related standards .2H7
201.2 Normative references.3H9
201.3 Terms and definitions.4H9
201.4 General requirements.5H12
201.5 General requirements for testing of ME EQUIPMENT.6H13
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .7H13
201.7 *ME EQUIPMENT identification, marking and documents .8H13
201.8 *Protection against electrical HAZARDS from ME EQUIPMENT .9H14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS .10H15
201.10 Protection against unwanted and excessive radiation HAZARDS.11H15
201.11 Protection against excessive temperatures and other HAZARDS.12H16
201.12 Accuracy of controls and instruments and protection against hazardous
outputs.13H19
201.13 HAZARDOUS SITUATIONS and fault conditions.14H21
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .15H21
201.15 Construction of ME EQUIPMENT .16H21
201.16 ME SYSTEMS .17H22
201.17 *Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .18H22
202 Electromagnetic compatibility – Requirements and tests .19H22
Annexes .20H23
Annex AA (informative) Particular guidance and rationale.21H24
Annex BB (informative) Example set-up to measure surface temperature of externally
applied TRANSDUCER ASSEMBLIES .22H29
Bibliography.23H32
Index of defined terms used in this particular standard.24H33

Figure BB.1 – Set-up of an example test object to measure the surface temperature of
externally applied transducers .25H31

Table 201.101 – List of symbols.26H12
Table 201.102 – Distributed ESSENTIAL PERFORMANCE requirements .27H13
Table 201.103 – Overview of the tests noted under 201.11.1.3 .28H19
Table BB.1 – Acoustic and thermal properties of tissues and materials .29H29
Table BB.2 – Weight % pure components .30H30

60601-2-5 © IEC:2009 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-5: Particular requirements for the basic safety and essential
performance of ultrasonic physiotherapy equipment

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
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between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
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5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
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expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-2-5 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This third edition cancels and replaces the second edition published in 2000. This edition
constitutes a technical revision.
The numbering was revised to agree with IEC 60601-1:2005 (third edition). Beyond this,
essential performance characteristics are defined in 201.4.3.101, guidance on maintenance is
added in 201.7.9.2.1, a new requirement regarding dielectric withstand was added in
201.8.8.3. The clause on transducer surface temperature rise, 201.11, has been modified to
allow for simulated use conditions. Measurements of ultrasound-related parameters are now
referenced to IEC 61689:2007 (second edition). The most important change in the ultrasound-
related parameters is the definition of EFFECTIVE RADIATING AREA, 201.3.207. This change will
also affect the value of the EFFECTIVE INTENSITY and its uncertainty.

– 4 – 60601-2-5 © IEC:2009
The text of this particular standard is based on the following documents:
Enquiry draft Report on voting
62D/693/CDV 62D/766/RVC
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.
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 31H Ann e x 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.

60601-2-5 © IEC:2009 – 5 –
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result 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.
– 6 – 60601-2-5 © IEC:2009
INTRODUCTION
In this particular standard, safety and performance requirements additional to those in the
general standard are specified for ULTRASONIC PHYSIOTHERAPY EQUIPMENT.
This particular standard takes into account IEC 61689.
The requirements are followed by specifications for the relevant tests.
A rationale for the more important requirements, where appropriate, is given in Annex AA. It is
considered that a knowledge of the reasons for these requirements will not only facilitate the
proper application of the particular 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.
The clauses and subclauses which have corresponding rationale statements are marked with
an asterisk * after their number.

60601-2-5 © IEC:2009 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-5: Particular requirements for the basic safety and essential
performance of ultrasonic physiotherapy equipment

201.1 Scope, object and related standards
1)
Clause 1 of the general standard 0F applies, except as follows:
201.1.1 Scope
Replacement:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
ULTRASONIC PHYSIOTHERAPY EQUIPMENT as defined in 201.3.216, hereafter referred to as
ME EQUIPMENT.
This standard only relates to ULTRASONIC PHYSIOTHERAPY EQUIPMENT employing a single plane
unfocused circular transducer per TREATMENT HEAD, producing static beams perpendicular to
the face of the TREATMENT HEAD.
This standard can also be applied to ULTRASONIC PHYSIOTHERAPY EQUIPMENT used for
compensation or alleviation of disease, injury or disability.
In the case of combined EQUIPMENT (e.g. EQUIPMENT additionally provided with a function or an
APPLIED PART for electrical stimulation) such EQUIPMENT shall also comply with any particular
standard specifying safety requirements for the additional function.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this standard are not covered by specific requirements in this standard
except in 7.2.13 and 8.4.1 of the general standard.
NOTE 1 See also 4.2 of the general standard.
This particular standard does not apply to:
– EQUIPMENT in which a tool is driven by ULTRASOUND (for example EQUIPMENT used in
surgery or dentistry);
– EQUIPMENT in which focused ULTRASOUND pulse waves are used to destroy conglomerates
such as stones in the kidneys or the bladder (lithotripters) (for information refer to
IEC 60601-2-36);
– ULTRASONIC PHYSIOTHERAPY EQUIPMENT in which focused ultrasound pulse waves are used.
—————————
1)
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance

– 8 – 60601-2-5 © IEC:2009
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for ULTRASONIC PHYSIOTHERAPY EQUIPMENT (as defined in
201.3.216).
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 subclause 201.2 of this particular standard.
IEC 60601-1-2 applies as modified in Clause 202. All other published collateral standards in
the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in 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 particular 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 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the 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.

60601-2-5 © IEC:2009 – 9 –
Subclauses or figures which are additional to those of a collateral standard are numbered
starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
201.2 Normative references
Clause 2 of the general standard applies, except as follows:
Amendment:
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 61689:2007, Ultrasonics – Physiotherapy systems – Field specifications and methods of
measurement in the frequency range 0,5 MHz to 5 MHz
IEC 62127-1:2007, Ultrasonics – Hydrophones – Part 1: Measurement and characterisation of
medical ultrasonic fields up to 40 MHz
IEC 62127-2:2007, Ultrasonics – Hydrophones – Part 2: Calibration for ultrasonic fields up to
40 MHz
NOTE Informative references are listed in the bibliography on page 32.
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in the general standard
and in IEC 61689 (some of which are repeated here for convenience), as well as the following
additional definitions apply:
NOTE 1 An index of defined terms is given after the Bibliography.
NOTE 2 A list of symbols used in this particular standard is found in Table 201.101.
Addition:
201.3.201
ACOUSTIC WORKING FREQUENCY
f
awf
frequency of an acoustic signal based on the observation of the output of a hydrophone
placed in an acoustic field. The signal is analysed using the zero-crossing frequency
technique
[IEC 61689:2007, definition 3.3, modified]

– 10 – 60601-2-5 © IEC:2009
NOTE Acoustic frequency is expressed in hertz (Hz).
201.3.202
ATTACHMENT HEAD
ACCESSORY intended to be attached to the TREATMENT HEAD for the purpose of modifying the
ultrasonic beam characteristics
201.3.203
BEAM NON-UNIFORMITY RATIO
R
BN
ratio of the square of the MAXIMUM R.M.S. ACOUSTIC PRESSURE to the spatial average of the
square of the R.M.S. ACOUSTIC PRESSURE, where the spatial average is taken over the
EFFECTIVE RADIATING AREA
[IEC 61689:2007, definition 3.9, modified]
201.3.204
BEAM TYPE
descriptive classification for the ultrasonic beam in one of three types: collimated, convergent
or divergent
[IEC 61689:2007, definition 3.11]
201.3.205
DUTY FACTOR
ratio of the PULSE DURATION to the PULSE REPETITION PERIOD
[IEC 61689:2007, definition 3.16]
201.3.206
EFFECTIVE INTENSITY
I
e
intensity given by I = P/A where P is the OUTPUT POWER and A is the EFFECTIVE
e ER ER
RADIATING AREA
NOTE Effective intensity is expressed in watt per centimetre squared (W/cm ).
[IEC 61689:2007, definition 3.17]
201.3.207
EFFECTIVE RADIATING AREA
A
ER
BEAM CROSS-SECTIONAL AREA determined at a distance of 0,3 cm from the front of the
TREATMENT HEAD, A (0,3), multiplied by a dimensionless factor, equal to 1,354
BCS
[IEC 61689:2007, definition 3.19, modified]
NOTE 1 Beam cross-sectional area is expressed in centimetre squared (cm ).
NOTE 2 This may be thought of as the area of the face of the treatment head which transmits 100% of the total
mean square acoustic power.
201.3.208
OUTPUT POWER
P
time-average ultrasonic power emitted by a TREATMENT HEAD of ULTRASONIC PHYSIOTHERAPY
EQUIPMENT into an approximately free field under specified conditions in a specified medium,
preferably in water
[IEC 61689:2007, definition 3.30]
NOTE OUTPUT POWER is expressed in watt (W).

60601-2-5 © IEC:2009 – 11 –
201.3.209
PULSE DURATION
time interval beginning at the first time the pressure amplitude exceeds a reference value and
ending at the last time the pressure amplitude returns to that value. The reference value is
equal to the sum of the minimum pressure amplitude and 10 % of the difference between the
maximum and minimum pressure amplitude
[IEC 61689:2007, definition 3.34]
NOTE PULSE DURATION is expressed in seconds (s).
201.3.210
PULSE REPETITION PERIOD
prp
time interval between two equal moments in time of successive pulses or tone-bursts
NOTE 1 This applies to single element non-automatic scanning systems and automatic scanning systems. See
also IEC 60469-1:1987, 5.3.2.1.
NOTE 2 PULSE REPETITION PERIOD is expressed in seconds (s).
[IEC 61689:2007, definition 3.35]
201.3.211
RATED OUTPUT POWER
maximum OUTPUT POWER of the ultrasonic physiotherapy EQUIPMENT at the rated value of the
mains voltage, with control settings configured to deliver maximum OUTPUT POWER
NOTE Rated output power is expressed in watt (W).
[IEC 61689:2007, definition 3.31]
201.3.212
TEMPORAL-MAXIMUM INTENSITY
I
m
in the case of an amplitude modulated wave, the ratio of the TEMPORAL-MAXIMUM OUTPUT
POWER to the EFFECTIVE RADIATING AREA
[IEC 61689:2007, definition 3.40, modified]
201.3.213
TEMPORAL-MAXIMUM OUTPUT POWER
p
tp
in the case of an amplitude modulated wave, a function of the actual OUTPUT POWER, the
temporal-peak acoustic pressure and the r.m.s. acoustic pressure, which is determined as
specified in IEC 61689
[IEC 61689:2007, definition 3.33, modified]
201.3.214
*TREATMENT HEAD
assembly comprising an ULTRASONIC TRANSDUCER and associated parts for local application of
ULTRASOUND to the PATIENT
NOTE A TREATMENT HEAD is also referred to as an applicator.
201.3.215
ULTRASOUND
acoustic oscillation whose frequency is above the high-frequency limit of audible sound (about
16 kHz)
– 12 – 60601-2-5 © IEC:2009
2)
[IEV 802-01-011F , modified]
201.3.216
ULTRASONIC PHYSIOTHERAPY EQUIPMENT (hereinafter referred to as EQUIPMENT)
EQUIPMENT for the generation and application of ULTRASOUND to a PATIENT for therapeutic
purposes
NOTE Essentially the EQUIPMENT comprises a generator of electric high-frequency power and a transducer for
converting this to ULTRASOUND.
201.3.217
ULTRASONIC TRANSDUCER
device capable of converting electrical energy to mechanical energy within the ultrasonic
frequency range and/or reciprocally of converting mechanical energy to electrical energy
[IEC 62127-1:2007, definition 3.73]
Table 201.101 – List of symbols used in this standard
Symbol Term Reference
BEAM CROSS-SECTIONAL AREA evaluated at 0,3 cm from the front face 3.7 of IEC 61689
A (0,3)
BCS
of the TREATMENT HEAD
A EFFECTIVE RADIATING AREA 201.3.206
ER
f ACOUSTIC WORKING FREQUENCY 201.3.201
awf
EFFECTIVE INTENSITY 201.3.206
I
e
I TEMPORAL MAXIMUM INTENSITY 201.3.212
m
P OUTPUT POWER 201.3.208
P TEMPORAL-MAXIMUM OUTPUT POWER 201.3.213
tm
prp PULSE REPETITION PERIOD 201.3.210
R BEAM NON-UNIFORMITY RATIO 201.3.203
BN
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Addition:
201.4.3.101 Additional ESSENTIAL PERFORMANCE requirements
Table 201.102 lists the potential sources of unacceptable risk identified to characterize the
ESSENTIAL PERFORMANCE of ULTRASONIC PHYSIOTHERAPY EQUIPMENT and the subclauses in
which the requirements are found.
—————————
2)
IEC 60050-802, International Electrotechnical Vocabulary – Part 802: Ultrasonics, to be published.

60601-2-5 © IEC:2009 – 13 –
Table 201.102 – Distributed ESSENTIAL PERFORMANCE requirements
Requirement Subclause
a
Free from the display of incorrect numerical values associated with the 201.12.1
therapy to be performed.
Free from the production of unwanted ultrasound output. 201.10.102
Free from the production of excessive ultrasound output. 201.12.4
Free from the production of unintended or excessive TRANSDUCER ASSEMBLY 201.11
surface temperature.
a
“Incorrect” in the sense that the displayed value is different from what is produced or
intended
201.4.11 Power input
Addition:
This subclause of the general standard applies with EQUIPMENT operated at maximum OUTPUT
POWER.
NOTE Complying to power input requirements may depend on the OUTPUT POWER LEVEL
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.1 *TYPE TESTS
Addition:
NOTE See Annex AA.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
201.7 *ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
Additional subclause:
201.7.2.101 Device type specific markings
a) The generator of an EQUIPMENT shall additionally be provided with the following markings:
– ACOUSTIC WORKING FREQUENCY or FREQUENCIES in MHz (in kHz for frequencies below
1 MHz)
– waveform (continuous, amplitude modulated (or pulsed))
– if amplitude modulated (or pulsed), a description or picture of the output waveforms,
along with values for the PULSE DURATION, PULSE REPETITION PERIOD, and DUTY FACTOR
for each modulation setting.
– 14 – 60601-2-5 © IEC:2009
b) The generator shall carry a nameplate, permanently attached, on which is given a unique
serial number so that it is individually identified.
c) The TREATMENT HEAD shall be marked with its RATED OUTPUT POWER in watts, the EFFECTIVE
RADIATING AREA in square centimetres, the BEAM NON-UNIFORMITY RATIO, the BEAM TYPE, a
designation of the specific generator (where applicable, see 201.7.9.2.1, last item) of the
equipment for which the TREATMENT HEAD is intended and a unique serial number.
201.7.9.2 Instructions for use
201.7.9.2.1 General
Addition:
The instructions for use shall additionally contain the following:
– information on ACOUSTIC WORKING FREQUENCY or FREQUENCIES in kilohertz or megahertz
and EFFECTIVE RADIATING AREA or AREAS in square centimetres of any TREATMENT HEAD or
ATTACHMENT HEAD;
– a recommendation calling the USER's attention to the need for periodic maintenance,
especially:
3)
• intervals for regular performance testing and calibration by the user [1] 2F ;
• inspection of the treatment head for cracks, which may allow the ingress of conductive
fluid;
• inspection of the treatment head cables and associated connectors;
NOTE Maintenance schemes are given in IEC 62462.
– advice on the procedures necessary for safe operation, drawing attention in the case of
TYPE B APPLIED PARTS to the SAFETY HAZARDS which may occur as a result of an inadequate
electrical installation;
– advice on the type of electrical installation to which the EQUIPMENT may be safely
connected, including the connection of any POTENTIAL EQUALIZATION CONDUCTOR;
– advice drawing the USER’s attention to the need for care when handling the TREATMENT
HEAD since rough handling may adversely affect its characteristics;
– a list of conditions for which ULTRASOUND treatment is contraindicated;
– a statement of intended use(s);
– information on available TREATMENT HEADS;
– where a TREATMENT HEAD has been designed for interchangeability, such that it is not
possible to specify a particular generator unit, this shall be stated and the method by
which interchangeability is achieved shall be described.
201.8 *Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies, except as follows:
201.8.1 Fundamental rule of protection against electric shock
Addition:
In the case of combined EQUIPMENT (e.g. EQUIPMENT additionally provided with a function or an
APPLIED PART for electrical stimulation) such EQUIPMENT shall also comply with any particular
standard specifying safety requirements for the additional function.
—————————
3)
Figures in square brackets refer to the Bibliography.

60601-2-5 © IEC:2009 – 15 –
201.8.7.4.8 Measurement of the PATIENT AUXILIARY CURRENT
Addition:
For testing the TRANSDUCER ASSEMBLIES, the APPLIED PART shall be immersed in a 0,9 % saline
solution.
201.8.8.3 Dielectric strength
Addition:
aa) For testing the TRANSDUCER ASSEMBLIES, the APPLIED PART shall be immersed in a 0,9 %
saline solution.
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, except as follows:
Additional paragraphs:
201.10.101 *Ultrasonic energy
The MANUFACTURER shall address the RISKS associated with ultrasonic energy in the RISK
MANAGEMENT PROCESS as described in the text of this standard.
Compliance is checked by inspection of the RISK MANAGEMENT FILE.
201.10.102 *Unwanted ultrasound radiation
The spatial-peak temporal-average intensity (see IEC 62127-1) of unwanted ULTRASOUND
radiation from a TREATMENT HEAD intended for hand-held use shall be less than
100 mW/cm when measured as described below.
Compliance shall be checked by the following test:
The front face of the TREATMENT HEAD is immersed in degassed water at a temperature of
22 °C ± 3 °C. The EQUIPMENT is operated at the RATED OUTPUT POWER specified for the
TREATMENT HEAD. The unwanted ULTRASOUND radiation is measured by scanning, by hand, the
side walls of the TREATMENT HEAD by means of a calibrated hydrophone coupled to the side
walls using a coupling gel.
Contrary to the definition in IEC 62127-1 the spatial-peak temporal-average intensity shall be
calculated using the approximation:
p
max
I = (1)
spta
ρ c
where:
p is the maximum r.m.s. acoustic pressure (see IEC 61689 Ed2);
max
ρ is the density of the coupling gel. For simplicity the density of water can be used;

– 16 – 60601-2-5 © IEC:2009
c is the velocity of sound in the medium. For simplicity the velocity of sound in water can be used.
NOTE Spatial-peak temporal-average intensity is expressed in watts per metre squared (W/m ).
The hydrophone used shall have an active element of diameter ≤ 1 mm.
The hydrophone used shall be calibrated following IEC 62127-2.
NOTE 1 Neither the principle of this method nor the arrangement used allow an exact determination of the
intensity value, however the value as measured does give an indication of the energy available at the sides of the
treatment head.
NOTE 2 For requirements concerning OUTPUT POWER and intensity distribution, see Clause 201.12.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies, except as follows:
201.11.1.2.2 *APPLIED PARTS not intended to supply heat to a PATIENT
Addition:
TREATMENT HEADS applied to the PATIENT shall have a PATIENT contact surface temperature not
exceeding 43 °C in NORMAL CONDITIONS when measured under test conditions
201.11.1.3.101.1.
TREATMENT HEADS applied to the PATIENT shall have a PATIENT contact surface temperature not
exceeding 50 °C when measured under test conditions 201.11.1.3.101.2.
Compliance is checked by operation of the ULTRASONIC PHYSOTHERAPY EQUIPMENT and
temperature tests as described in 201.11.1.3.101.
NOTE The PATIENT contact surface includes any part of the APPLIED PART, not just the radiating surface.
201.11.1.3 *Measurements
Addition:
201.11.1.3.101 Test conditions
The TREATMENT HEAD shall be tested under the following conditions:
201.11.1.3.101.1 Simulated use
The APPLIED PART of the TREATMENT HEAD shall be coupled acoustically to, and be initially in
thermal equilibrium with, a test object such that the ultrasound emitted from the active surface
of the TRANSDUCER ASSEMBLY enters the test object.
The positioning, and heating or cooling of the TREATMENT HEAD shall resemble those
corresponding to the intended application of that TREATMENT HEAD. This includes using a
typical amount of ultrasound coupling medium appropriate to the intended application.
The temperature shall be measured at the point on the APPLIED PART of the TREATMENT HEAD
that contacts the PATIENT during NORMAL USE and where the temperature is a maximum.
The test object shall have thermal and acoustical properties mimicking those of an
appropriate tissue. In the case where the TREATMENT HEAD is intended for external use this
test object shall account for a skin layer.

60601-2-5 © IEC:2009 – 17 –
For soft tissue, the material of the test object shall have the following properties:
– specific heat capacity: (3 500 ± 500) J/(kg⋅K);
– thermal conductivity: (0,5 ± 0,1) W/(m⋅K);
– attenuation: (0,5 ± 0,1) dB/cm/MHz.
NOTE 1 A general guidance for the acoustic properties of appropriate tissue is given in ICRU report 61[2].
NOTE 2 As heat develops differently in tissue surfaces containing skin, bone or soft tissue, careful consideration
should be given to the choice of the model in relation to the intended use of the APPLIED PART. Additional guidance
can be found in Annex AA and reference [3].
The test object shall be designed (for example, using acoustic absorbers) to reduce heating the
surface of the TREATMENT HEAD by minimizing ULTRASOUND reflections.
201.11.1.3.101.1.1 Test methods
Test method a) or b) specified below shall be selected.
Test method a) shall be used where the ULTRASOUND PHYSIOTHERAPY EQUIPMENT uses a closed
loop temperature monitoring system, as the use of test method b) could result in inappropriate
results.
a) Test criteria based on test object near human temperatures.
The initial temperature of the surface of the test object at the object-transducer interface
shall be not less than 33 °C and the ambient temperature shall be 23 °C ± 3 °C.
To meet the requirements of this test, the temperature of the surface of the APPLIED PART
shall not exceed 43 °C.
b) Test criteria based upon temperature rise measurements
The ambient temperature shall be 23 °C ± 3 °C. The initial temperature of the surface of
the test object at the object-transducer interface shall be between 20°C and 33°C, and the
surface temperature rise of the APPLIED PART shall not exceed 10 °C.
The temperature of the surface determined under the test conditions 201.11.1.3.101.1
shall be the sum of 33 °C and the measured temperature rise.
NOTE When following this test method, the temperature rise is defined as the difference between the temperature
of the TREATMENT HEAD just before the test and the maximum temperature of the TREATMENT HEAD during the test as
measured according to 201.11.1.3.101.1.
201.11.1.3.101.2 Still air
Suspend the TREATMENT HEAD in still air or place it in a stationary position in an environmental
chamber with minimal airflow across the APPLIED PART of the TREATMENT HEAD. Ensure that the
output face is clean (no coupling gel applied).
Test criteria are based upon temperature rise measurements.
The ambient temperature shall be 23 °C ± 3 °C and the initial temperature of the APPLIED PART
of the TREATMENT HEAD shall be the ambient temperature. During the test the temperature rise
of the APPLIED PART of the TREATMENT HEAD shall not exceed 27 °C.
To meet the requirements of not exceeding a surface temperature of 50 °C, the sum of the
surface temperature rise obtained under these test conditions and 23 °C shall be regarded as
the surface temperature under the test conditions of this subclause.

– 18 – 60601-2-5 © IEC:2009
201.11.1.3.101.3 Operating settings
Operate the ULTRASONIC PHYSIOTHERAPY EQUIPMENT at a setting that gives the highest surface
temperature of APPLIED PART of the TREATMENT HEAD. The requirements of 201.11.1.3.101.1
and 201.11.1.3.101.2 shall be performed using identical transmit parameters. The transmit
parameters of the test shall be recorded in the RISK MANAGEMENT FILE.
201.11.1.3.101.4 Test duration
The ULTRASONIC PHYSIOTHERAPY EQUIPMENT is continually operated for the duration of the test.
The test according to 201.11.1.3.101.1 and 201.11.1.2.101.2 shall be conducted for 30 min.
NOTE If the ULTRASONIC PHYSIOTHERAPY EQUIPMENT automatically “freezes” or halts its output earlier than the time
period given in this subclause, the ULTRASONIC PHYSIOTHERAPY EQUIPMENT shall be switched on again immediately.
201.11.1.3.101.5 Temperature measurement
The temperature of the TREATMENT HEAD should be measured by any appropriate means such
as radiometry or thermocouple methods.
If a thermocouple is used, the thermocouple junction and adjacent thermocouple lead wire
should be securely held in good thermal contact with the surface being measured. The
thermocouple should be positioned and secured in such a way that it has a negligible effect
on the temperature rise of the area being measured.
The size of the temperature measurement area of the sensor should be such that any
averaging effect is minimized.
The temperature shall be measur
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