IEC TS 62462:2007

TECHNICAL IEC
SPECIFICATION TS 62462
First edition
2007-05
Ultrasonics – Output test –
Guide for the maintenance of
ultrasound physiotherapy systems
Reference number
IEC/TS 62462:2007(E)
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TECHNICAL IEC
SPECIFICATION TS 62462
First edition
2007-05
Ultrasonics – Output test –
Guide for the maintenance of
ultrasound physiotherapy systems
PRICE CODE
Commission Electrotechnique Internationale U

International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
For price, see current catalogue

– 2 – TS 62462 © IEC:2007(E)
CONTENTS
FOREWORD.3
INTRODUCTION.5

1 Scope.6
2 Normative references .6
3 Terms and definitions .6
4 Testing regimes.7
4.1 Acceptance testing .7
4.2 Weekly testing.7
4.3 Annual testing .7
5 Performance testing .8
5.1 Acceptance testing .8
5.2 Weekly testing.9
5.3 Annual testing .10
5.4 Service requirement .12

Annex A (informative) Rationale for testing .14
Annex B (informative) Guidance for testers.15
Annex C (informative) Quantitative relative ultrasonic output test using temperature
rise .19
Annex D (informative) Quantitative relative ultrasonic output test using calorimetry .21
Annex E (informative) Example of weekly test report .23
Annex F (informative) Example of annual test report .24
Annex G (informative) Ultrasound portable power standard.28

Bibliography.29

Figure 1 – Several examples of how to prepare a set-up to check the distortion on the
water surface due to ultrasound .12
Figure 2 – Set-up where the slight angle of the treatment head to the vertical may
improve the image .13
Figure C.1 – Example of a measurement set-up to measure the temperature rise due to

ultrasound in absorbing material. .20
Figure D.1 – Schematic of equipment used within the calorimeter method for
monitoring power output of therapy treatment heads.21
Figure F.1 – Example of a power calibration graph for a large applicator head.26
Figure F.1 – Example of a power calibration graph for a large applicator head.26
Figure F.2 – Example of a power calibration graph for a small applicator head .27

TS 62462 © IEC:2007(E) – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
_______________
ULTRASONICS – OUTPUT TEST –
GUIDE FOR THE MAINTENANCE OF ULTRASOUND
PHYSIOTHERAPY SYSTEMS
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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The main task of IEC technical committees is to prepare International Standards. In
exceptional circumstances, a technical committee may propose the publication of a technical
specification when
• the required support cannot be obtained for the publication of an International Standard,
despite repeated efforts, or
• the subject is still under technical development or where, for any other reason, there is the
future but no immediate possibility of an agreement on an International Standard.
Technical specifications are subject to review within three years of publication to decide
whether they can be transformed into International Standards.
IEC 62462, which is a technical specification, has been prepared by IEC technical committee
87: Ultrasonics.
– 4 – TS 62462 © IEC:2007(E)
The text of this technical specification is based on the following documents:
Enquiry draft Report on voting
87/350/DTS 87/362/RVC
Full information on the voting for the approval of this technical specification 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.
NOTE The following print types are used:
• requirements: roman type;
• notes: in small roman type;
• words in bold in the text are defined in Clause 3.
• numbers in square brackets refer to the Bibliography.
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
• transformed into an International standard,
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
A bilingual version of this publication may be issued at a later date.

TS 62462 © IEC:2007(E) – 5 –
INTRODUCTION
The purpose of this technical specification is to establish standard methods for a qualitative
check of the performance of ultrasound physiotherapy devices during their lifetime, and to
provide guidance on calibration requirements and techniques.
To ensure that the ultrasound physiotherapy equipment is in an appropriate condition for use,
a regular quality check is necessary. This technical specification defines acceptance, weekly
and annual checks. The acceptance test checks the delivery of the device and its
performance at the start of its lifetime. The weekly check is a simple qualitative check of
device operation. In the annual check, in addition to a qualitative check, a quantitative check
is defined. Examples are provided of weekly and annual test reports.
This report also gives guidance to the testers concerning the measurement of acoustic output.
Annual testing is to be performed by a skilled tester, e.g. biomedical engineer, medical
physicist, medical device service agent, commercial tester, test house, national measurement
institute or manufacturer.
– 6 – TS 62462 © IEC:2007(E)
ULTRASONICS – OUTPUT TEST –
GUIDE FOR THE MAINTENANCE OF ULTRASOUND
PHYSIOTHERAPY SYSTEMS
1 Scope
This technical specification describes methods meant to assist users of ultrasound therapy
machines in checking the performance of such machines. It is applicable primarily to
physiotherapists, general medical practitioners, chiropractors, osteopaths, beauty therapists,
sports professionals, biomedical engineers, medical physicists, medical device service
agents, commercial testers, test houses or manufacturers.
NOTE The titles of all publications referred to informatively in this technical specification are listed in the
Bibliography.
2 Normative references
The following referenced documents are indispensable for the application of this document.
For dated references, only the edition cited applies. For undated references, the latest edition
of the referenced document (including any amendments) applies.
IEC 61689:2007, Ultrasonics – Physiotherapy systems – Performance requirements and
methods of measurement in the frequency range 0,5 MHz to 5 MHz
IEC 61161:2006, Ultrasonics – Power measurement – Radiation force balances and
performance requirements
IEC 60601-2-5, Medical electrical equipment – Part 2-5: Particular requirements for the safety
of ultrasonic physiotherapy equipment
BIPM, IEC, IFCC, ISO, IUPAC, IUPAP and OIML, Guide to the expression of uncertainty in
measurement
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
NOTE Most of the definitions described are taken from existing IEC standards. For use in the present guide such
definitions are simplified.
3.1
acoustic working frequency
rate at which the treatment head’s contact face is vibrating

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