Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment

IEC 61157:2007 specifies a standard means and format for the reporting of the acoustic output of medical diagnostic ultrasonic equipment. The numerical values for reporting purposes represent the average values for the maximum output conditions for a given discrete- or combined-operating mode and are derived from measurements made in water. Intensity parameters are specified in this standard, but these are regarded as derived quantities that are meaningful only under certain assumptions related to the ultrasonic field being measured. This International Standard is applicable to medical diagnostic ultrasonic equipment. It provides a set of traceable acoustic parameters describing the acoustic fields. It defines a standard means and format for the reporting of the acoustic output information. It also describes a reduced dataset recommended for equipment generating low acoustic output levels. This second edition cancels and replaces the first edition published in 1992. This edition constitutes a minor revision. The changes with respect to the previous edition are listed hereafter:
- maintenance on this standard and the referenced standards IEC 61161 and IEC 62127-1;
- and a clause on compliance has been added. The contents of the corrigendum of August 2008 have been included in this copy. The French version of this standard has not been voted upon.

Critères normalisés de déclaration des émissions acoustiques des appareils de diagnostic médical à ultrasons

La CEI 61157:2007 spécifie les critères et un format normalisés de déclaration des émissions acoustiques des appareils de diagnostic médical à ultrasons. Les valeurs numériques de déclaration représentent les valeurs moyennes des conditions d'émission maximale pour un mode opératoire discret ou combiné donné et proviennent de mesures réalisées dans l'eau. Les paramètres d'intensité sont spécifiés dans la présente norme. Cependant, ils sont considérés comme des grandeurs dérivées qui sont significatives uniquement dans le cadre de certaines hypothèses liées au champ ultrasonique mesuré. La présente Norme internationale s'applique aux appareils de diagnostic médical à ultrasons. Elle offre un jeu de paramètres acoustiques traçables décrivant les champs acoustiques. Elle définit des critères et un format normalisés de déclaration des informations relatives aux émissions acoustiques. Elle décrit également un jeu de données d'exemption pour les appareils générant de bas niveaux d'émissions acoustiques. Cette deuxième édition annule et remplace la première édition parue en 1992. La présente édition constitue une révision mineure. Les principaux changements effectués par rapport à l'édition précédente sont les suivants:
- mise à jour de la présente norme et des références aux normes CEI 61161 et CEI 62127-1;
- et un article relatif à la conformité a été ajouté. Le contenu du corrigendum (août 2008, disponible en anglais seulement) a été inclus dans cette norme. La version française n'a pas été soumise au vote.

General Information

Status
Published
Publication Date
08-Aug-2007
Technical Committee
Current Stage
PPUB - Publication issued
Start Date
09-Aug-2007
Completion Date
09-Aug-2007
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IEC 61157
Edition 2.0 2007-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Standard means for the reporting of the acoustic output of medical diagnostic
ultrasonic equipment
Critères normalisés de déclaration des émissions acoustiques des appareils
de diagnostic médical à ultrasons
IEC 61157:2007
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
IEC 61157
Edition 2.0 2007-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Standard means for the reporting of the acoustic output of medical diagnostic
ultrasonic equipment
Critères normalisés de déclaration des émissions acoustiques des appareils
de diagnostic médical à ultrasons
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX V
ICS 11.040.50; 17.140.50 ISBN 978-2-83220-132-9

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 3 ----------------------
– 2 – 61157  IEC:2007
CONTENTS

FOREWORD......................................................................................................................... 3

INTRODUCTION ................................................................................................................... 5

1 Scope ............................................................................................................................ 6

2 Normative references ..................................................................................................... 6

3 Terms, definitions and symbols ....................................................................................... 6

4 Requirements ............................................................................................................... 16

4.1 General ............................................................................................................... 16

4.2 Requirements for the reporting of acoustic output information ............................... 17

4.2.1 Technical data sheets information format .................................................. 17

4.2.2 Detailed operating mode data sheets information format ........................... 18

4.2.3 Background information ........................................................................... 19

4.2.4 Diagnostic fields in the absence of scan-frame synchronization ................. 20

4.2.5 Dataset for low acoustic output equipment ................................................ 20

5 Compliance statement .................................................................................................. 21

5.1 General ............................................................................................................... 21

5.2 Maximum probable values ................................................................................... 21

5.3 Sampling ............................................................................................................. 21

6 Test methods ............................................................................................................... 22

7 Presentation of results .................................................................................................. 22

Annex A (normative) Presentation of acoustic output information ........................................ 23

Annex B (informative) Reporting requirements for extensive systems .................................. 25

Annex C (informative) Rationale ......................................................................................... 26

Index of defined terms ........................................................................................................ 30

Bibliography ....................................................................................................................... 32

Figure C.1 – Schematic diagram showing the relationship between the various defined

surfaces and distances for a mechanical sector scanner with water stand-off distance

when applied to a patient .................................................................................................... 27

Figure C.2 – Schematic diagram showing the relationship between the various defined

parameters and distances for a mechanical sector scanner during the measurement of

acoustic output ................................................................................................................... 27

Figure C.3 – Schematic diagram showing various defined parameters associated with

the distribution of the scan lines in a linear array scanner and mechanically-scanned

sector scanner .................................................................................................................... 28

Figure C.4 – Schematic diagram illustrating the peak-rarefactional acoustic pressure

during an acoustic pulse ..................................................................................................... 29

Table 1 – List of symbols .................................................................................................... 15

Table A.1 – An example of reporting of the acoustic output of a 3,5 MHz scan-head for

a phased-array sector scanner in accordance with this standard ......................................... 24

---------------------- Page: 4 ----------------------
61157  IEC:2007 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
STANDARD MEANS FOR THE REPORTING
OF THE ACOUSTIC OUTPUT OF MEDICAL DIAGNOSTIC
ULTRASONIC EQUIPMENT
FOREWORD

1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

all national electrotechnical committees (IEC National Committees). The object of IEC is to promote

international co-operation on all questions concerning standardization in the electrical and electronic fields. To

this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,

Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC

Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested

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with the International Organization for Standardization (ISO) in accordance with conditions determined by

agreement between the two organizations.

2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

consensus of opinion on the relevant subjects since each technical committee has representation from all

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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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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 61157 has been prepared by IEC technical committee 87:

Ultrasonics.

This second edition cancels and replaces the first edition published in 1992. This edition

constitutes a minor revision.
The changes with respect to the previous edition are listed below:

• maintenance on this standard and the referenced standards IEC 61161 and IEC 62127-1.

• a clause on compliance has been added.

This bilingual version (2012-06) corresponds to the monolingual English version, published in

2007-08.
---------------------- Page: 5 ----------------------
– 4 – 61157  IEC:2007
The text of this standard is based on the following documents:
Enquiry draft Report on voting
87/356/CDV 87/374/RVC

Full information on the voting for the approval of this standard can be found in the report on

voting indicated in the above table.
The French version of this standard has not been voted upon.

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

NOTE The following print types are used:
– Requirements: in roman type
– Test specifications: in italic type
– Notes: in small roman type
– Words in bold in the text are defined in Clause 3.

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.
The contents of the corrigendum of August 2008 have been included in this copy.
---------------------- Page: 6 ----------------------
61157  IEC:2007 – 5 –
INTRODUCTION

This International Standard specifies a standard means and format for the reporting of the

acoustic output of medical diagnostic ultrasonic equipment. The numerical values for reporting

purposes represent the average values for the maximum output conditions for a given

discrete- or combined-operating mode and are derived from measurements made in water.

Intensity parameters are specified in this standard, but these are regarded as derived

quantities that are meaningful only under certain assumptions related to the ultrasonic field

being measured.
---------------------- Page: 7 ----------------------
– 6 – 61157  IEC:2007
STANDARD MEANS FOR THE REPORTING
OF THE ACOUSTIC OUTPUT OF MEDICAL DIAGNOSTIC
ULTRASONIC EQUIPMENT
1 Scope

This International Standard is applicable to medical diagnostic ultrasonic equipment.

– It provides a set of traceable acoustic parameters describing the acoustic fields.

– It defines a standard means and format for the reporting of the acoustic output information.

– It also describes a reduced dataset recommended for equipment generating low acoustic

output levels.
NOTE The information tabulated in this standard format can be used for
a) exposure planning for biological effects studies;

b) exposure data for prospective epidemiological studies conducted using exposure conditions similar to

those reported in this standard. In the absence of actual exposure data for retrospective epidemiological

studies, the information tabulated in this standard format might also be used with cautionary comment.

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 60050-801:1994 International Electrotechnical Vocabulary – Chapter 801: Acoustics and

electroacoustics

IEC 61161, Ultrasonics – Power measurement – Radiation force balances and performance

requirements

IEC 62127-1, Ultrasonics – Hydrophones – Part 1: Measurement and characterization of

medical ultrasonic fields up to 40 MHz

ISO 16269-6:2005, Statistical interpretation of data – Part 6: Determination of statistical

tolerance intervals

ISO/IEC Guide 98:1995, Guide to the expression of uncertainty in measurement (GUM)

3 Terms, definitions and symbols

For the purposes of this document, the terms and definitions given in IEC 62127-1, IEC 61161,

the Index of defined terms at the end of this standard and the following definitions apply.

Figures C.1 to C.4 illustrate some of the defined parameters given below.
3.1
acoustic output freeze

condition of a system for which the acoustic output is disabled when there is no active

updating of ultrasonic echo information
---------------------- Page: 8 ----------------------
61157  IEC:2007 – 7 –
3.2
acoustic pulse waveform

temporal waveform of the instantaneous acoustic pressure at a specified position in an

acoustic field and displayed over a period sufficiently long to include all significant acoustic

information in a single pulse or tone-burst, or in one or more cycles in a continuous wave

NOTE 1 Temporal waveform is a representation (e.g. oscilloscope presentation or equation) of the instantaneous

acoustic pressure.
NOTE 2 Definition adapted from IEC 60469-1.
3.3
acoustic repetition period
arp

pulse repetition period for non-automatic scanning systems and the scan repetition period

for automatic scanning systems, equal to the time interval between corresponding points of

consecutive cycles for continuous wave systems
NOTE The acoustic repetition period is expressed in seconds (s).
[IEC 62127-1, definition 3.2]
3.4
acoustic frequency
acoustic-working frequency

frequency of an acoustic signal based on the observation of the output of a hydrophone

placed in an acoustic field at the position corresponding to the spatial-peak temporal-peak

acoustic pressure

NOTE 1 The signal is analysed using either the zero-crossing acoustic-working frequency technique or a

spectrum analysis method. Acoustic-working frequencies are defined in 3.4.1 and 3.4.2.

NOTE 2 In a number of cases, the present definition is not very helpful or convenient, especially for broadband

transducers. In that case, a full description of the frequency spectrum should be given in order to enable any

frequency-dependent correction to the signal.
NOTE 3 Acoustic frequency is expressed in hertz (Hz).
3.4.1
zero-crossing acoustic-working frequency
awf
this is determined according to the procedure specified in IEC/TR 60854
NOTE This frequency is intended for continuous wave systems only.
3.4.2
arithmetic-mean acoustic-working frequency
awf

arithmetic mean of the most widely separated frequencies f and f , within the range of three

1 2

times f , at which the magnitude of the acoustic pressure spectrum is 3 dB below the peak

magnitude
NOTE 1 This frequency is intended for pulse-wave systems only.
NOTE 2 It is assumed that f < f
1 2
3.5
bandwidth

difference in the most widely separated frequencies f and f at which the magnitude of the

1 2

acoustic pressure spectrum becomes 3 dB below the peak magnitude, at a specified point in

the acoustic field
NOTE Bandwidth is expressed in hertz (Hz).
---------------------- Page: 9 ----------------------
– 8 – 61157  IEC:2007
3.6
beam area

area in a specified plane perpendicular to the beam axis consisting of all points at which the

pulse-pressure-squared integral is greater than a specified fraction of the maximum value

of the pulse-pressure-squared integral in that plane

NOTE 1 If the position of the plane is not specified, it is the plane passing through the point corresponding to the

spatial-peak temporal-peak acoustic pressure in the whole acoustic field.

NOTE 2 In a number of cases, the term pulse-pressure-squared integral is replaced everywhere in the above

definition by any linearly related quantity, for example:

a) in the case of a continuous wave signal the term pulse-pressure-squared integral is replaced by mean

square acoustic pressure as defined in IEC 61689;

b) in cases where signal synchronisation with the scanframe is not available the term pulse-pressure-squared

integral may be replaced by temporal average intensity.

NOTE 3 Some specified levels are 0,25 and 0,01 for the −6 dB and −20 dB beam areas, respectively.

NOTE 4 Beam area is expressed in metres squared (m ).
3.7
beam axis

straight line that passes through the beam centrepoints of two planes perpendicular to the

line which connects the point of maximal pulse-pressure-squared integral with the centre of

the external transducer aperture

NOTE 1 The location of the first plane is the location of the plane containing the maximum pulse-pressure-

squared integral or, alternatively, is one containing a single main lobe which is in the focal Fraunhofer zone. The

location of the second plane is as far as is practicable from the first plane and parallel to the first with the same two

orthogonal scan lines (x and y axes) used for the first plane.

NOTE 2 In a number of cases, the term pulse-pressure-squared integral is replaced in the above definition by

any linearly related quantity, for example:

a) in the case of a continuous wave signal the term pulse-pressure-squared integral is replaced by mean square

acoustic pressure as defined in IEC 61689;

b) in cases where signal synchronisation with the scanframe is not available, the term pulse-pressure-squared

integral may be replaced by temporal average intensity.
[IEC 62127-1,definition 3.8 modified]
3.8
beam centrepoint

position determined by the intersection of two lines passing through the beamwidth

midpoints of two orthogonal planes, xz and yz
3.9
beamwidth midpoint
linear average of the location of the centres of beamwidths in a plane

NOTE The average is taken over as many beamwidth levels given in Table K.1 of IEC 62127-1 as signal level

permits.
3.10
beamwidth
w , w , w
6 12 20

greatest distance between two points on a specified axis perpendicular to the beam axis

where the pulse-pressure-squared integral falls below its maximum on the specified axis by

a specified amount
---------------------- Page: 10 ----------------------
61157  IEC:2007 – 9 –

NOTE 1 In a number of cases, the term pulse-pressure-squared integral is replaced in the above definition by

any linearly related quantity, for example:

a) in the case of a continuous wave signal the term pulse-pressure-squared integral is replaced by mean

square acoustic pressure as defined in IEC 61689,

b) in cases where signal synchronisation with the scanframe is not available the term pulse-pressure-squared

integral may be replaced by temporal average intensity.

NOTE 2 Commonly used beamwidths are specified at –6 dB, –12 dB and –20 dB levels below the maximum. The

decibel calculation implies taking 10 times the logarithm of the ratios of the integrals.

NOTE 3 Beamwidth is expressed in metres (m).
3.11
central scan line

for automatic scanning systems, the ultrasonic scan line closest to the symmetry axis of the

scan plane
3.12
external transducer aperture

part of the surface of the ultrasonic transducer or ultrasonic transducer element group

assembly that emits ultrasonic radiation into the propagation medium

NOTE This surface is either directly in contact with the patient or is in contact with a water or liquid path to the

patient (see IEC 62127-1, Figure 1).
[IEC 62127-1,definition 3.27 modified]
3.13
instantaneous acoustic pressure
p(t)

pressure minus the ambient pressure at a particular instant in time and at a particular point in

an acoustic field (see also IEV 801-21-19)
NOTE Instantaneous acoustic pressure is expressed in pascals (Pa).
3.14
instantaneous intensity
I(t)

acoustic energy transmitted per unit time in the direction of acoustic wave propagation per

unit area normal to this direction at a particular instant in time and at a particular point in an

acoustic field

NOTE 1 Instantaneous intensity is the product of instantaneous acoustic pressure and particle velocity. It is

difficult to measure intensity in the ultrasound frequency range. For the measurement purposes referred to in this

standard, and if it is reasonable to assume far field conditions, the instantaneous intensity, I is approximated as

p(t)
I(t) = (1)
ρ c
where
p(t) is the instantaneous acoustic pressure;
ρ is the density of the medium;
c is the velocity of sound in the medium.
NOTE 2 Instantaneous intensity is expressed in watts per metre squared (W/m ).
3.15
medical diagnostic ultrasonic equipment (or system)

combination of the ultrasound instrument console and the transducer assembly making up

a complete diagnostic system
---------------------- Page: 11 ----------------------
– 10 – 61157  IEC:2007
3.16
nominal frequency

the ultrasonic frequency of operation of an ultrasonic transducer or ultrasonic transducer

element group quoted by the designer or manufacturer
[IEC 60854, definition 3.7 modified]
3.17
operating mode
3.17.1
combined-operating mode

mode of operation of a system that combines more than one discrete-operating modes

NOTE Examples of combined-operating modes are real-time B-mode combined with M-mode (B+M), real-time

B-mode combined with pulsed Doppler (B+D), colour M-mode (cM), real-time B-mode combined with M-mode and

pulsed Doppler (B+M+D), real-time B-mode combined with real-time flow-mapping Doppler (B+rD), i.e. flow-

mapping in which different types of acoustic pulses are used to generate the Doppler information and the imaging

information.
[IEC 62127-1, definition 3.39.1]
3.17.2
discrete-operating mode

mode of operation of medical diagnostic ultrasonic equipment in which the purpose of the

excitation of the ultrasonic transducer or ultrasonic transducer element group is to utilize only

one diagnostic methodology

NOTE Examples of discrete-operating modes are A-mode (A), M-mode (M), static B-mode (sB), real-time B-

mode (B), continuous wave Doppler (cwD), pulsed Doppler (D), static flow-mapping (sD) and real-time flow-

mapping Doppler (rD) using only one type of acoustic pulse.
[IEC 62127-1, definition 3.39.2]
3.17.3
inclusive mode
combined-operating mode having acoustic output levels (p and I ) less than those
r spta
corresponding to a specified discrete-operating mode
[IEC 62127-1, definition 3.39.3]
3.17.4
non-scanning mode

mode of operation of a system that involves a sequence of ultrasonic pulses which give rise

to ultrasonic scan lines that follow the same acoustic path
[IEC 62127-1, definition 3.39.4]
3.17.5
scanning mode

mode of operation of a system that involves a sequence of ultrasonic pulses which give rise

to ultrasonic scan lines that do not follow the same acoustic path

NOTE The sequence of pulses is not necessarily made up of identical pulses. For instance, the use of sequential

multiple focal-zones is considered a scanning mode.
[IEC 62127-1, definition 3.39.5]
---------------------- Page: 12 ----------------------
61157  IEC:2007 – 11 –
3.18
output beam area

area of the ultrasonic beam derived from the −12 dB beam area at the external transducer

aperture

NOTE 1 For reasons of measurement accuracy, the –12 dB output beam area may be derived from

measurements at a distance chosen to be as close as possible to the face of the transducer, and, if possible, no

more than 1 mm from the face.

NOTE 2 For contact transducers, this area can be taken as the geometrical area of the ultrasonic transducer or

ultrasonic transducer element group.
NOTE 3 The output beam area is expressed in metres squared (m ).
[IEC 62127-1, definition 3.40]
3.19
output beam dimensions
X , Y
ob ob

dimensions of the ultrasonic beam (–12 dB beamwidth) in specified directions perpendicular

to each other and in a direction normal to the beam axis and at the external transducer

aperture

NOTE 1 For reasons of measurement accuracy, the –12 dB output beam dimensions may be derived from

measurements at a distance chosen to be as close as possible to the face of the transducer, and, if possible, no

more than 1 mm from the face.

NOTE 2 For contact transducers, these dimensions can be taken as the geometrical dimensions of the ultrasonic

transducer or ultrasonic transducer element group.
NOTE 3 Output beam dimensions are expressed in metres (m)
[IEC 62127-1, definition 3.41]
3.20
output beam intensity
temporal-average power output divided by the output beam area
NOTE Output beam intensity is expressed in watts per metre squared (W/m
...

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