Amendment 1 - Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment

Amendement 1 - Critères normalisés de déclaration des émissions acoustiques des appareils de diagnostic médical à ultrasons

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Status
Published
Publication Date
27-Jan-2013
Technical Committee
Current Stage
PPUB - Publication issued
Start Date
28-Jan-2013
Completion Date
28-Jan-2013
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IEC 61157:2007/AMD1:2013 - Amendment 1 - Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
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IEC 61157
Edition 2.0 2013-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
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/A1:2013
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
IEC 61157
Edition 2.0 2013-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
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 H
ICS 11.040.50, 17.140.50 ISBN 978-2-83220-586-0

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® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 3 ----------------------
– 2 – 61157 Amend.1 © IEC:2013
FOREWORD
This amendment has been prepared by IEC technical committee 87: Ultrasonics.
The text of this amendment is based on the following documents:
FDIS Report on voting
87/517/FDIS 87/523/RVD

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

on voting indicated in the above table.

The committee has decided that the contents of this amendment and the base 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.
_____________
2 Normative references

Replace the dated references to IEC 60050-801:1994, ISO 16269-6:2005 and ISO/IEC Guide

98:1994 by the following undated references:

IEC 60050-801, International Electrotechnical Vocabulary – Chapter 801: Acoustics and

electroacoustics

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

intervals

ISO/IEC Guide 98-3, Uncertainty of measurement – Part 3: Guide to the expression of

uncertainty in measurement (GUM:1995)
Replace the existing reference to IEC 62127-1 with the following:

IEC 62127-1:2007, Ultrasonics – Hydrophones – Part 1: Measurement and characterization of

medical ultrasonic fields up to 40 MHz
Amendment 1:2013
Add the following new reference:

IEC 60050-802, International Electrotechnical Vocabulary – Chapter 802: Ultrasonics

---------------------- Page: 4 ----------------------
61157 Amend.1 © IEC:2013 – 3 –
3 Terms, definitions and symbols

Replace in definitions 3.14, 3.20, 3.31 and 3.32 “expressed in watts per metre squared” by

“expressed in watts per square metre”

Replace in definitions 3.6 and 3.18 “expressed in metres squared” by “expressed in square

metres”
3.2
acoustic pulse waveform
Remove the numbering from Note 1 and replace existing Note 2 by the following:
[SOURCE: IEC 62127-1:2007, definition 3.1]
3.4.1
zero-crossing acoustic-working frequency
awf
Replace the existing text of the definition by the following:

number, n, of consecutive half-cycles (irrespective of polarity) divided by twice the time

between the commencement of the first half-cycle and the end of the n-th half-cycle

NOTE 1 None of the n consecutive half-cycles should show evidence of phase change.

NOTE 2 The measurement should be performed at terminals in the receiver, that are as close as possible to the

receiving transducer (hydrophone) and, in all cases, before rectification.

NOTE 3 This frequency is determined according to the procedure specified in IEC/TR 60854.

NOTE 4 This frequency is intended for continuous-wave systems only.
[SOURCE: IEC 62127-1:2007/Amendment 1:—, definition 3.3.1]
3.4.2
arithmetic-mean acoustic-working frequency
awf
Add the following new note and source reference to the existing definition:

NOTE 3 If f is not found within the range < 3f , f is to be understood as the lowest frequency above this range

2 1 2
at which the spectrum magnitude is -3 dB from the peak magnitude.
[SOURCE: IEC 62127-1, definition 3.3.2]
3.5
bandwidth
Add, after the note, the following:
[SOURCE: IEC 62127-1:2007, definition 3.6]
3.6
beam area
Replace the symbol by: “A , A ”
b,6 b,20
Replace the existing text of Note 1 by the following:

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

maximum value of the pulse-pressure-squared integral in the whole acoustic field.

Replace, in Note 3, the word “levels” by “fractions”.
---------------------- Page: 5 ----------------------
– 4 – 61157 Amend.1 © IEC:2013
3.10
beamwidth
Add, after Note 3, the following source reference:
[SOURCE: IEC 62127-1:2007, definition 3.11]
3.14
instantaneous intensity
Replace the existing text of Note 1 by the following:

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

International Standard and under conditions of sufficient distance from the external transducer aperture (at least

one transducer diameter, or an equivalent transducer dimension in the case of a non-circular transducer) the

instantaneous intensity can be approximated by the derived instantaneous intensity.

3.43
ultrasonic transducer element group dimensions

Replace, in the definition, the term “ultrasonic transducer element group” by “ultrasonic

transducer element group” (bold font for the entire term).
Add the following new definitions:
3.44
derived instantaneous intensity

quotient of squared instantaneous acoustic pressure and characteristic acoustic impedance

of the medium at a particular instant in time at a particular point in an acoustic field

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 speed of sound in the medium.

NOTE 1 For measurement purposes referred to in this International Standard, the derived instantaneous

intensity is an approximation of the instantaneous intensity.

NOTE 2 Increased uncertainty should be taken into account for measurements very close to the transducer.

NOTE 3 Derived instantaneous intensity is expressed in watts per square metre (W/m ).

[SOURCE: IEC 62127-1:2007/Amendment 1:—, definition 3.78]
3.45
number of pulses per ultrasonic scan line
pps
the number of acoustic pulses travelling along a particular ultrasonic scan line

NOTE 1 Here ultrasonic scan line refers to the path of acoustic pulses on a particular beam axis in scanning

and non-scanning modes.

NOTE 2 This number can be used in the calculation of any ultrasound temporal average value from hydrophone

measurements.

NOTE 3 The following shows an example of the number of pulses per ultrasonic scanline and the number of

ultrasonic scanlines (shows the end of a frame):
---------------------- Page: 6 ----------------------
61157 Amend.1 © IEC:2013 – 5 –
1 2 3 4; 1 2 3 4; 1 2 3 4… n =1; n = 4
pps sl
1 1 2 2 3 3 4 4; 1 1 2 2 3 3 4 4; … n =2; n = 4
pps sl
1 1 1 1 2 2 2 2 3 3 3 3 4 4 4 4; 1 1 1 1 2 2 2 2 3 3 3 3 4 4 4 4; … n = 4; n = 4
pps sl

1 1 2 2 3 3 4 4 1 1 2 2 3 3 4 4; 1 1 2 2 3 3 4 4 1 1 2 2 3 3 4 4; … n = 4; n = 4 (within one frame the pulses

pps sl
down each line may not occur contiguously)
Within one frame, all scan lines may not have the same npps value.
An example is: 1 2 2 3 3 4; 1 2 2 3 3 4; … avg n =1,5; max n = 2; n = 4
pps pps sl
3.46
number of ultrasonic scanlines

the quantity of ultrasonic scanlines that are excited during one scan repetition period

NOTE This number can be used in the calculation of any ultrasound temporal average value from hydrophone

measurements.
Table 1 – List of symbols
Add the following new symbols:
n number of pulses per ultrasonic scan line
pps
n number of ultrasonic scan lines per image for spatial distribution
instantaneous acoustic pressure
p(t) IEC 62127-1
w -6 dB beamwidth IEC 62127-1
w -20 dB beamwidth IEC 62127-1
A A beam area corresponding to -6 dB beam area and -20 dB beam area IEC 62127-1
b,6 b,20
I(t) instantaneous intensity IEC 62127-1
bandwidth
BW IEC 62127-1

z distance from the transducer output face to the point of maximum pulse- IEC 62127-1

pressure-squared integral
4 Requirements
4.2 Requirements for the reporting of acoustic output information
4.2.2 Detailed operating mode data sheets information format
Replace existing item h) by the following:

h) Pulse repetition rate (prr) for non-scanning modes. For scanning modes list the scan

repetition rate (srr) and the number of ultrasonic scan lines (n ). In case there is more

than 1 pulse per ultrasonic scan line, list the pulse repetition rate (prr) and the number

of pulses per ultrasonic scan line (n ).
pps
4.2.5 Dataset for low acoustic output equipment
Replace the last sentence of the second paragraph by the following:
Table A.1 need not be completed.
5 Compliance statement
5.1 General
Replace the existing text of items a) and b) of the second paragraph as follows:
---------------------- Page: 7 ----------------------
– 6 – 61157 Amend.1 © IEC:2013

a) the arithmetic mean determined from measurements on a group of n nominally identical

systems, each with the acoustic output settings yielding the maximum output, where n ≥ 3

and
b) the overall uncertainty of the value determined under a).

This overall uncertainty shall be calculated using an appropriate measure (with 95 %

confidence, for 95 % of the population) of the statistical variation and the measurement

uncertainty (at a level of confidence of 95 %).
Replace the existing third paragraph with the following text:

The tolerance interval is to be understood in accordance with ISO 16269-6. More guidance on

assessment of uncertainties is given in IEC 62127-1, Annex I.

Measurement uncertainty involves many components (see IEC 62127-1, Annex I). It shall be

an assessment of the contributions of all uncertainties (these referring to measurements made

on one system). The measurement uncertainty shall be calculated as expanded uncertainty

corresponding to a level of confidence of 95 %. The method of combining the uncertainty

contributions specified by the ISO/IEC Guide 98-3, Guide to the expression of uncertainty in

measurement, shall be followed.

NOTE “Tolerance interval” refers to the production scatter and “uncertainty” refers to the measurement method.

5.2 Maximum probable values

Replace, in lettered item a) in the first paragraph, “as referred to in 4.2” by “as referred to in

4.2, where n ≥ 3”:
---------------------- Page: 8 ----------------------
61157 Amend.1 © IEC:2013 – 7 –
Annex A – Presentation of acoustic output information

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

Replace existing Table A.1 (including the captions above the table) with the following:

Manufacturer: ZZZ
Acoustic output information for the ZZZ phased-array sector scanner
3,5 MHz general
...

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