Amendment 1 - Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields

Amendement 1 - Ultrasons - Caractérisation du champ - Méthodes d'essais pour la détermination d'indices thermique et mécanique des champs d'ultrasons utilisés pour le diagnostic médical

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Status
Published
Publication Date
28-Sep-2017
Technical Committee
Current Stage
PPUB - Publication issued
Start Date
29-Sep-2017
Completion Date
29-Sep-2017
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IEC 62359:2010/AMD1:2017 - Amendment 1 - Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
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IEC 62359
Edition 2.0 2017-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Ultrasonics – Field characterization – Test methods for the determination of
thermal and mechanical indices related to medical diagnostic ultrasonic fields
Ultrasons – Caractérisation du champ – Méthodes d'essai pour la détermination
d'indices thermique et mécanique des champs d'ultrasons utilisés pour le
diagnostic médical
IEC 62359:2010-10/AMD1:2017-09(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
IEC 62359
Edition 2.0 2017-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Ultrasonics – Field characterization – Test methods for the determination of
thermal and mechanical indices related to medical diagnostic ultrasonic fields
Ultrasons – Caractérisation du champ – Méthodes d'essai pour la détermination
d'indices thermique et mécanique des champs d'ultrasons utilisés pour le
diagnostic médical
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 17.140.50 ISBN 978-2-8322-5301-4

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 – IEC 62359:2010/AMD1:2017
© IEC 2017
FOREWORD
This amendment has been prepared by IEC technical committee 87: Ultrasonics.

This bilingual version (2018-01) corresponds to the monolingual English version, published in

2017-09.
The text of this amendment is based on the following documents:
FDIS Report on voting
87/661/FDIS 87/665/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 French version of this amendment has not been voted upon.

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 website 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.
_____________
Introduction to Amendment
The second edition of IEC 62359 was published in 2010. Since then,

IEC 60601-2-37:2007/AMD1:2015 has been published and calls for provision of attenuated

spatial peak temporal average intensity, I , and attenuated spatial peak pulse
spta,a
, at specific spatial maximum points in the ultrasonic field on the
average intensity, I
sppa,a

beam axis. No IEC standard describes the determination of these quantities at these specific

positions. IEC 62359 for determining the thermal indices currently uses similar values at other

positions, therefore, the determination of attenuated spatial peak temporal average

intensity, I , and attenuated spatial peak pulse average intensity, I , has been
spta,a sppa,a
added as an annex in this amendment.

Additionally, references to newly published collateral standards have been updated.

_____________
---------------------- Page: 4 ----------------------
IEC 62359:2010/AMD1:2017 – 3 –
© IEC 2017
2 Normative references
Replace the first reference by the following:

IEC 60601-2-37:2007, Medical electrical equipment – Part 2-37: Particular requirements for

the basic safety and essential performance of ultrasonic medical diagnostic and monitoring

equipment
IEC 60601-2-37:2007/AMD1:2015
Replace the second reference by the following:

IEC 61157:2007, Standard means for the reporting of the acoustic output of medical

diagnostic ultrasonic equipment
IEC 61157:2007/AMD1:2013
Replace, in the third reference, "IEC 61161:2006" by "IEC 61161:2013".
Replace the fifth reference by the following:

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

medical ultrasonic fields up to 40 MHz
IEC 62127-1:2007/AMD1:2013
3 Terms and definitions
Replace the first existing paragraph by the following new paragraph:

For the purposes of this document, the terms and definitions given in IEC 60601-2-37,

IEC 62127-1, IEC 62127-2, IEC 62127-3, IEC 61157 and IEC 61161 apply. Several of these

are repeated below for convenience and others are listed because they have been modified

for application to this standard.
3.3
acoustic repetition period
Replace the existing definition by the following new definition:

time interval between corresponding points of consecutive cycles, pulses or scans, depending

on the current operating mode
Add the following new NOTES 2 and 3:

NOTE 2 For continuous wave modes, the acoustic repetition period is the time interval between corresponding

points of consecutive cycles

NOTE 3 For combined operating modes where transmit pulsing of the constituent modes may be interrupted,

the arp determination should take into account non-pulsing time to calculate an average period.

Replace "NOTE 2" by NOTE 4".
3.4
acoustic working frequency

Replace, in the existing definition, the words "at the position corresponding to the spatial-

peak temporal-peak acoustic pressure" by "on the beam axis, beyond the break-point

depth, corresponding to depth of maximum pulse-intensity integral z "
pii

Replace, in existing NOTE 2, the words "at the position of maximum pulse-pressure-squared

integral" by "at the depth for peak pulse-intensity integral".
---------------------- Page: 5 ----------------------
– 4 – IEC 62359:2010/AMD1:2017
© IEC 2017
3.7
attenuated peak-rarefactional acoustic pressure

Replace, in the existing definition, the words "at a specified distance from" by "on a plane

perpendicular to the beam axis at a specified distance z from".

Replace, in the definition list after Equation (2), the words "z is the distance from the external

transducer aperture to the point of interest" by "z is the distance from the external

transducer aperture along the beam axis to the plane containing the point of interest".

3.8
attenuated pulse-intensity integral

Replace, in the definition, the words "at a specified distance from" by "on a plane

perpendicular to the beam axis at a specified distance z from".

Replace, in the definition list after Equation (3), the words "z is the distance from the external

transducer aperture to the point of interest" by "z is the distance from the external

transducer aperture along the beam axis to the plane containing the point of interest".

Replace "NOTE" by "NOTE 1".
Add new NOTE 2:

NOTE 2 For measurement purposes of this standard, pii is equivalent to 1/(ρc) times the attenuated pulse-

pressure-squared integral at depth z, with ρc denoting the characteristic acoustic impedance of pure water.

3.9
attenuated spatial-average temporal-average intensity

Replace, in the definition, the words "at a specified distance from" by "on a plane

perpendicular to the beam axis at a specified distance z from".

Replace, in the definition list after Equation (4), the words "z is the distance from the external

transducer aperture to the point of interest" by "z is the distance from the external

transducer aperture along the beam axis to the plane containing the point of interest".

3.10
attenuated spatial-peak temporal-average intensity

Replace, in the definition, the words "at a specified distance from" by "on a plane

perpendicular to the beam axis at a specified distance z from".

Replace, in the definition list after Equation (5), the words "z is the distance from the external

transducer aperture to the point of interest" by "z is the distance from the external

transducer aperture along the beam axis to the plane containing the point of interest".

3.11
attenuated temporal-average intensity

Replace, in the definition, the words "at a specified distance from" by "on a plane

perpendicular to the beam axis at a specified distance z from".

Replace, in the definition list after Equation (6), the words "z is the distance from the external

is the distance from the external
transducer aperture to the point of interest" by "z

transducer aperture along the beam axis to the plane containing the point of interest".

3.13
beam-axis
Replace the term "beam-axis" by "beam axis".
---------------------- Page: 6 ----------------------
IEC 62359:2010/AMD1:2017 – 5 –
© IEC 2017
3.17
bone thermal index
Delete, in the definition, "or neonatal cephalic (through the fontanelle)".
3.19
break-point depth

Add, after the existing definition, the words "acoustic working frequency and intensity

parameters (such as attenuated spatial-peak temporal-average intensity)"

Add, after "where D is the equivalent aperture diameter" the words "for non-scanning

modes".
Replace the existing NOTE 2 by the following new note:

NOTE 2 For scanning modes, use the non-scanning mode D value calculation [Equation (8)]. Do this using

the output beam area of one ultrasonic scan line; the central scan line, corresponding to the beam axis (i.e. the

line where pii MI, and f are measured).
awf
3.21
cranial-bone thermal index
Replace the existing definition by the following new definition:

thermal index for applications in which the ultrasound beam passes through bone near the

beam entrance into the body, such as paediatric and adult cranial or neonatal cephalic

applications
3.22
default setting

Replace, in the definition, "ultrasonic diagnostic equipment" by "medical diagnostic

ultrasonic equipment".
3.23
depth for mechanical index

Replace, in the definition, the words "to the plane of maximum attenuated pulse-intensity

integral (pii )" by "to the plane of maximum attenuated pulse-pressure-squared-integral

(ppsi )".
Add new NOTE 1:

NOTE 1 Because z may occur closer to the transducer than the break-point depth z , use of ppsi rather than

MI bp α

pii is technically more appropriate. If z is larger than z , then z and z are equal.

α ppsi,α bp ppsi,α pii,α
Replace "NOTE" by "NOTE 2".
3.24
depth for peak pulse-intensity integral

Replace the existing term, definition and note by the following new term, definition and notes:

3.24
depth for maximum pulse intensity integral
depth z on the beam axis and beyond the break-point depth z from the external
transduscer aperture to the plane of maximum pulse-intensity integral (pii) as
approximated by the pulse-pressure-squared integral (ppsi)
NOTE 1 Depth for maximum pii is expressed in metres (m).

NOTE 2 Depth for maximum pii is termed "depth for peak pulse-intensity integral" in

IEC 60601-2-37:2007/AMD1:2015.
---------------------- Page: 7 ----------------------
– 6 – IEC 62359:2010/AMD1:2017
© IEC 2017
NOTE 3 At this depth the acoustic working frequency is determined.
3.27
Discrete-perating mode
Replace the term "Discrete-perating mode" by "discrete-operating mode".

Replace, in the definition, "ultrasonic diagnostic equipment" by "medical diagnostic

ultrasonic equipment".
3.28
equivalent aperture diameter

Replace the existing definition and equation by the following new definition and equation:

diameter of a circle the area A of which is the –12 dB output beam area A for non-

scanning modes and the –12 dB scanned aperture area A for scanning modes, given by

D = A
(8)
Replace the existing NOTE 1 by the following new note:

NOTE 1 Equation (8) is used in the calculation of the cranial-bone thermal index; for non-scanning modes with

A = A and for scanning modes with A = A .
ob sa
Add new NOTE 2:

NOTE 2 Equation (8) with A = A is also used in calculating the break-point depth.

Replace "NOTE 2" by "NOTE 3".
3.33
medical diagnostic ultrasonic equipment
Replace "NOTE" by "NOTE 1".
Add new NOTE 2:

NOTE 2 IEC 60601-2-37:2007 uses the term "ultrasonic diagnostic equipment" instead of medical diagnostic

ultrasonic equipment.
3.34
non-scanning mode

Replace, in the definition, the words "ultrasonic diagnostic equipment" by "medical

diagnostic ultrasonic equipment".
3.37
output power
Replace, in the source, "IEC 61161:2006" by "IEC 61161:2013".
3.40
prudent-use statements
Replace the existing definition by the following new definition:

affirmations of the principle that only necessary clinical information should be acquired and

that high exposure levels and long exposure times should be avoided
---------------------- Page: 8 ----------------------
IEC 62359:2010/AMD1:2017 – 7 –
© IEC 2017
3.44
pulse repetition period
Add new NOTE 1:

NOTE 1 In general, for non-scanning modes the pulse repetition period needs to be adjusted to represent a

‘per-second’ average taking into account interruptions-in, or non-constant, pulsing; e.g. such as may occur in

combined operating modes.
Replace "NOTE" by "NOTE 2".
3.49
scanning mode

Replace, in the definition, the words "an ultrasonic diagnostic equipment" by "a medical

diagnostic ultrasonic equipment".
3.54
spatial-peak temporal-average intensity
Replace the existing NOTE 1 by the following new note:

NOTE 1 For systems in combined-operating modes, the averaging time period needs to be sufficient to include

periods in which scanning or pulsing is interrupted.
3.56
thermal index

Replace, in the definition, the two occurrences of the words " attenuated acoustic power" by

"attenuated output power"
Add the following new definitions:
3.61
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
NOTE Instantaneous acoustic pressure is expressed in pascals (Pa).

[SOURCE: IEC 62127-1:2007, 3.33, modified – The reference to IEV 801-01-19 has been

removed in the definition]
3.62
attenuated instantaneous acoustic pressure
(z,t)

value of the instantaneous acoustic pressure at time t after attenuation on a plane

perpendicular to the beam axis at a specified distance z from the source, and given by

(−a z f 20 dB)
awf
( ) ( )
p z,t = p z,t 10 (26)
where
a is the acoustic attenuation coefficient;
z is the distance from the source to the point (plane) of interest;
f is the acoustic working frequency;
awf
p(z,t) is the instantaneous acoustic pressure
NOTE Attenuated instantaneous acoustic pressure is expressed in pascals (Pa).
---------------------- Page: 9 ----------------------
– 8 – IEC 62359:2010/AMD1:2017
© IEC 2017
3.63
attenuated pulse-pressure-squared integral
ppsi (z)

time integral of the square of the attenuated instantaneous acoustic pressure, integrated

over the acoustic pulse waveform, on a plane perpendicular to the beam axis at a specified

distance z in an acoustic field
2 (−a z f 20 dB) (−a z f 10 dB)
awf awf
ppsi (z)= p (z,t)dt= [p(z,t)10 ] dt= ppsi(z)×10
a a (27)
∫ ∫
where
p(z,t) is the instantaneous acoustic pressure at depth z.
a is the acoustic attenuation coefficient;
z is the distance from the source to the point (plane) of interest;
f is the acoustic working frequency;
awf
ppsi is the pulse-pressure-squared integral

NOTE 1 Attenuated pulse-pressure-squared integral is expressed in pascal squared seconds (Pa s).

NOTE 2 See definition 3.43 for the non-attenuated version; with the addition here of the perpendicular plane at

depth z.
3.64
attenuated scan intensity integral
sii (z)

sum of the attenuated pulse intensity integrals in one scan (one frame of ultrasonic scan

lines) at depth z

NOTE 1 Attenuated scan intensity integral is expressed in joules per square metre (Jm ).

NOTE 2 For measurement purposes of this standard, sii (z) is equivalent to 1/(ρc) times the sum of attenuated

pulse-pressure-squared integrals at depth z, for z ≥ z , with ρc denoting the characteristic acoustic impedance of

pure water.
NOTE 3 See definition 3.79 for the non-attenuated version.
3.65
attenuated spatial-peak pulse-average intensity
I (z)
sppa,α

maximum value of the spatial-peak pulse-average intensity after attenuation, on a plane

perpendicular to the beam axis at a specified distance z from the source, and given by

I (z)= pii (z)
sppa,a a (28)
t (z)
where
t (z) is the pulse duration at the same depth z;
pii (z) is the attenuated pulse-intensity integral at depth z.

NOTE 1 Attenuated spatial-peak pulse-average intensity is expressed in watts per square metre (Wm ).

NOTE 2 For measurement purposes of this standard, pii (z) is equivalent to 1/(ρc) times the attenuated pulse-

pressure-squared integrals at depth z, ppsi (z), for z ≥ z , with ρc denoting the characteristic acoustic impedance

α bp
of pure water.
NOTE 3 See definition 3.81 for the non-attenuated version.
---------------------- Page: 10 ----------------------
IEC 62359:2010/AMD1:2017 – 9 –
© IEC 2017
3.66
attenuated sum of pulse-pressure-squared integrals
s ppsi (z)

attenuated value of the sum of pulse-pressure-squared integrals in one scan (one frame of

ultrasonic scan lines) at depth z

NOTE 1 Attenuated sum of pulse-pressure-squared integrals is expressed in pascal squared seconds (Pa s).

NOTE 2 The attenuated sum of pulse-pressure-squared integrals at depth z will be equal to the sum of

attenuated pulse-pressure-squared integrals if each ultrasonic scan line in the frame which is included in the

sum has the same acoustic working frequency.
NOTE 3 See F.3.1.4.2 for additional explanation.
NOTE 4 See definition 3.83 for the non-attenuated version.
3.67
depth for maximum I
sppa
sppa,max

depth z on the beam axis and beyond the break-point depth z of maximum spatial-peak

pulse-average intensity
NOTE 1 Depth for maximum I is expressed in metres (m).
sppa
NOTE 2 This depth is equivalent to the depth for maximum pii.
3.68
depth for maximum I
sppa,α
sppa,α,max

depth z on the beam axis and beyond the break-point depth z of maximum attenuated

spatial-peak pulse-average intensity
NOTE 1 Depth for maximum I is expressed in metres (m).
sppa,α
NOTE 2 This depth is equivalent to the depth for maximum pii .
3.69
depth for maximum I
spta
spta,max

depth z on the beam axis and beyond the break-point depth z of maximum spatial-peak

temporal-average intensity
NOTE 1 Depth for maximum I is expressed in metres (m).
spta

NOTE 2 For non-scanning modes, this depth is equivalent to the depth for maximum pii. For scanning modes,

it is equivalent to the depth for maximum sii.
3.70
depth for maximum I
spta,α
spta,α,max

depth z on the beam axis and beyond the break-point depth z of maximum attenuated

spatial-peak temporal-average intensity
NOTE 1 Depth for maximum I is expressed in metres (m).
spta,α

NOTE 2 For non-scanning modes, this depth is equivalent to the depth for maximum pii . For scanning modes,

it is equivalent to the depth for maximum sii .
3.71
depth for maximum pii
pii,α

depth z on the beam axis and beyond the break-point depth z of maximum attenuated

pulse-intensity integral
---------------------- Page: 11 ----------------------
– 10 – IEC 62359:2010/AMD1:2017
© IEC 2017
NOTE 1 Depth for maximum pii is expressed in metres (m).

NOTE 2 This depth is equivalent to the depth for maximum ppsi , z , when z occurs beyond the break-

α ppsi,α ppsi,α
point depth (see 3.73).

NOTE 3 Depth for maximum pii is termed "depth for peak attenuated pulse-intensity integral" in

IEC 60601-2-37:2007+IEC 60601-2-37:2007/AMD1:2015.
3.72
depth for maximum ppsi
ppsi
depth z on the beam axis of maximum pulse-pressure-squared integral
NOTE 1 Depth for maximum ppsi is expressed in metres (m).

NOTE 2 When it occurs beyond the break-point depth, this depth is equivalent to the depth for maximum pii,

(see 3.24).
pii
3.73
depth for maximum ppsi
ppsi,α
depth z on the beam axis of maximum attenuated pulse-pressure-squared integral
NOTE 1 Depth for maximum ppsi is expressed in metres (m).

NOTE 2 When it occurs beyond the break-point depth, this depth is equivalent to the depth for maximum pii ,

z (i.e. depth for maximum attenuated pulse-intensity integral).
pii,α
NOTE 3 This depth is the depth for mechanical index, z (see 3.23).
3.74
sii
depth for maximum
sii

depth z on the beam axis and beyond the break-point depth z of maximum scan-intensity

integral
NOTE 1 Depth for maximum sii is expressed in metres (m).

NOTE 2 This depth is equivalent to the depth for maximum sppsi, z , when z occurs beyond the break-

sppsi sppsi
point depth (see 3.76).

NOTE 3 Depth for maximum sii is termed "depth for peak sum of pulse-intensity integrals" in

IEC 60601-2-37:2007+IEC 60601-2-37:2007/AMD1:2015.
3.75
depth for maximum sii
sii,α

depth z on the beam axis and beyond the break-point depth z of maximum attenuated

scan-intensity integral
NOTE 1 Depth for maximum sii is expressed in metres (m).

NOTE 2 This depth is equivalent to the depth for maximum sppsi , z , when z occurs beyond the

α sppsi,α sppsi,α
break-point depth (see 3.77).

NOTE 3 Depth for maximum sii is termed "depth for peak sum of attenuated pulse-intensity integrals" in

IEC 60601-2-37:2007+IEC 60601-2-37:2007/AMD1:2015.
3.76
depth for maximum sppsi
sppsi
depth z on the beam axis of maximum sum of pulse-pressure-squared integrals
NOTE 1 Depth for maximum sppsi is expressed in metres (m).
---------------------- Page: 12 ----------------------
IEC 62359:2010/AMD1:2017 – 11 –
© IEC 2017

NOTE 2 When it occurs beyond the break-point depth, this depth is equivalent to the depth for maximum sii, z

sii
(see 3.74).

NOTE 3 Depth for maximum sppsi is termed "depth for peak sum of pulse-intensity integrals" in

IEC 60601-2-37:2007+IEC 60601-2-37:2007/AMD1:2015.
3.77
depth for maximum sppsi
sppsi,α
depth z on the beam axis of maximum sum of attenuated pulse-pressure-squared
integrals
NOTE 1 Depth for maximum sppsi is expressed in metres (m).

NOTE 2 When it occurs beyond the break-point depth, this depth is equivalent to the depth for maximum sii ,

z (see 3.75).
sii,α

NOTE 3 Depth for maximum sppsi is termed "depth for peak sum of attenuated pulse-intensity integrals" in

IEC 60601-2-37:2007+IEC 60601-2-37:2007/AMD1:2015.
3.78
pulse-average intensity

quotient of the pulse-intensity integral to the pulse duration at a particular point in an

acoustic field
NOTE 1 This definition applies to pulses and bursts.
NOTE 2 Pulse-average intensity is expressed in watts per square metre (Wm ).
[IEC 62127-1:2007+IEC 62127-1:2007/AMD1:2013, 3.47]
3.79
scan intensity integral
sii

sum of the pulse intensity integrals in one scan (one frame of ultrasonic scan lines) at

depth z in the acoustic field
NOTE 1 Scan intensity integral is expressed in joules per square metre (Jm ).

NOTE 2 For measurement purposes of this standard, sii is equivalent to 1/(ρc) times the sum of pulse-pressure-

squared integral at depth z where ρc is the characteristic acoustic impedance of pure water.

3.80
scan repetition rate
srr
inverse of the scan repetition period (see 3.50)
NOTE Scan repetition rate is expressed in hertz (Hz).
3.81
spatial-peak pulse-average intensity
I (z)
sppa

maximum value of the pulse-average intensity on a plane perpendicular to the beam axis at

a specified distance z from the source, and given by
I (z)= pii(z)
sppa (29)
t (z)
where
t (z) is the pulse duration at the same depth z;
pii(z) is the pulse-intensity integral at depth z.
---------------------- Page: 13 ----------------------
– 12 – IEC 62359:2010/AMD1:2017
© IEC 2017

NOTE 1 Spatial-peak pulse-average intensity is expressed in watts per square metre (Wm ).

NOTE 2 For measurement purposes of this standard, pii(z) is equivalent to 1/(ρc) times the pulse-pressure-

squared integral at depth z, ppsi(z), for z ≥ z , with ρc denoting the characteristic acoustic impedance of pure

water.

NOTE 3 See IEC 62127-1:2007, 3.60, which has been modified to specify the perpendicular plane at depth z.

Equation (29) and Note 2 have been added, in accordance with IEC 62127-1:2007, Equation (15).

3.82
sum of attenuated pulse-pressure-squared integrals
sppsi (z)
sum of the attenua
...

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