EN 62359:2011/A1:2018
(Amendment)Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
Ultraschall - Charakterisierung von Feldern - Prüfverfahren für die Ermittlung des thermischen und des mechanischen Indexes, bezogen auf medizinische Ultraschalldiagnostikfelder
Ultrasons - Caractérisation du champ - Méthodes d'essai pour la détermination d'indices thermique et mécanique des champs d'ultrasons utilisés pour le diagnostic médical
Ultrazvok - Karakterizacija polj - Preskusne metode za ugotavljanje termičnih in mehanskih znakov glede medicinskih diagnostičnih ultrazvočnih polj - Dopolnilo A1
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Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2018
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Ultrasonics - Field characterization - Test methods for the determination of thermal and
mechanical indices related to medical diagnostic ultrasonic fields
Ultraschall - Charakterisierung von Feldern - Prüfverfahren für die Ermittlung des
thermischen und des mechanischen Indexes bezogen auf medizinische
Ultraschalldiagnostikfelder
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Ta slovenski standard je istoveten z: EN 62359:2011/A1:2018
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN 62359:2011/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2018
ICS 17.140.50
English Version
Ultrasonics - Field characterization - Test methods for the
determination of thermal and mechanical indices related to
medical diagnostic ultrasonic fields
(IEC 62359:2010/A1:2017)
Ultrasons - Caractérisation du champ - Méthodes d'essai Ultraschall - Charakterisierung von Feldern - Prüfverfahren
pour la détermination d'indices thermique et mécanique des für die Ermittlung des thermischen und des mechanischen
champs d'ultrasons utilisés pour le diagnostic médical Indexes bezogen auf medizinische
(IEC 62359:2010/A1:2017) Ultraschalldiagnostikfelder
(IEC 62359:2010/A1:2017)
This amendment A1 modifies the European Standard EN 62359:2011; it was approved by CENELEC on 2017-11-03. CENELEC members
are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment the status of a
national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation under the
responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as
the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden,
Switzerland, Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 62359:2011/A1:2018 E
European foreword
The text of document 87/661/FDIS, future edition 1 of IEC 62359:2010/A1:2017, prepared by IEC/TC
87 "Ultrasonics" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which this document has (dop) 2018-08-03
to be implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2020-11-03
standards conflicting with this
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Endorsement notice
The text of the International Standard IEC 62359:2010/A1:2017 was approved by CENELEC as a
European Standard without any modification.
Replace the Annex ZA by the following:
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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.
NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu.
P ublication Year Title EN/HD Year
IEC 60601-2-37 2007 Medical electrical equipment -- Part 2-37: EN 60601-2-37 2008
Particular requirements for the basic safety
and essential performance of ultrasonic
medical diagnostic and monitoring
equipment
- - + A11 2011
+ A1 2015 + A1 2015
IEC 61157 2007 Standard means for the reporting of the EN 61157 2007
acoustic output of medical diagnostic
ultrasonic equipment
+ A1 2013 + A1 2013
IEC 61161 2013 Ultrasonics - Power measurement - EN 61161 2013
Radiation force balances and performance
requirements
IEC 61828 2001 Ultrasonics - Focusing transducers - EN 61828 2001
Definitions and measurement methods for
the transmitted fields
IEC 62127-1 2007 Ultrasonics - Hydrophones -- Part 1: EN 62127-1 2007
Measurement and characterization of
medical ultrasonic fields up to 40 MHz
+ A1 2013 + A1 2013
IEC 62127-2 2007 Ultrasonics - Hydrophones -- Part 2: EN 62127-2 2007
Calibration for ultrasonic fields up to 40 MHz
IEC 62127-3 2007 Ultrasonics - Hydrophones -- Part 3: EN 62127-3 2007
Properties of hydrophones for ultrasonic
fields up to 40 MHz
IEC 62359 ®
Edition 2.0 2017-09
INTERNATIONAL
STANDARD
AMENDMENT 1
Ultrasonics – Field characterization –
Test methods for the determination of thermal and mechanical indices related
to medical diagnostic ultrasonic fields
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 17.140.50 ISBN 978-2-8322-4821-8
– 2 – IEC 62359:2010/AMD1:2017
© IEC 2017
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
87/661/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 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.
A bilingual version of this publication may be issued at a later date.
_____________
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
average intensity, I , at specific spatial maximum points in the ultrasonic field on the
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
, and attenuated spatial peak pulse average intensity, I , has been
intensity, I
spta,a sppa,a
added as an annex in this amendment.
Additionally, references to newly published collateral standards have been updated.
_____________
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".
– 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-
α
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".
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
eq
modes".
Replace the existing NOTE 2 by the following new note:
NOTE 2 For scanning modes, use the non-scanning mo
...
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