Ultrasonics - Therapeutic focused short pressure pulse sources - Characteristics of fields (IEC 61846:2025)

IEC 61846:2025 is applicable to:
– therapy equipment using extracorporeally induced focused pressure pulse waves;
– therapy equipment producing focused mechanical energy excluding thermal energy.
This document does not apply to percutaneous and laser lithotripsy equipment.
This document does not apply to:
– histotripsy or other therapeutic ultrasound bursts of longer time duration than that of the pressure pulse;
– non-focused pressure pulse equipment.
This document specifies:
– measurable parameters which could be used in the declaration of the acoustic output of extracorporeal focused pressure pulse equipment;
– methods of measurement and characterization of the pressure field generated by focused pressure pulse equipment.
While this document has been developed for equipment intended for use in lithotripsy, it has been developed such that, as long as no other specific standards are available to be used for other medical applications of therapeutic extracorporeal focused pressure pulse equipment, this document can be used as a guideline.
IEC 61846:2025 cancels and replaces the first edition published in 1998. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) Change of title: "pressure pulse lithotripters" in the previous edition is changed to "therapeutic focused short pressure pulse sources" in order to take into account the development in the relevant technical and biomedical applications of such sources, which were originally used only for (kidney) lithotripsy, while recent applications include a wide range for the treatment of, for example, stone diseases, orthopaedic pain, tissue, cardiac and brain diseases.
The term "focused" was added to differentiate IEC 61846 from IEC 63045.
The term "short" was added to align the nomenclature to IEC 63045 and to differentiate IEC 61846 from standards in the HIFU and HITU fields.
b) Clause 1 and elsewhere in the document: The term "lithotripsy" is changed to "therapy" in order to account for the wide range of applications beyond stone diseases.
c) Clause 3: The "−6 dB" parameter definitions are replaced by "−n dB" to avoid misconceptions in the significance and use of these parameters and to account for newer findings in literature.
Additional "n MPa" parameters are introduced for the same reasons.
The definitions of "derived" parameters are aligned to those in recently published standards, for example IEC 62127-1.
New definitions were added which describe parameters appearing in newer relevant literature, for example "momentum", "average positive acoustic pressure", "cavitation induction index", "pulse to pulse variability", "total pressure pulse energy dose".
d) Clause 6: The terms "focus hydrophone" and "field hydrophone" were removed to account for newer technical developments. New terms distinguish between "hydrophones for pressure pulse measurements" and "hydrophones for quality assurance".
e) Annexes: Descriptions, tables and figures were edited to account for newer literature and standards as well as technical developments.

Ultraschall - Druckpuls-Lithotripter - Feldcharakterisierung (IEC 61846:2025)

Ultrasons - Lithotripteurs à ondes de pression - Caractérisation des champs (IEC 61846:2025)

L'IEC 61846:2025 s'applique:
– aux appareils de traitement qui utilisent des ondes d'impulsions de pression focalisées générées de manière extracorporelle;
– aux appareils de traitement qui produisent une énergie mécanique focalisée, à l'exclusion de l'énergie thermique.
Le présent document ne s'applique pas aux appareils de lithotritie percutanée et laser.
Le présent document ne s'applique pas:
– à l'histotripsie ou autres salves d'ultrasons thérapeutiques d'une durée plus longue que celle de l'impulsion de pression;
– aux appareils à impulsions de pression non focalisées.
Le présent document spécifie:
– les paramètres mesurables qui peuvent être utilisés dans la déclaration des émissions acoustiques des appareils à impulsions de pression focalisées générées de manière extracorporelle;
– les méthodes de mesure et de caractérisation du champ de pression généré par les appareils à impulsions de pression focalisées.
Le présent document a été élaboré pour des appareils destinés à être utilisés en lithotritie. Il peut être utilisé comme ligne directrice pour d'autres applications médicales concernant des appareils thérapeutiques à impulsions de pression focalisées générées de manière extracorporelle, tant qu'aucune autre norme spécifique n'est disponible.
L'IEC 61846:2025 annule et remplace la première édition parue en 1998. Cette édition constitue une révision technique.
Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
a) Modification du titre:
Le terme "lithotriteurs à impulsion de pression" utilisé dans l'édition précédente a été modifié en "sources d'impulsions de pression courtes focalisées thérapeutiques" afin de prendre en compte le développement des applications techniques et biomédicales pertinentes de ces types de sources, qui n'étaient à l'origine utilisées que pour la lithotritie (rénale), tandis que les applications récentes couvrent un large éventail de traitements, par exemple, des maladies des calculs, des douleurs orthopédiques, ainsi que des maladies tissulaires, cardiaques et cérébrales.
L'adjectif "focalisées" a été ajouté pour distinguer l'IEC 61846 de l'IEC 63045.
L'adjectif "courtes" a été ajouté afin d'aligner la nomenclature sur l'IEC 63045 et de distinguer l'IEC 61846 des normes relatives aux champs à ultrasons focalisés de haute intensité (HIFU, High Intensity Focalised Ultrasound) et aux champs à ultrasons thérapeutiques de haute intensité (HITU, High Intensity Therapeutic Ultrasound).
b) Article 1 et ailleurs dans le document: Le terme "lithotritie" a été modifié en "thérapie" afin de tenir compte du large éventail d'applications qui dépassent le cadre des maladies des calculs.
c) Article 3: Les définitions des paramètres "−6 dB" ont été remplacées par "−n dB" afin d'éviter des malentendus concernant la signification et l'utilisation de ces paramètres, mais également pour refléter les dernières découvertes exposées dans les ouvrages de référence.
Des paramètres "n MPa" supplémentaires ont été ajoutés pour les mêmes raisons.
Les définitions des paramètres "dérivés" ont été alignées sur celles des normes récemment publiées, par exemple l'IEC 62127-1.
De nouvelles définitions ont été ajoutées pour décrire les paramètres qu

Ultrazvok - Terapevtsko usmerjeni viri kratkih tlačnih impulzov - Karakteristike polj (IEC 61846:2025)

General Information

Status
Published
Public Enquiry End Date
30-Sep-2023
Publication Date
01-Apr-2025
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
19-Mar-2025
Due Date
24-May-2025
Completion Date
02-Apr-2025

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SLOVENSKI STANDARD
01-maj-2025
Ultrazvok - Terapevtsko usmerjeni viri kratkih tlačnih impulzov - Karakteristike polj
(IEC 61846:2025)
Ultrasonics - Therapeutic focused short pressure pulse sources - Characteristics of fields
(IEC 61846:2025)
Ultraschall - Druckpuls-Lithotripter - Feldcharakterisierung (IEC 61846:2025)
Ultrasons - Lithotripteurs à ondes de pression - Caractérisation des champs (IEC
61846:2025)
Ta slovenski standard je istoveten z: EN IEC 61846:2025
ICS:
11.040.50 Radiografska oprema Radiographic equipment
17.140.50 Elektroakustika Electroacoustics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 61846

NORME EUROPÉENNE
EUROPÄISCHE NORM March 2025
ICS 11.040.50 Supersedes EN 61846:1998
English Version
Ultrasonics - Therapeutic focused short pressure pulse sources -
Characteristics of fields
(IEC 61846:2025)
Ultrasons - Sources d'impulsions de pression courtes Ultraschall - Therapeutisch fokussierte
focalisées thérapeutiques - Caractéristiques des champs Kurzdruckimpulsquellen - Feldeigenschaften
(IEC 61846:2025) (IEC 61846:2025)
This European Standard was approved by CENELEC on 2025-03-06. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard 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 European Standard 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye 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
© 2025 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 61846:2025 E
European foreword
The text of document 87/879/FDIS, future edition 2 of IEC 61846, prepared by 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 the document has to be implemented at national (dop) 2026-03-31
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2028-03-31
document have to be withdrawn
This document supersedes EN 61846:1998 and all of its amendments and corrigenda (if any).
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.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 61846:2025 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated:
IEC 61828:2020 NOTE Approved as EN IEC 61828:2021 (not modified)
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  Where 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.cencenelec.eu.
Publication Year Title EN/HD Year
IEC 60050-113 2011 International Electrotechnical Vocabulary - - -
Part 113: Physics for electrotechnology
IEC/TR 62781 - Ultrasonics - Conditioning of water for - -
ultrasonic measurements
IEC 60565-1 - Underwater acoustics - Hydrophones - EN IEC 60565-1 -
Calibration of hydrophones - Part 1:
Procedures for free-field calibration of
hydrophones
IEC 60565-2 - Underwater acoustics - Hydrophones - EN IEC 60565-2 -
Calibration of hydrophones - Part 2:
Procedures for low frequency pressure
calibration
IEC 62127-1 2022 Ultrasonics - Hydrophones - Part 1: EN IEC 62127-1 2022
Measurement and characterization of
medical ultrasonic fields
IEC 62127-2 2025 Ultrasonics - Hydrophones - Part 2: EN IEC 62127-2 2025
Calibration for ultrasonic fields
IEC 62127-3 - Ultrasonics - Hydrophones - Part 3: EN IEC 62127-3 -
Properties of hydrophones for ultrasonic
fields
IEC 63045 2020 Ultrasonics - Non-focusing short pressure EN IEC 63045 2020
pulse sources including ballistic pressure
pulse sources - Characteristics of fields

IEC 61846 ®
Edition 2.0 2025-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Ultrasonics – Therapeutic focused short pressure pulse sources –

Characteristics of fields
Ultrasons – Sources d'impulsions de pression courtes focalisées thérapeutiques –

Caractéristiques des champs
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50  ISBN 978-2-8327-0132-4

– 2 – IEC 61846:2025 © IEC 2025
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 8
3.1 Acoustic pulse energy . 8
4 List of symbols . 17
5 Conditions of measurement . 18
6 Test equipment . 18
6.1 Test chamber . 18
6.2 Hydrophone . 18
6.2.1 General . 18
6.2.2 Hydrophone for pressure pulse measurements . 19
6.2.3 Hydrophones for quality assurance . 19
6.3 Voltage measurement . 20
6.3.1 Oscilloscope or transient recorder . 20
6.3.2 Pressure-pulse-waveform recording . 20
7 Measurement procedure . 21
7.1 General . 21
7.2 Spatial measurements . 21
7.2.1 General . 21
7.2.2 Beam plots of peak-compressional acoustic pressure . 21
7.2.3 Beam plots of peak-rarefactional acoustic pressure . 22
7.2.4 Focus position . 22
7.2.5 Focal −n dB width . 22
7.2.6 Focal −n dB extent . 22
7.2.7 Focal −n dB cross sectional area . 22
7.2.8 Focal −n dB volume . 22
7.3 Temporal measurements . 22
7.4 Acoustic energy measurements . 23
7.4.1 Pulse-pressure-squared integral . 23
7.4.2 Derived pulse-intensity integral . 23
7.4.3 Derived focal acoustic pulse energy . 23
7.4.4 Derived acoustic pulse energy . 23
7.4.5 Average positive pressure . 24
7.4.6 Momentum . 24
Annex A (informative) Short pressure pulse therapy. 25
A.1 Background. 25
A.2 Percutaneous continuous wave systems and alternative burst wave
applications . 25
A.3 Exclusions . 25
A.4 Extracorporeally induced lithotripsy . 26
Annex B (informative) Types of pressure wave transducers . 27
B.1 Overview. 27
B.1.1 General . 27
B.1.2 Spark discharge . 27

IEC 61846:2025 © IEC 2025 – 3 –
B.1.3 Piezoelectric . 27
B.1.4 Electromagnetic . 27
B.2 Positioning systems . 28
Annex C (informative) Field measurement . 29
C.1 Measurement probes and hydrophones . 29
C.2 Test chamber . 31
C.3 Degassing procedures . 31
C.4 Acoustic pulse energy . 32
Bibliography . 36

Figure C.1 – Typical measured pressure pulse waveform and parameters at the focus . 33
Figure C.2 – Typical spatial pressure distribution measurements in three orthogonal
coordinates of a focused pressure pulse source . 34
Figure C.3 – Schematic of focusing and focal geometry of a high amplitude pulsed
focused acoustic pressure field produced by an electrohydraulic type shock wave
generator commonly used in ESWT . 35
Figure C.4 – Examples of the different focal regions according to −6 dB and 5 MPa

contour in the focal peak-compressional pressure axial and lateral distribution . 35

Table C.1 – Hydrophones for focus and field measurements .
...

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