FprEN IEC 61846:2024
(Main)Ultrasonics - Therapeutic focused short pressure pulse sources - Characteristics of fields
Ultrasonics - Therapeutic focused short pressure pulse sources - Characteristics of fields
Ultraschall - Therapeutisch fokussierte Kurzdruckimpulsquellen – Feldeigenschaften
Ultrasons - Sources d’impulsions de pression courtes focalisées thérapeutiques - Caractéristiques des champs
Ultrazvok - Terapevtsko usmerjeni viri kratkih tlačnih impulzov - Karakteristike polj
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN IEC 61846:2023
01-september-2023
Ultrazvok - Terapevtsko usmerjeni viri kratkih tlačnih impulzov - Karakteristike polj
Ultrasonics - Therapeutic focused short pressure pulse sources - Characteristics of fields
Ultraschall - Druckpuls-Lithotripter - Feldcharakterisierung
Ultrasons - Lithotripteurs à ondes de pression - Caractérisation des champs
Ta slovenski standard je istoveten z: prEN IEC 61846:2023
ICS:
11.040.50 Radiografska oprema Radiographic equipment
17.140.50 Elektroakustika Electroacoustics
oSIST prEN IEC 61846:2023 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN IEC 61846:2023
oSIST prEN IEC 61846:2023
87/836/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 61846 ED2
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2023-07-14 2023-10-06
SUPERSEDES DOCUMENTS:
87/806/CD, 87/821A/CC
IEC TC 87 : ULTRASONICS
SECRETARIAT: SECRETARY:
United Kingdom Mr Petar Luzajic
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
Other TC/SCs are requested to indicate their interest, if any, in this
CDV to the secretary.
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TITLE:
Ultrasonics – Therapeutic focused short pressure pulse sources – Characteristics of fields
PROPOSED STABILITY DATE: 2027
NOTE FROM TC/SC OFFICERS:
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oSIST prEN IEC 61846:2023
oSIST prEN IEC 61846:2023
87/836/CDV – 2 – IEC CDV 61846 © IEC:2023
1 CONTENTS
3 FOREWORD . 4
4 INTRODUCTION . 6
5 1 Scope . 7
6 2 Normative references . 7
7 3 Terms and definitions . 8
8 3.1 8
9 4 List of symbols . 16
10 5 Conditions of measurement . 17
11 6 Test equipment . 17
12 6.1 Test chamber . 17
13 6.2 Hydrophone . 18
14 6.2.1 Hydrophone for pressure pulse measurements . 18
15 6.2.2 Hydrophones for quality assurance . 18
16 6.3 Voltage measurement . 19
17 6.3.1 Oscilloscope or transient recorder . 19
18 6.3.2 Pressure-pulse-waveform recording . 19
19 7 Measurement procedure . 19
20 7.1 Spatial measurements . 20
21 7.1.1 Beam plots of peak-compressional acoustic pressure . 20
22 7.1.2 Beam plots of peak-rarefactional acoustic pressure . 20
23 7.1.3 Focus position . 20
24 7.1.4 Focal −n dB width . 21
25 7.1.5 Focal −n dB extent . 21
26 7.1.6 Focal −n dB cross sectional area . 21
27 7.1.7 Focal −n dB volume . 21
28 7.2 Temporal measurements . 21
29 7.3 Acoustic energy measurements . 21
30 7.3.1 Pulse-pressure-squared integral . 21
31 7.3.2 Derived pulse-intensity integral . 21
32 7.3.3 Derived focal acoustic pulse energy. 22
33 7.3.4 Derived acoustic pulse energy . 22
34 7.3.5 Average positive pressure . 22
35 7.3.6 Momentum . 22
36 Annex A (informative) Short Pressure Pulse lithotripsy . 24
37 A.1 Background . 24
38 A.2 Percutaneous continuous wave systems and alternative burst wave
39 applications . 24
40 A.3 Exclusions . 24
41 A.4 Extracorporeally induced lithotripsy . 24
42 Annex B (informative) Types of pressure wave transducers . 26
43 B.1 Introduction . 26
44 B.1.1 Spark discharge. 26
45 B.1.2 Piezoelectric . 26
46 B.1.3 Electromagnetic . 26
47 B.2 Positioning systems . 27
oSIST prEN IEC 61846:2023
IEC CDV 61846 © IEC:2023 – 3 – 87/836/CDV
48 Annex C (informative) Field measurement . 28
49 C.1 Measurement probes and hydrophones . 28
50 C.2 Test chamber . 30
51 C.3 Degassing procedures . 30
52 C.4 Acoustic pulse energy . 30
53 Annex D (informative) Bibliography . 34
oSIST prEN IEC 61846:2023
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58 INTERNATIONAL ELECTROTECHNICAL COMMISSION
59 ____________
61 ULTRASONICS – THERAPEUTIC FOCUSED SHORT PRESSUREPULSE
62 SOURCES – CHARACTERISTICS OF FIELDS
66 FOREWORD
67 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
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99 International Standard IEC 61846 has been prepared by IEC technical committee 87:
100 Ultrasonics.
101 This second edition cancels and replaces the first edition published in [1998], This edition
102 constitutes a technical revision.
103 This edition includes the following significant technical changes with respect to the previous
104 edition:
105 a) Change of title: Old standard: PRESSURE PULSE LITHOTRIPTERS is changed to
106 “THERAPEUTIC FOCUSED SHORT PRESSURE-PULSE SOURCES” in order to take into
107 account the development in the relevant technical and biomedical applications of such
108 sources, which were originally used only for (kidney) lithotripsy, while recent applications
109 include a wide range for the treatment of e.g. stone diseases, orthopaedic pain, tissue,
110 cardiac and brain diseases.
111 The term “focused” was added to differentiate this standard from IEC 63045 “Non -focusing
112 short pressure pulse sources including ballistic pressure pulse sources” [26].
oSIST prEN IEC 61846:2023
IEC CDV 61846 © IEC:2023 – 5 – 87/836/CDV
113 The term “short” was added to align the nomenclature to IEC 63045 and differenti ate this
114 standard from standards in the HIFU / HITU fields.
115 b) Scope and elsewhere in the document: The term “lithotripsy” is changed to “therapy” in
116 order to account for the wide range of applications beyond stone diseases.
117 c) 3. Definitions: The “-6 dB” parameter definitions are replaced by “-n dB” to avoid
118 misconceptions in the significance and use of these parameters and to account for newer
119 findings in literature.
120 Additional “n MPa” parameters are introduced for the same reasons.
121 The definitions of “derived” parameters was aligned to those in recently published
122 standards, e.g. IEC 62127-1.
123 New definitions were added which describe parameters appearing in newer relevant
124 literature, e.g. “momentum”, “average positive acoustic pressure”, “ca
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