oSIST prEN IEC 61846:2023
(Main)Ultrasonics - Therapeutic focused short pressure pulse sources - Characteristics of fields
Ultrasonics - Therapeutic focused short pressure pulse sources - Characteristics of fields
Ultraschall - Druckpuls-Lithotripter - Feldcharakterisierung
Ultrasons - Lithotripteurs à ondes de pression - Caractérisation des champs
Ultrazvok - Terapevtsko usmerjeni viri kratkih tlačnih impulzov - Karakteristike polj
General Information
Relations
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.
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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.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
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This document is still under study and subject to change. It should not be used for reference purposes.
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Recipients of this document are invited to submit, with their comments, notification of any relevant “In So me Countries” clauses
to be included should this proposal proceed. Recipients are reminded that the CDV stage is the final stage for submitting ISC
clauses. (SEE AC/22/2007 OR NEW GUIDANCE DOC).
TITLE:
Ultrasonics – Therapeutic focused short pressure pulse sources – Characteristics of fields
PROPOSED STABILITY DATE: 2027
NOTE FROM TC/SC OFFICERS:
Copyright © 2023 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download this
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You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without
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oSIST prEN IEC 61846:2023
87/836/CDV – 2 – IEC CDV 61846 © IEC:2023
1 CONTENTS
2
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
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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
54
55
56
57
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58 INTERNATIONAL ELECTROTECHNICAL COMMISSION
59 ____________
60
61 ULTRASONICS – THERAPEUTIC FOCUSED SHORT PRESSUREPULSE
62 SOURCES – CHARACTERISTICS OF FIELDS
63
64
65
66 FOREWORD
67 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
68 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
69 co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
70 in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
71 Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their
72 preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
73 may participate in this preparatory work. International, governmental and non-governmental organizations liaising
74 with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
75 Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
76 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possibl e, an international
77 consensus of opinion on the relevant subjects since each technical committee has representation from all
78 interested IEC National Committees.
79 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
80 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
81 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
82 misinterpretation by any end user.
83 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
84 transparently to the maximum extent possible in their national and regional publications. Any divergence between
85 any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
86 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
87 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
88 services carried out by independent certification bodies.
89 6) All users should ensure that they have the latest edition of this publication.
90 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
91 members of its technical committees and IEC National Committees for any personal injury, property damage or
92 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
93 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
94 Publications.
95 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
96 indispensable for the correct application of this publication.
97 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
98 rights. IEC shall not be held responsible for identifying any or all such patent ri ghts.
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].
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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”, “cavitation induction
125 index”, “pulse to pulse variability”, “total pressure pulse energy dose”.
126 d) 6. Test equipment: The terms “focus hydrophone” and “field hydrophone” were removed to
127 account for newer technical developments. New terms distinguish between “Hydrophones
128 for pressure pulse measurements” and “Hydrophones for quality assurance”
129 e) Annexes: Descriptions, tables and figures were edited to account for newer literature and
130 standards as well as technical developments.
131
132 The text of this International Standard is based on the following documents:
FDIS Report on voting
XX/XX/FDIS XX/XX/RVD
133
134 Full information on the voting for the approval of this International Standard can be found in the
135 report on voting indicated in the above table.
136 This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
137 The committee has decided that the contents of this document will remain unchanged until the
138 stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
139 the specific document. At this date, the document will be
140 • reconfirmed,
141 • withdrawn,
142 • replaced by a revised edition, or
143 • amended.
144
145 The National Committees are requested to note that for this document the stability date
146 is 20XX.
147 THIS TEXT IS INCLUDED FOR THE INFORMATION OF THE NATIONAL COMMITTEES AND WILL BE DELETED
148 AT THE PUBLICATION STAGE.
149
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150 INTRODUCTION
151 Focused Short Pressure Pulses were initially (since February 1980) applied clinically in
152 lithotripsy, to break up and disrupt calcific deposits within the body, in particular, stones within
153 the renal, biliary and salivary glands tracts. Extracorporeal pressure pulse lithotripsy is up
154 today regarded as the most applied therapeutic option for treating most renal calculi [18], [23],
155 [24].
156 The use of pressure pulses has been evolved to a more general use, often called
157 ‘Extracorporeal shock wave therapy (ESWT)’ which expands its application to a broad range of
158 musculoskeletal conditions, including plantar fasciitis, calcific tendinitis of the shoulder, lateral
159 or medial epicondylitis of the elbow, pain treatment, non-union and delayed union of fractures
160 [25]. Some of these are also treated using unfocused pressure pulse sources, which are
161 specified in another standard (IEC 63045:2020).
162 Several different forms of equipment for lithotripsy and for ESWT are commercially available
163 from a number of manufacturers
164
165 This International Standard specifies methods of measuring and characterizing the acoustic
166 pressure field generated by focusing pressure pulse equipment.
167
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168 ULTRASONICS – THERAPEUTIC FOCUSED SHORT PRESSURE PULSE
169 SOURCES – CHARACTERISTICS OF FIELDS
170
171
172 1 Scope
173 This International Standard is applicable to
174 –
175 therapy equipment using extracorporeally induced focused pressure pulse waves;
176 – therapy equipment producing focused mechanical energy excluding thermal energy.
177 This International Standard does not apply to percutaneous and laser lithotripsy equipment.
178 This international standard does not apply to:
179 - Histotripsy or other therapeutic ultrasound bursts of longer time duration than that of the
180 pressure pulse
181 - Non-focused pressure pulse equipment
182
183 This International Standard specifies
184 – measurable parameters which could be used in the declaration of the acoustic output of
185 extracorporeal focused pressure pulse equipment,
186 – methods of measurement and characterization of the pressure field generated by focused
187 pressure pulse equipment.
188
189 NOTE – The parameters defined in this International Standard do not – at the present time – allow quantitative
190 statements to be made about effectiveness and possible hazard. In particular, it is not possible to make a statement
191 about the limits for these effects.
192 While this particular standard has been developed for equipment intended for use in lithotripsy,
193 it has been developed such that, as long as no other specific standards are available to be used
194 for other medical applications of therapeutic extracorporeal focused pressure pulse
195 equipment, this standard may be used as a guideline.
196
197 2 Normative references
198 The following documents are referred to in the text in such a way that some or all of their content
199 constitutes requirements of this document. For dated references, only the edition cited applies.
200 For undated references, the latest edition of the referenced document (including any
201 amendments) applies.
202 IEC 60050-13:2011 International Electrotechnical Vocabulary – Part. 113: Physics for
203 electrotechnology,
204 IEC/TR 62781:2012 Ultrasonics – Conditioning water for ultrasonic measurement,
205 IEC 60565-1:2020 Underwater acoustics – Hydrophones – Calibration of hydrophones –
206 Part 1: Procedures for free field calibration of hydrophones,
207 IEC 60565-2:2019 Underwater acoustics – Hydrophones – Calibration of hydrophones – Part 2:
208 Procedures for low frequency pressure calibration,
209 IEC 62127-1:2022 ULTRASONICS – HYDROPHONES – Part 1: Measurement and
210 characterization of medical ultrasonic fields
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211 3 Terms and definitions
212 For the purposes of this document, the following terms and definitions apply.
213 ISO and IEC maintain terminological databases for use in standardization at the following
214 addresses:
215 • IEC Electropedia: available at http://www.electropedia.org/
216 • ISO Online browsing platform: available at http://www.iso.org/obp
217
218 3.1
219 acoustic pulse energy
220
221 3.1.1
222 derived acoustic pulse energy
223 ER
224 spatial integral of the derived pulse-intensity integral over a circular cross-sectional area of
225 radius R in the x-y plane which contains the focus
226 Note 1 to entry: The radius R is derived either from the largest size of a threshold value of pressure, derived pulse
227 intensity integral, or any other quantity. This quantity is stated as a second index. The manufacturer choses the
228 appropriate quantity and threshold value based on their clinical significance, based on literature and/or risk analysis.”
229 Note 2 to entry: The derived acoustic pulse energy is expressed in Units of joules (J)
230 3.1.2
231 derived focal acoustic pulse energy
232 E
f
233 spatial integral of the derived pulse-intensity integral over the focal cross-sectional area
234 Note 1 to entry: The derived focal acoustic pulse energy is expressed in Units of joules (J)
235 3.2
236 beam axis
237 line passing through the geometric centre of the aperture of the pressure pulse generator and
238 the focus
239 Note 1 to entry: This line is taken as the z axis. See 6.1 and clause 7
240 3.3
241 compressional pulse duration
242 t
FWHMpC
243 time interval beginning at the first time the instantaneous acoustic pressure exceeds 50 %
244 of the peak-compressional acoustic pressure and ending at the next time the instantaneous
245 acoustic pressure has that value (see figure C.1)
246 Note to entry: The compressional pulse duration is expressed in Units of seconds (s)
247 Note 1 to entry: The subscript "FWHM" stands for "full width, half maximum".
248 3.4
249 rarefactional pulse duration
250 t
pr
251 time interval beginning at the first time the instantaneous acoustic pressure is less than 10%
252 of the peak-rarefactional acoustic pressure after the decay of the peak-compressional
253 acoustic pressure and ending at the next time the instantaneous acoustic pressure has that
254 value (see figure C.1)
255 Note to entry: The compressional pulse duration is expressed in Units of seconds (s)
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256 3.5
257 derived pulse-intensity integral
258 PII(x,y,z)time integral of the instantaneous intensity at a particular point in a pressure pulse
259 field over the pressure pulse waveform
260 Note 1 to entry: This parameter is often called "energy flux density".
2
261 Note 2 to entry: The derived pulse-intensity integral is expressed in units of joule per metre squared (J/m ).
262 Note 3 to entry: The temporal limits for the calculation of the derived pulse-intensity integral are specified in the
263 temporal integration limits definitions.
264 3.6
265 end-of-cable loaded sensitivity of a hydrophone
266 M
L
267 quotient of the Fourier transformed hydrophone voltage-time signal at the end of any integral
268 cable or output connector of a hydrophone or hydrophone-assembly, when connected to a
269 specified electric load impedance, to the Fourier transformed instantaneous acoustic
270 pressure waveform in the undisturbed free field of a plane wave in the position of the acoustic
271 centre of the hydrophone if the hydrophone were removed
272 Note 1 to entry: The end-of-cable loaded sensitivity of a hydrophone is a complex-valued parameter. Its modulus
−1
273 is expressed in units of volt per pascal (V Pa ). Its phase angle is expressed in degrees, and represents the phase
274 difference between the electrical voltage and the sound pressure.
275 Note 2 to entry: Reformulated from 3.25 of IEC 62127-1:2022.
276
277 3.7
278 focal −n dB cross-sectional area
279 A
f,ndB
280 area of the peak-compressional acoustic pressure contour which is in the plane,
281 perpendicular to the beam axis and containing the focus, where all points on the contour have
282 a pressure of −n dB relative to the value at the focus
283 Note 1 to entry: The value of n and the axial distance z from the measurement centre point is stated as subscript.
284 Note 2 to entry: Typical values of −n dB are: −3 dB, −6 dB, −10 dB, −12 dB, −20 dB. Reasonable values of n for
285 clinical approval and communication to the users can be identified by a risk analysis process, by applicable safety
286 standards, by consulting notified bodies, expert communities (e.g. ISMST – International Society for Medical
287 Shockwave Treatment) or through literature.
2
288 Note 3 to entry: The focal −n dB cross-sectional area is expressed in units of metre squared (m ).
289 3.8
290 focal −n dB extent
291 f
z,ndB
292 shortest distance along the z axis that connects points on the contour of peak-compressional
293 acoustic pressure which have a value of −n dB relative to the acoustic pressure at the focus
294 Note 1 to entry: The value of n is stated as subscript.
295 Note 2 to entry: Typical values of −n dB are: −3 dB, −6 dB, −10 dB, −12 dB, −20 dB. Reasonable values of n for
296 clinical approval and communication to the users can be identified by a risk analysis process, by applicable safety
297 standards, by consulting notified bodies, expert communities (e.g. ISMST – International Society for Medical
298 Shockwave Treatment) or through literature.
299 Note 3 to entry: The focal −n dB extent is expressed in metres (m).
300 3.9
301 focal −n dB volume
302 V
f,ndB
303 volume in space contained within the surface defined by the −n dB (relative to the focal
304 pressure maximum value) peak-compressional acoustic pressure contours measured
305 around the focus
306 Note 1 to entry: It may be difficult to measure −n dB points throughout the volume around the focus. It is reasonable
307 in practice to approximate the focal -n dB volume from measurements taken in three orthogonal directions: the
308 beam axis (z axis); the direction of maximum beam diameter (x axis); the axis perpendicular to the x axis (y axis),
309 which are also orthogonal to the beam axis.
310 Note 2 to entry: Typical values of −n dB are: −3 dB, −6 dB, −10 dB, −12 dB, −20 dB. Reasonable values of n for
311 clinical approval and communication to the users can be identified by a risk analysis process, by applicable safety
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312 standards, by consulting notified bodies, expert communities (e.g. ISMST – International Society for Medical
313 Shockwave Treatment) or through literature.
3
314 Note 3 to entry: The beam −n dB volume is expressed in units of metre cubed (m ).
315 Note 4 to entry: The value of n is stated as a subscript.
316 Note 5 to entry: See IEC 61828.
317 3.10
318 focal −n dB width, maximum
319 f
x,ndB
320 maximum width of the −n dB (relative to the focal pressure maximum value) contour of p
+
321 around the focus in the x- y plane which contains the focus
322 Note 1 to entry: Typical values of −n dB are: −3 dB, −6 dB, −10 dB, −12 dB, −20 dB. Reasonable values of n for
323 clinical approval and communication to the users can be identified by a risk analysis process, by applicable safety
324 standards, by consulting notified bodies, expert communities (e.g. ISMST – International Society for Medical
325 Shockwave Treatment) or through literature.
326 3.11 Note 2 to entry: The focal width, maximum is expressed in Units of metre (m)
327 focal −n dB width, orthogonal
328 f
y,ndB
329 width of the −n dB (relative to the focal pressure maximum value) contour of p+ around the
330 focus, in the x- y plane which contains the focus, in the direction perpendicular to fx
331 Note 1 to entry: Typical values of −n dB are: −3 dB, −6 dB, −10 dB, −12 dB, −20 dB. Reasonable values of n for
332 clinical approval and communication to the users can be identified by a risk analysis process, by applicable safety
333 standards, by consulting notified bodies, expert communities (e.g. ISMST – International Society for Medical
334 Shockwave Treatment) or through literature.
335 Note 2 to entry: The focal width, orthogonal is expressed in Units of metre (m)
336 3.12
337 focal n MPa cross-sectional area
338 A
f,nMPa
339 area of the peak-compressional acoustic pressure contour which is in the plane,
340 perpendicular to the beam axis and containing the focus, where all points on the contour have
341 a pressure of n MPa
342 Note 1 to entry: The value of n and the axial distance z from the measurement centre point is stated as subscript.
343 Note 2 to entry: Typical values of n are: 5 MPa. Reasonable values of n for clinical approval and communication to
344 the users can be identified by a risk analysis process, by applicable safety standards, by consulting notified bodies,
345 ex
...
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