oSIST prEN IEC 60601-2-37:2023
(Main)Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Medizinische elektrische Geräte - Teil 2-37: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Ultraschallgeräten für die medizinische Diagnose und Überwachung
Appareils électromédicaux - Partie 2-37: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de diagnostic et de surveillance médicaux à ultrasons
Medicinska električna oprema - 2-37. del: Posebne zahteve za osnovno varnost in bistvene lastnosti ultrazvočne medicinske diagnostične in nadzorovalne opreme
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN IEC 60601-2-37:2023
01-september-2023
Medicinska električna oprema - 2-37. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti ultrazvočne medicinske diagnostične in nadzorovalne opreme
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and
essential performance of ultrasonic medical diagnostic and monitoring equipment
Medizinische elektrische Geräte - Teil 2-37: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Ultraschallgeräten für die
medizinische Diagnose und Überwachung
Appareils électromédicaux - Partie 2-37: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de diagnostic et de surveillance médicaux
à ultrasons
Ta slovenski standard je istoveten z: prEN IEC 60601-2-37:2023
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
17.140.50 Elektroakustika Electroacoustics
oSIST prEN IEC 60601-2-37:2023 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN IEC 60601-2-37:2023
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62B/1318/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-37 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2023-06-16 2023-09-08
SUPERSEDES DOCUMENTS:
62B/1295/CD, 62B/1304A/CC
IEC SC 62B : MEDICAL IMAGING EQUIPMENT, SOFTWARE, AND SYSTEMS
SECRETARIAT: SECRETARY:
Germany Ms Regina Geierhofer
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
TC 87
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
CENELEC online voting system.
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which they
are aware and to provide supporting documentation.
Recipients of this document are invited to submit, with their comments, notification of any relevant “In Some Countries” clau ses
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:
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and monitoring equipment
PROPOSED STABILITY DATE: 2026
Copyright © 2023 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download this
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions.
You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without
permission in writing from IEC.
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NOTE FROM TC/SC OFFICERS:
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1 CONTENTS
2 CONTENTS . 1
3 FOREWORD . 4
4 INTRODUCTION . 6
5 INTRODUCTION TO AMENDMENT 1 . 6
6 INTRODUCTION TO EDITION 3 . 6
7 201.1Scope, object and related standards . 7
8 201.2Normative references . 8
9 201.3Terms and definitions . 9
10 201.4General requirements . 15
11 201.5General requirements for testing ME EQUIPMENT . 15
12 201.6Classification of ME EQUIPMENT and ME SYSTEMS . 16
13 201.7ME EQUIPMENT identification, marking and documents . 16
14 201.8Protection against electrical HAZARDS from ME EQUIPMENT . 20
15 201.9Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 20
16 201.10Protection against unwanted and excessive radiation HAZARDS . 20
17 201.11Protection against excessive temperatures and other HAZARDS . 21
18 201.12Accuracy of controls and instruments and protection against hazardous outputs . 25
19 201.13HAZARDOUS SITUATIONS and fault conditions . 27
20 201.14PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 28
21 201.15Construction of ME EQUIPMENT . 28
22 201.16ME SYSTEMS . 28
23 201.17*Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 28
24 212Requirements for medical electrical equipment and medical electrical systems
25 intended for use in the emergency medical services environment (EMS) . 29
26 Annex AA (informative) . 31
27 Index of defined terms . 54
28
29 Figure DD.1 – Set-up of an example test object to measure the surface temperature of
30 externally applied transducers . 46
31
32 Table 201.101 – List of symbols . 14
33 Table 201.102 – Distributed essential performance requirements . 15
34 Table 201.103 – Acoustic output reporting table . 19
35 Table 201.104 – Overview of the tests noted under 201.11.1.3 . 25
36 Table CC.1 – Relative importance of maintaining low exposure indices in various
37 scanning situations . 43
38 Table DD.1 – Acoustic and thermal properties of tissues & materials . 44
39 Table DD.2 – Weight % pure components . 45
40
41
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42 INTERNATIONAL ELECTROTECHNICAL COMMISSION
43 ______________
44
45 MEDICAL ELECTRICAL EQUIPMENT –
46
47 Part 2-37: Particular requirements for the basic safety
48 and essential performance of ultrasonic medical
49 diagnostic and monitoring equipment
50
51
52 FOREWORD
53 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
54 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
55 co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
56 in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Report s,
57 Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their
58 preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
59 may participate in this preparatory work. International, governmental and non-governmental organizations liaising
60 with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
61 Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
62 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
63 consensus of opinion on the relevant subjects since each technical committee has representati on from all
64 interested IEC National Committees.
65 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
66 Committees in that sense. While all reasonable efforts are made to ensure that the technical conten t of IEC
67 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
68 misinterpretation by any end user.
69 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
70 transparently to the maximum extent possible in their national and regional publications. Any divergence between
71 any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
72 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
73 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
74 services carried out by independent certification bodies.
75 6) All users should ensure that they have the latest edition of this publication.
76 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
77 members of its technical committees and IEC National Committees for any personal injury, property damage or
78 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
79 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other I EC
80 Publications.
81 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
82 indispensable for the correct application of this publication.
83 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
84 rights. IEC shall not be held responsible for identifying any or all such patent rights.
DISCLAIMER
This Consolidated version is not an official IEC Standard and has been prepared for user
convenience. Only the current versions of the standard and its amendment(s) are to be
considered the official documents.
85 This Consolidated version of IEC 60601-2-37 bears the edition number 2.1. It consists of
86 the second edition (2007-08) [documents 62B/624/CDV and 62B/657/RVC] and its
87 amendment 1 (2015-06) [documents 62B/978/FDIS and 62B/988/RVD]. The technical
88 content is identical to the base edition and its amendment.
89 This Final version does not show where the technical content is modified by amendment
90 1. A separate Redline version with all changes highlighted is available in this publication.
91 International standard IEC 60601-2-37 has been prepared by IEC subcommittee 62B: Medical
92 imaging equipment, software, and systems, of IEC technical committee 62: Medical equipment,
93 software, and systems.
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94 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
95 In this standard, the following print types are used:
96 – Requirements and definitions: roman type.
97 – Test specifications: italic type.
98 – Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
99 Normative text of tables is also in a smaller type.
100 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
101 NOTED: SMALL CAPITALS.
102 In referring to the structure of this standard, the term
103 – “clause” means one of the seventeen numbered divisions within the table of contents,
104 inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
105 – “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
106 subclauses of Clause 7).
107 References to clauses within this standard are preceded by the term “Clause” followed by the
108 clause number. References to subclauses within this particular standard are by number only.
109 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
110 combination of the conditions is true.
111 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
112 Directives, Part 2. For the purposes of this standard, the auxiliary verb:
113 – “shall” means that compliance with a requirement or a test is mandatory for compliance with
114 this standard;
115 – “should” means that compliance with a requirement or a test is recommended but is not
116 mandatory for compliance with this standard;
117 – “may” is used to describe a permissible way to achieve compliance with a requirement or
118 test.
119 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
120 indicates that there is guidance or rationale related to that item in Annex AA.
121 A list of all parts of the IEC 60601 series, published under the general title: Medical electrical
122 equipment, can be found on the IEC website
123 The committee has decided that the contents of the base publication and its amendment will
124 remain unchanged until the stability date indicated on the IEC web site under
125 "http://webstore.iec.ch" in the data related to the specific publication. At this date, the
126 publication will be
127 • reconfirmed,
128 • withdrawn,
129 • replaced by a revised edition, or
130 • amended.
131
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132 INTRODUCTION
133 In this particular standard, safety requirements additional to those in th e general standard are
134 specified for ULTRASONIC DIAGNOSTIC EQUIPMENT.
135 A general guidance and rationale for the requirements of this particular standard are given in
136 Annex AA.
137 Knowledge of the reasons for these requirements will not only facilitate the prop er application
138 of this particular standard but will, in due course, expedite any revision necessitated by changes
139 in clinical practice or as a result of developments in technology.
140 The approach and philosophy used in drafting this particular standard for s afety of ULTRASONIC
141 DIAGNOSTIC EQUIPMENT are consistent with those in standards of the IEC 60601-2-xx series that
142 apply to other diagnostic modalities, such as X-ray equipment and magnetic resonance systems.
143 In each case, the safety standard is intended to require increasing sophistication of output
144 display indicators and/or controls with increasing energy levels in the interrogating field of
145 diagnosis. Thus, for all such diagnostic modalities, it is the responsibility of the OPERATOR to
146 understand the risk of the output of the ULTRASONIC DIAGNOSTIC EQUIPMENT, and to act
147 appropriately in order to obtain the needed diagnostic information with the minimum risk to the
148 PATIENT.
149 INTRODUCTION TO AMENDMENT 1
150 The second edition of IEC 60601-2-37 was published in 2007. Since that publication, the parent
151 standard, IEC 60601-1:2005, entered maintenance, under which an amendment (IEC 60601-
152 1:2005/AMD1:2012) and a consolidated edition 3.1 (IEC 60601-1:2005 and IEC 60601-
153 1:2005/AMD1:2012) were published. This amendment to IEC 60601-2-37:2007 addresses
154 three issues:
155 1) technical changes proposed by National Committees as a result of 4 years of practical
156 usage,
157 2) technical and editorial changes resulting from the amended general standard
158 IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 and its collateral standards
159 IEC 60601-1-xx, and
160 3) technical changes as a result of maintenance to normative references.
161 INTRODUCTION TO EDITION 3
162 This third edition of IEC 60601-2-37 further updates the standard in order to address:
163 4) Technical and editorial changes resulting from the amended general standard IEC 60601
164 1:2005 and IEC 60601-1:2005/AMD1:2012 and its collateral standards IEC 60601-1-xx,
165 5) Technical and editorial changes as a result of maintenance to normative references
166 6) Technical and editorial changes resulting from relevant developments in TC 87 Ultrasonics
167 standards. In particular, the clause 201.11 Protection against excessive temperatures and
168 other HAZARDS has been fully revised.
169
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170 MEDICAL ELECTRICAL EQUIPMENT –
171
172 Part 2-37: Particular requirements for the basic safety
173 and essential performance of ultrasonic medical
174 diagnostic and monitoring equipment
175
176 The clauses and subclauses of the general standard apply except as follows:
177 201.1 Scope, object and related standards
178 Clause 1 of the general standard applies, except as follows:
179 201.1.1 *Scope
180 Replacement:
181 This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
182 ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as ME
183 EQUIPMENT.
184 If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
185 ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is no t the
186 case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
187 HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within
188 the scope of this standard are not covered by specific requirements in this standard except in
189 7.2.13 and 8.4.1 of this standard.
190 NOTE See also subclause 4.2 of this standard.
191 This particular standard does not cover ultrasonic therapeutic equipment. Equipment used for
192 the imaging or diagnosis of body structures by ultrasound in conjunction with other medical
193 procedures is covered.
194 201.1.2 Object
195 Replacement:
196 The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
197 PERFORMANCE requirements for ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217.
198 201.1.4 Particular standards
199 Replacement:
200 In the IEC 60601 series, particular standards may modify, replace or delete requirements
201 contained in the general standard as appropriate for the particular ME EQUIPMENT under
202 consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements.
203 A requirement of a particular standard takes priority over the general standard.
204 For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
205 Collateral standards are referred to by their document number.
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206 The numbering of sections, clauses and subclauses of this particular standard corresponds to
207 that of the general standard with the prefix “201” (e.g. 201.1 in this particular standard
208 addresses the content of Clause 1 of the general standard) or applicable collateral s tandard
209 with the prefix “20x” where x is the final digit(s) of the collateral standard document number
210 (e.g. 202.6 in this particular standard addresses the content of Clause 6 of the 60601 -1-2
211 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the
212 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are
213 specified by the use of the following words:
214 "Replacement" means that the clause or subclause of the general standard or applicable
215 collateral standard is replaced completely by the text of this particular standard.
216 "Addition" means that the text of this particular standard is additional to the requirements of the
217 general standard or applicable collateral standard.
218 "Amendment" means that the clause or subclause of the general standard or applicable
219 collateral standard is amended as indicated by the text of this particular standard.
220 Subclauses, figures or tables which are additional to those of the general standard are
221 numbered starting from 201.101, additional annexes are lettered AA, BB, etc., and additional
222 items aa), bb), etc.
223 Subclauses or figures which are additional to those of a collateral standard are numbered
224 starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-
225 2, 203 for IEC 60601-1-3, etc.
226 The term "this standard" is used to make reference to the general standard, any applicable
227 collateral standards and this particular standard taken together.
228 Where there is no corresponding section, clause or subclause in this particular standard, the
229 section, clause or subclause of the general standard or applicable collateral standard, although
230 possibly not relevant, applies without modification; where it is intended that any part of the
231 general standard or applicable collateral standard, although possibly relevant, is not to be
232 applied, a statement to that effect is given in this particular standard.
233 201.2 Normative references
234 Clause 2 of the general standard applies except as follows:
235 Addition:
236 IEC 60601-1:2020 Ed. 3.2, Medical electrical equipment – Part 1: General requirements for
237 basic safety and essential performance
238 IEC 60601-1-12:2014, General requirements for basic safety and essential performance –
239 Collateral Standard: Requirements for medical electrical equipment and medical electrical
240 systems intended for use in the emergency medical services environment (EMS)
241 IEC 60601-2-18:2009, Medical electrical equipment – Part 2-18: Particular requirements for the
242 basic safety and essential performance of endoscopic equipment
243 IEC 62127-1:2022, Ultrasonics – Hydrophones – Part 1: Measurement and characterization of
244 medical ultrasonic fields
245 IEC 62359:2010+A1:2017, Ultrasonics – Field characterization – Test methods for the
246 determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
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247 CISPR 11:2015, Industrial, scientific and medical equipment – Radio-frequency disturbance
248 characteristics – Limits and methods of measurement
249 Amendment 1:2016
250 Amendment 2:2019
251 201.3 Terms and definitions
252 For the purposes of this document, the terms and definitions given in the general standard and
253 in IEC 62359, as well as the following additions apply:
254 NOTE 1 An index of defined terms is given after the Bibliography.
255 NOTE 2 A list of symbols used in this particular standard is found in Table 201.101.
256 201.3.201
257 BONE THERMAL INDEX
258 TIB
259 THERMAL INDEX for applications such as foetal (second and third trimester), in which the
260 ultrasound beam passes through soft tissue and a focal region is in the immediate vicinity of
261 bone
262 Unit: None
263 [SOURCE: IEC 62359:2010+A1:2017, 3.17, modified –The original notes have been deleted]
264 201.3.202
265 COMBINED-OPERATING MODE
266 mode of operation of ULTRASONIC DIAGNOSTIC EQUIPMENT that combines more than one DISCRETE-
267 OPERATING MODE
268 201.3.203
269 CRANIAL-BONE THERMAL INDEX
270 TIC
271 THERMAL INDEX for applications, in which the ultrasound beam passes through bone near the
272 beam entrance into the body, such as paediatric and adult cranial or neonatal cephalic
273 applications
274 Unit: None
275 [SOURCE: IEC 62359:2010+A1:2017, 3.21, modified – The original notes have been deleted.]
276 201.3.204
277 DEFAULT SETTING
278 specific state of control the ULTRASONIC DIAGNOSTIC EQUIPMENT will enter upon power-up, new
279 PATIENT select, or change from non-foetal to foetal applications
280 201.3.205
281 DISCRETE-OPERATING MODE
282 mode of operation of ULTRASONIC DIAGNOSTIC EQUIPMENT in which the purpose of the excitation
283 of the ULTRASONIC TRANSDUCER or ULTRASONIC TRANSDUCER element group is to utilise only one
284 diagnostic methodology
285 201.3.206
286 FULL SOFTWARE CONTROL OF ACOUSTIC OUTPUT
287 means by which the ULTRASONIC DIAGNOSTIC EQUIPMENT manages the acoustic output
288 independent of direct OPERATOR control
289 201.3.207
290 INVASIVE TRANSDUCER ASSEMBLY
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291 a transducer which, in whole or in part, penetrates inside the body, either through a body orifice
292 or through the surface of the body
293 201.3.208
294 MECHANICAL INDEX
295 Indicator of the risk for bioeffects due to mechanical or nonthermal mechanisms, such as
296 cavitation
297 Symbol: MI
298 Unit: None
299 NOTE See IEC 62359 for methods of determining the MECHANICAL INDEX.
300 201.3.209
301 MULTI-PURPOSE ULTRASONIC DIAGNOSTIC EQUIPMENT
302 ULTRASONIC DIAGNOSTIC EQUIPMENT that is intended for more than one clinical application
303 201.3.210
304 NON-SCANNING MODE
305 mode of operation of ULTRASONIC DIAGNOSTIC EQUIPMENT that involves a sequence of ultrasonic
306 pulses that give rise to ultrasonic scan lines that follow the same acoustic path
307 201.3.211
308 PRUDENT USE STATEMENT
309 affirmation of the principle that only necessary clinical information should be acquired and that
310 high exposure levels and long exposure times should be avoided
311 [SOURCE: IEC 62359:2010+A1:2017, 3.40, modified – The definition has been reworded.]
312 201.3.212
313 SCANNING MODE
314 mode of operation of ULTRASONIC DIAGNOSTIC EQUIPMENT that involves a sequence of ultrasonic
315 pulses that give rise to scan lines that do not follow the same acoustic path
316 201.3.213
317 SOFT TISSUE THERMAL INDEX
318 TIS
319 THERMAL INDEX related to soft tissues
320 Unit: None
321 [SOURCE: IEC 62359:2010+A1:2017, 3.52, modified – The original notes have been deleted.]
322 201.3.214
323 THERMAL INDEX
324 TI
325 Indicator of the risk of bioeffect due to thermal mechanisms expressed as the ratio of
326 ATTENUATED OUTPUT POWER at a specified point to the ATTENUATED OUTPUT POWER required to
327 raise the temperature at that point in a specific tissue model by 1 °C.
328 Unit: None
329 [SOURCE: IEC 62359:2010+A1:2017, 3.56, modified – The term "ATTENUATED ACOUSTIC POWER"
330 has been replaced twice by the term "ATTENUATED OUTPUT POWER", and the original note has
331 been deleted.]
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332 201.3.215
333 TRANSDUCER ASSEMBLY
334 those parts of ULTRASONIC DIAGNOSTIC EQUIPMENT comprising the ULTRASONIC TRANSDUCER
335 and/or ULTRASONIC TRANSDUCER ELEMENT GROUP, together with any integral components, such
336 as an acoustic lens or integral stand-off
337 Note 1 to entry: The TRANSDUCER ASSEMBLY is usually separable from the ultrasound instrument console.
338 [SOURCE: IEC 62359:2010+A1:2017, 3.69, modified – the original term "medical diagnostic
339 ultrasound equipment" has been replaced by "ULTRASONIC DIAGNOSTIC EQUIPMENT" in the
340 definition.]
341 201.3.216
342 TRANSMIT PATTERN
343 combination of a specific set of transducer beam-forming characteristics (determined by the
344 transmit aperture size, apodisation shape, and relative timing/phase delay pattern across the
345 aperture, resulting in a specific focal length and direction), and an electrical drive waveform of
346 a specific fixed shape but variable amplitude
347 [SOURCE: IEC 62359:2010+A1:2017, 3.58]
348 201.3.217
349 ULTRASONIC DIAGNOSTIC EQUIPMENT
350 MEDICAL ELECTRICAL EQUIPMENT that is intended for ultrasonic medical examination
351 201.
...
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