prEN IEC 63440:2025
(Main)Ultrasonics - Measurement of temperature rise produced by medical ultrasonic equipment
Ultrasonics - Measurement of temperature rise produced by medical ultrasonic equipment
Ultrasons - Mesurage de l'élévation de température produite par les appareils médicaux à ultrasons
Ultrazvok - Merjenje dviga temperature, ki ga povzroča medicinska ultrazvočna oprema
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2025
Ultrazvok - Merjenje dviga temperature, ki ga povzroča medicinska ultrazvočna
oprema
Ultrasonics - Measurement of temperature rise produced by medical ultrasonic
equipment
Ultrasons - Mesurage de l'élévation de température produite par les appareils médicaux
à ultrasons
Ta slovenski standard je istoveten z: prEN IEC 63440:2025
ICS:
17.140.50 Elektroakustika Electroacoustics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
87/916/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 63440 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2025-10-24 2026-01-16
SUPERSEDES DOCUMENTS:
87/883/CD, 87/889A/CC
IEC TC 87 : ULTRASONICS
SECRETARIAT: SECRETARY:
United Kingdom Mr Petar Luzajic
OF INTEREST TO THE FOLLOWING COMMITTEES: HORIZONTAL FUNCTION(S):
SC 62B,SC 62D
ASPECTS CONCERNED:
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” 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 - Measurement of temperature rise produced by medical ultrasonic equipment
PROPOSED STABILITY DATE: 2029
NOTE FROM TC/SC OFFICERS:
download this electronic file, to make a copy and to print out the content for the sole purpose of preparing National
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IEC CDV 63440 © IEC 2025
1 CONTENTS
3 FOREWORD . 5
4 INTRODUCTION . 7
5 1 Scope . 8
6 2 Normative references . 8
7 3 Terms and definitions . 8
8 4 List of Symbols . 11
9 5 Measurement of patient contact surface temperature for Diagnostic Ultrasound . 12
10 5.1 12
11 5.1.1 Thermal sensor types . 12
12 5.1.2 Spatial averaging and heat dissipation . 12
13 5.1.3 Measurement resolution and measurement uncertainties . 13
14 5.1.4 Positioning of thermal sensor . 13
15 5.1.5 Environmental chamber and ambient temperature monitoring . 15
16 5.1.6 Sampling Rate . 16
17 5.1.7 Measurement Duration . 16
18 5.1.8 Data to Record . 16
19 5.1.9 Temperature Rise with One-Sensor or Two-Sensor Methods . 17
20 5.1.10 Extrapolation Protocol . 20
21 5.2 Measurements in still air . 24
22 5.2.1 Measurement setup description . 24
23 5.2.2 Calculation of measurement result . 24
24 5.3 Measurements in contact with test object– TMM or BMF (blood mimicking
25 fluid) . 25
26 5.3.1 Measurement setup description . 26
27 5.3.2 Calculation of the measurement result . 33
28 6 Temperature measurements for Physiotherapy Equipment . 34
29 6.1 Treatment Head Test Methods . 34
30 6.1.1 Simulated Use . 34
31 6.1.2 Test Methods . 35
32 6.1.3 Still air . 35
33 6.1.4 Operating Settings . 35
34 6.1.5 Temperature Measurement . 35
35 Annex A (informative) Reference Temperature Chamber . 37
36 A.1 General . 37
37 Annex B (informative) Measurement uncertainty and accuracy . 39
38 Annex C (informative) TMM and BMF Recipes . 40
39 C.1 General . 40
40 C.2 Preparation of the soft TMM [17] . 40
41 C.2.1 Recipe to prepare the soft TMM and the set-up . 41
42 C.2.2 Maintenance . 41
43 C.3 Preparation of glycerol blood-mimicking fluid BMF . 42
44 C.3.1 Recipe to prepare the blood-mimicking fluid and setup . 42
45 C.3.2 Maintenance . 43
46 C.4 Preparation of polyurethane blood-mimicking fluid BMF [15] . 43
IEC CDV 63440 © IEC 2025
47 C.4.1 Recipe to prepare the polyurethane blood-mimicking fluid and setup . 43
48 C.4.2 Maintenance . 43
49 Annex D (informative) Measurement procedure of the transducer surface temperature
50 in still air using an infra-red camera . 46
51 D.1 General . 46
52 D.2 Measurement setups . 46
53 D.3 Procedures . 47
54 Annex E (informative) Measurement Methods a) and b) at Different Ambient
55 Temperatures . 50
56 E.1 General . 50
57 E.2 Figures for Further Clarification. 50
58 Annex F (informative) Workflow for Temperature or Temperature Rise Measurement . 54
59 F.1 General . 54
60 F.2 Temperature Measurement Workflow . 54
61 F.3 F.3 Key Points of Temperature Measurement in Each Process . 55
62 F.3.1 General . 55
63 F.3.2 The Type of Measurement Required in Each Process . 55
64 F.3.3 Report of Measurement Required . 56
65 F.3.4 Summary . 56
66 F.4 How to Use Estimation Methods for Determining Thermal Steady State . 56
67 F.4.1 General . 56
68 F.4.2 Features of Estimation Methods . 56
69 F.4.3 How to Use Estimation Methods . 57
70 Annex G (informative) Future Considerations . 59
71 G.1 General . 59
72 Bibliography . 60
74 Figure 1 – hot spot location determination with infrared camera image . 15
75 Figure 2 – off-centered hot spot location . 16
76 Figure 3 – still-air measurement setup example . 17
77 Figure 4 – visualization of measurement methods and measurement evaluation
78 methods . 20
79 Figure 5a – Example of three consecutive measurements using the two-sensor
80 method. The time, t, corresponds to 30 min per measurement with no cooling between
81 measurements. . 21
82 Figure 5b – Example of three consecutive measurements (orange lines) using the two-
83 sensor method with no cooling between measurements and shortened measurement
84 times and extrapolated values. 22
85 Figure 5c – Example of three consecutive measurements using the two-sensor
86 method. The time, t, corresponds to 30 min per measurement with transition periods of
87 1 min between transmit conditions. . 23
88 Figure 5d – Example of three consecutive measurements (orange lines) using the two-
89 sensor method with transition periods of 1 min between transmit conditions and
90 showing shortened measurement times and extrapolated values. . 24
91 Figure 6 – measurement cycle with output hold at the beginning and a 30-minutes
92 measurement after the initial thermal steady state condition is reached for several
93 consecutive measurements using one or two sensors . 24
94 Figure 7 – Graphical depiction of calculation of ∆T (t) . 26
3,X
95 Figure 8 – Example of temperature measurement for a closed-loop system that
96 decreases output during a measurement, with (a) 30-minute measurement, and (b) 24-
IEC CDV 63440 © IEC 2025
97 minute measurement and extrapolation. In both cases, the maximum temperature is
98 43,0°C. . 28
99 Figure 9 – Example of shear wave elastography temperature measurement with
100 significant fluctuations . . 29
101 Figure 10 – Example of different amount of coupling gel used for large footprint and
102 small footprint transducer assemblies . 33
103 Figure 12 – Example of a setup with a heated TMM for external transducer assemblies . 35
104 Figure 13 – Example of a setup with heated TMM for internal transducer assemblies . 35
105 Figure 14 – Example of a setup with unheated TMM for external transducer
106 assemblies; left: one-sensor method; right: two-sensor method . 36
107 Figure 15 – Example of a setup with unheated TMM for internal transducer assemblies;
108 left: one-sensor method; right: two-sensor method . 36
109 Figure 16 – Set up of a heated TMM with an internal transducer assembly and two-
110 sensor method (left sensor is the dummy sensor and the right sensor is the sensor on
111 the applied part) .
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