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YY/T 1767-2021: Ultrasonics - Power measurement - High intensity therapeutic ultrasound (HITU) transducers and systems
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Ultrasonics - Power measurement - High intensity therapeutic ultrasound (HITU) transducers and systems
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YY/T 1767-2021
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Basic data | Standard ID | YY/T 1767-2021 (YY/T1767-2021) | | Description (Translated English) | Ultrasonics - Power measurement - High intensity therapeutic ultrasound (HITU) transducers and systems | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C41 | | Word Count Estimation | 48,449 | | Issuing agency(ies) | State Drug Administration | YY/T 1767-2021: Ultrasonics - Power measurement - High intensity therapeutic ultrasound (HITU) transducers and systems
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Ultrasonics - Power measurement - High intensity therapeutic ultrasound (HITU) transducers and systems
ICS 11.040.50
C41
People's Republic of China Pharmaceutical Industry Standards
Ultrasonic power measurement High Intensity Therapeutic Ultrasound (HITU)
Transducer and system
(IEC 62555.2013, IDT)
Released on 2021-03-09
2022-04-01 implementation
Issued by the National Medical Products Administration
Table of contents
Foreword Ⅴ
Introduction Ⅵ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 List of symbols 4
5 Power measurement of HITU equipment 5
6 Radiation force acting on the target 5
6.1 General 5
6.2 Requirements for equipment 6
6.3 Requirements for measurement conditions 7
6.4 Measurement uncertainty 8
6.5 Calculation of output power 11
7 Changes in target buoyancy 11
7.1 General 11
7.2 Requirements for equipment 11
7.3 Requirements for measurement conditions 13
7.4 Measurement uncertainty 14
7.5 Calculation of output power 16
8 Electrical properties 16
8.1 Electrical impedance 16
8.2 Radiated conductance 16
8.3 Efficiency 16
Appendix A (informative appendix) Other measurement methods 18
A.1 Radiation force acting on the transducer 18
A.2 Calorimetry 18
A.3 Plane scanning of hydrophone 18
Appendix B (informative appendix) Target size 19
B.1 Non-focused transducer 19
B.2 Focusing transducer 19
Appendix C (informative appendix) Radiation force calculation formula 21
C.1 General 21
C.2 Guidelines for Focusing Transducers 21
C.3 Guidelines for Multi-element Transducers 21
C.4 Guidelines for Phased Arrays 23
C.5 Guidelines for movable or adjustable sound sources 23
C.6 Guidelines for cross beams 23
C.7 Guidelines for non-focused transducers 23
C.8 Other geometric structures 24
Appendix D (informative appendix) Expansion method 25
D.1 Overview 25
D.2 Principle 25
D.3 Examples of expansion targets 27
D.4 Determine buoyancy sensitivity 27
D.5 Curve fitting method 28
D.6 Correction of heat loss 29
D.7 Uncertainty 29
Appendix E (informative appendix) The influence of attenuation and sound impulse on the measurement of incident power and output power 31
E.1 General 31
E.2 Linear propagation 31
E.3 Non-linear propagation 32
Appendix F (informative appendix) Avoiding cavitation 34
F.1 General 34
Appendix G (informative appendix) Transducer efficiency 35
G.1 Overview 35
G.2 Terms and definitions 35
G.3 Electroacoustic efficiency 36
G.4 Introduction to Electrical Efficiency Measurement 37
G.5 Introduction to radiation efficiency measurement 38
G.6 Measurement of electroacoustic efficiency 38
G.7 Measurement of electrical efficiency and radiation efficiency 38
Reference 41
Figure 1 Linearity check. the relationship between balance readings and input 9
Figure C.1 The relationship between the sound field plane wave correction factor of the circular piston ultrasonic transducer and the product of the circular wave number and the radius of the transducer 22
Figure D.1 Schematic diagram of expansion target 25
Figure D.2 Example of relationship between weight weight and time series 26
Figure D.3 Changes in the apparent mass of castor oil with time after irradiation with ultrasonic 1W sound power of different frequencies for 10 seconds 29
Figure G.1 Voltage source under different load conditions 39
Figure G.2 Voltage power supply, electrical matching network and transducer equivalent circuit 39
Figure G.3 Schematic diagram of electrical loss 40
Table D.1 Relevant properties of castor oil from Acros? Organics in the range of 10℃ to 60℃28
Table D.2 The relationship between the absorption coefficient of castor oil and temperature 28
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard uses the translation method equivalent to IEC 62555.2013 "Ultrasonic Power Measurement High Intensity Therapeutic Ultrasound (HITU) Transducer"
And System.
Please note that some of the contents of this document may involve patents. The issuing organization of this standard does not bear the responsibility for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is organized by the National Medical Electrical Appliance Standardization Technical Committee Medical Ultrasonic Equipment Standardization Subcommittee (SAC/TC10/SC2)
Focus.
Drafting organizations of this standard. Chongqing Haifu Medical Technology Co., Ltd., Hubei Provincial Medical Device Quality Supervision and Inspection Institute, Chongqing Rong
Hai Ultrasound Medical Engineering Research Center Co., Ltd., China Jiliang University and China Institute of Metrology.
The main drafters of this standard. Ye Fangwei, Jiang Shilin, Zeng Deping, Wang Yuebing, Yang Ping, Li Tao, Xu Guihua.
Introduction
For an ultrasonic sound field with a frequency in the order of megahertz, the radiation force balance method is generally used to measure the radiation force acting on the target to determine the ultrasonic sound field.
Acoustic output power [1-3]. However, the relationship between the radiation force and the ultrasonic output power is affected by factors such as sound field focusing or other geometric factors, and targets.
The type and shape, the distance between the target and the transducer, the absorption of sound energy in the water section (including "impact loss"), and the sound impulse flow, etc.
influences. Although many of the above factors have little effect on the general diagnostic and physical therapy ultrasound sound field, for high-intensity therapeutic ultrasound (HITU),
Especially for the high-intensity focused ultrasound (HIFU) [4] sound field that people often say, these effects are usually not negligible. In addition, for HI-
TU, the physical quantity that people pay attention to is the power entering the patient's body, not the output power of the transducer surface. Because of the difference between the transducer and the patient
Water is often used for coupling, so the impact of sound energy absorption and impact loss in the water section may be very large, and it will vary with distance.
Variety.
The purpose of this standard is to establish a standard method for measuring the ultrasonic power of HITU equipment in the low MHz frequency range in liquid.
The gravitational balance method measures the radiation force, and the other is the use of calorimetry to measure thermal expansion. This standard identifies the source of error and how to evaluate
The total uncertainty of measurement is systematically described. At the same time, the precautions and uncertain factors that should be considered in the process of power measurement are given.
The standard also provides practical guidance on how to determine the sound power of HITU transducers of various geometric shapes. With IEC 61161
The method of measuring "time average power" with radiation force is different. This standard gives another power measurement method.
Part of the structure and content of this standard is based on IEC 61161.2013.The power concerned by IEC 61161 is the output power, which specifies the measurement
The position of the time target is close to the transducer, so it is not very suitable for a strong focus transducer. In some cases, it is more necessary to be at a certain distance from the transducer.
The incident power is measured on a specific surface (such as the surface of the patient's skin).
Will cause significant non-linear losses. Therefore, the main consideration in this standard is measured as the incident power, not the output power. Of course, using
With an appropriate model combined with its own uncertainty, the incident power can be used as the basis for determining the output power.
Ultrasonic power measurement High Intensity Therapeutic Ultrasound (HITU)
Transducer and system
1 Scope
This standard.
Established a radiation force balance method for measuring the HITU sound field with an acoustic target;
Standardizes the calorimetry method of measuring the thermal expansion of the fluid to determine the total emitted sound power of the ultrasonic transducer;
Standardize the requirements for describing the electrical power characteristics of ultrasonic transducers;
Provides guidance and suggestions to prevent acoustic cavitation during the measurement process;
Provides HITU transducers for measuring different structures and geometries (including collimated, divergent and convergent transducers, as well as multivariate
Transducer) guidance and suggestions;
Provides guidance on choosing the most appropriate measurement method;
Provides information for evaluating the total uncertainty of the measurement.
This standard is applicable to the measurement of ultrasonic power with an upper limit of 500W generated by HITU equipment in the frequency range of 0.5MHz to 5MHz.
The sound field can be convergent, collimated or divergent.
This standard does not verify that the frequency is lower than 500kHz, and the user should be uncertain about the power measurement and measurement system at this frequency.
Degree to be evaluated.
This standard does not apply to ultrasound equipment used in physical therapy, lithotripsy, and routine pain relief.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document.
IEC 61161.2013 Ultra-acoustic power measurement radiation force balance and performance requirements (Ultrasonics-Powermeasure-
ment-Radiationforcebalancesandperformancerequirements)
IEC /T R62781 Ultrasonic ultrasonic measurement water treatment (Ultrasonics-Conditioning of waterforultrasonic
measurements)
3 Terms and definitions
3.1
Acoustical efficiency
ηa
The ratio of the output sound power of the ultrasonic transducer to the electrical power of the transducer.
Note. The acoustic efficiency is a dimensionless value.
3.2
Acousticstreaming
One-way movement of fluid caused by sound field.
[Source. IEC 61161.2013, 3.1]
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