Establishment the Testing Procedure for

Medical Measuring Devices on

Therapeutic Ultrasound in Thailand

Patchariya Petchpong, PhD.

Ultrasound Laboratory
Acoustics and Vibration Group
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 Acoustics & Vibration Group
Leading to a better quality life
Acoustics and Vibration Group has been established since 1998 of which the main
mission is to maintain the primary standard of acoustics, vibration, and ultrasound
metrology and its traceability. The following time line illustrates the history in the past .

Free-field microphone
calibration system by 2004
substitute method
Primary calibration system for
2003 pressure calibration of
standard microphones

Sound calibrator calibration

2001
Sound level meter calibration

Charge amplifier,
2000 Accelerometer and Exciter
by back to back method

Vibration meter 1999

calibration system
Timeline Continued in Next Page
1998
 Acoustics & Vibration Group
Leading to a better quality life
Acoustics and Vibration Group has been established since 1998 of which the main
mission is to maintain the primary standard of acoustics, vibration, and ultrasound
metrology and its traceability. The following time line illustrates the history in the past .

Ultrasound Pressure Calibration System 2014

Ultrasonic Power
2009
Calibration System

Pressure microphone calibration system

by insert voltage technique 2006
Shock sensor calibration system

Primary transducer vibration calibration

2005 system by fringe counting method, minimum
point method, and sine approximation method
Timeline Continued in Next Page
 Acoustics & Vibration Group
Leading to a better quality life
Acoustics and Vibration Group has been established since 1998 of which the main
mission is to maintain the primary standard of acoustics, vibration, and ultrasound
metrology and its traceability. The following time line illustrates the history in the past .

Noise Dose Meter Calibration System

Sound Transmission Loss Testing 2017

Sound Absorption Coefficient of Material

2016
Testing

Primary Medium-Shock Transducer

Calibration System: 20 m/s2 to 20,000 m/s2
Primary High-Shock Transducer Calibration 2015
System: 20,000 m/s2 to 750,000 m/s2
Current Status of Measurement Capability
Number of Staff Members : 8 people
Laboratory Doctoral Master’s Bachelor’s Total
Degree Degree Degree

Acoustics 1 2 1 4

Ultrasound 1 1 - 2
(Trainee)
Vibration - 2 - 2
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Current Status for Ultrasound Calibration System
Ultrasound Power System
 Ultrasound Power Primary Calibration System using Radiation
Force Balance Method :
Power range: 10 mW to 10 W (1 MHz to 5 MHz)
Uncertainty: 6% to 7% (k = 2)

Calibration Service:
 Ultrasound Check Source Calibration
Power range: 10 mW, 100 mW and 1 W (3.5 MHz)
Uncertainty: 6% (k = 2)
 Ultrasound Power Meter Calibration for Physiotherapy
Power range: 0.5 W to 10 W (1 MHz to 5 MHz)
Uncertainty: 6% to 7% (k = 2) “I AM NIMT”
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 Current Status for Ultrasound Calibration System
Ultrasound Pressure System
 Hydrophone Calibration System
Calibration Range: 1 MHz to15 MHz
Uncertainty: 14% to 15%
 Characterization of Ultrasonic Transducer - Ultrasonic parameters
(pressure, intensity) using Planar Scanning Method
Calibration Range: 1 MHz to 15 MHz
Uncertainty: 15%
 Ultrasonic Transducerfor Physiotherapy - Effective Radiating Area (ERA),
Beam non-uniformity ratio (BRN)) using Planar Scanning Method
Calibration Range: 1 MHz to 3 MHz
Uncertainty: 17% “I AM NIMT”
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 Ultrasound Laboratory

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 Works & Future Plan in Ultrasound Lab
•• InIn 2016,
2016, The
The testing
testing procedure
procedure ofof medical
medical measuring
measuring devices
devices on
on
Therapeutic Ultrasound
Therapeutic Ultrasound hashas been
been published
published inin Thailand.
Thailand.
•• InIn 2018,
2018, NIMT
NIMT joined
joined thethe Official
official International
international Comparison
comparison inin
Ultrasound Power
Ultrasound Power asas referred
referred inin the
the Technical
Technical Protocol
Protocol :: TCAUV/APMP
TCAUV/APMP
key comparison
key comparison ultrasonic
ultrasonic power
power APMP.AUV.U-K3
APMP.AUV.U-K3
•• InIn 2019,
2019, We
We are
are going
going toto set
set upup the
the ultrasound
ultrasound power
power system
system for
for
testing the
testing the Therapeutic
Therapeutic Ultrasound
Ultrasound for for Physiotherapy
Physiotherapy (on-site
(on-site service)
service)
•• InIn 2019,
2019,WeWehave
will move
the planon for
to the accreditation process
the accreditation process for supporting
Calibration and Measurement Capability (CMC) submission

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 Testing Guideline for Medical Measuring
Devices on Ultrasonic Physiotherapy
Equipment in Thailand

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 Testing Guideline for
Medical Measuring
Devices of Therapeutic
Ultrasound

ISBN: 978-616-11-3010-7
as published in Thai version

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 Collaborative Project
This project is conducted under a
collaborative project between the ultrasound
laboratory of the National Institute of Metrology,
Thailand (NIMT) and the department of medical
sciences (DMSC), and the department of health
service support (DHSS), ministry of public health.
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 Aims :
This project has been carried out to develop the standard
testing guideline procedure for the acceptance testing or
periodic testing of the therapeutic ultrasound, which meet the
requirements from the authorities in Thailand.
To ensure the new devices work properly as the requirement
of specification for the safe use.
To develop transfer standard devices for ensuring the
accurate calibration of ultrasonic physiotherapy in clinical use.
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 Notes :
This particular standard does not apply to:
- EQUIPMENT in which a tool is driven by ULTRASOUND (for
example EQUIPMENT used in surgery or densitry);
- EQUIPMENT in which focused ULTRASOUND pulse waves
are used to destroy conglomerates such as stones in the
kidneys or the bladder (lithotripters)
- ULTRASOUND PHYSIOTHERAPY EQUIPMENT in which
focused ultrasound pulse waves are used.
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 Therapeutic Ultrasound

Credit: http://www.championpt.net/ultrasound/
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 Therapeutic Ultrasound

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 Diagram of Functional Therapeutic Ultrasound

To clarify the precision of the acoustic power, the primary standard calibration
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measurement (radiation force balance, RFB) based on IEC 61161 is used to
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the transducer use the “Ultrasound Power Meter”.
(Thailand)
 Ultrasound Transducer

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 Therapeutic Ultrasound
Therapeutic Ultrasound (TU) has been largely used, in the frequency
range of 1.0 MHz to 3.0 MHz, to treat soft tissue harms, for instance,
musculoskeletal injures. The TU applies a variety of energy and time
dosages to achieve clinical results.
Tissue temperature elevation is related to the intensity levels
irradiated through the patient’s body.
The effective acoustic intensity of the physiotherapy system, obtained
from the ratio of the maximum ultrasonic output power (Pout) and the
effective radiation area (ERA) , is limited to 3 W/cm2 [1]
[1] B. Zeqiri and M. Hodnett, Ä new method for measuring the effective radiating area of physiotherapy treatment heads”,
Ultrasound in Med. & Biol. 24, 761-770 (1998) “I AM NIMT”
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 Therapeutic Ultrasound
The maximum ultrasonic output power (Pout) is measured using a
radiation force balance system based on IEC 61161, whilst and the effective
radiation area (ERA) is based on mapping of the ultrasonic pressure field
using needle hydrophones as followed IEC 61689.

Spatial Average Intensity (SAI) = measured output power (W) /measured ERA (cm2)

Therefore, the therapeutic ultrasound efficacy should include accurate

measures of ERA, total output power and SAI to make the results
generalizable to the clinician.

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 Test Apparatus and Conditions

Ultrasound Power Meter

(UPM)

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 Schematic Diagram of Ultrasound Power Meter
with Therapeutic Ultrasound
Therapeutic
Ultrasound
Ultrasonic
Transducer
Temperature
Sensor
Target Support Arm

Conical
Target Support Stem
Target

Degassed Water
Water Tank

Target Support Tube

Electro-balance
(Power or Weight Units)
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 Testing Guideline for
Medical Measuring
Devices of Therapeutic
Ultrasound

ISBN: 978-616-11-3010-7
as published in Thai version

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 Reference Standards
International Electrotechnical Commission (IEC): 62353:
2014-09 Medical electrical equipment – Recurrent test and
test after repair of medical electrical equipment
International Electrotechnical Commission (IEC): 60601-
2-5 : 2009-7 (3rd ed.) Medical electrical equipment – Part 2-
5: Particular requirements for the basic safety and essential
performance of ultrasonic physiotherapy equipment
Emergency Care Research Institute (ECRI): Physical
Therapy Ultrasound Units no. 470-20130829-01: 2014
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 Reference Standards
IEC 60601-2-5 : 2009-7 Medical electrical equipment – Part 2-5:
Particular requirements for the basic safety and essential
performance of ultrasonic physiotherapy equipment
Performance Requirements
Free from the display of incorrect numerical values associated with
the therapy to be performed.
Free from the production of unwanted ultrasound output.
Free from the production of excessive ultrasound output.
Free from the production of unintended or excessive Transducer
Assembly surface temperature. “I AM NIMT”
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 Performance Requirements: IEC 60601-2-5

Free from the display of incorrect numerical values associated

with the therapy to be performed.
The accuracy of the data and controls specific to acoustic output
power shall be determined. (Estimation of uncertainties, the ISO/IEC
guide to the expression of uncertainty in measurement should be used.
Free from the production of unwanted ultrasound output.
The unwanted ultrasound radiation is measured by scanning, the
side walls of the treatment head by means of a calibrated hydrophone
coupled, which is presented in terms of “the spatial-peak temporal-
average intensity , Ispta”. The value shall be less than 100 W/cm2

Ispta = P2max/ρc
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 Performance Requirements: IEC 60601-2-5

Free from the production of excessive ultrasound output.

The maximum effective intensity shall not exceed 3 W/cm2 with any
treatment head.
Effective Intensity = rated output power (W) / effective radiating area (cm2)
Free from the production of unintended or excessive Transducer
Assembly surface temperature
Checked by the radiometry or thermocouple methods by use the
simulated test.
Treatment head applied to the patient shall have a patent contact
surface temperature not exceed 43o C under simulated test on mimic
tissue.
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 Simulated Test for Temperature Measurement

1. Ultrasound Transducer under

test, coupled to the test object
using acoustic coupling gel

2. Thermal Sensor

3. Silicone rubber thickness 1.5

mm.

4. Soft tissue mimicking material

5. Acoustic absorber

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 Test Apparatus and Conditions
This guideline shall be provided in
the three main elements, which are

1. The Qualitative Tests

2. The Electrical Safety Tests

3. The Quantitative Tests

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 Qualitative Tests
The examinations of the exterior device have to be verified that can
be operated in properly function.
Labeling includes the model and serial number shall be checked.
The AC power plug shall be examined for any damages and also to
ensure that the grounding can be performed.
All controls and switches need to be investigated for physical
condition, secure mounting, and correct motion, it is to confirm that
each control and switch work its proper function.
The visual displays, gauges, meters or indicators shall be verified that
all segments work properly.
Transducers and electrodes need to be checked that they are in
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 Electrical Safety Tests
The electrical safety analyzer is used for the electrical
safety tests. This is to check the protection earth resistance
with the maximum of 0.5 ohms except the double-insulated,
grounding resistance. However, the measurement accuracy of
the resistance value is given within ±15% of reading.
Furthermore, the leakage current shall be realized as referred
to IEC 62353. Chassis leakage current to ground should be
≤500 µA. Moreover, the accuracy of leakage current
measurement shall be ≤15% of reading.
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 Electrical Safety Tests
Testing Criteria Descriptions
Grounding ≤ 0.5 ohms - To check the protection
Resistance earth resistance
- Except the double-
insulated or Class II does
not need the test.
Chassis Leakage ≤ 500 µA - Chassis leakage current to
Current ground
IEC 62353 : Medical electrical equipment – Recurrent test and test after repair of
medical electrical equipment
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 Quantitative tests
The verifications of quantitative tests
can be divided into three parts, which are
1. Ultrasonic Output Power
2. Timer
3. Stimulation Current *
*In case: the therapeutic ultrasound has worked with the electrical stimulation
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 Ultrasonic Output Power

Ultrasound Power Meter

(UPM)

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 Reference Standards
Ultrasound Power Meter (UPM)
International Electrotechnical Commission (IEC): 61161:
2013 (3rd ed.) - Ultrasonics - Power measurement - Radiation
force balances and performance requirements)

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 Ultrasound Power Measurements
According to the standard IEC 61161 , the acoustic power (P) of
the ultrasonic transducer shall be evaluated to complete the
calibration measurement. Therefore, the evaluation of ultrasonic
power output can be written as in the following equation;

P=Fxc
F is the radiation force acting on the target ( F =m x g )
c is the speed of sound in water
m is the deviated weight in the measurement
g is the gravitational acceleration, 9.78297034 m/s2 in Thailand

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 • In order to approach the acoustic output power, the sound speed (c)
in the fluid medium is considered as a function of temperature and
ambient pressure. This is expressed mathematically as:
•
• c = 1402.7 + 488t – 482t 2+ 135t 3 + (15.9 + 2.8t + 2.4t2)∙ (PG/100)
•
• Where t is the water temperature (t = T/100), with T in degree
Celsius) and PG is the gauge pressure in bars. This equation is
accurate to within 0.05 percent for oC and bars (1 bar = 105 Pa).

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 TRACEABILITY OF ULTRASOUND POWER MEASUREMENT
Before Thai testing procedure for medical measuring
devices on ultrasonic physiotherapy was published, two categories
of UPM calibration method, which are the mass calibration
technique and the radiation force balance method, were
investigated to confirm the proper technique that shall be
performed the traceable calibration with the ultrasonic power
measurement system.

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 Comparison Two Measurement Methods
The measurements of ultrasound power meter are investigated
in two categories;
1. Mass Calibration Method
Standard Weight Set (F1)
1 mg to 200 g (s/n: NIMT-SF1-02) was used for calibrating the
ultrasound power meter at the various nominal output powers
2. Power Calibration Method
0.95 MHz and 3 MHz Ultrasonic Transducers were used for
calibrating the ultrasound power meter at the various nominal
output powers

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 4 Participants agreed to take part in the measurements
1. Bureau of Radiation and Medical Devices, Department of Medical

Sciences, Ministry of Public Health

2. Division of Medical Engineering, Department of Health Service

Support, Ministry of Public Health

3. National Healthcare Systems Co., Ltd.

4. Ultrasound Laboratory, National Institute of Metrology (Thailand)

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 Ultrasound Power Measurement by Mass Calibration
Actual mass of standard weight for setting the nominal power

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 Ultrasound Power Measurement by Mass Calibration

Therapeutic
Ultrasound
Ultrasonic
Transducer
Temperature
Sensor
Target Support Arm

Conical
Target Support Stem
Target

Degassed Water
Water Tank

Target Support Tube

Electro-balance
(Power or Weight Units)
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Measurement results of output power affected from the standard weight calibration at 0.5 W to 10
W checked by UPMs from four laboratories. 𝑈𝑒 is the expanded uncertainty (k=2).

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 Radiation Force Balance Calibration Results
Measurement Results of acoustics output power checked by RFB
method at 0.5 W to 10 W in terms of frequency at 0.95 MHz

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 Radiation Force Balance Calibration Results
Measurement Results of acoustics output power checked by RFB
method at 0.5 W to 10 W in terms of frequency at 3 MHz

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 At 1 MHz “I AM NIMT”
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 The most data taken from mass method give the deviation (%) more
than or equal to the limitation of the criterion of standard testing, whereas
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from RFB are within ±30% tolerance of device indication. That means the
สถาบันtraceability
suitable มาตรวิทยาแห่ of งUPM
ชาติ shall be the RFB.
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 Ultrasound Therapy

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 Equipment
List of Devices Criteria and Description
Resistance:
Range: 0.0 ohm to 0.5 ohms
Accuracy : ≤±15 % of reading
Electrical Safety Analyzer Test Current : ≥200 mA at 0.5 ohms
Leakage Current:
Range: 10 µA to 500 µA
Accuracy : ≤±15 % of reading
Range: 0.5 W to 30 W
Ultrasound Power Meter Accuracy: ≤ ±10% of reading
Resolution : ≤ 0.02 W

Temperature Sensor in Water Accuracy : ≤1.0 oC, Resolution : ≤ 0.1 oC

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 Equipment
List of Devices Criteria and Description
Temperature Function:
Temperature and Humidity Sensors Accuracy : ≤1.0 oC, Resolution : ≤ 0.1 oC
For Environmental Condition Humidity Function:
Accuracy : ≤1.0 oC, Resolution : ≤ 0.1 oC

Stop Watch Accuracy : ≤1.0 %

Oscilloscope -

Water Distilled Water

The testing of water temperature of Degassed Water (> 5 W) “I AM NIMT”
สถาบัน19.5
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oC to 28.5 oC is chosen
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 From the research in Thailand, we found that the accuracy of
UPM shall be within ≤10%. In term of accuracy ratio, it provides
the relationship between the accuracy of the standard device and
the accuracy of the instrument under test. An accuracy ratio of 3:1
is recommended to use for ensuring the consistency of calibration
measurement.
To meet the needs of appropriate use criteria, as well as
requirements in the areas of the testing guideline of ultrasonic
physiotherapy equipment, the actual power output of ultrasonic
physiotherapy shall be within ±30% of the device indication

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 Timer
For the timer determinations, the
ultrasonic physiotherapy is investigated a timer
setting of 1, 5 and 10 minutes at maximum
output by use the stopwatch. The accuracy of
timer setting shall be within ±10%.

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 Stimulation Current

** In case: the therapeutic

ultrasound has worked with
the electrical stimulation **

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 Stimulation Current
The stimulation current must be measured in
case the working of ultrasonic physiotherapy has
included the eletrical stimulation section. The
oscilloscope would be used in this process. The
measured output can be expected to be within
±10%.

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 Quantitative tests
Testing Criteria
Accuracy of Ultrasonic Output Power ± 30%

Accuracy of Timer ± 10%

**In case, the therapeutic ultrasound has worked with the

electrical stimulation, the error of stimulation current will be
considered.
Testing Criteria
Error of Stimulation Current ± 10%
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 Ultrasound Power Measurement
The ultrasound power meter (UPM) is used to determine the
actual power output of ultrasonic physiotherapy, needs to be
performed the traceable calibration, which has the accuracy of
≤10% based on IEC 61161 Ultrasonics – power measurement –
radiation force balances and performance requirements.
The output power indication shall be within ±30% of the
actual value.
The measured output powers have to be checked at least
three points; maximum, midrange and low settings in terms of
watt at desired frequency as used in the normal conditions for
patients. “I AM NIMT”
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 Conclusions
This testing guideline of ultrasonic physiotherapy
equipment is developed in Thailand (ISBN: 978-616-11-3010-7 as
published in Thai version). This project has been carried out to
establish the reference procedure for the acceptance testing or
periodic testing of the therapeutic ultrasound, which meet the
requirements from the authorities in Thailand. This is to avoid
the devices damage to patient injury as well as mistreatment,
which can be ensure the therapeutic ultrasound is safe for use.
Three main parts must be investigated, which are the
qualitative tests, the electrical safety tests and the quantitative
tests.
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 Conclusions
To verify the quantitative examination, the actual power
output of ultrasonic physiotherapy shall be within ±30% of the
device indication. The UPM shall be used to evaluate the output
power of the ultrasonic head of the therapeutic ultrasound, which
shall be calibrated has the accuracy of ≤10% based on IEC 61161.
For the timer checking, the ultrasonic physiotherapy is determined
a timer setting with the accuracy within ±10%. Finally, the
stimulation current must be measured in case the working of
ultrasonic physiotherapy has included the electrical stimulation
section. The measured output can be expected to be within ±10%.
“I AM NIMT”
สถาบันมาตรวิทยาแห่ งชาติ
National Institute of Metrology (Thailand)
 More Information:
Testing Guideline for Medical Measuring Devices on Ultrasonic
Physiotherapy Equipment in Thailand, SICE ANNUAL CONFERENCE 2017
Proceedings (International Conference on Instrumentation, Control,
Information Technology and System Integration) (ISBN: 978-4-907764-56-
2), pp. 745-750.

Confirmation the Traceability of Ultrasound Power Meter Calibration

Method for Testing the Therapeutic Ultrasound, Fourth International
Conference on Sensors and Electronic Instrumentation Advances in (SEIA'
2018) (on process)
“I AM NIMT”
สถาบันมาตรวิทยาแห่ งชาติ
National Institute of Metrology (Thailand)
 [email protected]

Ultrasound Laboratory,
Acoustics and Vibration Group

“I AM NIMT”
สถาบันมาตรวิทยาแห่ งชาติ
National Institute of Metrology (Thailand)