=Paper=
{{Paper
|id=Vol-2851/paper15
|storemode=property
|title=Creation of a System for Providing Metrological Control of Output Parameters of Ultrasound Medical Equipment
|pdfUrl=https://ceur-ws.org/Vol-2851/paper15.pdf
|volume=Vol-2851
|authors=Ivan Kizlivskyi,Oleksandr Shpak,Nataliia Kunanets,Antonii Rzheuskyi
|dblpUrl=https://dblp.org/rec/conf/itpm/KizlivskyiSKR21
}}
==Creation of a System for Providing Metrological Control of Output Parameters of Ultrasound Medical Equipment==
https://ceur-ws.org/Vol-2851/paper15.pdf
Creation of a System for Providing Metrological Control of
Output Parameters of Ultrasound Medical Equipment
Ivan Kizlivskyia, Oleksandr Shpaka, Nataliia Kunanetsa,b and Antonii Rzheuskyia
a
Lviv Polytechnic National University, Stepana Bandery Street 32-a, Lviv, 79013, Ukraine
b
Ivan Franko National University of Lviv, Universutetska Street 1, Lviv, 79000, Ukraine
Abstract
A project of creating a system of metrological control of the initial parameters of ultrasound
medical equipment, the introduction of which will improve the control of ultrasound medical
equipment and ensure the safety of medical and diagnostic care to the population is
considered in this paper. Ultrasound in modern medicine is one of the basic methods for
diagnosing many diseases, which are successfully used to detect developmental abnormalities
and various pathologies. High diagnostic efficiency during its reduction can be achieved only
by using serviceable and calibrated equipment. The introduction of a comprehensive system
for monitoring the output parameters of ultrasound medical equipment will improve the
control of ultrasound medical equipment, which is widely used in health care facilities,
prevent the use of defective or uncredited equipment, and ensure the safety of medical
services for diagnosis and treatment. The proposed system should provide a clear
interpretation of measurement results, identify the main errors and uncertainties of
measurement and ensure traceability of measurements to national standards.
Keywords 1
Calibration, error, traceability of measurement results, ultrasonic medical equipment,
ultrasonic power, ultrasonic pressure.
1. Introduction
In recent decades, there has been a steady trend in the world to expand the scope of ultrasonic
measurements in the sectors of the economy. They have made special progress in medicine, where the
use of ultrasound in the development of diagnostic, surgical and therapeutic systems is rapidly being
introduced. In general, ultrasound medical equipment can be classified according to the methods of
clinical application (diagnosis, therapy, surgery, cosmetology) and the types of ultrasound fields that
they generate. The acoustic output of such medical equipment is characterized by the following
acoustic parameters: ultrasonic power, ultrasonic pressure, intensity of ultrasonic radiation, frequency
of radiation, mechanical and thermal indices [1].
To ensure the unity of measurements, a clear identity of units is required, in which all means of
technical measurements of the same physical quantity would be graduated. This is achieved by
accurately reproducing and preserving the units of physical quantities adopted at the International
Conference on Measures and Weights and transmitting their dimensions to measuring instruments.
Reproduction, storage and transmission of unit sizes is carried out using standards and sample
measuring instruments. The highest link in the metrological circle of transmission of the sizes of units
of measurement of physical quantities are standards. Given the extreme importance of the reference
base for the national economy, the Government of Ukraine approved the State Program for the
Development of the Reference Base for 2006–2010[2].
Proceedings of the 2nd International Workshop IT Project Management (ITPM 2021), February 16-18, 2021, Slavsko, Lviv region, Ukraine
EMAIL: ivan.h.kizlivskyi@lpnu.ua (Ivan Kizlivskyi); oleksandr.v.shpak@lpnu.ua (Oleksandr Shpak); nek.lviv@gmail.com (Nataliia
Kunanets); antonii.v.rzheuskyi@lpnu.ua (Antonii Rzheuskyi)
ORCID: 0000-0002-2282-4575 (Ivan Kizlivskyi); 0000-0002-7289-9882 (Oleksandr Shpak); 0000-0003-3007-2462 (Nataliia Kunanets);
0000-0001-8711-4163 (Antonii Rzheuskyi)
©️ 2021 Copyright for this paper by its authors.
Use permitted under Creative Commons License Attribution 4.0 International (CC BY 4.0).
CEUR Workshop Proceedings (CEUR-WS.org)
Within the framework of this program it was necessary to create 29 and improve 24 state primary
standards, 21 secondary standards were created and 5 were improved to ensure uniformity of
measurement in the state [3]. In particular, the creation of a standard unit of ultrasound power was
included in the State program for the development of the reference base for 2006-2010 to ensure the
unity and accuracy of measurements in the field of megahertz (medical) ultrasound in the aquatic
environment.
The short wavelength determines the radial nature of the propagation of ultrasonic waves, and near
the emitter, the transverse size of the beam is approximately equal to the size of the emitter. On large
obstacles (or inhomogeneities) the reflection and refraction of the ultrasonic beam is regular, on small
– there is a scattered wave, which allows you to form in optically opaque media sound image of
objects. Shortwave ultrasound is also associated with the ability to focus the ultrasound beam and
concentrate sound energy at a given point in the medium.
Intense interaction of ultrasound with substances, significant absorption of ultrasound by the
medium, its interaction with light, the occurrence of acoustic currents, radiation force when
interacting with an obstacle, dispersion of the speed of sound in the environment, cavitation, etc. are
also associated with short wavelength ultrasound [4].
An indispensable condition for the effective use of ultrasound in all these cases is accurate
measurements of its characteristics and reliable control of the initial acoustic parameters of the
equipment. In medicine, for example, if the level of ultrasound is insufficient, the therapeutic effect is
not achieved, and a reliable diagnosis cannot be made. At the same inflated level of ultrasound, living
tissues of the human body are destroyed due to heating and / or cavitation, which is dangerous for
both patients and nurses [5].
That is, the safe and efficient use of ultrasound requires sufficient accuracy and reliability of
measurement results, which would be traced to the standards of the SI system of units and would be
recognized internationally. Until recently, Ukraine did not have a system of metrological support for
measuring acoustic quantities in the megahertz frequency range as such: there were no standards and
a scheme of metrological verification (verification scheme) to ensure traceability. Methods and means
of metrological support developed in hydroacoustics for sound and infrasonic frequencies cannot be
used in the range of megahertz ultrasound due to its specific features.
This Program was designed to promote the development and implementation of new precision
measuring equipment, as well as improving the quality of products, works and services; conducting
research projects relevant to the economy, creating the latest technologies; as well as: creating
conditions for the implementation of the Agreement on the Elimination of Technical Barriers to
Trade, in order to sign the Agreement on Conformity Assessment and Acceptance of Industrial Goods
and Access of Domestic Products to the International, in particular European, Market; increasing the
level of ensuring the uniformity of measurements during production and conformity assessment of
products; conducting scientific research in compliance with the requirements of the Law of Ukraine
"On Metrology and Metrological Activities", harmonization of technical regulations and other
regulations in the field of metrology and metrological activities; introduction of modern methods of
measurement and means of measuring equipment in the process of development of perspective
technologies; bringing the capabilities of the reference base and the system of transmission of the size
of units of measurement in line with the needs of the economy, strengthening control over the state of
health and safety of working conditions.
As part of this program, it was necessary to create 14 new and improve 17 existing state primary
standards, to ensure the accuracy, unity and traceability of measurements in the state.
It should be noted that the creation of a primary standard of the unit of ultrasound power in the
aquatic environment and a primary standard of the unit of ultrasonic pressure in the aquatic
environment was included in this program to ensure accuracy and uniformity of measurements in the
field of megahertz (medical) ultrasound in the aquatic environment. Subsequently, this program was
changed and a new program for the period 2018-2022 was formed.
Emitted ultrasonic power and ultrasonic pressure are one of the main initial parameters of
ultrasonic equipment. Regarding the ultrasonic power, the small wavelength determines the radial
nature of the propagation of ultrasonic waves, and near the emitter, the transverse size of the beam is
approximately equal to the size of the emitter. On large obstacles (or inhomogeneities of the
propagation medium) the reflection and refraction of the ultrasonic beam is regular, on small ones -
there is a scattered wave, which allows to form a sound image of objects in optically opaque media.
Shortwave ultrasound is also associated with the ability to focus the ultrasound beam and concentrate
sound energy at a given point in the medium.
Intense interaction of ultrasound with substances, significant absorption of ultrasound by the
medium, its interaction with light, the occurrence of acoustic currents, radiation force when
interacting with an obstacle, dispersion of the speed of sound in the environment, cavitation, etc. are
also associated with short ultrasound wavelengths.
An indispensable condition for the effective use of ultrasound in all these cases is accurate
measurements of its characteristics and reliable control of the initial acoustic parameters of the
equipment, which would be traced to the standards of the SI unit and would be recognized
internationally.
Until recently, Ukraine did not have a system of metrological support for measuring acoustic
quantities in the megahertz frequency range, as such: there were no standards and schemes of
metrological verification (traceability schemes) to ensure traceability. Methods and means of
metrological support developed in hydroacoustics for sound and infrasonic frequencies cannot be used
in the range of megahertz ultrasound due to its specific features.
Ultrasound power and ultrasonic pressure are parameters that need to be monitored, as they
determine the safety of using ultrasound equipment for both the patient and the medical staff.
2. Main part of research
It should be noted that in the field of ultrasound measurement, in particular the megahertz range,
which is most widely used in medicine, excessive power or intensity of radiation can damage organs
and tissues of the body due to excessive heating, and thus endanger the health of the patient. In case
of insufficient power or intensity of radiation, there is a possibility of incorrect diagnosis on
diagnostic equipment, or failure to achieve a therapeutic effect on therapeutic equipment. For surgical
equipment, control of ultrasonic power and pressure is necessary to determine the duration of action
of ultrasound in order to determine the required dose of radiation. Research of initial parameters
Ultrasonic medical equipment is carried out by manufacturers of such equipment as requirements to
them are described in a number of the international standards concerning safety of use. In particular,
the standards of the series ІЕС 60601-2-5 [6], ІЕС 60601-2-37 [7], ІЕС 61157 [8] and ІЕС 61689 [9]
establish requirements and limits of error for measuring the initial parameters of ultrasonic medical
equipment.
Since the protection of life and health of citizens belongs to the field of legally regulated
metrology (Law of Ukraine on "Metrology and Metrological Activities"), periodic monitoring of
ultrasound medical equipment is essential.
Therefore, in our opinion, in Ukraine it is necessary to create a system of control of initial
parameters Ultrasonic medical equipment, which should provide a clear interpretation of
measurement results, determine the main errors and uncertainties of measurement and ensure
traceability of measurements to national standards. Such a control system should include:
• national standards,
• working standards of transmission of units and means of measuring equipment,
• test objects,
• verification and calibration methods,
• national safety standards for the use of ultrasonic medical equipment.
To create a comprehensive system, there was a project proposal, which was supported and state
enterprise research institute "System" (Lviv) was instructed to implement the task. To implement
them, a project was developed to create a system of metrological control of ultrasonic medical
equipment.
In developing the project relied on the standard PMBOK – a Guide to the Project Management
Body of Knowledge (Project Management Guide, then just PMBOK) 10 areas of knowledge which
define: project life cycle, group of processes, methods, external and internal organizational factors
that have impact on project success and are used in project design and management. Forming sub-
stages of project implementation used the recommendations formed in the section Project Content
Management, understanding content management - a set of processes that allow sampling, filtering
and grouping of those works that are necessary for the project manager to successfully complete.
Project content management is directly related to defining and controlling what will be included in the
project.
To implement the project to create a system of metrological control Ultrasonic medical equipment,
you must perform the steps listed in the Table. 1.
Table 1.
Stages of project implementation to create a system of metrological support of ultrasonic medical
equipment
№ The name of the stage
1 Stage 1. Analysis of the current state of metrological support for measuring the initial
parameters of ultrasonic medical equipment
1.1 analysis of modern fleet of ultrasonic medical equipment and control and measuring
equipment
1.2 analysis of the state of the national regulatory framework to ensure the accuracy and
reliability of the results of measuring ultrasonic parameters
2 Stage 2. Calculation of economic indicators and social effect from the project
implementation to create a system of metrological control of the initial parameters of
ultrasonic medical equipment
2.1 calculation of economic indicators on the effectiveness of the application of working
standards and precision measuring equipment
2.2 calculation of the social effect
3 Stage 3. Development of proposals for the creation of a comprehensive system of
metrological control of the initial parameters of ultrasonic medical equipment
The first stage of the study – initiation is seen as a process of formal approval of a new project or
the transition to its next phase. Project initiation is usually preceded by an initiation phase, in which a
feasibility analysis, cost-effectiveness assessment, pre-planning or other similar analysis is performed,
initiated independently of the project.
This stage is called "Analysis of the current state of metrological support for measuring the initial
parameters of ultrasound medical equipment" is divided into two sub-stages, each of which involved a
number of preparatory processes typical of the first stage of IT projects.
At the first sub-stage of the first stage of the project, an analysis of the modern fleet of ultrasonic
medical equipment and control and measuring equipment was conducted, which showed that today in
Ukraine there is a large fleet of ultrasound equipment, and mainly imported devices, namely:
• ultrasonic echo-pulse scanners;
• diagnostic ultrasound devices for diagnostics of abdominal organs and cardiovascular system;
• ultrasonic scanners with spectral Doppler;
• obstetric fetal monitors;
• sinuscopes for the maxillofacial part;
• therapeutic ultrasound devices;
• surgical ultrasonic lithotriptors and others.
According to the resolution of the Cabinet of Ministers of Ukraine № 347 of June 4, 2015 on
"Approval of the list of categories of legally regulated measuring instruments subject to periodic
verification" and the order of the Ministry of Economic Development and Trade of Ukraine № 1719
of 21.12. 2015 on "Approval of time required for calibration of legally regulated measuring
equipment in operation", the updated editions of documents included only ultrasonic diagnostic
devices, in particular: echo-ophthalmoscopes and ultrasonic ophthalmic scanners, ultrasonic Doppler
diagnostic and.
Moreover, the devices of ultrasound therapy and means of measuring the parameters of the power
of ultrasonic radiation, which were previously in the list of means subject to periodic verification,
were removed.
Regarding traceability of ultrasonic measurement results: today two national standards have been
developed and are functioning in Ukraine: the National Standard of Unit of Ultrasound Power in
Aquatic Environment [10] and the National Standard of Unit of Sound Pressure in Aquatic
Environment [11], which are stored in a state enterprise research institute "System" (Lviv).
It is known that the national standard of the unit of ultrasound power in the aquatic environment is
designed to reproduce, store the unit of ultrasonic power in the aquatic environment – Watts (W) and
transmit the unit size (during calibration) to working standards, precision measuring instruments and
ultrasonic equipment, which are used in the sectors of the economy and in the social sphere in order to
ensure the unity of measurement in the country and the traceability of measurement results to the
standards of the system of SI units.
The standard consists of a set of the following measuring instruments:
• a set of tools for generating and measuring electrical signals;
• set of reference ultrasonic transducers;
• ultrasonic unit;
• data processing unit;
• control and measuring devices and auxiliary equipment.
The range of values of ultrasound power in the aqueous medium, reproduced by the standard, is
from 0.005 W to 10 W in the frequency range from 0.5 MHz to 15 MHz.
The standard provides reproduction and storage of a unit of ultrasound power with an uncertainty
not exceeding:
• standard uncertainty for type A: uA = 0.7%;
• standard uncertainty for type B: uB = 5.3%;
• total standard uncertainty: us = 5.4%;
• extended uncertainty U = 10.7% (with coverage factor k = 2 with a confidence level of P =
0.95) depending on power and frequency.
The standard is used to calibrate and transmit the size of a unit of ultrasound power in an aqueous
medium by direct measurement.
The national standard of the ultrasonic pressure unit in the aquatic environment is designed to
reproduce, store the ultrasonic pressure unit – Pascal (Pa) and transfer the unit size to working
standards and working means of measuring pressure used in the country to ensure uniformity of
measurement and traceability of measurement results to SI system standards.
The standard consists of a set of the following measuring instruments:
• a set of measuring equipment;
• a set of auxiliary ultrasonic transducers;
• set of measuring hydrophones;
• coordinate-rotary device for positioning hydrophones and measuring capacity;
• water treatment system;
• control and measuring devices and auxiliary equipment.
The standard provides reproduction and storage of the unit of ultrasonic pressure in the frequency
range from 0.5 MHz to 10 MHz within the levels of ultrasonic pressure from 10 kPa to 100 kPa.
The standard provides reproduction and storage of a unit of ultrasonic pressure with an uncertainty
not exceeding:
• standard uncertainty for type A: uA = 5.8%;
• standard uncertainty for type B: uB = 6.6%;
• total standard uncertainty: us = 8.8%;
• extended uncertainty U = 18.0% (with the coverage factor k = 2 with a confidence level of
P = 0.95).
The standard is used to calibrate and transmit the unit size of ultrasonic pressure in an aqueous
medium by direct measurement.
Calibration laboratories of Ukraine are equipped with a number of precision measuring equipment,
including ultrasonic power meters such as: UPM-DT (made in the USA), IMU-Quantum (domestic
production), IMA-2, IMU-3 and IMUTAP (Russian Federation production), a number of acoustic
ultrasonic phantoms (measures of acoustic length) such as phantom "549", Gammex 1430 LE and
MAD-05; measures of blood flow velocity type MBV-03 and measures of frequency of heart rate type
MFHH-02.
However, this equipment only calibrates the geometric dimensions of objects, but at the same time
does not control such parameters of the devices as: ultrasonic pressure and ultrasound intensity, the
measurement of which determines the safety characteristics of the output acoustic parameters of
ultrasonic medical equipment.
Regarding measurements of ultrasonic pressure and intensity Ultrasonic medical equipment, such
equipment is available only at the National Metrological Institute, state enterprise research institute
"System" – a set of interchangeable needle hydrophones with a pre-amplifier and a spatial scanning
system.
In the second sub-stage of the first stage, work was carried out to analyze the state of the national
regulatory framework to ensure the accuracy and reliability of the results of measuring ultrasonic
parameters.
One of the main regulatory problems of metrological support and standardization of ultrasonic
measurements in Ukraine is the outdated, inherited from the Soviet Union, regulatory and regulatory
framework of the 70–90s of last century, which does not meet modern requirements.
In particular, there is a lack of quality standards, many methods of measurement and verification
of the former USSR in accordance with the laws of Ukraine have become invalid, and since there
were no Ukrainian analogues of these methods, their use is virtually illegal.
An analysis of recent publications has shown that in Ukraine since independence there have been
no harmonized methods of measurement, calibration or calibration, no requirements for ultrasound
medical equipment, taking into account the requirements of international standards.
In order to bring the regulatory framework of ultrasound measurements in Ukraine in line with the
European one, the harmonization of domestic standards with international ones and the development
of own methods is extremely important.
Thus, in July 2020, verification methods (in the range of national standards) came into force in
Ukraine, in particular: calibration of ophthalmic ultrasound devices [12], fetal monitors [13] and
diagnostic Doppler devices [14]. However, the latter does not include a control point for ultrasonic
pressure and radiation intensity.
At the initiative of state enterprise research institute "System", international standards in the field
of measuring ultrasonic radiation parameters came into force. Ultrasonic medical equipment [15 –
21], which relate to diagnostic, therapeutic and surgical ultrasound equipment.
However, the standards are accepted only by the method of confirmation, which means that they
are available only in the original language.
In order to be able to fully apply them, it is necessary to translate and officially adopt them in
accordance with the Law of Ukraine on Standardization.
3. Substantiation of expediency of creation of system of metrological control
The created system will ensure compliance with the requirements of the Law of Ukraine on
Metrology and Metrology and Technical Regulations "On Medical Devices", and will give impetus to
increase the number of calibration and calibration laboratories, organizations for repair and
maintenance of medical ultrasound equipment.
Let's consider how the economic component of this project will work on the example of calibration
of ultrasonic diagnostic devices.
As a basis we will take the data used at creation of national ultrasonic standards [22]. The number
of ultrasound diagnostic tests and ultrasound diagnostic devices used in medical institutions and the
need for their verification are shown in the Table 2.
Table 2.
Quantitative characteristics of the use of ultrasonic diagnostic devices
Devices of Number of
Number of Ultrasound tests
Ultrasound Ultrasound
№ Territorial unit diagnostic
diagnostic
Available Attorneys tests per 1
tests
device
1 Vinnytsia 1 164 022 201 170 6 847
2 Volyn 825 203 153 129 6 397
3 Dniprovsk 2 317 415 515 448 5 173
4 Donetsk 796 363 183 160 4 977
5 Zhytomyr 867 634 218 190 4 566
6 Transcarpathian 903 742 169 148 6 106
7 Zaporozhye 734 508 214 190 3 866
8 Ivano-Frankivsk 1 398 112 206 181 7 724
9 Kyiv 1 023 928 256 231 4 433
10 Kirovograd 784 569 154 121 6 484
11 Luhansk 286 468 92 75 3 820
12 Lviv 1 964 981 332 306 6 422
13 Mykolayiv 829 782 118 108 7 683
14 Odessa 1 758 759 319 299 5 882
15 Poltava 980 791 202 172 5 702
16 Rivne 1 319 523 153 143 9 227
17 Sumy 677 426 167 149 4 546
18 Ternopil 742 909 117 109 6 816
19 Kharkiv 2 688 851 516 465 5 782
20 Kherson 1 182 221 132 114 10 370
21 Khmelnytsky 671 598 193 160 4 197
22 Cherkasy 1 019 363 156 142 7 179
23 Chernivtsi 1 016 417 131 118 8 614
24 Chernihiv 674 234 137 119 5 666
25 Kyiv 3 506 251 951 856 4 096
In general 30 135 070 5985 5 303 5 683
In the second stage of the study, the content was determined, with the main results of the project
divided into smaller, more manageable components to form a basic project plan. At the same time, the
global goal of the project was decomposed into several components, the structure of the project work
was formed, the list of project works was determined, their duration was determined, restrictions were
established, links were established, resources were fixed and the basic project plan was fixed. The
process of determining the content is aimed at: improving the accuracy of cost estimates, duration of
work and required resources, development of a basic plan as a basis for measuring the implementation
and management of the project.
As part of the first sub-stage of the second stage of the project, the calculation of economic
indicators on the effectiveness of working standards and precision measuring equipment. The price of
one calibration of the Ultrasonic diagnostic device makes from 3 650 UAH (including VAT). The
estimated number of calibrations on working standards and precision measuring equipment per year is
5,303 calibrations. Determine the estimated annual gross income (income from sales) calibrations:
3 650х5 303=19 355 950 UAH
According to Order № 1719 of 21.12.2015 of the Ministry of Economic Development, the
standard time for calibration of one ultrasound diagnostic device is 16.7 hours, the norms of working
hours for 2020 under the condition of a forty-hour five-day working week are 2002 hours [23]
5 303х16,7/2 002= 44,2 units
That is, 45 units of precision ultrasonic measuring instruments and / or working standards must be
involved in the maintenance of the diagnostic equipment fleet. Calibration of this equipment requires
the presence of national standards or their calibration must be carried out abroad. Given the situation
with customs clearance and prices for metrological services abroad, the cost of calibration abroad will
be much higher than in Ukraine.
The calculation of economic indicators on the effectiveness of the use of national standards in the
implementation of the first sub-stage of the second stage of the project, showed that the number of
required calibrations of measuring instruments on national standards is 45 units. The estimated cost of
calibration of one precision tool is UAH 5,560 UAH (including VAT).
Determine the annual gross income (income from sales) calibrations on the primary standards.
5 560×45=250 200 UAH
4. Calculation of the social effect (substage two of stage two)
Ultrasound in modern medicine is one of the basic methods for diagnosing many diseases[24],
which are successfully used to detect developmental abnormalities and various pathologies. High
diagnostic efficiency during its reduction can be achieved only by using serviceable and calibrated
equipment. Unfortunately, the results of metrological supervision indicate that medical institutions of
the Ministry of Health of Ukraine do not comply with metrological norms and rules of application of
Ultrasound medical equipment. And, as a result, the results of research obtained on non-attested
Ultrasound medical equipment may be incorrect and lead to misdiagnosis and misdiagnosis.
According to the data given in [22], in the period of 2016, 30,135,070 ultrasound examinations
were performed on 5,303 ultrasound diagnostic devices. Based on the calculations above, the results
of the Ultrasound examinations could be inaccurate in 3,616,209 cases (provided that 12% of the
Ultrasound diagnostic devices were probably not certified) and dangerous for patients and medical
staff. It should be borne in mind that the inaccuracy of the results of ultrasound examinations leads to
an increase in the length of stay of patients in treatment. Based on the above considerations, it is
possible to determine the social effect [25–30] of the implementation of verifications, including
security parameters, which will reduce the cost of the hospital payment fund.
In addition, new jobs will be created in calibration and calibration laboratories, which will provide
employment for up to 30 people, the social effect of creating one job in this industry is 15 000 UAH,
respectively, for 30 people it will be 450, 0 thousand UAH per month.
Therefore, in order to implement the project on introduction of the system of metrological control
of initial parameters of ultrasonic medical equipment it is necessary, within the framework of the third
stage of the project the following is offered:
• submit proposals to the Ministry of Economy and the Ministry of Health regarding
organizational and administrative documents on control of parameters of ultrasonic
medical equipment;
• to harmonize a number of European standards in the field of ultrasound measurements and
safety of ultrasound in medicine;
• to create measuring devices for spatial scanning of ultrasonic fields, which will allow to
measure the level of ultrasonic pressure radiation and its intensity, to equip calibration and
calibration laboratories with them[31–35];
• to equip calibration and calibration laboratories with test objects and other standard
samples for imitation of human tissues and organs with the use of artificial intelligence
technologies;
• to develop methods of calibration of the created working standards and test objects;
• review and update existing verification methods.
5. Conclusions
The introduction of a comprehensive system for monitoring the output parameters of ultrasound
medical equipment will improve the control of ultrasound medical equipment, which is widely used in
health care facilities, prevent the use of defective or uncredited equipment, and ensure the safety of
medical services for diagnosis and treatment.
The proposed system should provide a clear interpretation of measurement results, identify the
main errors and uncertainties of measurement and ensure traceability of measurements to national
standards.
6. References
[1] Roy C. Output measurements for medical ultrasound. URL:
https://link.springer.com/book/10.1007/978-1-4471-1883-1.
[2] State program of development of the reference base for 2006–2010. URL:
http://zakon4.rada.gov.ua/laws/show/228- 2006-п.
[3] List of tasks for the implementation of the Measures of the State program of development of
the reference base for 2006–2010. URL: http://ua-info.biz/legal/basezt/ua-dmtber/index.htm.
[4] Tetyana Ilnytska, Scientific and technical bases of development of the standard of unit of
power of ultrasound in the water environment, Lviv, 2006.
[5] A. Enyakov, Metrological support of ultrasonic medical equipment, Moscow, 2006.
[6] IEC 60601-2-5 Medical electrical equipment. Part 2-5: Particular requirements for the basic
safety and essential performance of ultrasonic physiotherapy equipment. URL:
https://webstore.iec.ch/searchform&q=IEC%2060601-2-5.
[7] IEC 60601-2-37 Medical electrical equipment. Part 2-37: Particular requirements for the basic
safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
URL: https://webstore.iec.ch/searchform&q=IEC%2060601-2-37.
[8] ІЕС 61157 Standard means for the reporting of the acoustic output of medicaldiagnostic
ultrasonic equipment. URL: https://webstore.iec.ch/publication/4620.
[9] ІЕС 61689:2007 Ultrasonics – Physiotherapy systems – Field specifications and methods of
measurement in the frequency range 0,5 MHz to 5 MHz. URL:
https://shop.bsigroup.com/ProductDetail/?pid=000000000030115968.
[10] Information report on research work "Creation of the state primary standard of
ultrasound power unit in the aquatic environment" (code 06.17.24). (Final), Sistema Research
Institute, Lviv, 2017
[11] Information report on research work "Creation of the state primary standard of the
unit of ultrasonic pressure in the aquatic environment" (code 06.17.23). (Final), Sistema
Research Institute, Lviv, 2017.
[12] SSU 8884: 2019 Metrology. Ophthalmic ultrasonic devices. Method of verification
on the state primary standard.
[13] SSU 8884: 2019 Metrology. Fetal monitors. Calibration technique.
[14] SSU 8883: 2019 Metrology. Doppler ultrasound diagnostic devices. Calibration
technique.
[15] SSU EN 61206: 2018 (EN 61206: 1995, IDT; IEC / TS 61206: 1993, IDT)
Ultrasound. Doppler systems with a continuous wave. Test methods.
[16] SSU EN 61391-1: 2018 (EN 61391-1: 2006, IDT; IEC 61391-1: 2006, IDT)
Ultrasound. Echo-pulse scanners. Part 1. Methods of calibration of spatial measuring systems
and measurement of scattering of the functional response point.
[17] SSU EN 61828: 2018 (EN 61828: 2001, IDT; IEC 61828: 2001, IDT) Ultrasound.
Focused converters. Definitions and methods of measurement for radiated fields.
[18] SSU IEC 61846: 2018 (IEC 61846: 1998, IDT) Ultrasound. Pulse pressure
lithotriptors. Characteristics of fields.
[19] SSU EN 61847: 2018 (EN 61847: 1998, IDT; IEC 61847: 1998, IDT) Ultrasound.
Surgical systems. Measurement and declaration of basic initial characteristics.
[20] SSU EN 62359: 2018 (EN 62359: 2011, IDT; IEC 62359: 2010, IDT) Ultrasound.
Field characteristics. Test methods for determining thermal and mechanical indices associated
with diagnostic ultrasonic fields.
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