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Metrology, Standardization and Certification of Medical Devices
Major: Biomedical Engineering (Internet of Things)
Code of subject: 6.163.03.E.056
Credits: 4.00
Department: Theoretical Radio Engineering and Radio Measurement
Lecturer: Assoc. prof., PhD Lazko Oksana
Semester: 7 семестр
Mode of study: денна
Завдання: The study of an educational discipline involves the formation of competencies in students of education:
general competencies: Ability to apply knowledge in practical situations. Knowledge and understanding of the subject area and understanding of professional activity. Ability to communicate with representatives of other professional groups at different levels (with experts from other fields of knowledge/types of economic activity).Skills of performing safe activities. The ability to evaluate and ensure the quality of the work performed.
professional competences: Ability to provide engineering expertise in the planning, development, evaluation and specification of medical equipment. Ability to provide technical and functional characteristics of systems and tools used in medicine and biology (for prevention, diagnosis, treatment and rehabilitation). Ability to effectively use tools and methods for analysis, design, calculation and testing in the development of biomedical products and services. The ability to plan, design, develop, install, operate, maintain, maintain, monitor and coordinate the repair of devices, equipment and systems for prevention, diagnosis, treatment and rehabilitation, as well as Internet of Things devices used in hospitals and research institutes. professional competences of a professional direction:Knowledge of the organization of measurements of electrical and non-electrical quantities and assessment of their accuracy during metrological support of the life cycle of biomedical products.
Learning outcomes: Understanding the organization of measurements of physical quantities and assessment of their accuracy during quality control and certification of medical equipment
Familiarity with the organization of technological preparation for the production of biotechnical and medical devices and systems.
Ability to develop and operate diagnostic and therapeutic medical devices, electronic means of information and computer technologies, telemedicine and Internet of Things devices. UM14. The ability to develop a structure and relevant technical documentation in compliance with the requirements of regulatory documents, using modern application programs.
The ability to organize the measurement of electrical, magnetic and non-electrical quantities and their accuracy assessment during quality control and
certification of medical equipment.
Required prior and related subjects: Medical devices and systems, part 1
Medical devices and systems, part 2
Information technologies in biomedical engineering
Display systems in medical technology
Biomedical measuring transducers
Databases in biomedical information and computer systems
Summary of the subject: The course "Metrology and standardization and certification of biomedical devices" examines the basics of the science "Metrology" as a theoretical and practical basis for ensuring the accuracy and unity of the measurement of electrical and non-electrical physical quantities by electrical methods. The course is focused on ensuring the quality and reliability of radio-electronic equipment at the stage of design, production and operation. Issues of testing and drafting regulatory documents are studied.
Опис: Content and main tasks of the discipline. Basis of metrology. State metrological system of Ukraine.
Measured physical quantities. System of physical quantities and their units. Principles and methods of measuring physical quantities.
Measuring equipment, their classification and purpose. Structure and parameters of measuring equipment.
Measurement errors and mathematical processing of measurement results.
Numerical characteristics of random errors. Laws of distribution of random errors
Verification of the fit of measurement error distributions to selected models. Verification of measurement results according to the Pearson test
Ensuring the unity of measurements.
Metrological inspection of measuring equipment.
Measuring instruments in radio electronics.
Measuring transducers. Voltage dividers. Measuring amplifiers.
Current and voltage measurement. Resistance measurement. Measurement of parameters of electric circuits on alternating current.
Measurement of frequency and time intervals, phase shift angle.
Electrical measurements of non-electric quantities.
Basics of standardization. State standardization system of Ukraine.
The main theoretical provisions of standardization, objects of standardization, categories and types of standards.
Quality management of products and services.
Bar coding.
International cooperation of Ukraine in the field of metrology and standardization.
Assessment methods and criteria: Current monitoring of laboratory classes is conducted in order to identify the student's readiness for classes in the following forms: ? a selective oral survey before classes begin; ? assessment of the student's activity in the process of classes, submitted proposals, original decisions, clarifications and definitions, additions to previous answers, etc.Control questions are divided into: ? a) test tasks - choose the correct answers; ? b) problematic – creation of problematic situations; ? c) questions-replies - to identify cause-and-effect relationships; ? d) situational tasks – to determine the answer according to a certain situation; ? e) issues of a reproductive nature - determination of practical significance. The final control is carried out based on the results of the current control and performance of the control work.
Критерії оцінювання результатів навчання:
Current control (30 points):
• laboratory work - 15 points;
• calculation works - 15 points.
Examination control (70 points):
• written component - 60 points;
• oral component - 10 points.
TOTAL - 100 points.
Recommended books: 1.Поліщук Є.С., Дорожовець М.М., Яцук В.О. Навч. посібник. Метрологія та вимірювальна техніка. Львів. Втд. Бескід. 2015.
2. Імпульсна і частотна діагностика коаксіальних ліній зв?язку: навч. посіб. для студ. базових напрямків ?Радіотехніка? та ?Телекомунікації? / Недоступ Л. А., Лазько О. В., Кіселичник М. Д., Бобало Ю. Я. – Львів: Вид-во Держ. ун-ту Львів. політехніка, 2000. — 48с.
3. Недоступ Л.А. Осцилографи і осцилографічні методи вимірювання. К.: ІСД ВО, 1994.
4 ДСТУ 2681-94 Метрологія. Терміни та визначення.
5. ДСТУ 3651-097. Метрологія. Одиниці фізичних величин. Міжнародна система одиниць SI.
6. Бичківський Р.В. та ін. Метрологія, стандартизація, управління якістю і сертифікація: Підручник – Львів: Вид. НУ ЛП, 2004.- 560с.
7. ДСТУ 3215-95. Метрологія. Метрологічна атестація вимірювальної техніки. Організація та порядок проведення.
8. ДСТУ 1.0-93. Державна система стандартизації України. Основні положення.
9. ДСТУ 3279-95. Стандартизація послуг. Основні положення
E-mail address of the course "Metrology, standardization" in the Virtual educational environment of the Lviv Polytechnic:
https://vns.lpnu.ua/course/view.php?id=9064