Metrology, Standardization and Certification of Medical Devices

Major: Biomedical Engineering (Internet of Things)
Code of subject: 6.163.03.E.83
Credits: 4.00
Department: Theoretical Radio Engineering and Radio Measurement
Lecturer: Assoc. prof., PhD Lazko Oksana
Semester: 7 семестр
Mode of study: денна
Learning outcomes: 1. Understand the structure and main tasks of the State Metrological System of Ukraine in accordance with the Law of Ukraine "On Metrology and Metrological Activity"; 2. To know the main methods and means of measurement in radio electronics, as well as in communication technology, telecommunication networks and systems, the peculiarities of their practical use; 3. To have methods and techniques for processing measurement results and ways of presenting measurement results; 4. Orientate yourself in the structure and tasks of the State Standardization System of Ukraine; 5. To know about the current state of international cooperation of Ukraine in the field of metrology and standardization. 6. At the modern level, carry out parameter measurements and control of electronic devices using new and promising methods and means of measurement, competently evaluate the results. 7. Ability to practically use modern electronic computing tools.
Required prior and related subjects: From the physics course: from the sections "Electric current in materials of conductors, semiconductors, insulators", "Fundamentals of magnetism", from the higher mathematics course: from the sections "Linear and nonlinear algebra", "Differential and integral calculus", "Differential equations", "Fundamentals of probability theory and mathematical statistics", "Mathematical modeling". combined with related disciplines "Fundamentals of circuit theory", "Signals and processes". Knowledge will be used in such disciplines as: "Methods of generating and forming signals", "Methods of receiving and processing signals", "Power supply of devices and systems", as well as in other special disciplines studied in subsequent courses.
Summary of the subject: 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. International cooperation of Ukraine in the field of metrology and standardization
Assessment methods and criteria: 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. Основи радіоелектроніки: Навч. посібник/. Бобало Ю.Я., Желяк Р.І., Кіселичник М.Д., Мандзій Б.А., Якубенко В.М. За ред. проф. Мандзія Б. А. -Львів: Вид. Нац. ун-ту “Львівська політехніка“, 2008. - 456 с. 2. Поліщук Є.С., Дорожовець М.М., Яцук В.О. Навч. посібник. Метро¬логія та вимірювальна техніка. Львів. Втд. Бескід. 2015. 3. 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. 4. Недоступ Л.А. Осцилографи і осцилографічні методи вимірювання. К.: ІСД ВО, 1994. 5 ДСТУ 2681-94 Метрологія. Терміни та визначення. 6. ДСТУ 3651-097. Метрологія. Одиниці фізичних величин. Міжнародна система одиниць SI. 7. Бичківський Р.В. та ін. Метрологія, стандартизація, управління якістю і сертифікація: Підручник – Львів: Вид. НУ ЛП, 2004.- 560с. 8. ДСТУ 3215-95. Метрологія. Метрологічна атестація вимірювальної техніки. Організація та порядок проведення. 9. ДСТУ 1.0-93. Державна система стандартизації України. Основні положення. 10. ДСТУ 3279-95. Стандартизація послуг. Основні положення. 11. Методичні вказівки. 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