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| ECZ5015 | biomedical products and devices | 2+0+0 | ECTS:4 | | Year / Semester | Fall Semester | | Level of Course | Second Cycle | | Status | Elective | | Department | DEPARTMENT of PHARMACEUTICS | | Prerequisites and co-requisites | None | | Mode of Delivery | | | Contact Hours | 14 weeks - 2 hours of lectures per week | | Lecturer | Doç. Dr. İnci Selin DOĞAN | | Co-Lecturer | Asis.Prof.Özlem Çoban | | Language of instruction | Turkish | | Professional practise ( internship ) | None | | | | The aim of the course: | | Definition of medical devices and medicinal products for non-drug diagnostic and therapeutic purposes used in health sector,
naming, usage purpose, application and maintenance. |
| Learning Outcomes | CTPO | TOA | | Upon successful completion of the course, the students will be able to : | | | | CTPO : Contribution to programme outcomes, TOA :Type of assessment (1: written exam, 2: Oral exam, 3: Homework assignment, 4: Laboratory exercise/exam, 5: Seminar / presentation, 6: Term paper), LO : Learning Outcome | | |
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Illustrate the application areas of related medical devices and medical products. Distinguish medical devices and medical products. |
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| Course Syllabus | | Week | Subject | Related Notes / Files | | Week 1 | Professional definitions, general concepts, application areas, basic product information | | | Week 2 | First aid equipment-II, ambulance equipment | | | Week 3 | Devices used in diagnosis and treatment | | | Week 4 | Medical device regulation | | | Week 5 | Device regulation for invaziv devices to the body.
Related regulations, CE, Barcode, Warranty documents, Technical specification, TİTUBB | | | Week 6 | Classification of medical devices | | | Week 7 | Types, calibrations, maintenance and uses of medical devices | | | Week 8 | mid term exam | | | Week 9 | Eye and ENT units and products used | | | Week 10 | Devices and equipment in radiology and laboratory units | | | Week 11 | Operating room, Intensive care, Emergency unit tools and equipment | | | Week 12 | Surgical instruments, Surgical products, several combination products | | | Week 13 | Orthopedic products and physical therapy | | | Week 16 | final examination | | | |
| Method of Assessment | | Type of assessment | Week No | Date | Duration (hours) | Weight (%) | | Mid-term exam | 8 | | | 50 | | In-term studies (second mid-term exam) | 4 | | | 10 | | Oral exam | 10 | | | | | Presentation | 12 | | | 5 | | Homework/Assignment/Term-paper | 13 | | | 5 | | End-of-term exam | 14 | | | 25 | | |
| Student Work Load and its Distribution | | Type of work | Duration (hours pw) | No of weeks / Number of activity | Hours in total per term | | | | | |
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