COURSE UNIT TITLE

: TEST, CONTROL AND CALIBRATION IN MEDICAL DEVICES

DEGREE PROGRAMMES

Description of Individual Course Units

Course Unit Code Course Unit Title Type Of Course D U L ECTS
ETE 3042 TEST, CONTROL AND CALIBRATION IN MEDICAL DEVICES ELECTIVE 3 2 0 6

Offered By

Faculty of Engineering

Level of Course Unit

First Cycle Programmes (Bachelor's Degree)

Course Coordinator

ASSISTANT PROFESSOR GÜLTER GÜLDEN KÖKTÜRK

Offered to

Industrial Engineering
Mechanical Engineering (Evening)
Mechanical Engineering
Computer Engineering
Metallurgical and Materials Engineering
Electrical and Electronics Engineering

Course Objective

Doctors' need for medical devices has increased compared to 20-30 years ago. While the doctor is making a diagnosis, the correct operation and reliability of the medical devices are included in the calibration, testing and control of the devices. The aim of this course is to teach students the concept of calibration, its importance, necessity and how to calibrate medical devices, calibration tests and calculations. In addition, it is aimed to evaluate the calibration results and to teach the device function tests.

Learning Outcomes of the Course Unit

1   To teach students the essential requirements for calibration, testing and control of biomedical devices.
2   To teach the standards related to calibration.
3   To enable them to know the calibrators.
4   To gain the ability to test using calibrators and measuring instruments.
5   To achieve the proficiency to calibrate biomedical devices.

Mode of Delivery

Face -to- Face

Prerequisites and Co-requisites

None

Recomended Optional Programme Components

None

Course Contents

Week Subject Description
1 Definitions and introduction, measuring instruments used in calibration, calibrators and test equipment used in biomedical devices Calibration of clinical laboratory analysis equipment cont.
2 Basic theories of measurement, test devices used in biomedical devices, calibration environments, considerations in biomedical device measurements Calibration and quality control of laboratory equipment (Microscopes, micropipettes, sterilization and sterilizers, autoclave and oven calibration tests, dry air sterilizers, centrifuge devices, spectrophotometer, coagulometer, blood count devices, auto analyzers)
3 Measurement uncertainty and standards, the effect of measurement limits on the results of standard deviation calculations, actions to be taken with out-of-limits values Electrophysiological measuring devices and their calibration (ECG, EMG and EEG devices calibration tests, electroretinogram device, audiometer), radiology equipment calibration and quality control (X-ray device, computed tomography device, MR, fluoroscopy, mammography, ultrasound devices)
4 Acceptance criteria and tolerances in medical devices Life support devices and calibration (Defibrillator device calibration tests, pacemakers, invasive-non-invasive ventilator calibration tests, anesthesia devices, heart lung machine, electrosurgical device calibration tests, electro cautery, surgical aspirators, intravenous therapy devices, dialysis devices, physical therapy devices)
5 Quality standards in calibration
6 Medical safety standards and tests on devices
7 Electrical safety and electrical safety tests
8 Midterm exam
9 Flow, pressure, temperature measurements and calibration
10 Calibration of clinical laboratory analysis equipment (sphygmomanometer calibration, bedside monitor calibration tests, blood pressure measurement device calibration, blood gas measurement techniques, infusion pump calibration tests)

Recomended or Required Reading

Joseph J. Carr, John M. Brown (2000). Introduction to Biomedical Equipment Technology (4th Edition), Pearson Publishing.
Türkiye Ilaç ve Tıbbi Cihaz Kurumu (2022). Tıbbi Cihazların Test, Kontrol Ve Kalibrasyonu Hakkında Yönetmelik Kapsamında Yürütülecek Test, Kontrol Ve Kalibrasyon Faaliyetlerine Ilişkin Kılavuz, TITCK, Ankara.
Türkiye Ilaç ve Tıbbi Cihaz Kurumu (2015). Tıbbi Cihazların Test, Kontrol ve Kalibrasyonu Hakkında Yönetmelik, Resmi Gazete, Ankara, Sayı No: 29397.
Mana Sezdi (2012), Accreditation of Biomedical Calibration Measurements in Türkiye, InTech Open Publishing, 79-99, http://dx.doi.org/10.5772/51075.
Marie B. Teixeira (2019). Design Controls for the Medical Device Industry, Third Edition, CRC Press.

Planned Learning Activities and Teaching Methods

The course is taught in a class presentation and discussion format. In addition to the lesson, project will be prepared by the students.

Assessment Methods

SORTING NUMBER SHORT CODE LONG CODE FORMULA
1 MTE MIDTERM EXAM
2 LAB LABORATORY
3 FIN FINAL EXAM
4 FCG FINAL COURSE GRADE MTE * 0.25 + LAB * 0.25 + FIN * 0.50
5 RST RESIT
6 FCGR FINAL COURSE GRADE (RESIT) MTE * 0.25 + LAB * 0.25 + RST * 0.50


Further Notes About Assessment Methods

None

Assessment Criteria

After the subjects of calibration, test and control methods in medical devices are explained to the students with examples and laboratory work, these learning outcomes will be evaluated with midterm, project and final exams.

Language of Instruction

English

Course Policies and Rules

Attendance to the classroom is compulsory with the 70% rate of the lectures.

Contact Details for the Lecturer(s)

Dr. Öğr. Ü. Gülden Köktürk, gulden.kokturk@deu.edu.tr

Office Hours

To be announced.

Work Placement(s)

None

Workload Calculation

Activities Number Time (hours) Total Work Load (hours)
Lectures 8 3 24
Tutorials 6 2 12
Preparations before/after weekly lectures 9 3 27
Preparation for midterm exam 1 8 8
Preparation for final exam 1 10 10
Design Project 13 3 39
Preparing presentations 10 2 20
Final 1 4 4
Midterm 1 3 3
Project Assignment 1 3 3
TOTAL WORKLOAD (hours) 150

Contribution of Learning Outcomes to Programme Outcomes

PO/LOPO.1PO.2PO.3PO.4PO.5PO.6PO.7PO.8PO.9PO.10PO.11PO.12PO.13
LO.13133212221
LO.2522
LO.32521
LO.43323
LO.5342

CONTACT INFORMATION
Dokuz Eylül Üniversitesi Cumhuriyet Bulvarı No: 144 35210 Alsancak / İZMİR
Phone: +90(232) 412 12 12 - Fax: +90 (232) 464 81 35

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