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Information
| Unit | FACULTY OF ENGINEERING |
| BIOMEDICAL ENGINEERING PR. | |
| Code | BMM411 |
| Name | Engineering Standards and Ethics |
| Term | 2026-2027 Academic Year |
| Semester | 7. Semester |
| Duration (T+A) | 1-0 (T-A) (17 Week) |
| ECTS | 1 ECTS |
| National Credit | 1 National Credit |
| Teaching Language | Türkçe |
| Level | Lisans Dersi |
| Type | Normal |
| Label | C Compulsory |
| Mode of study | Yüz Yüze Öğretim |
| Catalog Information Coordinator | Prof. Dr. MUTLU AVCI |
| Course Instructor |
The current term course schedule has not been prepared yet.
|
Course Goal / Objective
The aim of this course is to provide biomedical engineering students with knowledge about engineering ethics, professional responsibility, and national/international standards. Students are expected to develop awareness regarding patient safety, data privacy, clinical device standards, and ethical decision-making.
Course Content
Engineering ethics concepts, professional ethics principles, ethical dilemmas, biomedical device standards, ISO and IEC standards, patient safety, data privacy, clinical research ethics, quality management systems, CE marking, and regulatory processes.
Course Precondition
None
Resources
• Harris, Pritchard & Rabins – Engineering Ethics. • Martin & Schinzinger – Ethics in Engineering. • ISO 13485 Medical Devices Quality Management Systems. • IEC 60601 Medical Electrical Equipment Standards. • World Medical Association – Declaration of Helsinki.
Notes
Short Notes
Course Learning Outcomes
| Order | Course Learning Outcomes |
|---|---|
| LO01 | Explain engineering ethics principles. |
| LO02 | Interpret biomedical device standards. |
| LO03 | Analyze ethical dilemmas and propose solutions. |
| LO04 | Evaluate patient safety and data privacy requirements. |
| LO05 | Explain the role of ISO and IEC standards in engineering applications. |
| LO06 | Evaluate regulatory and quality management processes. |
Relation with Program Learning Outcome
| Order | Type | Program Learning Outcomes | Level |
|---|---|---|---|
| PLO01 | Bilgi - Kuramsal, Olgusal | Have sufficient knowledge in mathematics, natural sciences, and biomedical engineering, along with the ability to use theoretical and applied knowledge in these areas to solve complex engineering problems. | |
| PLO02 | Bilgi - Kuramsal, Olgusal | Acquire the ability to identify, formulate, and solve complex Biomedical Engineering problems; for this purpose, will have the ability to choose and apply appropriate analysis and modeling methods. | |
| PLO03 | Bilgi - Kuramsal, Olgusal | The ability to design a complex system, process, device, or product in Biomedical Engineering under realistic constraints and conditions to meet specific requirements; the ability to apply modern design methods for this purpose. | |
| PLO04 | Bilgi - Kuramsal, Olgusal | The ability to select and use modern techniques and tools necessary for analyzing and solving complex problems encountered in Biomedical Engineering applications; the ability to use information technologies effectively. | |
| PLO05 | Bilgi - Kuramsal, Olgusal | Ability to design and conduct experiments, collect data, analyze and interpret results to investigate complex engineering problems or discipline-specific research topics in Biomedical Engineering. | |
| PLO06 | Bilgi - Kuramsal, Olgusal | The ability to work effectively in intra-disciplinary (Biomedical Engineering) and multi-disciplinary teams; ability to work individually. | |
| PLO07 | Beceriler - Bilişsel, Uygulamalı | The ability to communicate effectively verbally and in writing; knowledge of at least one foreign language; ability to write effective reports in Biomedical Engineering and understand written reports, prepare design and production reports, make effective presentations, and give and receive clear and understandable instructions. | |
| PLO08 | Beceriler - Bilişsel, Uygulamalı | Get awareness of the necessity of lifelong learning; the ability to access information in the field of Biomedical Engineering, to follow developments in science and technology, and the ability to constantly self-renewal. | |
| PLO09 | Yetkinlikler - Öğrenme Yetkinliği | Acting following ethical principles, professional and ethical responsibility in the field of Biomedical Engineering, and knowledge of the standards used in engineering practice. | 5 |
| PLO10 | Yetkinlikler - Öğrenme Yetkinliği | Knowledge of project management and practices in the field of Biomedical Engineering, such as risk management and change management; awareness about entrepreneurship, innovation, and sustainable development. | |
| PLO11 | Yetkinlikler - Bağımsız Çalışabilme ve Sorumluluk Alabilme Yetkinliği | Understanding the universal and societal impacts of Biomedical Engineering applications on health, environment, and safety; awareness of the legal implications of Biomedical Engineering solutions. | 3 |
| PLO12 | Bilgi - Kuramsal, Olgusal | Sufficient knowledge in the disciplines of anatomy and physiology | |
| PLO13 | Beceriler - Bilişsel, Uygulamalı | Ability to perform measurements on living systems and to interpret the data collected from these measurements. | |
| PLO14 | Bilgi - Kuramsal, Olgusal | Solving problems related to the interaction of living organisms with materials and systems, and interpreting the outcomes. |
Week Plan
| Week | Topic | Preparation | Methods |
|---|---|---|---|
| 1 | Introduction to engineering ethics | Reading lecture materials | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 2 | Professional responsibility and ethical decision-making. | Reading lecture materials | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 3 | Ethical theories and engineering applications | Reading lecture materials | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 4 | Ethical issues in biomedical engineering | Reading lecture materials | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 5 | Patient safety and clinical risk management | Reading lecture materials | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 6 | Introduction to medical device standards | Reading lecture materials | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 7 | ISO 13485 quality management system | Reading lecture materials | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 8 | Mid-Term Exam | Reading lecture materials | Ölçme Yöntemleri: Yazılı Sınav |
| 9 | IEC 60601 and electrical safety standards. | Reading lecture materials | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 10 | Data security and personal health data | Reading lecture materials | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 11 | Ethics of clinical research and human trials | Reading lecture materials | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 12 | CE mark and MDR regulations | Reading lecture materials | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 13 | Artificial intelligence and ethics | Reading lecture materials | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 14 | Sustainability in biomedical engineering | Reading lecture materials | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 15 | Case studies and ethical discussions | Reading lecture materials | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 16 | Term Exams | Reading lecture materials | Ölçme Yöntemleri: Yazılı Sınav |
| 17 | Term Exams | Reading lecture materials | Ölçme Yöntemleri: Yazılı Sınav |
Student Workload - ECTS
| Works | Number | Time (Hour) | Workload (Hour) |
|---|---|---|---|
| Course Related Works | |||
| Class Time (Exam weeks are excluded) | 14 | 1 | 14 |
| Out of Class Study (Preliminary Work, Practice) | 14 | 1 | 14 |
| Assesment Related Works | |||
| Homeworks, Projects, Others | 0 | 0 | 0 |
| Mid-term Exams (Written, Oral, etc.) | 1 | 3 | 3 |
| Final Exam | 1 | 6 | 6 |
| Total Workload (Hour) | 37 | ||
| Total Workload / 25 (h) | 1,48 | ||
| ECTS | 1 ECTS | ||