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Safety in biomedical engineering and hazard analysis, 4 Credits

Swedish name: Medicinteknisk säkerhet och riskhantering

This syllabus is valid: 2021-08-02 and until further notice

Course code: 5RA040

Credit points: 4

Education level: Second cycle

Main Field of Study and progress level: Electronics: Second cycle, in-depth level of the course cannot be classified

Grading scale: TH teknisk betygsskala

Responsible department: Department of Physics

Revised by: Faculty Board of Science and Technology, 2021-02-24


To ensure high patient and user safety, medical equipment is surrounded by special legislation. This puts great demands on companies and engineers to have sufficient knowledge about managing risks in the development and management of such products and systems. Today's medical equipment are often connected to the hospitals' medical records, giving complex digitized systems that are demanding to overview and control.
This course gives you knowledge of how medical equipment and power supply should be designed to meet the safety requirements for patients and hospital staff. The course addresses risks and security aspects concerning medical devices in the areas of electrical, gas and radiation safety, and provides an insight into the security issues surrounding information data systems and software development within the area of medical technology. A practical introduction is given to the field of risk management. The course also includes one smaller project as well as laboratory work.

The course consists of two parts:
1. Theory, 3 ECTS
2. Project and laboratory work, 1 ECTS

Expected learning outcomes

Knowledge and understanding
Give detailed descriptions of how medical equipment and electricity distribution should be designed to meet current safety requirements.
Thoroughly describe the safety problems concerning equipment for gas as well as gas distribution within a hospital.
Thoroughly describe important safety aspects when working with different types of radiation.
In detail explain security issues concerning information data systems and software development in the area of biomedical engineering. 

Competence and skills
Perform a hazard analysis on a medical device or method.

Judgement and approach
Reflect on patient and user safety when using technology in healthcare.
Evaluate and analyze potential risks with medical equipment to ensure safe working methods.
Evaluate and analyze risk-benefit ratios when developing safe medical devices.

Required Knowledge

Univ: Biomedical Engineering 10 ECTS (5RA037), or Biomedical Sensors and analyses 7.5 ECTS (5RA042) and  an instroductory course in medicine 5 ECTS (Introductory Course in Medicine, 5RA001),or equivalent. At least 90 credits completed of a three-year engineering degree, or at least 90 credits in one of the main fields of computer science, electronics, physics, chemistry, mathematics or mathematical statistics. Proficiency in English equivalent to Swedish upper Secondary course English A/5. Where the language of instruction is Swedish, applicants must prove proficiency in Swedish to the level required for basic eligibility for higher studies.

Form of instruction

The teaching is conducted in the form of lectures as well as project and laboratory work. Participation in the project and laboratory work is mandatory.

Examination modes

Part 1: Theory 3 ECTS
This part is examined with a written examination. The grade is assessed with Fail (U), Pass (3), Pass with Credit (4) or Pass with Distinction (5).
Part 2: Laboratory and project work 1 ECTS.
This part is examined with written laboratory reports and oral presentation. The grade is assessed with Fail (U) or Pass (G).
On the whole course the grades Fail (U), Pass (3), Pass with merit (4) or Pass with distinction (5) are set. To pass the course it requires that all examinations and obligatory tasks are approved. The grade is based on the grade received on part 1.
Students who received a passing grade on an examination may not retake the examination.
For students who do not pass the regular examination renewed examination in accordance with the Umeå University Regulations for tests and examinations at the undergraduate and graduate level (FS 1.1.2-553-14) could be arranged. The first re-test is offered not later than two months after the first examination. When the ordinary examination takes place in May or June, the first retesting opportunity is given within three months after the first examination. In addition, at least another re-test within one year of regular examination is offered.
In cases where the exam cannot be repeated under the current rules for retesting the exam should instead be replaced with another task. The scope and content of such task should not be disproportionate to the missed exam.
A student who has taken two examinations in a course or part of a course without passing, has the right to have another examiner appointed, unless there are specific reasons against it (6 ch. 22, § HF). Requests for new examiners should be addressed to the head of the Department of Radiation Sciences.

Other regulations

In the event that the course expires or major changes are introduced, the students are assured at least three occasions of examination (including regular examination) as prescribed in the syllabus to the course that the student originally registered in over a period of a maximum of two years from the previous syllabus expired.


The literature list is not available through the web. Please contact the faculty.