Medical Devices Directive
Safety
Medical measurement technology and measurement uncertainty
Risk management
Electrical Safety
Electromagnetic compatibility
CM1003 Test for Medical Engineering 3.0 credits
The course provides an overall understanding of what the regulatory landscape of medical technology products looks like and provides basic knowledge in medical technology testing.
Information per course offering
Course offerings are missing for current or upcoming semesters.
Course syllabus as PDF
Please note: all information from the Course syllabus is available on this page in an accessible format.
Course syllabus CM1003 (Autumn 2019–)Headings with content from the Course syllabus CM1003 (Autumn 2019–) are denoted with an asterisk ( )
Content and learning outcomes
Course contents
Intended learning outcomes
After passing the course the student should be able to:
· Explain the content of the Medical Devices Directive
· Describe the procedure for measurement within medical engineering and indicate sources of uncertainty in suc
· Describe how risk management of new medical technology products is implemented
· Perform an electrical safety test on a medical devi
· Explain basic requirements for electromagnetic compatibility for medical devices
Literature and preparations
Specific prerequisites
Basic knowledge in Physiology corresponding to completed course HL1001 or completed module TEN1 in the course HL1201. Basic knowledge of Electrical Circuits equivalent to completed course HE1200 or HE1027.
Recommended prerequisites
No information inserted
Equipment
No information inserted
Literature
No information inserted
Examination and completion
If the course is discontinued, students may request to be examined during the following two academic years.
Grading scale
P, F
Examination
- VFU1 - Workplace training, 3.0 credits, grading scale: P, F
Based on recommendation from KTH’s coordinator for disabilities, the examiner will decide how to adapt an examination for students with documented disability.
The examiner may apply another examination format when re-examining individual students.
Opportunity to complete the requirements via supplementary examination
No information inserted
Opportunity to raise an approved grade via renewed examination
No information inserted
Examiner
Ethical approach
- All members of a group are responsible for the group's work.
- In any assessment, every student shall honestly disclose any help received and sources used.
- In an oral assessment, every student shall be able to present and answer questions about the entire assignment and solution.
Further information
Course room in Canvas
Registered students find further information about the implementation of the course in the course room in Canvas. A link to the course room can be found under the tab Studies in the Personal menu at the start of the course.
Offered by
Main field of study
Medical Engineering
Education cycle
First cycle
Add-on studies
No information inserted
Contact
fernando.seoane.martinez@sth.kth.se