Course detail

Standardization in Medicine

FEKT-BPC-STDAcad. year: 2025/2026

Standards for medical instruments –basic standard, electrical safety of instruments, standards for individual instruments (its relationship to basic standard), problems with medicinal gases, radiation safety, problems with metronomic, approval procedure for medical technique. Standards for health-care securing in exceptional and emergency situations.

Language of instruction

Czech

Number of ECTS credits

2

Mode of study

Not applicable.

Guarantor

Ing. Oto Janoušek, Ph.D.

Department

Department of Biomedical Engineering (UBMI)

Entry knowledge

Medical diagnostic technology. Therapeutic and protetic technology. Imaging systems in medicine.

Rules for evaluation and completion of the course

The condition for successful completion of the course is obtaining at least 50 points in the final exam. The final exam demonstrates the ability to navigate the basic medical standard ČSN EN 60601-1 and the standards used in the healthcare sector and verifies understanding of the reasons for their origin. 

Aims

The aim of this subject is partly to inform of students with problems, which are related with construction of health technique, with its introduction to operation, with monitoring of this technique in practice. The next aim of this subject is notice to reality which must be respected at purchasing of this technique.
Ability to view the devices from the position of both the designer and the user.

Study aids

Not applicable.

Prerequisites and corequisites

Not applicable.

Basic literature

Chmelař M.: Lékařská laboratorní technika – VUT Brno 2000 (CS)
Chmelař M. : Lékařská přístrojová technika I – CERM, s.r.o. 1995 (CS)

Recommended reading

Not applicable.

Classification of course in study plans

  • Programme BPC-BTB Bachelor's 3 year of study, summer semester, compulsory

Type of course unit

 

Lecture

26 hod., compulsory

Teacher / Lecturer

Ing. Oto Janoušek, Ph.D.

Syllabus

1. Standards for medical devices -the basic standard.
2. Electric security of devices – diagnostic devices using electrodes on the patient’s body.
3. Electric security of devices – therapeutic devices using electrodes on the patient’s body.
4. Standards for apparatus operated in the operating theatre.
5. Standards for devices and operation of intensive care unit.
6. Standards for medical gases – requirements, distribution and requirements for devices where the gases are used.
7. Standards for the workplace using ionizing radiation for diagnostics.
8. Standards for the workplace using ionizing radiation for therapy
9. Standards for devices operated in biochemical and hematological laboratories.
10. Metronomy as related to verification of the technical parameters of devices operated in practice.
11. Sterilization in medicine – basic concepts and standards.
12. Standards for materials used in medicine.
13. The approval process for medical devices – authorized test rooms, statement of agreement and other.