Course detail

Standardization in Medicine

FEKT-ASTDAcad. year: 2018/2019

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

3

Mode of study

Not applicable.

Guarantor

Ing. Oto Janoušek, Ph.D.

Department

Department of Biomedical Engineering (UBMI)

Learning outcomes of the course unit

Ability to view the devices from the position of both the designer and the user.

Prerequisites

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

Co-requisites

Not applicable.

Planned learning activities and teaching methods

Teaching methods depend on the method of teaching and they are specified in the article 7 of BUT Rules for Studies and Examinations.

Assesment methods and criteria linked to learning outcomes

Requirements for successful course completion are specified by guarantor’s regulation updated for every academic year.

Course curriculum

Standards for health instruments – basic standard, electrical safety of instruments, standards for individual instruments (its relationship to basic standard), problems with medicinal gases, radiation safety, problems with calibration, approval procedure for health technique, standards for health care at extraordinary and emergency situations.
1. Standards for health instruments – basic standard
2. Electrical safety of instruments – diagnostic instruments, which are using electrodes located to patient.
3. Electrical safety of instruments . therapeutic instruments, which are using electrodes located to patient.
4. Standards for operation rooms and its working
5. Standards for ARO instruments and its operation
6. Standards for medicinal gases – requirements on gases, its distribution and requirements to instruments which are using it.
7. Standards for radiation diagnostic
8. Standards for radiation therapy
9. Verification instruments technical parameters in practical operation
10. Sterilization at healthcare – basic terms and standards for sterilization
11. Standard for materials in health care
13. Approval procedure for health technique – authorized testing laboratory, declaration about conformity etc.

Work placements

Not applicable.

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.

Specification of controlled education, way of implementation and compensation for absences

Extent and forms of monitored teaching are specified bu guarantor’s regulation updated for every academic year.

Recommended optional programme components

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 BTBIO-A Bachelor's

    branch A-BTB , 3 year of study, summer semester, compulsory

  • Programme EEKR-CZV lifelong learning

    branch EE-FLE , 1 year of study, summer semester, compulsory

Type of course unit

 

Lecture

26 hod., optionally

Teacher / Lecturer

Ing. Jiří Sekora, MBA
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.