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CZECH TECHNICAL UNIVERSITY IN PRAGUE
STUDY PLANS
2023/2024
UPOZORNĚNÍ: Jsou dostupné studijní plány pro následující akademický rok.

Technical and Health-Care Regulations

The course is not on the list Without time-table
Code Completion Credits Range
16TZP Z 2 2+0
Garant předmětu:
Lecturer:
Tutor:
Supervisor:
Department of Dosimetry and Application of Ionizing Radiation
Synopsis:

This course provides an overview of technical and health-care specific legal and other regulations associated with utilization of health-care devices based on ionizing radiation and/or nuclear energy in health care. Problematics of judgement of accordance, in-market implementation, acquisition, commission, utilization, maintenance, service and evidence of health-care resources and problems of clinical evaluation and clinical tests. („Law on technical requirements on products“, „Law on health-care resources, Law on metrology, Atomic law, and related regulations, EC directives, relevant norms - CSN, EN, ISO). Furthermore, the “Law on health services„, the “Law on specific health services„, system of special health care for people irradiated by radiation accidents. Legislation concerning radiological health professions: Laws on clinician and non-clinician health professions“, and related regulations, including system of graduate, specialization and continuing education, certifications, registrations. Indication criteria for imaging modalities and radiological medical standards, including determination and evaluation of patient doses, and audits of patient doses.

Requirements:
Syllabus of lectures:

1. Overview of technical and health-care specific legal and other regulations associated with utilization of health-care devices based on ionizing radiation and/or nuclear energy in health care.

2. Problematics of judgement of accordance, in-market implementation, acquisition, commission, utilization, maintenance, service and evidence of health-care resources.

3. Problems of clinical evaluation and clinical tests.

4. „Law on technical requirements on products“, "Law on health-care resources, Law on metrology.

5. Atomic law, and related regulations, EC directives, relevant norms - CSN, EN, ISO).

6. „Law on health services“, „Law on specific health services“.

7. System of special health care for people irradiated by radiation accidents.

8. Legislation concerning radiological health professions: Laws on clinician and non-clinician health professions", and related regulations.

9. System of graduate, specialization and continuing education, certifications, registrations.

10. Indication criteria for imaging modalities.

11. Radiological medical standards, including determination and evaluation of patient doses.

12. Clinical audits.

Syllabus of tutorials:
Study Objective:

Knowledge:

Knowledge about technical and health-care specific legal and other regulations associated with utilization of health-care devices based on ionizing radiation and/or nuclear energy in health care.

Skills:

Use of appropriate laws and regulations related to the use of medical equipment using ionizing radiation.

Study materials:

Key references:

[1] Law on health services Act (No. 372/2011 Coll.). (in Czech)

[2] Law on metrology (No. 505/1990 Coll.). (in Czech)

[3] Atomic Law (No. 263/2016 Coll.). (in Czech)

[4] National Radiological Standards - RDG, RT, NM and RF (including recommended literature). (in Czech)

[5] Technical standards ČSN EN harmonized with Government Decree No. 336/2004 Coll. (in Czech)

Recommended references:

[6] Law on Specific Health Services (No. 373/2011 Coll.). (in Czech)

[7] Law on technical requirements for products   (No. 22/1997 Coll.). (in Czech)

[8] Law on Medical Devices (No. 268/2014 Coll.). (in Czech)

[9] Recommendations of the European Commission; IAEA; ICRP; EFOMP; ESTRO, EANM, SÚJB - related to medical exposure. (in Czech)

[10] Klener, V. et al .: Principy a praxe radiační ochrany, AZIN Praha, 2000. (in Czech)

Note:
Further information:
No time-table has been prepared for this course
The course is a part of the following study plans:
Data valid to 2024-03-27
Aktualizace výše uvedených informací naleznete na adrese https://bilakniha.cvut.cz/en/predmet24361705.html