Management and quality systems in production of biomaterials - N106039
Title: Systém managementu a jakosti ve výrobě materiálů
Guaranteed by: Department of Metals and Corrosion Engineering (106)
Faculty: Faculty of Chemical Technology
Actual: from 2013 to 2019
Semester: winter
Points: winter s.:5
E-Credits: winter s.:5
Examination process: winter s.:
Hours per week, examination: winter s.:3/0, Ex [HT]
Capacity: unknown / unknown (unknown)
Min. number of students: unlimited
State of the course: taught
Language: Czech
Teaching methods: full-time
Teaching methods: full-time
Guarantor: Volenec Karel doc. RNDr. PhMr. CSc.
Is interchangeable with: M106013
Examination dates   Schedule   
Annotation -
The aim of the subject is to give basic information on the management system and regulations connected with the production of medical devices and biomaterials. In addition, specific aspects of the production of medical devices and biomaterials will be given.
Last update: Šerák Jan (25.02.2013)
Aim of the course -

Student will be able to understrand the following:

Basic principles of management system in production of biomaterials.

Basic regulations connected with production of biomaterials.

Specific aspects of production of biomaterials.

Last update: TAJ106 (28.11.2013)
Literature -

R: Zákon č. 123/2000 Sb. o zdravotnických prostředcích, v aktuálním znění.

R: Nařízení vlády ČR č. 336/2004 Sb., stanovení technických požadavků na zdravotnické prostředky, v aktuálním znění.

A: Buddy D. Ratner, Allan S. Hoffman, Frederick J. Schoen, Jack E. Lemons. Biomaterials Science: An Introduction to Materials in Medicine. 2dn edition, Academic Press, 2004.

Last update: TAJ106 (23.07.2013)
Learning resources -

Learning materials are available by teacher.

Last update: TAJ106 (23.07.2013)
Syllabus -

1. Certifications of producers of medical devices (ČSN EN ISO 13485, risk management)

2. Certifications of products � CE designation (93/42/EEC regulation)

3. Regulation of the applications of biomaterials in production of medical devices

4. Czech legislation connected with the production of medical devices from biomaterials

5. Research and development of medical devices from biomaterials

6. Industrial infrastructure in the production of medical devices

7. Basic requirements for the production inputs in the area of biomaterials

8. Assessment of the quality of biomaterials

9. Medical devices from metallic biomaterials

10. Medical devices from polymeric biomaterials

11. Medical devices from inorganic non-metallic biomaterials

12. Medical devices from composite and hybrid biomaterials and coatings

13. Sterilization, adjustation and distribution of biomaterials, vigilance system

14. Utility models, patents

Last update: Šerák Jan (25.02.2013)
Registration requirements -

Introduction to Study of Materials

Last update: TAJ106 (23.07.2013)
Teaching methods
Activity Credits Hours
Účast na přednáškách 3 84
Příprava na přednášky, semináře, laboratoře, exkurzi nebo praxi 1 28
Příprava na zkoušku a její absolvování 1 28
5 / 5 140 / 140
Coursework assessment
Form Significance
Regular attendance 20
Oral examination 80