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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: Pátková Vlasta (04.01.2018)
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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: Pátková Vlasta (04.01.2018)
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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: Pátková Vlasta (04.01.2018)
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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: Pátková Vlasta (04.01.2018)
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Learning materials are available by teacher. Last update: Pátková Vlasta (04.01.2018)
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Introduction to Study of Materials Last update: Pátková Vlasta (04.01.2018)
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