1. ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
2. REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Presentation from lectures
Preclinical biocompatibility testing
| Language of instruction | čeština |
|---|---|
| Code | 660-2013 |
| Abbreviation | PTB |
| Course title | Preclinical biocompatibility testing |
| Coordinating department | Centre for Advanced Innovation Technologies |
| Course coordinator | Ing. Petr Straka |
Summary
Overall, the course should equip students with the knowledge and skills necessary to design and conduct preclinical biocompatibility studies for medical devices and interpret the resulting data. The course focuses on making students understand the principles and procedures associated with the biocompatibility assessment of medical devices.
Literature
Advised literature
1. Bollen, L. S. (2005). New trends in biological evaluation of medical devices. Medical device technology, 16(5), 10-15.
2. Standard, B., & ISO, B. (2003). Biological evaluation of medical devices—. Biol. Eval. Med. devices, 10993-1.
2. Standard, B., & ISO, B. (2003). Biological evaluation of medical devices—. Biol. Eval. Med. devices, 10993-1.