660-2013/01 – Preclinical biocompatibility testing (PTB)
| Gurantor department | Centre for Advanced Innovation Technologies | Credits | 4 |
| Subject guarantor | Ing. Petr Straka | Subject version guarantor | Ing. Petr Straka |
| Study level | undergraduate or graduate | Requirement | Compulsory |
| Year | 2 | Semester | summer |
| | Study language | Czech |
| Year of introduction | 2024/2025 | Year of cancellation | |
| Intended for the faculties | FMT | Intended for study types | Bachelor |
Subject aims expressed by acquired skills and competences
The aim of the subject preclinical biological testing of medical devices is to provide students with a basic understanding of the principles and procedures for evaluating the safety and effectiveness of medical devices from the point of view of the biological safety of the materials used before clinical trials.
Teaching methods
Lectures
Seminars
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.
Compulsory literature:
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
Recommended 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.
Way of continuous check of knowledge in the course of semester
At least 90% participation in exercises
Elaboration and submission of measurement protocols
E-learning
Other requirements
No further student requirements are required
Prerequisities
Subject has no prerequisities.
Co-requisities
Subject has no co-requisities.
Subject syllabus:
1. Regulatory requirements for preclinical biological testing of medical devices
2. Biocompatibility testing of medical devices, biological evaluation as a systematic and planned process
3. Animal models for evaluating the safety and effectiveness of medical devices
4. Risk assessment and risk management for medical devices from the point of view of biological assessment
5. Design and development of ZP, selection of materials, types of medical devices and their potential biological effects on living tissue
6. Standards of the ISO10993-x series and other standards
7. Biocompatibility testing methods available for the evaluation of medical devices
8. Categorization of ZP according to contact with the slide body, consideration of available data, literature search
9. Physical and chemical information for biological risk analysis, material and product characteristics
10. Chemical characterization of materials and its procedure, configuration of material composition of ZP, assessment of equivalence
11. Release of chemical substances, analytical assessment threshold, exposure assessment
12. Calculation of Tolerable Intake, Tolerable Exposure and practical examples
13. In vitro and in vivo tests for the purpose of evaluating the biocompatibility of medical devices
14. Transfer of preclinical findings from biological evaluation to clinical studies.
Conditions for subject completion
Occurrence in study plans
Occurrence in special blocks
Assessment of instruction
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