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.
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.