Lutsenko, TetianaYang Chen2025-01-222025-01-222024Yang Chen. Technical regulations for the production for Biomedical Devices with Biomolecular Sensors for early detection of oncological diseases : мaster's Thesis : 163 Biomedical engineering / Yang Chen. - Kyiv, 2024. - 71 pages.https://ela.kpi.ua/handle/123456789/72132This study aims to establish a scientific and rigorous "Technical Regulations for the Production of Biosensor Medical Devices for Early Detection of Tumor Diseases". The regulations focus on the early diagnosis requirements of tumor diseases, delving into the design principles of biosensor medical devices, emphasizing the selection and preparation of sensitive components, optimization of signal conversion and amplification mechanisms, as well as the biological compatibility and stability of device structures. In terms of production process, we provide a detailed description of the entire process from material preparation, sensor assembly to quality control, ensuring product performance consistency and reliability. Through computer simulation, we evaluated and optimized the sensitivity, specificity, and response speed of the sensors, with simulation results aligning well with experimental data, validating the model's rationality. Experimental results show that the prepared biosensors exhibit high sensitivity and specificity in detecting tumor markers, effectively identifying tumor signals in the early stages. Additionally, we conducted a comprehensive evaluation of the safety of biosensor medical devices, including biotoxicity, immunogenicity, and long-term biological stability, to ensure safety in clinical applications. conclusion, this regulation provides technical guidance for the production of biosensor medical devices for early tumor disease detection, promoting the application of precision medicine in the field of early tumor diagnosis71 c.enBiosensorEarly Cancer DetectionMedical DeviceProduction Technology SpecificationNanobiological SensorMaster Thesis544.6:57