With the continuous development of modern medical technology, medical titanium alloys are widely used in medical devices such as artificial joints, dental implants, and bone fixation devices due to their excellent biocompatibility, corrosion resistance, and good mechanical properties. However, the surface cleanliness of medical titanium alloys directly affects their biocompatibility and long-term stability after being implanted in the human body during the production, processing, and use process. Therefore, how to effectively ensure the cleanliness of medical titanium alloy materials has become a key link in the manufacturing and quality control of medical devices.



Firstly, at the stage of raw material selection, it is necessary to ensure the purity of the titanium alloy material itself. Medical titanium alloys usually use high-purity titanium (such as TA1, TA2, or Ti6Al4V ELI, etc.) and strictly control the content of impurity elements. These materials must meet the chemical composition requirements of international standards (such as ASTM F1341, ISO 5832) to reduce the risk of introducing pollutants from the source.



Secondly, maintaining the cleanliness of the environment and the controllability of the process during the manufacturing process is crucial. The processing workshop of medical devices should reach a certain cleanliness level, usually ISO Class 7 or higher, to prevent dust, bacteria, and other particles from contaminating the surface of the material. In addition, processing equipment and tools should be cleaned and maintained regularly to avoid metal shavings or other impurities from mixing with the surface of the titanium alloy.



Thirdly, the surface treatment process has a direct impact on the cleanliness of titanium alloys. Common surface treatment methods include acid pickling, polishing, sandblasting, anodic oxidation, and plasma spraying. These treatments not only improve the surface morphology of the material but also remove surface oxide layers, oil stains, and other adherent substances. Among them, acid pickling can effectively remove surface impurities, while ultrasonic cleaning can remove micro-particles at the microscopic level, which is an important means to improve cleanliness.



Finally, the cleaning and sterilization process is a critical step to ensure the cleanliness of the final product. Titanium alloy implants must undergo multiple cleaning procedures before shipment, usually a combination of deionized water flushing, solvent cleaning, and ultrasonic cleaning to thoroughly remove grease, metal particles, and microorganisms that may remain during the processing. The subsequent sterilization treatment (such as high-temperature steam sterilization, ethylene oxide sterilization, or radiation sterilization) must also effectively kill all potential sources of contamination while ensuring that the material properties are not damaged.



In summary, the cleanliness assurance of medical titanium alloys is a systematic project, covering multiple links such as raw material selection, production process control, surface treatment, cleaning, and sterilization. Only through strict quality management and technical control can the high cleanliness of medical titanium alloy products be ensured, thereby guaranteeing the health and safety of patients and enhancing the overall performance and clinical application effect of medical devices.