The composition, purity, microstructure, and other elements of metal materials can influence their biocompatibility. For instance, contaminants in materials may set off immunological responses; varying metal components and their ratios can influence a material's corrosion resistance and interaction with human tissues.
Surface quality, internal structure, and mechanical properties of the printed product can be influenced by the parameter settings during the printing process, including laser power, scanning speed, layer thickness, etc. While internal flaws can cause stress concentration and compromise the long-term stability of implants, rough surfaces could offer bacterial attachment sites, hence raising the risk of infection.
Improving the characteristics and biocompatibility of materials depends much on post-treatment procedures, including surface treatment, heat treatment, etc. Inappropriate post-processing could introduce additional hazardous compounds or lead to unstable material characteristics.
The remaining materials-support materials and lubricants-used in the printing process may harm the human body, so we must closely regulate their use and residue.
Choose materials of medical grade: Select medical-grade metal materials, including stainless steel, medical titanium alloys, etc., that satisfy pertinent domestic and international criteria. Thorough biocompatibility testing and clinical validation have demonstrated the good biocompatibility and stability of these materials.
Materials testing involves thoroughly analysing chemical compositions, testing mechanical properties, and pre-evaluating raw materials for biocompatibility. Make sure the mechanical qualities satisfy the criteria for the use of medical equipment and that the content of dangerous elements in the material is within a safe range.
Optimisation of parameters: Choose the best combination of printing parameters by means of experiments and data analysis based on various metal materials and product designs, including laser power, scanning speed, layer thickness, etc. Make sure printed goods' mechanical qualities, internal structure, and surface quality satisfy the needs.
Process observation: real-time tracking of important factors, including temperature, pressure, gas flow rate, etc., during printing. Quick identification and correction of aberrant conditions guarantee the consistency of product quality and printing process stability.
Heat treatment: Appropriate heat treatment can increase biocompatibility and mechanical qualities of materials by means of microstructure enhancement. Annealing, for instance, can remove the internal stress produced during printing, therefore lowering the danger of material deformation and cracking under use.
Surface treatment involves lowering surface roughness and minimising the risk of bacterial adherence and immunological responses. Surface treatment techniques include chemical treatment, polishing and sandblasting. To increase the biocompatibility of the material, surface coatings-such as bioactive coatings-are also applied concurrently.
Dimensional accuracy testing: Test the dimensional accuracy of printed goods carefully using highly accurate measurement tools, including coordinate measuring machines. Please ensure the measurements meet the design criteria and prevent dimensional deviations from affecting the efficiency of use.
Mechanical performance assessments: Test printed goods' mechanical qualities in line with pertinent criteria, including tensile strength, yield strength, hardness, etc. Make sure the mechanical qualities satisfy the requirements for the operation of medical equipment.
Assessing biocompatibility: The ISO 10993 series guidelines state that metal 3D printed medical devices-including cytotoxicity testing, sensitisation testing, irritation testing, etc.-are biocompatible. Make sure the product satisfies biocompatibility criteria and is benign for the human body. Abide by rules and guidelines.
Compliance with regulations: China's "Regulations on the Supervision and Administration of Medical Devices," ISO 10993 series standards, etc.-domestic and international rules and standards on the biocompatibility of medical devices should be understood and followed. Verify that the product's production, testing, and research and development procedures follow legal guidelines.
Examining certifications: Actively assist certification organisations in conducting product certification and reviews. Quickly finding and fixing any issues with products that don't meet the rules and standards is done through the review and support of certifying organisations, which helps ensure that getting market access credentials is straightforward.
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