YY/T 1802-2021Additive manufacturing medical products - Evaluation method for metal ion release of 3D printed titanium alloy implants (English PDF)

3.1 Ion precipitation

The sample is placed in the solution configured according to 4.3, and the four element ions of titanium, aluminum, vanadium and iron are precipitated under the time and conditions specified in 6.1.

Note. Other elements. tin, molybdenum, chromium, manganese, zirconium, nickel, copper, silicon, yttrium refer to the provisions of 3.2 in GB/T 3620.1-2016 to be determined as needed, not as mandatory elements.

4.1 Sample

The samples selected for testing are fully processed and can represent the preparation process and structure of the final 3D printed product, where the same The preparation process includes the same process category, process parameters, processing direction and post-processing, etc. The same structure includes the same pore structure, pores porosity, precision and surface quality.

The size of the test sample is a circular sheet-like structure with a diameter of 20mm and a height of 3mm. For the schematic diagram of the cross-sectional structure of the sample, please refer to Appendix A Center Figure A.1.

The test sample should have the same manufacturing, post-processing, cleaning and sterilization process as the final product.

4.2 Blank control

A blank control group was set, that is, the extraction medium without the test material. During leaching, place in the same container as the test material and use the same extraction conditions.

4.3 Hank's artificial simulation of body fluids

Use the reagents listed in Table 1 to prepare a simulated physiological solution with a pH of 7.4. All reagents should be of superior grade and above, and should not contain Four kinds of ions, Ti, Al, V and Fe, can be used immediately after configuration.