Analysis and Evaluation Method for Macro- and Micro-Structural Characterization of
3D Printing Porous Ceramic Surgical Implants
ZHANG Chen1,2, DONG Shuangpeng1,2, ZHANG Shu1,2, MA Hui1, DONG Enchun3,4,
KANG Jianfeng3,4, LI Dichen3,4, WANG Ling3,4
1. Tianjin Medical Devices Supervision and Testing Center, State Food and Drug Administration, Tianjin 300384, China; 2. NMPA
Key Laboratory for Quality Evaluation of Non-Active Implant Devices, Tianjin 300384, China; 3. State Key Laboratory for
Manufacturing System Engineering, School of Mechanical Engineering, Xi’an Jiaotong University, Xi’an Shaanxi 710054, China;
4. National Medical Products Administration (NMPA) Key Laboratory for Research and Evaluation of Additive Manufacturing
Medical Devices, Xi’an Shaanxi 710054, China
Abstract：Objective To explore the macro- and micro-structural characterization analysis and evaluation method of pore structure of
the 3D-printing porous ceramic surgical implants. Methods Based on the porous sample image data obtained by Micro-CT scanning,
and the porous structure analysis function of VG Studio MAX 3.0 and Mimics 16.0 software, the macro-structural characterization
of porous structure, including total porosity, macro pore size, internal connection, open/closed pore ratio were determined and
statistically analyzed. Moreover, scanning electron microscope (SEM) was used to analyze and evaluate the morphology of samples
for its micropores on the surface of samples. Results Based on micro-CT and SEM scanning and imaging analysis, the macro- and
micro-characterization and statistical analysis of the pore structure of 3D printed porous structure ceramic samples were realized,
and its feasibility and accuracy were verified. A set of effective measurement and evaluation method for the macro- and microstructural
size characterization of 3D printing porous structure ceramic materials surgical implants were formed. Conclusion The
statistical method proposed in this paper is based on the micro-CT and SEM scanning imaging method for the characterization and
analysis of macro- and micro-structured of the porous 3D printing ceramic samples, it helps ensure that the relevant test content
and test process of macro- and micro-characterization of porous structure are unified and consistent and ensure that the test process
method is evidence-based and the result evaluation is accurate and effective. The accuracy and the effectiveness of such a method has
been proved. It was conducive to improving the processing accuracy of products, facilitating the equivalent comparison between the
characteristic parameters of porous structure from different enterprises, laying a foundation for the data accumulation of macro- and
micro- characterization of porous structure in the 3D printing medical device industry, and promoting the research and development
and manufacturing level of surgical implants closely related to human life safety.
张晨1,2，董双鹏1,2，张述1,2，马会1，董恩纯3,4，康建峰3,4，李涤尘3,4，王玲3,4. 面向3D打印多孔陶瓷材料外科植入物宏微观结构特征的分析评价方法[J]. 中国医疗设备, 2023, 38(2): 17-24.
ZHANG Chen1,2, DONG Shuangpeng1,2, ZHANG Shu1,2, MA Hui1, DONG Enchun3,4,
KANG Jianfeng3,4, LI Dichen3,4, WANG Ling3,4. Analysis and Evaluation Method for Macro- and Micro-Structural Characterization of
3D Printing Porous Ceramic Surgical Implants. China Medical Devices, 2023, 38(2): 17-24.
