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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

Translated title of the contribution: Analysis and Evaluation Method for Macro- and Micro-Structural Characterization of 3D Printing Porous Ceramic Surgical Implants
  • Chen Zhang
  • , Shuangpeng Dong
  • , Shu Zhang
  • , Hui Ma
  • , Enchun Dong
  • , Jianfeng Kang
  • , Dichen Li
  • , Ling Wang
  • State Food and Drug Administration
  • NMPA Key Laboratory for Quality Evaluation of Non-Active Implant Devices
  • Xi'an Jiaotong University
  • National Medical Products Administration

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

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 micro-structural 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.

Translated title of the contributionAnalysis and Evaluation Method for Macro- and Micro-Structural Characterization of 3D Printing Porous Ceramic Surgical Implants
Original languageChinese (Traditional)
Pages (from-to)17-24
Number of pages8
JournalChina Medical Devices
Volume38
Issue number2
DOIs
StatePublished - 10 Feb 2023

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