Risks and quality control of production of 3D printed navigational template for orthopedic surgery
10.19745/j.1003-8868.2024097
- VernacularTitle:3D打印骨科手术导板生产环节风险以及质量控制的思考
- Author:
Bi-Rong HU
1
;
Xiao-Yue BIAN
;
Jun-Feng BAI
;
Xue-Ying YANG
Author Information
1. 陕西省药品和疫苗检查中心,西安 716000
- Keywords:
3D printing;
surgery template;
orthopedic surgery;
quality control
- From:
Chinese Medical Equipment Journal
2024;45(5):80-85
- CountryChina
- Language:Chinese
-
Abstract:
The regulatory requirements of 3D printing products were introduced.The risks during the production of 3D printed navigational template for orthopedic surgery were summarized in terms of data acquisition,medical-industrial intera-ction design,3D printing,post-processing and sterilization.Some quality control measures were proposed from the aspects of quality control of raw materials,validation of data and software,verification of printing process parameters,post-processing method and verification,sterilization verification and testing of semi-finished and final products,so as to enhance the safety and effectiveness of 3D printed navigational template for orthopedic surgery.[Chinese Medical Equipment Journal,2024,45(5):80-85]
