Feasibility of finite element analysis in the application of quality inspection on implantable medical devices
- VernacularTitle:应用有限元检测植入器械的可行性分析
- Author:
Jia-hua HUANG
1
;
Feng LIN
1
;
Tian-ping YAO
1
Author Information
1. Shanghai Testing & Inspection Institute for Medical Devices
- Publication Type:Journal Article
- Keywords:
Implantable medical devices;
Quality inspection;
Finite elements analysis;
Mechanical testing
- From:
Journal of Medical Biomechanics
2014;29(1):E001-E006
- CountryChina
- Language:Chinese
-
Abstract:
For implantable medical devices, traditional mechanical property testing is achieved by mechanical testing devices, while such method is lack of pertinence during sampling of series of products, and also time consuming during experimental testing. With the complete development of finite element analysis (FEA) techniques, introducing FEA to quality supervision and inspection will become a scientific method for saving resources and time, and also improve the pertinence. In this study, the creditability of FEA in application of highest risk sample selection, failure analysis of marketed products and auxiliary optimization of fatigue test testing was verified through case study and experimental testing. The feasibility of FEA during implants inspection was illustrated. In order to ensure the accuracy and reliability of FEA in the application of implants inspection, the essentials of establishing related finite element standards were proposed.
