Study on Pre-Clinical In-Vitro Test Methods of Unicondylar Knee Prosthesis.
10.12455/j.issn.1671-7104.240327
- Author:
Shu YANG
1
;
Dan HAN
1
;
Wen CUI
2
;
Zhenxian CHEN
3
;
Jinju DING
1
;
Jintao GAO
1
;
Bin LIU
1
Author Information
1. GBA Center for Medical Device Evaluation and Inspection, NMPA, Shenzhen,
2. School of Materials Science and Engineering, Peking University, Beijing,
3. School of Mechanical Engineering, Chang'an University, Xi'an,
- Publication Type:Journal Article
- Keywords:
in-vitro testing;
medical device registration;
pre-clinical performance evaluation;
unicondylar knee prosthesis
- MeSH:
Knee Prosthesis;
Arthroplasty, Replacement, Knee;
Humans;
Prosthesis Design;
Materials Testing
- From:
Chinese Journal of Medical Instrumentation
2025;49(1):111-118
- CountryChina
- Language:Chinese
-
Abstract:
Compared with total knee arthroplasty, unicondylar knee replacement has the advantage of preserving the knee tissue structure and motor function to the greatest extent. Pre-clinical in-vitro test is an important tool to evaluate the safety and effectiveness of unicondylar knee prostheses, and it is also a key focus of the product registration process. Through collection, comparison, and analysis of current regulations, technical standards, guidelines, and related research literature, this paper expounds on the relevant research methods for the pre-clinical in-vitrotesting of unicondylar knee prostheses. At the same time, in conjunction with current evaluation requirements and experience, the study discusses the focus of pre-clinical performance research for unicondylar knee prostheses during the registration process to clarify the performance evaluation requirements of this product category. This aims to provide a reference for the pre-clinical performance research of unicondylar knee prostheses and to standardize industry testing standards.
