Discussion of Application Status and Key Attentions on Registration for Ossicular Replacement Prosthesis / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
; (6): 684-689, 2023.
Article
in Zh
| WPRIM
| ID: wpr-1010262
Responsible library:
WPRO
ABSTRACT
The ossicular replacement prosthesis should have good biocompatibility, stability, easy to install, and excellent sound transmission capacity. In this study, the characteristics of ideal materials for the ossicular replacement prosthesis were analyzed by searching the types of materials used in clinical practice and comparing the advantages and disadvantages of various materials and structures. At the same time, in combination with the current evaluation requirements and evaluation experience, the focus of the performance research project of ossicular replacement prosthesis in the process of registration is discussed to clarify the performance evaluation requirements of these products, so as to provide reference for the future work of manufacturers and regulators. The performance evaluation of ossicular replacement prosthesis focuses on its mechanical properties, fixation stability, sound transmission characteristics, biological characteristics, and magnetic resonance compatibility.
Key words
Full text:
1
Index:
WPRIM
Main subject:
Prosthesis Design
/
Sound
/
Ossicular Prosthesis
/
Treatment Outcome
/
Ossicular Replacement
Language:
Zh
Journal:
Chinese Journal of Medical Instrumentation
Year:
2023
Type:
Article