Recent Advance of Stainless Steel Used In Non-active Surgical Implantable Medical Device and Regulatory Perspective.
10.3969/j.issn.1671-7104.2022.03.016
- Author:
Guo-Hui JIAO
1
;
Jing-Jing MIAO
1
;
Kun WU
1
Author Information
1. Center for Medical Device Evaluation, NMPA, Beijing, 100081.
- Publication Type:Journal Article
- Keywords:
stainless steel;
standard;
surgical implantable medical device
- MeSH:
Prostheses and Implants;
Stainless Steel
- From:
Chinese Journal of Medical Instrumentation
2022;46(3):312-317
- CountryChina
- Language:Chinese
-
Abstract:
Stainless steel has been widely used in non-active surgical implantable medical device of cardiovascular, orthopedics, dental and ophthalmology. In this paper, we mainly focused on development of stainless steel, as well as the material-related standard evolution. We further summarized the recent advancement of stainless steel use in surgical implantable medical device. Insight and regulatory perspective has been further demonstrated.