Research Status of Nanomaterial Medical Device and Discussion on Biological Evaluation
10.3969/j.issn.1671-7104.230286
- VernacularTitle:应用纳米材料的医疗器械研究现状与生物学评价探讨
- Author:
Lingxiao SUN
1
,
2
,
3
;
Min WAN
;
Xiaoxia SUN
;
Jia LIU
;
Xiaoxiao GAI
;
Guowei WANG
;
Wenting RUAN
;
Yang QIN
;
Chenghu LIU
Author Information
1. 山东省医疗器械和药品包装检验研究院,济南市,250101
2. 国家药品监督管理局生物材料器械安全性评价重点实验室,济南市,250101
3. 山东省医疗器械生物学评价重点实验室,济南市,250101
- Keywords:
nanomaterial;
biomaterial;
medical device;
biological evaluation
- From:
Chinese Journal of Medical Instrumentation
2024;48(1):88-93
- CountryChina
- Language:Chinese
-
Abstract:
In recent years,China has made great progress in basic nanomedicine,nanotoxicology and nanobiology research.Nanotechnology has been continuously applied in biomaterial and medical device,more and more medical devices applying nanomaterials are developed and manufactured.In order to gain more comprehension and accurate understanding of the research and industrial development in nanobiomaterial medical devices,this study reviewed the common nanomaterial in medical devices and the regulatory situation of nanomaterial medical devices at home and abroad,and discussed the current challenges in biological evaluation of nanomaterial medical devices,with a view to providing ideas for the safety evaluation and research of related products.