Development and safety evaluation of implantable medical device of collagen
10.3760/cma.j.issn.1673-4181.2015.04.012
- VernacularTitle:胶原蛋白类植入性医疗器械及其安全性评价探讨
- Author:
Wenbo LIU
- Publication Type:Journal Article
- Keywords:
Collagen;
Medical device;
Safety evaluation
- From:
International Journal of Biomedical Engineering
2015;38(4):238-241,246
- CountryChina
- Language:Chinese
-
Abstract:
This paper categorizes implantable medical device of collagen on Chinese market according to manufacturing technique and performance.Combining with supervision requirements from China Food and Drug Administration (CFDA), this paper discusses safety evaluation in following aspects, such as immunogenicity risk,virus and infectious pathogen risk, and product technical requirements.Finally, the paper looks into the future of collagen implants considering technology progress in biomedical engineering, tissue engineering, and genetic engineering fields.
