Biosafety evaluation strategy and practice of tissue induced biomaterials
10.3969/j.issn.2095-4344.0712
- VernacularTitle:组织诱导性材料生物安全性评价研究策略与实践
- Author:
Wen ZOU
1
;
Tun YUAN
;
Yong-Fu CAI
;
Li-Ping ZHENG
;
Jie LIANG
Author Information
1. 四川大学国家生物医学材料工程技术研究中心
- From:
Chinese Journal of Tissue Engineering Research
2018;22(10):1534-1539
- CountryChina
- Language:Chinese
-
Abstract:
BACKGROUND: Due to the complexity of tissue induced biomaterials, the current biosafety evaluation standard is not available. For years, to choose an effective evaluation strategy and practice in tissue induced materials has been always a hot topic, but still with no conclusion. The existence of this problem results in numerous issues for manufactures when conducting the biosafety evaluation of tissue induced medical devices. OBJECTIVE: To formulate the biosafety evaluation strategy that should be followed by the material samples at the research and development stage and to provides some ideas and lessons for the selection of the product biology experimental items to be listed and registered. METHODS: In 2016, a statistical analysis was carried out for biological test items of tissue induced biomaterials. Cytotoxicity, irritation and sensitization tests were the most commonly used tests for biomaterials and medical devices. A biosafety evaluation only via the above three tests had been applied in 58 kinds of materials with 81 batches of samples. In this study, immune toxicity tests were performed in 17 kinds of materials and biodegradation tests were done in some samples. RESULTS AND CONCLUSION: It had been found that different test programs or evaluation strategies may be adopted in the product development or listing registration stage. At early stage of development, cytotoxicity, irritation and sensitization tests are suitable for sample screening. In the later stage of research and development, more in-depth tests, such as subchronic toxicity, degradation and immunity toxicity, should be employed to meet the safety evaluation requirements.
