Strategy on biological evaluation for biodegradable/absorbable materials and medical devices

Article type: Research Article

Authors: Liu, Chenghu^{a; b} | Luo, Hongyu^{a; b} | Wan, Min^{a; b} | Hou, Li^{a; b} | Wang, Xin^{a; b} | Shi, Yanping^{a; b; *}

Affiliations: [a] Shandong Quality Inspection Center for Medical Devices, Jinan, 250101, P.R. China | [b] Shandong Key Laboratory of Biological Evaluation for Medical Devices, Jinan, 250101, P.R. China

Correspondence: [*] Corresponding author: Yanping Shi, NO.15166 Century Avenue, Jinan H-T Industrial Development Zone, Shandong Province 250101, P.R. China. Tel.: +8653182682976; E-mail: sdzxsyp@163.com.

Abstract: During the last two decades, biodegradable/absorbable materials which have many benefits over conventional implants are being sought in clinical practices. However, to date, it still remains obscure for us to perform full physic-chemical characterization and biological risk assessment for these materials and related devices due to their complex design and coherent processing. In this review, based on the art of knowledge for biodegradable/absorbable materials and biological risk assessment, we demonstrated some promising strategies to establish and improve the current biological evaluation systems for these biodegradable/absorbable materials and related medical devices.

Keywords: Biodegradable/absorbable materials, medical device, biological evaluation

DOI: 10.3233/BME-181735

Journal: Bio-Medical Materials and Engineering, vol. 29, no. 3, pp. 269-278, 2018