For the development of medical device especially the orthopedic implant in Taiwan, this project is focused on the biosafety evaluation of a newly bone filling materials under the medical device regulation which could fulfill the premarketing certification. The orthopedic biomaterials made by poly prooylene carbonate (PPC), poly lactic acid (PLA) and tricalcium phosphate (TCP) was fabricated into a porous scaffold then combined with plate rich plasma for osteoinducted supplement. The aim of this project contents three tasks, first for establishment the standard operation process following the guidance of ISO 10993 “Biological Evaluation of Medical Devices” for in vitro genotoxicity test and in vivo biosafety evaluation; second perform the sensitization, irritation and acute systemic toxicity in the tested animal in this year; finally also cooperation with clinician in hospital to establishment bone effect model for test this orthopedic materials to develop an optimal testing procedure for new developed orthopedic biomaterials for large defect repair. With the increasing need of biomedical implants for orthopedic diseases, the biosafety and biocompatibility of the orthopedic biomaterials examine with the standard exanimation that fit the medical device regulation could be a certification report for preclinical trial application.
|Effective start/end date
|1/1/14 → 12/31/14
- Orthopedic biomaterials
- acute toxicity
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