含药递送系统的骨软骨修复支架材料的安全性检验报告

含药递送系统的骨软骨修复支架材料(PT/A10E)的生物安全性检测，包括含药可降解高分子骨修复材料遗传毒性试验、细胞毒性试验、致敏试验、皮内刺激试验、急性全身毒性试验、溶血试验等。该部分支持数据为第三方生物安全性检验报告，由第三方检测机构深圳市医疗器械检测中心完成，采集时间为：2023年03月-2023年06月，涉及设备为多功能酶标仪，PCR仪，光学显微镜等。Biosafety testing of the osteochondral repair scaffold material (PT/A10E) with a drug delivery system, including genotoxicity, cytotoxicity, sensitization, intradermal irritation, acute systemic toxicity, and hemolysis tests for the drug-loaded biodegradable polymer bone repair material. The supporting data for this section consists of third-party biosafety test reports completed by Shenzhen Medical Device Testing Center, a third-party testing institution. Data collection was carried out from March 2023 to June 2023, involving equipment such as multi-functional microplate readers, PCR instruments, and optical microscopes.