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目的:采用GB/T16175-1997和ISO10993-6:2007标准中植入后局部反应试验的结果判定方法,评价房间隔缺损闭合器植入体内后的组织相容性,探讨两种方法在组织相容性评价中的作用。方法:采用试验动物家兔皮下植入试验,将试验样品植入家兔背部皮下组织,分别于植入后1周、4周和12周后处死动物,取材,常规制片,HE染色,组织学观察采用炎症和纤维囊腔分级法及半定量记分法。结果:样品皮下植入后随着时间的延长,其周围组织的反应程度呈加重趋势。植入后12周,组织学反应未达到稳态。两种方法的组织学观察结果是一致的。结论:两种方法在组织学评价中均有其局限性,实际中可将两种方法结合来评价医疗器械的组织相容性,建议继续观察该样品植入后26周的局部反应,以减少临床使用的风险。
OBJECTIVE: To evaluate the method of determining the local response after implantation in GB / T16175-1997 and ISO10993-6: 2007 standards and to evaluate the histocompatibility of atrial septal defect occluder implanted in vivo. The role of capacitive assessment. Methods: The experimental animals were implanted subcutaneously in rabbits subcutaneously. The animals were sacrificed at 1 week, 4 weeks and 12 weeks after implantation. The animals were sacrificed, The observation of inflammation and the use of fiber capsule classification and semi-quantitative scoring method. Results: With the extension of time after subcutaneous implantation, the reaction degree of surrounding tissues tended to increase. Twelve weeks after implantation, the histological response did not reach steady state. Histological observation of the two methods is consistent. CONCLUSIONS: Both methods have their limitations in histological evaluation. In practice, both methods can be used to evaluate the histocompatibility of medical devices. It is recommended to continue observing the local response at 26 weeks after implantation to reduce The risk of clinical use.