目的:银针和不锈钢针的生物安全性进行评价,为蒙医针的发展和推广提供科学依据和技术支持。方法:实验参照医疗器械生物学评价系列标准,其中银针与不锈钢针浸提液的提取标准参照《医疗器械生物学评价 第12部分:样品制备与参照材料》(GB/T 16886.12-2023),皮外和皮下的致敏实验参照《医疗器械生物学评价 第10部分:刺激与皮肤致敏试验》(GB/T 16886.10-2017),血液相容性实验参照《医疗器械生物学评价 第4部分:与血液相互作用试验选择》(GB/T 16886.4-2022)。本研究采用皮外和皮下的致敏实验以及血液相容性实验,分别评价银针和不锈钢针的生物安全性。实验动物为雄性SD大鼠,实验针具为银针和不锈钢针,实验溶剂为针具浸提液和生理盐水。实验观察大鼠的一般指标和局部指标以及血液相容性指标。结果:银针和不锈钢针在皮外和皮下致敏实验中均未引起大鼠的明显过敏反应,也未影响大鼠的一般指标和局部指标。银针和不锈钢针在血液相容性实验中均未引起大鼠的血液凝固、溶血和血小板聚集等异常现象。结论:银针和不锈钢针具有良好的生物相容性和生物学效应,对人体无明显的不良影响,适用于蒙医医疗过程中的使用。

Objective: This article evaluates the biological safety of silver and stainless steel needles,which are used in Mongolian medicine.It provides scientific and technical support for their development and promotion. Methods: The experimental method followed the series of standards for biological evaluation of medical devices.Among them,Extraction standards for silver needle and stainless steel needle extracts followed the《Biological evaluation of medical devices - Part 12: Sample preparation and reference materials》(GB/T 16886.12-2023),Reference for extra-dermal and subcutaneous sensitization experiments followed the 《Biological evaluation of medical devices - Part 10: Irritation and skin sensitization tests》(GB/T 16886.10-2017),Blood compatibility test followed the《Biological evaluation of medical devices - Part 4: Selection of blood interaction tests》(GB/T 16886.4-2022),In this study, dermal and subcutaneous sensitization tests as well as blood compatibility tests were adopted to evaluate the biosafety of silver needles and stainless steel needles respectively.Male SD rats were used as experimental animals.The experimental needles were silver and stainless steel needles.The experimental solvent was needle extract and physiological saline.The general and local indicators,and the blood compatibility indicators of rats were observed in the experiment. Results: Silver and stainless steel needles did not cause obvious allergic reactions in rats in extracutaneous and subcutaneous sensitisation experiments,and did not affect the general and local indexes of rats.Silver and stainless steel needles did not cause any abnormalities such as blood coagulation,haemolysis and platelet aggregation in rats in the blood compatibility test. Conclusion: Silver and stainless steel needles are biocompatible and biologically effective,and have no significant adverse effects on the human body.They are suitable for Mongolian medical processes.