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.