Objective:To select sterility test method of the disinfection-type medical ultrasound coupling agent and verify the feasibility and effectiveness of the method.Methods:According to the 2020 edition of the Chinese Pharmacopoeia (Part Ⅳ) General Rule 1101 sterility test method,the disinfection-type medical ultrasound coupling agent was taken as the research object,the suitability test of sterility test method was conducted separately using the "direct inoculation" and "membrane filtration after appropriate pretreatment of samples"to determine the suitable sterilization test method for the product.Results:"membrane filtration after appropriate pretreatment of the product"was used for the suitability test of the sterility test method,these test bacteria in the sample control group and the bacterial suspension control group all grew well.In the suitability test of the sterility test method using the direct inoculation method,these test bacteria in the bacterial suspension control group grew well,while some test bacteria in the sample control group did not grow.Conclusion:The pretreatment method combined with the membrane filtration method in this study is suitable for the sterility test of disinfection type medical ultrasound coupling agent.
disinfection-type medical ultrasound coupling agentsterility testmethod verification
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