Test method for steel property of medical stainless steel needle tube

I purpose of testing the steel property of medical stainless steel needle tube: Medical stainless steel syringe is a kind of widely used medical device Through a long-term clinical investigation and Discussion on syringes, especially disposable sterile syringes, the author believes that the three principles of injection safety organized by who are the upper principles that disposable sterile syringes should follow, while disposable sterile syringes that only meet the upper principles cannot As a device, it should not only meet the upper principle of safety, but also meet the different requirements and principles of social responsibility, medical institutions and manufacturers Therefore, the State Food and Drug Administration will strengthen the quality management of medical stainless steel needle tubes In the process of injection, the rigid straight stainless steel needle tube for the medical devices with unqualified steel has the risk of fracture, causing secondary injury to the patients In addition, the national standard GB 18457-2015 also requires rigid straight stainless steel needle tubes for medical devices to be tested for steel Medical stainless steel needle and tube steel tester II Reference standard for medical stainless steel needle and tube steel test: GB 18457-2015 "manufacturing stainless steel needle for medical machinery" specifies the measurement of deflection value of injection needle and tube used in skin, subcutaneous, muscle and vein of human body and other rigid stainless steel needle and tube used in medical devices III medical stainless steel needle and tube steel testing equipment: medical stainless steel needle and tube steel tester gxy-02, which meets the requirements of GB 18457-2015 standard, and can detect the steel properties of injection steel needles in normal wall, thin wall and ultra-thin wall quickly and easily IV steel detection method of medical stainless steel needle tube: 1 Take a proper amount of infusion needle separated from plastic needle tube, place a rigid test instrument [it can act on the needle tube vertically downward through the force of the force applying push rod Zui up to 60N (accuracy: ± 0.1N)) 2 Prepare for the commissioning of the medical needle tube rigidity tester The lower end of the force applying push rod is composed of a mold with an angle of 60 ° and a cylindrical surface with a radius of curvature of 1 mm The width of the push rod is at least 5 mm The displacement measurement error of the instrument is shown in Figure 1] Adjust the needle tube and rigidity tester according to the following requirements: 1) make the span corresponding to the specification of the needle tube measured in Table 1; 2) make the end surface of the force application push rod at the center of the span; 3) keep the needle tube perpendicular to the two needle holders and the force application push rod, and make the center line of the needle tube coincide with the center line of the needle holder 3 Carry out the test according to the span and load conditions specified in Table 1: according to the stress corresponding to the specification of the needle tube in Table 1, apply the bending force to the needle tube downward through the force applying push rod at the rate of LMM / min 4 Measure and record the deflection of the needle tube at the force application point to 0.01mm The infusion needle shall have good rigidity and Zui large deflection shall meet the requirements The medical stainless steel needle tube steel tester is the reference GB of Jinan Sanquan Zhongshi Experimental Instrument Co., Ltd 18457-2015 "manufacturing stainless steel needle for medical machinery" standard R & D and production, can detect infusion needle, pre filling, injection needle, blood sampling needle, puncture needle and other rigid straight stainless steel needle tube steel test, the equipment is widely used in quality inspection institute, drug inspection institute, pharmaceutical factory, third-party inspection agency, etc.