The GB 15810-2019 - One-time Use Sterile Syringe standard specifies the naming, physical requirements, chemical requirements, biological requirements for packaging, marking, storage, etc. of disposable sterile syringes.
Test method for leakage at the piston or sealing ring and separation of the piston and mandrel when the syringe is pumped under negative pressure.
FY15810-C Syringe Fit Negative Pressure Tester.
Test principle. Connect the syringe cone to the device, and aspirate the water in the syringe. Apply negative pressure through the cone to check for leaks at the syringe piston and seal and determine if the piston has detached from the mandrel rod.
d.2 Instruments and reagents.
d.2.1. A clamp capable of clamping the device of the syringe mandrel and fixing its position.
d.2.2. Vacuum pump, as shown in Figure D1 shown, including vacuum pump with air valve, pressure gauge and vacuum seal valve.
d.2.3 Freshly brewed boiling water, cooled to 18 28.
d.Step 3.
d.3.1. The syringe sucks not less than 25% of the nominal capacity of water (d.).2.3)d.3.2 cone head up, back to the core rod, so that the reference line coincides with the nominal capacity scale line, and then in Figure D1. The position shown is to install the person fixture (d.).2.1)。d.3.3. Combine the syringe cone with a vacuum pump (D.).2.2) Connected.
d.3.4 as shown in Figure D1. The test equipment is arranged. Start the vacuum pump while keeping the air valve open3.5. Adjust the air valve to gradually reduce the pressure so that the pressure gauge reading reaches 88kpa.
Note: Due to the difference between the atmospheric pressure in the plateau area and the standard atmospheric pressure, the test force conversion example is as follows: a standard atmospheric pressure is 1013kpa, the atmospheric pressure in Lhasa is 6524kPa, the difference from a standard atmosphere is 3606kpa, then the test pressure should be set to 88 kpa-3606 kpa=51.94 kpa.
d.3.6. Check whether there is air leakage at the piston and sealing ring of the syringe, and there should be no continuous bubble formation.
d.3.7. Close the vacuum seal valve.
d.3.After 8 (60+) s, observe the pressure gauge readings and record any drops in readings d3.9. Check whether the piston of the syringe has been detached from the core rod.
d.4 Test report.
At least the following information is given in the test report: the nominal volume of the syringe, milliliters (ml); whether leaks at the piston and seals have been observed; If there is a leak, the reading after the pressure gauge is lowered: whether the piston has detached from the mandrel;
Date of the trial. FY15810-C Syringe Fit Negative Pressure Tester is developed according to GB 15810-2019 Disposable Sterile Syringes, which is specially designed to determine the physical properties of syringes.
The instrument has non-standard customization characteristics, can expand a variety of test items, can be controlled by touch screen, a variety of specifications, compatible with one machine, automatic generation of test reports, on-board printer, and rapid printing of test results.
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