The GB18671 standard for disposable intravenous infusion needles specifies that the flow rate of the infusion needle must reach 80% -125% (nominal outer diameter<1.0mm) or 90% -115% (nominal outer diameter ≥ 1.0mm) of the labeled value under specific pressure conditions. This requirement poses a severe challenge to the accuracy, stability, and compliance of the testing equipment. Below, Shanghai Yingle will provide a detailed introduction:

Product configuration introduction:

This product is mainly used for flow detection of medical devices such as infusion sets, blood transfusion sets, infusion needles, injection needles, catheters, anesthesia filters, etc. The 7-inch K600+core touch screen supports bilingual switching between Chinese and English. The operation interface integrates modules such as nominal specifications, test load, and time settings, achieving a "one click" testing process. Its digital closed-loop control system collects data in real-time at a sampling frequency of 500KHz, coupled with a high-precision clock chip, which can store test records even when power is off, avoiding data loss. In addition, the equipment has overload alarm shutdown protection function, which automatically terminates the test when the pressure or flow exceeds the safe range, ensuring operational safety.

Technical core: precise and efficient

Adopting high-precision pressure sensors and PLC+ARM dual core control system, the main unit is equipped with a 6mm standard trachea and a pressure output range of 2.3. The pressure output range is higher than the local atmospheric pressure, with a pressure output range of 10kPa~100kPa and LCD digital display; The pressure output value can be set arbitrarily, and the verification error is not greater than ± 2.5% of the reading. The test duration is 5 seconds to 99.9 minutes, with LCD digital display and an error of no more than ± 1S. For catheters with a nominal outer diameter less than 1.0 mm, the flow rate should be 80% to 125% of the manufacturer's labeled value, and for catheters with a nominal outer diameter greater than or equal to 1.0 mm, the flow rate should be 90% to 115% of the manufacturer's labeled value

Test execution standards:

GB15811 "Disposable Sterile Injection Needles" and GB18671 "Disposable Intravenous Infusion Needles"

Equipment operation process:

When installing the sample, the selected indwelling needle sample should be securely installed on the flow testing device, with a focus on ensuring a tight connection between the indwelling needle catheter and the testing device to prevent leakage. At the same time, carefully adjust the position of the indwelling needle to allow it to be in a natural straight state, preventing the catheter from bending or twisting and interfering with the flow test results.

The parameter setting process should be based on the testing standards and specifications of the indwelling needle, and reasonable parameters such as testing time and testing pressure should be set on the device. The testing pressure should simulate the normal pressure range of clinical infusion and be tested under static pressure conditions to ensure that the results are in line with reality.

After starting the test, the simulated liquid will pass through the indwelling needle catheter at the set pressure and flow rate. During testing, closely monitor the device display data to ensure stable testing and accurate data. The device will record real-time traffic data and generate a detailed report after the test is completed.

In the data processing stage, the flow data is sorted and analyzed to calculate the actual flow value of each sample. For multiple samples, statistical parameters such as mean and standard deviation need to be calculated to evaluate the flow situation of the entire batch of products. Finally, the actual flow value is compared with the nominal value and judged according to the standard ratio. If it fails, the cause is analyzed and the entire batch of products is processed.

Functional features:

Chinese input, test indicators can be set by oneself, production unit batch number can be entered, and intelligent operation; Software and hardware protection function, overload alarm and shutdown; Power off automatic storage, optional three-level password security protection; Implantable remote control, human-machine dialogue platform; Customized solutions can be provided according to user needs; On board printing or USB export of data, flexible and convenient.

In summary, the GB18671 disposable infusion needle flow tester from Shanghai Yingle Instrument Co., Ltd. is widely used in the factory quality inspection of medical device manufacturing enterprises, type inspection of third-party testing institutions, and research and development verification of scientific research institutions, providing data support for the development of new infusion needles.