Medical suture needle strength puncture force testerIt is a professional equipment designed according to standards such as YY 0043-2016 "Medical Suture Needles", used to accurately evaluate the needle tip strength and puncture force of suture needles, ensuring that they meet clinical use requirements. The following are the detailed operation steps:

1、 Equipment inspection and calibration

1. Visual inspectionBefore starting up, it is necessary to confirm that the appearance of the equipment is not damaged, all components are firmly connected, and key components such as sensors and fixtures are not loose or abnormal.

2. Power on self-testAfter connecting the power, observe whether the display screen displays data normally and whether the operation buttons are sensitive. If the display screen is abnormal or the buttons are unresponsive, the machine should be stopped immediately for maintenance.

3. Calibration operationCalibrate the instrument using standard needle samples or test materials of known strength. For example, fix the standard needle on the fixture and apply the load at the standard force application speed to ensure that the force measurement accuracy is within the specified range.

2、 Sample preparation and installation

1. Sample selectionAccording to YY 0043-2016 standard, select representative suture needle samples to ensure that the surface is free of defects and burrs, and the needle body is straight. Different specifications and models need to be marked separately.

2. Fixture selectionSelect the appropriate fixture based on the type of suture needle (such as straight needle, curved needle) to ensure a secure grip without damaging the needle tip. For example, an arc-shaped needle requires the use of an arc-shaped fixture to align the needle tip direction with the puncture direction.

3. Sample installationFix the suture needle vertically on the fixture, with a recommended exposed length of 1-3mm to avoid other parts of the needle body touching the test material. Adjust the fixture position to align the axis of the suture needle with the direction of force application.

3、 Parameter setting and testing startup

1. Parameter Settings：

• test speedUsually set at (100 ± 10) mm/min to ensure stable testing process.

• Range of force valuesEstimate the puncture force based on the specifications of the suture needle, set the range reasonably (such as 0-20N), and avoid exceeding the instrument range.

• test modeSelect the "Suture Needle Test" mode and set parameters such as return position.

2. Start testingPress the start button, and the device will drive the suture needle to insert the test material (such as standard test film or simulated tissue) at the set speed. Sensors record changes in force values in real-time, forming force displacement curves.

4、 Data recording and analysis

1. data collectionAfter the needle tip completely penetrates the material, the system automatically records the maximum piercing force value. Repeat the test 3-5 times for each sample and record the data for each test.

2. statistical analysisCalculate the average and standard deviation of multiple tests to evaluate the stability of suture needle strength and puncture force. For example, if the data fluctuates greatly, it is necessary to check the sample uniformity or instrument status.

3. Result determinationCompare the test data with YY 0043-2016 standard to determine if it is qualified. If the piercing force exceeds the standard range, the cause (such as material and process defects) needs to be analyzed.

5、 Equipment maintenance and safety

1. Cleaning and maintenanceAfter the test is completed, clean the fixtures and test platform residue, regularly lubricate the transmission components, and check the sensor sensitivity.

2. safe operationAvoid placing fingers near the fixture area during testing to prevent needle tip breakage and injury. Operators are required to wear protective gloves and goggles.

3. periodic calibrationRegular comprehensive maintenance should be carried out according to the manufacturer's recommendations, such as replacing vulnerable parts and verifying accuracy, to ensure long-term stable operation of the equipment.

By standardizing operations, reliable test data can be obtained, providing scientific basis for quality control of medical suture needles and ensuring clinical safety.