The single-use sterile syringe is a medical device commonly used in clinical treatment for the aspiration and injection of fluids. International and national regulations set strict, explicit rules for this product, requiring rigorous testing of the seal integrity of single-use sterile syringes to ensure product quality and medication safety.
Seal Integrity Test Methods:
- Positive Pressure Method: Draw water up to the nominal capacity into the syringe. Apply axial and lateral pressure as specified in the standard to the plunger rod for 30 seconds; there shall be no leakage at the contact area between the barrel and the piston.
- Negative Pressure Method: Maintain a negative pressure of 88 kPa for 60 seconds (±5 seconds). No leakage shall occur at the contact interface between the barrel and the gasket, and the piston must not detach from the plunger rod.
The Labthink C610M Tensile Tester is a multi-functional testing instrument designed precisely to evaluate syringes and needles to ISO 7886-1 (syringes) and ISO7864 (needles). It integrates the mechanical tests required for quality control and regulatory compliance:
- Seal Integrity Test: Performs positive pressure tests to verify that the barrel-piston seal and plunger assembly prevent leakage under stress.
- Sliding Performance: Measures the force required to move the piston smoothly within the barrel during aspiration and injection.
- Puncture & Separation Forces: Evaluates needle tip puncture force, needle hub-to-tubing connection strength, and shield pull-off/detachment force.
Seal Integrity Testing Workflow:
- Prepare the test specimens according to relevant standards, fill the syringe with water, expel any residual air, attach the needle protective cap to block the needle, and adjust the fixtures to mount the test specimen.
- In the test type selection box, choose "Seal Integrity" test, and set the corresponding test parameters and specimen parameters.
- Click "Start Test" and observe the specimen; no leakage should be observed at the needle hub or behind the piston.
- After a single test is completed, the upper grip automatically returns to its initial position, the system calculates the result, and the interface prepares for the next specimen. Once all specimens have been tested, click "Generate Results."
Negative Pressure Method Air Leakage Test
The Labthink C660B Leak Tester is designed to execute the negative pressure method (vacuum decay/immersion method) for seal integrity testing to ISO7886-1. By submerging the syringe in water inside a vacuum chamber and drawing a specified negative pressure (such as the 88 kPa requirement mentioned in standard regulations), any micro-leaks in the barrel or piston seal become immediately visible as escaping bubbles, ensuring that the syringe remains completely airtight and structurally secure under suction.
