Needle Bonding Strength Test
ISO 11040-4 Annex G1
In the medical device industry, especially for prefilled syringes with staked needles, the needle pull-out force test is essential for verifying the bonding integrity between the needle and the syringe. According to ISO 11040-4 Annex G1, this mechanical test is critical to assess the safety, reliability, and regulatory compliance of syringe systems. Proper implementation of this test ensures that needles do not detach under normal or stress-use conditions, which is crucial for both clinical use and patient safety.
Importance of Needle Pull-Out Force
Needle pull-out force refers to the maximum axial force required to detach the needle from a syringe. Poor bonding between needle and hub could lead to detachment during injection, potentially causing injuries, dosage errors, or contamination. This test plays a significant role in validating the needle bonding strength during production, ensuring it meets predefined performance standards under ISO 11040-4.
Test Methods in ISO 11040-4 Annex G1
To carry out the needle pull-out force test properly, manufacturers must follow the ISO 11040-4 Annex G1 procedure. Below is a breakdown of the standardized method.
Test Setup and Equipment Requirements
The core equipment includes a universal tensile and compression testing machine meeting the following conditions:
Load Cell: Max 500 N (or appropriate based on sample strength)
Test Speed: 50 mm/min (recommended default)
Sampling Rate: ≥500 Hz for peak accuracy
Needle Gripper Device: Secure grip without slippage
Syringe Holder: Supports syringe by flange or shoulder
Cell Instruments’ MPT-01 Medical Packaging Tester is an excellent solution for this purpose. Designed for medical packaging and device testing, it provides adjustable test speed, PLC-controlled precision, and configurable clamps tailored for syringe and needle evaluations.
Sample Preparation and Handling
Use sterilized subassembled syringes ready for filling with a staked needle.
Ensure that test samples mirror actual production conditions to maintain result relevance.
Avoid pre-loads before starting the measurement — set the load cell to zero without additional pressure.
Needle Bonding Strength Testing Procedure
Mount the syringe vertically in the test fixture.
Securely grip the needle to prevent slippage.
Set the load cell to zero before applying load.
Start the pull-out test at 50 mm/min.
Continue until the needle detaches or breaks.
Record the force vs. displacement curve.
Note the maximum peak force, which represents the needle pull-out force.
Reporting the Results
According to ISO 11040-4 Annex G1, test report should include:
Maximum force peak (N)
Force vs. displacement graph
Test speed (mm/min)
Sample quantity
Any deviations, observations, or anomalies
For advanced data processing, the MPT-01 supports result visualization, real-time display, and optional RS232 output or microprinter integration.
Our Needle Bonding Strength Tester?
With expertise in medical device and packaging testing, Cell Instruments Co., Ltd. offers tailored solutions for needle pull-out force evaluations. Our MPT-01 tester enables:
High accuracy (0.5% F.S.)
Multi-functionality for pulling and compression tests
Custom fixture designs for syringe and needle configurations
Programmable, repeatable test protocols
Compliance with ISO 11040-4 and other relevant standards
Whether you’re a syringe manufacturer or a quality control specialist, we support your regulatory needs and testing challenges with dependable solutions.
FAQs
This test evaluates the mechanical fixation of the needle to the syringe to ensure it won’t detach during use, maintaining safety and performance standards.
ISO 11040-4, specifically Annex G1, defines the methodology for conducting needle pull-out force tests on staked needle syringes.
The number depends on your internal validation protocols and customer agreements, but multiple samples are recommended for statistical reliability.
A universal testing machine with 500 N capacity, test speed of 50 mm/min, appropriate grippers, and high sampling rate (≥500 Hz) is required.
Yes, the MPT-01 offers customizable fixtures, programmable settings, and automation features tailored for needle bonding strength and other medical device tests.