Needle Penetration Testing

ISO 11040-4 Annex F

The syringes needle penetration test is a crucial procedure in the medical device industry, ensuring the sharpness and effectiveness of needles used in medical applications. This test evaluates the needle penetration force required to pierce a test foil, reflecting the ease with which a needle can penetrate human skin or other materials.

To guarantee patient safety and product reliability, international standards like ISO 11040-4 outline precise testing methodologies for syringe needles. These standards help manufacturers maintain quality control and regulatory compliance.

Needle Penetration Test Equipment Required

According to ISO 11040-4, the following apparatus is essential for conducting a needle penetration test:

Universal tensile and compression testing machine with a measurement range of up to 10 N (or as required) and a test speed between 20 mm/min and 200 mm/min.
Needle holder to secure the needle during testing.
Test foil, with specifications agreed upon by manufacturers and clients.

Syringes Needle Penetration Test Method Procedure

Secure the test foil in a tension-free holder.
Fix the needle perpendicularly in the holder, aligning its tip to the geometric center of the test foil.
Initiate the test and allow the needle to penetrate the foil at a controlled speed.
Record the force-displacement curve to analyze penetration characteristics.
Repeat the test with a fresh section of foil for each measurement.

Higher sampling rates, such as 500 Hz, enhance measurement accuracy when recording peak force values.

Key Needle Penetration Force Parameters in Testing

The force exerted during penetration is categorized into different stages:

Piercing force (F₀): The force required to pass the needle tip through the foil.
Cutting force (F₁): The force used by the cutting edges.
Heel force (F₂): The force exerted when the heel of the needle passes through.
Drag penetration force (F₃): The resistance force after full penetration.

By evaluating these parameters, manufacturers can ensure that needles meet the required sharpness and usability standards.

Compliance with ISO 11040-4 for Quality Assurance

ISO 11040-4 sets forth comprehensive guidelines for testing prefilled syringes, ensuring:

Standardized needle penetration force measurement.
Consistency across different needle and syringe types.
Compliance with global medical safety requirements.
Reduction of risks associated with improper needle penetration.

NPT-01 Needle Penetration Test Equipment

The NPT-01 needle penetration test equipment is designed to meet ISO 11040-4 compliance while offering precise testing solutions. It features:

PLC control and 7-inch HMI touch screen for easy operation.
Stepper motor and precision ball screw ensuring consistent results.
Variable test speeds (1-500mm/min) for flexible testing conditions.
Multiple sample holding jigs to accommodate various needle and syringe types.
Embedded microprinter and RS232 output for efficient data recording.

The syringes needle penetration test is vital for ensuring needle sharpness, patient safety, and regulatory compliance. By following ISO 11040-4 guidelines and using advanced testing equipment like the NPT-01, manufacturers can enhance product quality while meeting industry standards.