Test Method for Penetration Testing of Needles for Surgical Sutures

Curved needles are used within the biomedical industry for wound closure procedures. Their curved shape is specifically designed to work with surgical sutures and improve a physician's ability to maneuver the needle. The curved geometry is also optimal for ensuring that an even and consistent tension is applied to the suture during the procedure.
Test At A Glance
Materials:Biomedical
Test Types: Bend, Penetration
Standard: ASTM F3014, ASTM F1874
KEY CONSIDERATIONS FOR TESTING

Penetration testing is key to identifying a needle coating with the ideal balance of lubricity and durability. This ensures that the needle can be used reliably for the minimum number of throws to close a wound. Bend testing can also be used during the material selection process or as an in-process quality control check for manufacturing consistency. A material defect causing the tip of the needle to break could cause undue pain for a patient.
During the manufacturing process, penetration testing primarily serves to ensure that the needle retains its sharpness and that the applied coating is performing as expected, as the lubricity of the coating is a main driver of the penetration force. Since a curved needle will be threaded multiple times in practice, the penetration test must be performed a minimum of 10 times per needle to ensure that coating will not wear out over repeated use, causing an increase in the penetration force. The result will be a maximum penetration force for each run, as well as qualitative evaluation of the coating's durability from penetration force range.