There are multiple testing standards outlining methods for evaluating straight stainless steel needles used in healthcare applications. These standards are used by injection device manufacturers and the pharmaceutical companies that use them for drug delivery. Testing standards for syringe needles are necessary in order to regulate the products that reach the healthcare frontlines. They are critical for ensuring that sharps injuries are prevented and that injection doses can be delivered successfully. Failure can result in injury to the patient or the healthcare professional administering the drug. Failure can also cause an incorrect dosage to be administered to the patient, which leads to additional adverse effects. There are a number of testing standards that follow the raw material through the entire product development process:
ISO 9626
ISO 9626 is typically the first standard referenced, as it defines the mechanical properties requires for stainless steel tubing intended to be manufactured into needles. This standard includes methods to assess the strength and durability of the steel tubing to ensure it meets the requirements necessary for the end product. The required forces are dependent on the needle gauge and wall thickness, two factors that will dictate which application the needle will be used for. Testing is performed using a three-point bending assembly to determine the stiffness of the material. Additionally, a cantilever bend test is performed to assess the tubing's ability to withstand breakage. This test is critical to ensure the needle can withstand the shearing forces it may encounter in clinical environments.
ISO 7864
After the raw tubing has proven it meets the required specifications, it is
further machined to have a beveled fine point and mated with a hub to ultimately attach to medical devices. ISO 7864 tests the finished component, evaluating the penetration force of the needle tip as well as the bonding strength between the needle and the hub. The substrate choice for penetration is critical in gathering valid data from the test, and ensuring the substrate layer is taught prior to testing is also very important for getting repeatable results. The standard explicitly outlines the options available for testing.
