Syringe Needle Testing
Standard At A Glance
- ISO 9626
- ISO 7864
- ASTM F3014
- ISO 11040
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:
Materials Testing System
Syringe needle testing should be performed on a low force universal testing system such as Instron's 68SC-1 with Bluehill Universal software. Penetration forces are less than 10 N but for all other tests 100 N capacity is appropriate. ISO 11608-2 testing requires Torsion Add-On 3.0. For ISO 9626, custom test fixtures are required (bend fixture and cantilever bend fixture). When testing the needle hub bond strength, proper alignment is required between the hub and the needle. Any angular or concentric misalignment can cause additional force to be required for the needle removal.
|ISO 11040 Test Setup|
|1)||6800 Series Universal Testing System
|2)||Bluehill Universal Software
|3)||2527 Series Load Cell
|4)||Torsion Add-On 3.0
|5)||CP132121 Modular Test Fixture
Instron 6800 Series Universal Testing Systems provide unparalleled accuracy and reliability. Built on a patent-pending Operator Protect system architecture with an all-new Smart-Close Air Kit and Collision Mitigation features, the 6800 Series makes materials testing simpler, smarter, and safer than ever before.
Bluehill Universal Software is built from the ground-up for touch interaction and an intuitive user experience. Discover simpler and smarter testing with features such as pre-loaded test methods, QuickTest in seconds, enhanced data exporting: and Instron Connect – a new feature that provides a direct communication link to Service. Users of previous versions of software such as Bluehill 2 and Bluehill 3 can easily upgrade to the newest version of Bluehill.
Torsion Add-On 3.0 offers a simple solution for characterizing the performance of medical devices, electronics, consumer products, packaging, and automotive components that require both axial and torsional testing.