We provide testing for ISO 11608, Needle-Based Injection Systems for Medical Use. It specifies testing for needle-based injection systems (NISs) intended to be used with replaceable or nonreplaceable containers. Our testing covers the following parts:

  • Part 1: Needle-based injection systems
  • Part 2: Needles
  • Part 3: Finished containers
  • Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
  • Part 5: Automated functions

For general-use injectors, the FDA recommends that the final ejector for marketing undergo performance testing. At this time, the characteristics of the drugs and biological products to be used in the injector in their final approved dosing form should be taken into account. In addition to ISO 11608 testing, our experts provide complementary testing for drug delivery and combination products, such as container integrity closure (CCI) and package and distribution testing.

We provide many different syringe-testing services to ensure your product is ready for submission to the appropriate regulatory agency. ISO 7886 and ISO 8537 are two of the major syringe-testing standards.

Our experts measure the force to operate, freedom from air and liquid leakage and many other tests. We provide testing services to meet the following standards:

  • ISO 7886: Sterile Hypodermic Syringes for Single Use
  • ISO 8537: Sterile Single-Use Syringes (with or without needle, for insulin)
  • ISO 594-1: Conical Fittings With 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment – Part 1: General Requirements
  • ISO 594-2: Conical Fittings With 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment – Part 2: Lock Fittings

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