ISO 7886-1 Testing Sterile Hypodermic Syringes

ISO 7886-1 specifies the test conditions for testing the aspiration and injection of fluids using sterile single-use hypodermic syringes. Annex E (2017) and Annex G (1993) specify the conditions for determining the forces required to operate the plunger.

For this test, we used our ISO 7886-1 compliant syringe fixture, which consists of a plunger holder, a syringe holder, and a reservoir table, with a universal testing system. First, water is extracted from the reservoir that is placed on the syringe test fixture. Then the machine applies a compressive force to the syringe to expel the fluid back into the reservoir. Some of the common calculations performed as a result of this test are: the force required to initiate movement of the plunger, the mean force to return the plunger, and the minimum and maximum forces during the return of the plunger.

Since syringes have different physical dimensions, plunger arrangements, and plunger geometries, our syringe fixture is highly adaptable and can accommodate syringes ranging from 5 - 35 mm in diameter. We recommend using Bluehill^® Software, equipped with the Test profiler module, to accurately run the test, perform the necessary calculations, and generate a report compliant with ISO 7886-1.

We recommend that you review ISO 7886-1 in its entirety to understand the full requirements prior to performing any testing.