ISO 7886-1 Testing Sterile Hypodermic Syringes
The ISO 7886-1 standard regulates the mechanical properties of hypodermic syringes and outlines the specifications for single use hypodermic syringes. It also includes information related to the design, manufacture, and functionality of the devices, while the annexes of the standard describe the standard operating procedure for testing these devices. Whereas ISO 7886-1:1993 discusses mechanical testing in annex G, the newer version of the standard, ISO 7886-1:2017 discusses it in annexes D and E.
Annex D measures the quality of the plunger stopper seal by simultaneously applying a perpendicular force to the syringe barrel and maintaining a constant compressive force on the syringe piston. A visual check is performed to ensure that no liquid escapes past the plunger stopper seal. This annex is less commonly tested than Annex E, which measures the forces needed to operate the syringe plunger with water in the barrel. The force profile typically displays an initial peak force known as the break loose force, and an average force of the remaining plunger travel, known as the glide force. This test also requires the recording of maximum force during plunger travel excluding the break loose force.
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