In accordance with ISO 11608-1, this document describes the specifications and test procedures for design verification of containers and integrated fluid routes used with Needle-Based Injection Systems (NISs).
It is applicable to single-dose and multiple-dose containers that are filled at the point of production by the manufacturer (primary container closure) or by the end user (reservoir) (such as cartridges and syringes). It also applies to fluid routes that are integrated with the NIS.
When used with a NIS, this document is also relevant to prefilled syringes (see ISO 11040-8; also see the application of ISO 11608-1:2022).
Sterile hypodermic needles, sterile hypodermic syringes, sterile single-use insulin syringes with or without needles, refillable containers, dental-use containers, and catheters or infusion sets that the user attaches or assembles independently are not covered by this document.
Drug administration, Containers, Dimensions, Parenteral infusion equipment, Injection guns, Medical instruments, Measuring cylinders, Leak tests, Design, Injection instruments, Performance, Medical equipment, Performance testing, Syringes
