1 Scope

This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608‑1.

It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated with the NIS at the point of manufacture.

This document is also applicable to prefilled syringes (see ISO 11040‑8) when used with a NIS (see also scope of ISO 11608‑1:2022).

This document is not applicable to the following products:

• sterile hypodermic needles;

• sterile hypodermic syringes;

• sterile single-use syringes, with or without needle, for insulin;

• containers that can be refilled multiple times;

• containers intended for dental use;

• catheters or infusion sets that are attached or assembled separately by the user.