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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.