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.