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.