Corrected version 2023-01

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.