UNE-EN ISO 11608-3:2022

This document specifies requirements and test methods for design verification of containers and integrated fluid paths to be used with Needle-Based Injection Systems (NIS) that fulfil the requirements of ISO 11608-1 (and other subparts as appropriate). It is applicable to single and multi-dose containers (either filled by the manufacturer [primary container closure] or by the end-user [reservoir]) and fluid paths that are integrated with the NIS at the point of manufacture.

NOTE Prefilled syringes (ISO 11040-8) are included in the scope when used with a NIS; see also scope of ISO 11608-1:20xx.

Products excluded from scope are:

sterile hypodermic needles for single use;

sterile hypodermic syringes for single use;

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.