scope:

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.