DANSK DSF/PREN ISO 11608-3 PDF

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.