DANSK DSF/PREN ISO 11608-2 PDF

This document specifies requirements, test methods and compatibility requirements for singleuse, double-ended, sterile needles used with needle-based injection systems (NISs) that fulfil the specifications of ISO 11608-1. NOTE – Needles provided by the manufacturer integrated into the fluid path or container are covered in ISO 11608-3, and hypodermic needles provided separately are covered in ISO 7864. This document is not applicable to: – needles for dental use; – pre-filled syringe needles; – needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular).