Part 2: Double-ended pen needles - ISO 11608-2

ISO 11608-2 - Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles


This document specifies requirements and test methods for single-use, double-ended, sterile needles intended to be used with some needle-based injection systems (NISs) that use a non-integrated double-ended needle.

The test methods include:

  • Flow rate through the needle
  • Bond between hub and needle tube
  • Dose delivery / dose accuracy
  • Needle removal torque