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