Part 3: Containers and integrated fluid paths - ISO 11608-3

ISO 11608-3 - Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths


This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs). It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated with the NIS at the point of manufacture.

The test methods include:

  • Resealability for multi-dose cartridges or reservoirs
  • Fragmentation (disc coring) – cartridges or reservoirs
  • Sub-visible particulates
  • Visible particulates