Part 5: Automated functions - ISO 11608-5

Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions


This ISO 11608-5 standard specifies requirements and test methods for the automated functions of needle-based injection systems with automated functions (NIS-AUTO), for the administration of medicinal products in humans. Functions to be tested may be:

  • needle preparation
  • air removal
  • priming
  • dose setting
  • actuation
  • needle insertion
  • injection of the medicinal product
  • disabling the NIS-AUTO
  • needle retraction
  • needle shielding
  • needle hiding
  • needle removal