Chapter 30: Standards for Injectable Delivery Devices: ISO 11608 Series and Others

  • Robert R. NesbittEmail author
  • Harold K. Yeager
  • Michael J. Roe
  • Niels Hansen
Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 35)


An overview of the international standards which apply to injectable therapeutics, how they have evolved over time, and how they can be utilized in the development of a medication delivery system. It is intended as a road map for new and experienced developers in the application of the ISO 11608 family and other standards, how they relate to other syringe and medical device standards and address electromechanical delivery systems and on-body delivery systems.


Design verification Patient self-administration Pen injector Pen needle Needle-based injection system (NIS) Needle-free Automated functions On-body delivery system (OBDS) 

Copyright information

© American Association of Pharmaceutical Scientists 2020

Authors and Affiliations

  • Robert R. Nesbitt
    • 1
    Email author
  • Harold K. Yeager
    • 2
  • Michael J. Roe
    • 3
  • Niels Hansen
    • 4
  1. 1.Combination Product DevelopmentAbbVie, Inc.North ChicagoUSA
  2. 2.Yeager Device Solutions, LLCIndianapolisUSA
  3. 3.Kaléo PharmaRichmondUSA
  4. 4.Strategic DevelopmentNovo NordiskHillerodDenmark

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