ISO 11608-1 Needle-based injection systems for medical use -- Requirements and test methods -- Part 1: Needle-based injection systems, provides study design parameters for deliverable volume measurement for most types of pre-filled or cartridge drug delivery devices. The systems are categorised according to single dose, fixed dose, adjustable dose and whether or not cartridges can be replaced. The sequence of dosing and pre-conditioning requirements vary according to the product specification. It also gives detailed information on the statistical analysis of dosing results.

The ISO 11040 standard series forms a complimentary range of requirements without the emphasis on dose volume accuracy.

ISO 11608 gives parameters for examining:

•   Automated functions (anti needle-stick activation)
•   Biological safety
•   Determination of dose accuracy
  • Preconditions
    • Dry heat
    • Cold storage
    • Cyclic atmosphere
    • Free fall
    • Vibration
  •   Testing conditions
    • Cool
    • Hot
    • Last dose
    • Life cycle (maximum number of activations)
    • Standard
•   Needle performance
  • Bond strength
  • Dimensions
  • Dislocation
  • Ease of assembly / disassembly
  • Flow rate
  • Freedom from defects
  • Lubrication
  • Needle points
  • Patency
  • Unscrewing torque
• Packaging
  • Stability
  • Transit
• Sterility

There is FDA Guidance for pen, jet and related injectors. It also adds performance requirements for:

• Accuracy of marking
• Actuation, assembly, and disassembly forces
• Analysis of leachables arising from the interaction between the drug/biological product and injector
• Analysis of extractables from the injector components using solvents under laboratory conditions and providing the extraction profiles
• Analysis of adsorption of drugs/biological products (including preservatives) onto injector components
• Analysis of head-space volatile compounds when the injector is the primary containment closure for the drug/biologic
• Analysis of drug-injector interaction over time for re-useable injectors
• Analysis of functional materials corrosion from contact with the drug/biologic product.
• Anti-needle-stick performance and force to overcome
• Compliance with ISO 7886-1: Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use and ISO 21649: Needle-Free Injectors for Medical Use - Requirements and Test
• Methods
• Coring
• Depth and duration of injection and also injection force
• Effect of needle deflection
• Human factors
• Shelf life / stability
  • Dose accuracy
  • Drug formulation
  • Freedom from defects
  • Integrity of components
  • Maintenance of sterility
• Sterility maintenance following transit, following ASTM D4169

Many of these characteristics are described in other standards, some of which are listed here.

The full list of components of ISO 11608 is:

ISO 11608-1: Needle-based injection systems for medical use -- Requirements and test methods -- Part 1: Needle-based injection systems

ISO 11608-2: Needle-based injection systems for medical use -- Requirements and test methods -- Part 2: Needles

ISO 11608-3: Needle-based injection systems for medical use -- Requirements and test methods -- Part 3: Finished containers

ISO 11608-4: Pen-injectors for medical use -- Part 4: Requirements and test methods for electronic and electromechanical pen-injectors

ISO 11608-5: Needle-based injection systems for medical use -- Requirements and test methods -- Part 5: Automated functions

ISO 11608-7: Needle-based injection systems for medical use -- Requirements and test methods -- Part 7: Accessibility for persons with visual impairment

MET delivers design validation services (often with ISO 17025 accreditation) for all of these standards and methods.

Contact us about your project, you will find us really helpful.