ISO 11608-1

Smithers Pira tests needle-based injection systems (NISs) to ISO 11608-1, assessing their functional performance against the various tests specified in this standard series.

Standard name: Needle-based injection systems for medical use -- Requirements and test methods -- Part 1: Needle-based injection systems (ISO 11608-1:2015)

Applicable medical devices:

This standard applies to systems intended for use with needles and either replaceable or non-replaceable containers. The containers covered by the standard can be single or multi-dose syringe-based and cartridge-based systems – filled either by the manufacturer or by the user.

Testing capabilities to ISO 11608-1 include:

  • Dose accuracy as defined by design specifications of the NIS
  • Preparation and operation of needle-based injection systems
  • Cool, standard and warm atmosphere testing
  • Last dose accuracy
  • Life-cycle testing
  • Free-fall testing
  • Dry-heat and cold-storage testing
  • Damp-heat testing
  • Cyclical testing
  • Vibration testing
  • Visual Inspection of NIS and container
  • Flow rate through the needle
  • Bond between hub and needle tube
  • Ease of assembly with containers and needles
  • Automated function – needle hiding and shielding, insertion distance, retraction and minimum overriding forces

Other ISO 11608 Sections include:

  • ISO 11608-2: 2012 Needles
  • ISO 11608-3: 2012 Finished containers
  • ISO 11608-4: 2007 Electronic and electromechanical pen-injectors
  • ISO 11608-5: 2012 Automated functions

Part 2, 3 and 5 of ISO 11608 series specifies common test methods to support performance requirements for sterile double-ended needles and containers intended for use in conjunction with needle-based injection systems and the automated function of NISs.

Bespoke Testing

In many instances, testing requirements are beyond the test method parameters set out in a standard. Alongside our standard testing services, our expert team is able to develop a custom testing programme to meet your specific testing requirements and resolve and design or functionality issues you might have.

Please note: The information outlined above is to be used as a reference. Please refer to the appropiate competent standards agency in your country for full details and implementation of EN ISO 11608-1:2015.

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