Standard name: Needle-based injection systems for medical use — Requirements and test methods — Part 6: On-body delivery

Applicable medical devices:

This standard applies to on-body delivery systems (OBDS) which are applied onto the body for single patient use, intended for subcutaneous, intramuscular or intradermal delivery of a discrete volume (bolus) of medicinal product, through needles or soft cannulas, incorporating pre-filled or user-filled, replaceable or non-replaceable containers.

Testing capabilities to ISO 11608-6 include:

  • Systems comprising rigid needles
  • Systems comprising a soft cannula(s)
  • Leakage from the OBDS
  • Means of attachment for body-worn OBDS
  • Occlusion
  • Functional performance requirements and test methods
  • Dosing requirements and methods
  • Sharps injury protection
  • Automated functions
  • Injection depth and needle extension
  • Biological requirements of the OBDS
  • Sterility of OBDS
  • Biocompatibility
  • Medicinal product compatibility
  • Particulates
  • Pyrogenicity
  • Extractables and leachables
  • Electrical safety and software requirements

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.

Custom 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 program 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 appropriate competent standards agency in your country for full details and implementation of EN ISO 11608-6.

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