BS EN ISO-11608-1  Needle-based Injection Systems Test Machine

BS EN ISO-11608-2  

BS EN ISO-11608-3  

BS EN ISO-11608-4

BS EN ISO-11608-5  

BS EN ISO-11608-7 

• BS EN ISO-11608-3 – Needle-based injection systems for medical use. Requirements and test methods. Finished containers. Push-off / Push-out
• ISO 11608 consists of the following parts, under the general title Needle-based injection systems for medical use — Requirements and test methods:

  • — Part 1: Needle-based injection systems
  • — Part 2: Needles
  • — Part 3: Finished containers
  • — Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
  • — Part 5: Automated function

  1   Scope

  This part of ISO 11608 specifies the functional and design considerations for containers to be used with needle-based injection systems (NIS) that fulfil the specifications of ISO 11608-1. It is applicable to single and multi-dose containers (either filled by the manufacturer or by the end-user) which can be provided to the end-user integrated in the NIS or assembled with the NIS at the time of use.

  This part of ISO 11608 includes specifications and test methods to describe and evaluate cartridges for use in NIS with pen needles (as defined in ISO 11608-2) and outlines design considerations for other potential containers, including syringes to be used with a NIS.

  This part of ISO 11608 is not applicable to cartridges intended for dental use.

  Syringes and needles that are sold separately and not intended for use in a NIS are outside the scope of this part of ISO 11608.

  NOTE See ISO 7864 (needles), ISO 8537 (insulin syringes) and ISO 7886-1 (manual syringes).

  2   Normative references

  The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

  • ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
  • ISO 11040-3, Prefilled syringes — Part 3: Seals for dental local anaesthetic cartridges
  • 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 13926-1:2004, Pen systems — Part 1: Glass cylinders for pen-injectors for medical us