ISO 11608-3  Needle Based Injection System Testing

ISO 11608-3 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 enduser integrated in the

NIS or assembled with the NIS at the time of use.

It 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.

*** It  is not applicable to cartridges intended for dental use.

*** Before conducting this ISO standard  , it is important to read the entire specification. Standards can be obtained from appropriate standard authorities.