ISO/TC 84/WG 3 - Needle-based injection systems - Injector, container and pen needle

ISO 11608-1:2014 specifies requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers. Containers covered in ISO 11608-1:2014 include single- and multi-dose syringe-based and cartridge-based systems, filled either by the manufacturer or by the end-user.

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 enduser 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).

ISO 11608-2:2012 specifies requirements and test methods for single-use, double-ended, sterile needles for needle-based injection systems (NISs) that fulfil the specifications of ISO 11608-1.

ISO 11608-4:2006 specifies requirements and test methods for electromechanically driven injectors intended to be used with needles and with replaceable or non-replaceable cartridges. The injector may be for single-use or multiple-use. The injector system is intended to deliver medication to an end-user by self-administration or with assistance.

ISO 8537:2007 specifies requirements and test methods for sterile syringes, with or without needles, solely for the injection of insulin. The syringes are single-use only, primarily for use in humans. It covers syringes for use with 40 units of insulin/ml (U-40) and 100 units of insulin/ml (U-100). Sterile syringes specified in ISO 8537:2007 are intended for use soon after filling as they are not suitable for containing insulin over extended periods of time.

Specifies requirements and test methods for syringes. Applies to syringes for use with 40 units of insulin/ml (U-40) and 100 units of insulin/ml (U-100). Annexes A, B, C, D, E, F and G forms an integral part of this standard. Annexes H and J are for information only.