ISO 11608-3:2012 PDF

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 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

ISO 11608-3:2012 Referenced Document

ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
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*， 2022-04-07 Update
ISO 13926-1:2004 Pen systems - Part 1: Glass cylinders for pen-injectors for medical use

2022 ISO 11608-3:2022 Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths
2012 ISO 11608-3:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers
2000 ISO 11608-3:2000 Pen-injectors for medical use - Part 3: Finished cartridges; Requirements and test methods