ISO DIS 11608-5

Description / Abstract: This standard specifies requirements and test methods for the following needle-based injection systems with automated functions (referred to in the standard as NIS-AUTO), for the administration of medicinal products in humans:

— drug product preparation (e.g. reconstitution)

— needle preparation

— air removal

— priming

— dose setting

— actuation

— needle insertion

— injection of the medicinal product

— needle retraction

— disabling the NIS-AUTO

— needle shielding or hiding

— sharps injury protection

NOTE The NIS-AUTO may provide an automated function (whether active or passive per the definition in ISO 23908) that is designed to minimize the risks of accidental sharps injury, which is distinct from needle shielding or hiding. In order to make the claim of sharps injury protection, the NIS-AUTO must also meet the requirements of ISO 23908.

— needle removal.

This standard will reference as appropriate and not duplicate requirements and test methods in ISO 11608 (all parts), ISO 8537, ISO 7886 and ISO 23908.