Nålbaserade injektionssystem för medicinsk användning - Krav och provningsmetoder - Del 1: Nålbaserade injektionssystem (ISO 11608-1:2014)
This part of ISO 11608 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 this part of ISO 11608 include single- and multi-dose syringe-based and cartridge-based systems, filled either by the manufacturer or by the end-user.
Additional guidance for NISs equipped with electronic or electromechanical components and NISs equipped with automated functions is given in ISO 11608-4 and ISO 11608-5 respectively.
Needle-free injectors, and requirements relating to methods or equipment associated with end-user filling of containers, are outside the scope of this part of ISO 11608.