DIN EN ISO 11608-2:2012-12

ISO 11608-2 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. The standard is not applicable to needles for dental use, pre-filled syringe needles, needles pre-assembled by the manufacturer and needles not requiring assembly or attachment to the NIS. The underlying standard ISO 11608-2:2012 has been prepared by Technical Committee ISO/TC 84 "Devices for administration of medicinal products and intravascular catheters" in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices" with the collaboration of German experts. At DIN, the German Institute for Standardization e. V., the responsible committee is Working Committee NA 063-02-01 AA "Injektionssysteme" ("Injection systems") at the Medical Standards Committee (NAMed).