BS EN ISO 11608-2:2012 PDF

1   Scope This part of ISO 11608 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. It is not applicable to:

— needles for dental use;

— pre-filled syringe needles;

— needles pre-assembled by the manufacturer;

— needles not requiring assembly or attachment to the NIS .