BS EN ISO 11608-2:2012

Needle-based injection systems for medical use. Requirements and test methods. Needles | Status: Superseded, Withdrawn

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.