BS EN ISO 11608-2. Needle-based injection systems for medical use. Requirements and test methods Part 2. Double-ended needles
|Standard number:||20/30381877 DC|
|Status:||Draft for Comment|
This standard 20/30381877 DC BS EN ISO 11608-2. Needle-based injection systems for medical use. Requirements and test methods is classified in these ICS categories:
- 11.040.25 Syringes, needles and catheters
This document specifies requirements, test methods and compatibility requirements for single-use, double-ended, sterile needles used with needle-based injection systems (NISs) that fulfil the specifications of ISO 11608-1.
Needles provided by the manufacturer integrated into the fluid path or container are covered in ISO 11608-3, and hypodermic needles provided separately are covered in ISO 7864.
This document is not applicable to:
needles for dental use;
pre-filled syringe needles;
needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular).