EN ISO 11608-2:2012
Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012)

Standard No.

EN ISO 11608-2:2012

Release Date

2012

Published By

European Committee for Standardization (CEN)

Status

Be replaced 2022-08

Replace By

EN ISO 11608-2:2022

Latest

EN ISO 11608-2:2022

Scope

This part of ISO 11608 specifies requirements and test methods for single-use, double-ended, sterile needlesfor 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.

EN ISO 11608-2:2012 history

• 2022 EN ISO 11608-2:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles (ISO 11608-2:2022)
• 2012 EN ISO 11608-2:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012)
• 2000 EN ISO 11608-2:2000 Pen-Injectors for Medical Use - Part 2: Needles - Requirements and Test Methods ISO 11608-2: 2000