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)

General information

60.60 Standard published   May 4, 2022


CEN/TC 205 Non-active medical devices

European Norm

11.040.25   Syringes, needles and catheters


This document specifies requirements and test methods for single-use, double-ended, sterile needles intended to be used with some needle-based injection systems (NISs) that use a non-integrated double-ended needle according to ISO 11608-1.
This document is not applicable to the following:
—    needles for dental use;
—    pre-attached syringe needles;
—    hypodermic needles;
—    needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular);
—    materials that form the medicinal product contact surfaces of the primary container closure.
However, while this document is not intended to directly apply to these needle products, it does contain requirements and tests methods that can be used to help design and evaluate them.
NOTE       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.

Life cycle


EN ISO 11608-2:2012


EN ISO 11608-2:2022
60.60 Standard published
May 4, 2022