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.