ISO/AWI 11194

Single-use syringes and needles — Requirements for ophthalmic use

Scope

This document specifies requirements for empty, sterile, single-use syringe, and needles attached or not to the syringe, intended solely for the aspiration and injection of fluids after filling by the end-users of a drug or a substance into an eye or its tissues. This covers devices intended for single-use only. That comprises, but not only, configuration with co-packaged devices, syringe with fixed needle, transfer needle, and injection needle.

The syringes are intended to be used after filling and are not intended to store the drug or the substance.

This document excludes any other application other than ophthalmic tissue injection and syringes which are pre-filled e.g. pre-filled syringes are covered within ISO 11040 series.

Topical route of administration and the devices accordingly intended to be used for it are not considered as an injection and therefore out of scope of this document.