Ehdotuksen tiedot

This document specifies requirements for empty, sterile, single-use syringe, and needles attached or not to the syringe, intended solely for the withdrawal and injection of fluids of a drug or a substance into an eye or its tissues or into an ocular implantable device. It covers devices intended for single use only that comprises, but not limited to, configurations of co-packaged devices, device kits, syringe with fixed needle, transfer needle, and injection needle, with or without a filter membrane. The syringes are intended to be used immediately after filling and are not intended to store the drug or the substance. This document does not preclude the use of platform delivery systems validated for multiple ophthalmic clinical indications, provided that the device complies with all specific provisions of this standard for its intended intraocular use-case. This document does not specify materials to be used for the construction and lubrication of sterile syringes and needles intended for ophthalmic use because their selection will depend, to some extent, upon the manufacturer’s specific design, process of manufacture, and sterilization method. This document excludes any other application other than ophthalmic tissue injections and excludes syringes which are pre-filled, e.g. pre-filled syringes are covered within ISO 11040 series. Non-invasive route of administration and its drug delivery type of devices like eye droppers or contact lenses are not considered as an injection and therefore out of scope of this document.