NF EN ISO 11608-3

<p> La présente partie de l'ISO 11608 spécifie les performances et les méthodes d'essai relatives aux cartouches préremplies multidoses à chambre simple servant d'emballages primaires dans les stylos-injecteurs conformes aux spécifications de l'ISO 11608. Elle spécifie la conception et les dimensions relatives aux cartouches de type A. La présente partie de l'ISO 11608 ne s'applique pas aux cartouches multichambres, les cartouches que l'utilisateur remplit lui-même ni les cartouches pour usage dentaire. </p>

<p>This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1.</p> <p>It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated with the NIS at the point of manufacture.</p> <p>This document is also applicable to prefilled syringes (see ISO 11040-8) when used with a NIS (see also scope of ISO 11608-1:2022).</p> <p>This document is not applicable to the following products:</p> <p>—    sterile hypodermic needles;</p> <p>—    sterile hypodermic syringes;</p> <p>—    sterile single-use syringes, with or without needle, for insulin;</p> <p>—    containers that can be refilled multiple times;</p> <p>—    containers intended for dental use;</p> <p>—    catheters or infusion sets that are attached or assembled separately by the user.</p>