本文件规定了根据ISO？11608-1对针式注射系统（NISs）使用的容器和集成流体通道进行设计验证的要求和试验方法。 它适用于由制造商（主容器密封）或最终用户（贮存器）（例如药筒、注射器）填充的单剂量和多剂量容器，以及在制造点与NIS集成的流体路径。 当与NIS一起使用时，本文件也适用于预填充注射器（参见ISO？11040-8）（另请参见ISO 11608-1:2022的范围）。 本文件不适用于以下产品: -？无菌皮下注射针； -？无菌皮下注射器； -？用于胰岛素的无菌一次性注射器，带或不带针头； -？可多次重新填充的容器； -？牙科用容器； -？由用户单独连接或组装的导管或输液器。

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. 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. 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). This document is not applicable to the following products: —    sterile hypodermic needles; —    sterile hypodermic syringes; —    sterile single-use syringes, with or without needle, for insulin; —    containers that can be refilled multiple times; —    containers intended for dental use; —    catheters or infusion sets that are attached or assembled separately by the user.